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Federal Requirements — All Questions

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Federal Requirements — All Questions

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Federal Requirements: Controlled Substance Rx 0%
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Federal Requirements: Fda Recalls 0%
Federal Requirements: Hazardous Waste Disposal 0%
Federal Requirements: Restricted Drug Programs 0%
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Question 1 of 667

1. Question

Category: Federal Requirements: Controlled Substance Rx

Sarah T. Williams requested and received a DEA number before she got married when she was Sarah T. Cooper. Which is a possible DEA number for her?

BC1234563
Correct Incorrect Correct answer

SW1234563
Correct Incorrect Correct answer

BF1234563
Correct Incorrect Correct answer

FW1234563
Correct Incorrect Correct answer

Correct

Incorrect
Question 2 of 667

2. Question

Category: Federal Requirements: Controlled Substance Rx

For a non-LTCF patient, how long does a pharmacy have to fill the remainder of a partially filled Schedule II prescription?

72 hours
Correct Incorrect Correct answer

24 hours
Correct Incorrect Correct answer

48 hours
Correct Incorrect Correct answer

96 hours
Correct Incorrect Correct answer

Correct

Incorrect
Question 3 of 667

3. Question

Category: Federal Requirements: Controlled Substance Rx

Which law prohibits interstate sales of adulterated or misbranded drugs?

Pure Food and Drug Act of 1906
Correct Incorrect Correct answer

Food Drug and Cosmetic Act of 1938
Correct Incorrect Correct answer

Durham Humphrey Act of 1951
Correct Incorrect Correct answer

Kefauver Harris Act of 1962
Correct Incorrect Correct answer

Correct

Incorrect
Question 4 of 667

4. Question

Category: Federal Requirements: Controlled Substance Rx

Which law requires all drugs to have adequate directions for use?

Durham Humphrey Act of 1951
Correct Incorrect Correct answer

Pure Food and Drug Act of 1906
Correct Incorrect Correct answer

Food Drug and Cosmetic Act of 1938
Correct Incorrect Correct answer

Kefauver Harris Act of 1962
Correct Incorrect Correct answer

Correct

Incorrect
Question 5 of 667

5. Question

Category: Federal Requirements: Controlled Substance Rx

Which law is broken when prescription labels are not put on medication containers?

Food Drug and Cosmetic Act of 1938
Correct Incorrect Correct answer

Pure Food and Drug Act of 1906
Correct Incorrect Correct answer

Durham Humphrey Act of 1951
Correct Incorrect Correct answer

Kefauver Harris Act of 1962
Correct Incorrect Correct answer

Correct

Incorrect
Question 6 of 667

6. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Pure Food and Drug Act of 1906 created for?

To prohibit interstate sales of adulterated or misbranded drugs
Correct Incorrect Correct answer

To define adulteration and misbranding of drugs
Correct Incorrect Correct answer

To require all drugs to have adequate directions for use
Correct Incorrect Correct answer

To require all drugs to be pure, safe, and effective
Correct Incorrect Correct answer

Correct

Incorrect
Question 7 of 667

7. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Food Drug and Cosmetic Act of 1938 created for?

To define adulteration and misbranding of drugs
Correct Incorrect Correct answer

To prohibit interstate sales of adulterated or misbranded drugs
Correct Incorrect Correct answer

To require all drugs to have adequate directions for use
Correct Incorrect Correct answer

To require all drugs to be pure, safe, and effective
Correct Incorrect Correct answer

Correct

Incorrect
Question 8 of 667

8. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Durham Humphrey Act of 1951 created for?

To require all drugs to have adequate directions for use
Correct Incorrect Correct answer

To prohibit interstate sales of adulterated or misbranded drugs
Correct Incorrect Correct answer

To define adulteration and misbranding of drugs
Correct Incorrect Correct answer

To require all drugs to be pure, safe, and effective
Correct Incorrect Correct answer

Correct

Incorrect
Question 9 of 667

9. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Comprehensive Drug Abuse Prevention and Control Act of 1970?

Establishing the controlled substance scheduling system (CSA)
Correct Incorrect Correct answer

To define adulteration and misbranding of drugs
Correct Incorrect Correct answer

To require all drugs to have adequate directions for use
Correct Incorrect Correct answer

To require all drugs to be pure, safe, and effective
Correct Incorrect Correct answer

Correct

Incorrect
Question 10 of 667

10. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Orphan Drug Act of 1983 created for?

To create tax incentives and licensing for the development of medications that treat diseases that affect 200000 or less people in the United States
Correct Incorrect Correct answer

To create NDC numbers for each drug
Correct Incorrect Correct answer

To establish the modern system for generic drugs
Correct Incorrect Correct answer

To discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs by prohibiting reimportation
Correct Incorrect Correct answer

Correct

Incorrect
Question 11 of 667

11. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Drug Price Competition and Patent Term Restoration Act of 1984 created for?

To establish the modern system for generic drugs
Correct Incorrect Correct answer

To create NDC numbers for each drug
Correct Incorrect Correct answer

To create tax incentives and licensing for the development of medications that treat diseases that affect 200000 or less people in the world
Correct Incorrect Correct answer

To discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs by prohibiting reimportation
Correct Incorrect Correct answer

Correct

Incorrect
Question 12 of 667

12. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Prescription Drug Marketing Act of 1987 created for?

To discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs by prohibiting reimportation
Correct Incorrect Correct answer

To create NDC numbers for each drug
Correct Incorrect Correct answer

To create tax incentives and licensing for the development of medications that treat diseases that affect 200000 or less people in the world
Correct Incorrect Correct answer

To establish the modern system for generic drugs
Correct Incorrect Correct answer

Correct

Incorrect
Question 13 of 667

13. Question

Category: Federal Requirements: Controlled Substance Rx

Which act established the modern system for generic drugs?

Drug Price Competition and Patent Term Restoration Act of 1984
Correct Incorrect Correct answer

Drug Listing Act of 1972
Correct Incorrect Correct answer

Orphan Drug Act of 1983
Correct Incorrect Correct answer

Prescription Drug Marketing Act of 1987
Correct Incorrect Correct answer

Correct

Incorrect
Question 14 of 667

14. Question

Category: Federal Requirements: Controlled Substance Rx

Which act discourages the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs by prohibiting reimportation?

Prescription Drug Marketing Act of 1987
Correct Incorrect Correct answer

Drug Listing Act of 1972
Correct Incorrect Correct answer

Orphan Drug Act of 1983
Correct Incorrect Correct answer

Drug Price Competition and Patent Term Restoration Act of 1984
Correct Incorrect Correct answer

Correct

Incorrect
Question 15 of 667

15. Question

Category: Federal Requirements: Controlled Substance Rx

Which act reduces accidental poisoning in children?

Poison Prevention Packaging Act of 1970
Correct Incorrect Correct answer

Occupational Safety and Health Act of 1970
Correct Incorrect Correct answer

Kefauver Harris Act of 1962
Correct Incorrect Correct answer

Drug Listing Act of 1972
Correct Incorrect Correct answer

Correct

Incorrect
Question 16 of 667

16. Question

Category: Federal Requirements: Controlled Substance Rx

Which act ensures safe and healthy workplaces for employees?

Occupational Safety and Health Act of 1970
Correct Incorrect Correct answer

Poison Prevention Packaging Act of 1970
Correct Incorrect Correct answer

Kefauver Harris Act of 1962
Correct Incorrect Correct answer

Freedom of Choice Act
Correct Incorrect Correct answer

Correct

Incorrect
Question 17 of 667

17. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Poison Prevention Packaging Act of 1970 created for?

To reduce accidental poisoning in children
Correct Incorrect Correct answer

To ensure safe and healthy workplaces for employees
Correct Incorrect Correct answer

To prevent discrimination against potential employees who have disabilities
Correct Incorrect Correct answer

To allows patients to select any pharmacy for their pharmacy needs
Correct Incorrect Correct answer

Correct

Incorrect
Question 18 of 667

18. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Occupational Safety and Health Act of 1970 created for?

To ensure safe and healthy workplaces for employees
Correct Incorrect Correct answer

To reduce accidental poisoning in children
Correct Incorrect Correct answer

To prevent discrimination against potential employees who have disabilities
Correct Incorrect Correct answer

To allows patients to select any pharmacy for their pharmacy needs
Correct Incorrect Correct answer

Correct

Incorrect
Question 19 of 667

19. Question

Category: Federal Requirements: Controlled Substance Rx

Which act established revisions to Medicare and Medicaid Conditions of Participation regarding long term care facilities and pharmacy?

Omnibus Reconciliation Act of 1987
Correct Incorrect Correct answer

Omnibus Reconciliation Act of 1990
Correct Incorrect Correct answer

Prescription Drug Equity Law
Correct Incorrect Correct answer

Medicare Drug Improvement and Modernization Act of 2003
Correct Incorrect Correct answer

Correct

Incorrect
Question 20 of 667

20. Question

Category: Federal Requirements: Controlled Substance Rx

Which act enacted pursuant to the budget reconciliation process to reduce the United States federal budget deficit?

Omnibus Reconciliation Act of 1990
Correct Incorrect Correct answer

Omnibus Reconciliation Act of 1987
Correct Incorrect Correct answer

Prescription Drug Equity Law
Correct Incorrect Correct answer

Medicare Drug Improvement and Modernization Act of 2003
Correct Incorrect Correct answer

Correct

Incorrect
Question 21 of 667

21. Question

Category: Federal Requirements: Controlled Substance Rx

Which act enforces coverage requiring mail order prescription to also provide non-mail order coverage?

Prescription Drug Equity Law
Correct Incorrect Correct answer

Omnibus Reconciliation Act of 1987
Correct Incorrect Correct answer

Omnibus Reconciliation Act of 1990
Correct Incorrect Correct answer

Medicare Drug Improvement and Modernization Act of 2003
Correct Incorrect Correct answer

Correct

Incorrect
Question 22 of 667

22. Question

Category: Federal Requirements: Controlled Substance Rx

Which act introduced an entitlement benefit for prescription drugs, through tax breaks and subsidies?

Medicare Drug Improvement and Modernization Act of 2003
Correct Incorrect Correct answer

Omnibus Reconciliation Act of 1987
Correct Incorrect Correct answer

Omnibus Reconciliation Act of 1990
Correct Incorrect Correct answer

Prescription Drug Equity Law
Correct Incorrect Correct answer

Correct

Incorrect
Question 23 of 667

23. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Omnibus Reconciliation Act of 1987 created for?

To establish revisions to Medicare and Medicaid Conditions of Participation regarding long term care facilities and pharmacy
Correct Incorrect Correct answer

To enact pursuant to the budget reconciliation process to reduce the United States federal budget deficit
Correct Incorrect Correct answer

To enforce coverage requiring mail order prescription to also provide non-mail order coverage
Correct Incorrect Correct answer

Introduced an entitlement benefit for prescription drugs, through tax breaks and subsidies
Correct Incorrect Correct answer

Correct

Incorrect
Question 24 of 667

24. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Omnibus Reconciliation Act of 1990 created for?

To enact pursuant to the budget reconciliation process to reduce the United States federal budget deficit
Correct Incorrect Correct answer

To establish revisions to Medicare and Medicaid Conditions of Participation regarding long term care facilities and pharmacy
Correct Incorrect Correct answer

To enforce coverage requiring mail order prescription to also provide non-mail order coverage
Correct Incorrect Correct answer

Introduced an entitlement benefit for prescription drugs, through tax breaks and subsidies
Correct Incorrect Correct answer

Correct

Incorrect
Question 25 of 667

25. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Prescription Drug Equity Law created for?

To enforce coverage requiring mail order prescription to also provide non-mail order coverage
Correct Incorrect Correct answer

To establish revisions to Medicare and Medicaid Conditions of Participation regarding long term care facilities and pharmacy
Correct Incorrect Correct answer

To enact pursuant to the budget reconciliation process to reduce the United States federal budget deficit
Correct Incorrect Correct answer

Introduced an entitlement benefit for prescription drugs, through tax breaks and subsidies
Correct Incorrect Correct answer

Correct

Incorrect
Question 26 of 667

26. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Medicare Drug Improvement and Modernization Act of 2003 created for?

Introduced an entitlement benefit for prescription drugs, through tax breaks and subsidies
Correct Incorrect Correct answer

To establish revisions to Medicare and Medicaid Conditions of Participation regarding long term care facilities and pharmacy
Correct Incorrect Correct answer

To enact pursuant to the budget reconciliation process to reduce the United States federal budget deficit
Correct Incorrect Correct answer

To enforce coverage requiring mail order prescription to also provide non-mail order coverage
Correct Incorrect Correct answer

Correct

Incorrect
Question 27 of 667

27. Question

Category: Federal Requirements: Controlled Substance Rx

Which act regulated and taxed the production, importation, and distribution of opiates?

Harrison Narcotic Act
Correct Incorrect Correct answer

Comprehensive Drug Abuse Prevention and Control Act
Correct Incorrect Correct answer

Anabolic Steroid Control Act
Correct Incorrect Correct answer

Isotretinoin Safety and Risk Management Act
Correct Incorrect Correct answer

Correct

Incorrect
Question 28 of 667

28. Question

Category: Federal Requirements: Controlled Substance Rx

Which act requires the pharmaceutical industry to maintain physical security and strict record keeping for controlled substances?

Comprehensive Drug Abuse Prevention and Control Act
Correct Incorrect Correct answer

Harrison Narcotic Act
Correct Incorrect Correct answer

Anabolic Steroid Control Act
Correct Incorrect Correct answer

Isotretinoin Safety and Risk Management Act
Correct Incorrect Correct answer

Correct

Incorrect
Question 29 of 667

29. Question

Category: Federal Requirements: Controlled Substance Rx

Which act created harsher penalties for the abuse of anabolic steroids?

Anabolic Steroid Control Act
Correct Incorrect Correct answer

Harrison Narcotic Act
Correct Incorrect Correct answer

Comprehensive Drug Abuse Prevention and Control Act
Correct Incorrect Correct answer

Isotretinoin Safety and Risk Management Act
Correct Incorrect Correct answer

Correct

Incorrect
Question 30 of 667

30. Question

Category: Federal Requirements: Controlled Substance Rx

Which act created regulations regarding the use of Accutane?

Isotretinoin Safety and Risk Management Act
Correct Incorrect Correct answer

Harrison Narcotic Act
Correct Incorrect Correct answer

Comprehensive Drug Abuse Prevention and Control Act
Correct Incorrect Correct answer

Anabolic Steroid Control Act
Correct Incorrect Correct answer

Correct

Incorrect
Question 31 of 667

31. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Harrison Narcotic Act created for?

To regulate and tax the production, importation, and distribution of opiates
Correct Incorrect Correct answer

To require the pharmaceutical industry to maintain physical security and strict record keeping for controlled substances
Correct Incorrect Correct answer

To create harsher penalties for the abuse of anabolic steroids
Correct Incorrect Correct answer

To create regulations regarding the use of Accutane
Correct Incorrect Correct answer

Correct

Incorrect
Question 32 of 667

32. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Comprehensive Drug Abuse Prevention and Control Act created for?

To require the pharmaceutical industry to maintain physical security and strict record keeping for controlled substances
Correct Incorrect Correct answer

To regulate and tax the production, importation, and distribution of opiates
Correct Incorrect Correct answer

To create harsher penalties for the abuse of anabolic steroids
Correct Incorrect Correct answer

To create regulations regarding the use of Accutane
Correct Incorrect Correct answer

Correct

Incorrect
Question 33 of 667

33. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Anabolic Steroid Control Act created for?

To create harsher penalties for the abuse of anabolic steroids
Correct Incorrect Correct answer

To regulate and tax the production, importation, and distribution of opiates
Correct Incorrect Correct answer

To require the pharmaceutical industry to maintain physical security and strict record keeping for controlled substances
Correct Incorrect Correct answer

To create regulations regarding the use of Accutane
Correct Incorrect Correct answer

Correct

Incorrect
Question 34 of 667

34. Question

Category: Federal Requirements: Controlled Substance Rx

What was the Isotretinoin Safety and Risk Management Act created for?

To create regulations regarding the use of Accutane
Correct Incorrect Correct answer

To regulate and tax the production, importation, and distribution of opiates
Correct Incorrect Correct answer

To require the pharmaceutical industry to maintain physical security and strict record keeping for controlled substances
Correct Incorrect Correct answer

To create harsher penalties for the abuse of anabolic steroids
Correct Incorrect Correct answer

Correct

Incorrect
Question 35 of 667

35. Question

Category: Federal Requirements: Controlled Substance Handling

Which agency enforces regulations set by the Controlled Substances Act?

DEA
Correct Incorrect Correct answer

CMS
Correct Incorrect Correct answer

FDA
Correct Incorrect Correct answer

TJC
Correct Incorrect Correct answer

Correct

Incorrect
Question 36 of 667

36. Question

Category: Federal Requirements: Controlled Substance Handling

Which agency ensures that all drugs are pure, safe, and effective?

FDA
Correct Incorrect Correct answer

CMS
Correct Incorrect Correct answer

DEA
Correct Incorrect Correct answer

TJC
Correct Incorrect Correct answer

Correct

Incorrect
Question 37 of 667

37. Question

Category: Federal Requirements: Controlled Substance Handling

Which agency is made up of all of the state boards of pharmacy?

NABP
Correct Incorrect Correct answer

EPA
Correct Incorrect Correct answer

BOP
Correct Incorrect Correct answer

USP
Correct Incorrect Correct answer

Correct

Incorrect
Question 38 of 667

38. Question

Category: Federal Requirements: Controlled Substance Handling

Which agency sets quality and purity standards for OTC and prescription drugs?

USP
Correct Incorrect Correct answer

EPA
Correct Incorrect Correct answer

NABP
Correct Incorrect Correct answer

BOP
Correct Incorrect Correct answer

Correct

Incorrect
Question 39 of 667

39. Question

Category: Federal Requirements: Controlled Substance Handling

What is the NABP?

Make up of all of the state boards of pharmacy
Correct Incorrect Correct answer

Regulates the disposal of hazardous waste
Correct Incorrect Correct answer

Regulates the pharmacy procedures
Correct Incorrect Correct answer

Sets quality and purity standards for OTC and prescription drugs
Correct Incorrect Correct answer

Correct

Incorrect
Question 40 of 667

40. Question

Category: Federal Requirements: Controlled Substance Handling

What is the USP responsible for?

Sets quality and purity standards for OTC and prescription drugs
Correct Incorrect Correct answer

Regulates the disposal of hazardous waste
Correct Incorrect Correct answer

Make up of all of the state boards of pharmacy
Correct Incorrect Correct answer

Regulates the pharmacy procedures
Correct Incorrect Correct answer

Correct

Incorrect
Question 41 of 667

41. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which of the following is characteristic of Cross-training?

Persons of different functions working together
Correct Incorrect Correct answer

Person trained to perform different functions
Correct Incorrect Correct answer

Persons linked together electronically through computers
Correct Incorrect Correct answer

None of the other options
Correct Incorrect Correct answer

Correct

Incorrect
Question 42 of 667

42. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which of the following is characteristic of Multiskilling?

Person trained to perform different functions
Correct Incorrect Correct answer

Persons of different functions working together
Correct Incorrect Correct answer

Persons linked together electronically through computers
Correct Incorrect Correct answer

None of the other options
Correct Incorrect Correct answer

Correct

Incorrect
Question 43 of 667

43. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which of the following is characteristic of Virtual Groups?

Persons linked together electronically through computers
Correct Incorrect Correct answer

Person trained to perform different functions
Correct Incorrect Correct answer

Persons of different functions working together
Correct Incorrect Correct answer

None of the other options
Correct Incorrect Correct answer

Correct

Incorrect
Question 44 of 667

44. Question

Category: Federal Requirements: Hazardous Waste Disposal

Who pays for freight costs in a FOB destination scenario?

Seller
Correct Incorrect Correct answer

Buyer
Correct Incorrect Correct answer

Both Buyer and Seller
Correct Incorrect Correct answer

No One
Correct Incorrect Correct answer

Correct

Incorrect
Question 45 of 667

45. Question

Category: Federal Requirements: Hazardous Waste Disposal

Who pays for freight costs in a FOB shipping point scenario?

Buyer
Correct Incorrect Correct answer

Seller
Correct Incorrect Correct answer

Both Buyer and Seller
Correct Incorrect Correct answer

No One
Correct Incorrect Correct answer

Correct

Incorrect
Question 46 of 667

46. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which of the following is the most effective channel of communication?

Face to Face
Correct Incorrect Correct answer

Phone
Correct Incorrect Correct answer

Email
Correct Incorrect Correct answer

Bulletin
Correct Incorrect Correct answer

Correct

Incorrect
Question 47 of 667

47. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which of the following is the least effective channel of communication?

Bulletin
Correct Incorrect Correct answer

Phone
Correct Incorrect Correct answer

Email
Correct Incorrect Correct answer

Letter
Correct Incorrect Correct answer

Correct

Incorrect
Question 48 of 667

48. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which organization regulates the standards of the shipment of hazardous substances?

Department of Transportation
Correct Incorrect Correct answer

Food and Drug Administration
Correct Incorrect Correct answer

Drug Enforcement Agency
Correct Incorrect Correct answer

Environmental Protection Agency
Correct Incorrect Correct answer

Correct

Incorrect
Question 49 of 667

49. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which radioactive classification contains the highest concentration of radiation?

Yellow III
Correct Incorrect Correct answer

Yellow II
Correct Incorrect Correct answer

White I
Correct Incorrect Correct answer

Orange II
Correct Incorrect Correct answer

Correct

Incorrect
Question 50 of 667

50. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following must always be used when medication is given to a patient?

Medication Administration Record
Correct Incorrect Correct answer

Medication Delivery Record
Correct Incorrect Correct answer

Resident Monitoring Form
Correct Incorrect Correct answer

Physician Order Sheet
Correct Incorrect Correct answer

Correct

Incorrect
Question 51 of 667

51. Question

Category: Federal Requirements: Controlled Substance Handling

Which is not included in a medication administration record?

Pharmacist
Correct Incorrect Correct answer

Drug
Correct Incorrect Correct answer

Dose
Correct Incorrect Correct answer

Patient allergies
Correct Incorrect Correct answer

Correct

Incorrect
Question 52 of 667

52. Question

Category: Federal Requirements: Controlled Substance Handling

Which is not included in a patient profile?

Preferred Pharmacy
Correct Incorrect Correct answer

Social Security Number
Correct Incorrect Correct answer

Patient's Billing Information
Correct Incorrect Correct answer

Medical History
Correct Incorrect Correct answer

Correct

Incorrect
Question 53 of 667

53. Question

Category: Federal Requirements: Controlled Substance Handling

Which is included in a patient profile?

All of the other options
Correct Incorrect Correct answer

Patient's Billing Information
Correct Incorrect Correct answer

Easy-Open Requests
Correct Incorrect Correct answer

Social Security Number
Correct Incorrect Correct answer

Correct

Incorrect
Question 54 of 667

54. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is used to provide accountability for distribution between pharmacies and hospitals?

Medication Delivery Record
Correct Incorrect Correct answer

Medication Administration Record
Correct Incorrect Correct answer

Physician Order Sheet
Correct Incorrect Correct answer

Resident Monitoring Form
Correct Incorrect Correct answer

Correct

Incorrect
Question 55 of 667

55. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is used to document orders for a patient including both drug and nondrug orders?

Physician Order Sheet
Correct Incorrect Correct answer

Medication Delivery Record
Correct Incorrect Correct answer

Medication Administration Record
Correct Incorrect Correct answer

Resident Monitoring Form
Correct Incorrect Correct answer

Correct

Incorrect
Question 56 of 667

56. Question

Category: Federal Requirements: Controlled Substance Handling

Which is used to document patient behavior reactions to drug and nondrug orders?

Resident Monitoring Form
Correct Incorrect Correct answer

Physician Order Sheet
Correct Incorrect Correct answer

Medication Delivery Record
Correct Incorrect Correct answer

Medication Administration Record
Correct Incorrect Correct answer

Correct

Incorrect
Question 57 of 667

57. Question

Category: Federal Requirements: Controlled Substance Handling

What is a medication administration record used for?

Document medication given to a patient
Correct Incorrect Correct answer

Document patient behavior reactions to drug and nondrug orders
Correct Incorrect Correct answer

Document drug and nondrug orders for a patient
Correct Incorrect Correct answer

Provide accountability for distribution between pharmacies and hospitals
Correct Incorrect Correct answer

Correct

Incorrect
Question 58 of 667

58. Question

Category: Federal Requirements: Controlled Substance Handling

What is a medication delivery record used for?

Provide accountability for distribution between pharmacies and hospitals
Correct Incorrect Correct answer

Document medication given to a patient
Correct Incorrect Correct answer

Document patient behavior reactions to drug and nondrug orders
Correct Incorrect Correct answer

Document drug and nondrug orders for a patient
Correct Incorrect Correct answer

Correct

Incorrect
Question 59 of 667

59. Question

Category: Federal Requirements: Controlled Substance Handling

What is a physician order sheet used for?

Document drug and nondrug orders for a patient
Correct Incorrect Correct answer

Provide accountability for distribution between pharmacies and hospitals
Correct Incorrect Correct answer

Document medication given to a patient
Correct Incorrect Correct answer

Document patient behavior reactions to drug and nondrug orders
Correct Incorrect Correct answer

Correct

Incorrect
Question 60 of 667

60. Question

Category: Federal Requirements: Controlled Substance Handling

What is a resident monitoring form used form?

Document patient behavior reactions to drug and nondrug orders
Correct Incorrect Correct answer

Document drug and nondrug orders for a patient
Correct Incorrect Correct answer

Provide accountability for distribution between pharmacies and hospitals
Correct Incorrect Correct answer

Document medication given to a patient
Correct Incorrect Correct answer

Correct

Incorrect
Question 61 of 667

61. Question

Category: Federal Requirements: Controlled Substance Handling

ISO Class 5 refers to an area with less than how many 0.5+ micron particles per cubic foot?

100
Correct Incorrect Correct answer

1000
Correct Incorrect Correct answer

10000
Correct Incorrect Correct answer

100000
Correct Incorrect Correct answer

Correct

Incorrect
Question 62 of 667

62. Question

Category: Federal Requirements: Controlled Substance Handling

ISO Class 6 refers to an area with less than how many 0.5+ micron particles per cubic foot?

1000
Correct Incorrect Correct answer

100
Correct Incorrect Correct answer

10000
Correct Incorrect Correct answer

100000
Correct Incorrect Correct answer

Correct

Incorrect
Question 63 of 667

63. Question

Category: Federal Requirements: Controlled Substance Handling

ISO Class 7 refers to an area with less than how many 0.5+ micron particles per cubic foot?

10000
Correct Incorrect Correct answer

100
Correct Incorrect Correct answer

1000
Correct Incorrect Correct answer

100000
Correct Incorrect Correct answer

Correct

Incorrect
Question 64 of 667

64. Question

Category: Federal Requirements: Controlled Substance Handling

ISO Class 8 refers to an area with less than how many 0.5+ micron particles per cubic foot?

100000
Correct Incorrect Correct answer

100
Correct Incorrect Correct answer

1000
Correct Incorrect Correct answer

10000
Correct Incorrect Correct answer

Correct

Incorrect
Question 65 of 667

65. Question

Category: Federal Requirements: Controlled Substance Handling

ISO Class 5 was formerly known as?

Class 100
Correct Incorrect Correct answer

Class 100000
Correct Incorrect Correct answer

Class 10000
Correct Incorrect Correct answer

Class 1000
Correct Incorrect Correct answer

Correct

Incorrect
Question 66 of 667

66. Question

Category: Federal Requirements: Controlled Substance Handling

ISO Class 6 was formerly known as?

Class 1000
Correct Incorrect Correct answer

Class 100
Correct Incorrect Correct answer

Class 100000
Correct Incorrect Correct answer

Class 10000
Correct Incorrect Correct answer

Correct

Incorrect
Question 67 of 667

67. Question

Category: Federal Requirements: Controlled Substance Handling

ISO Class 7 was formerly known as?

Class 10000
Correct Incorrect Correct answer

Class 1000
Correct Incorrect Correct answer

Class 100
Correct Incorrect Correct answer

Class 100000
Correct Incorrect Correct answer

Correct

Incorrect
Question 68 of 667

68. Question

Category: Federal Requirements: Controlled Substance Handling

ISO Class 8 was formerly known as?

Class 100000
Correct Incorrect Correct answer

Class 10000
Correct Incorrect Correct answer

Class 1000
Correct Incorrect Correct answer

Class 100
Correct Incorrect Correct answer

Correct

Incorrect
Question 69 of 667

69. Question

Category: Federal Requirements: Controlled Substance Handling

How often must pharmacy scales and weights be evaluated and calibrated?

Every 12 months
Correct Incorrect Correct answer

Every 6 months
Correct Incorrect Correct answer

Every 24 months
Correct Incorrect Correct answer

Every 3 months
Correct Incorrect Correct answer

Correct

Incorrect
Question 70 of 667

70. Question

Category: Federal Requirements: Controlled Substance Handling

How long must a laminar flow hood be turned on for before use?

30 min
Correct Incorrect Correct answer

15 min
Correct Incorrect Correct answer

60 min
Correct Incorrect Correct answer

45 min
Correct Incorrect Correct answer

Correct

Incorrect
Question 71 of 667

71. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is used to accurately weigh 3 kg?

Counter Balance
Correct Incorrect Correct answer

Class A Balance
Correct Incorrect Correct answer

Class B Balance
Correct Incorrect Correct answer

Class 7 Balance
Correct Incorrect Correct answer

Correct

Incorrect
Question 72 of 667

72. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is used to accurately weigh 300 mg?

Class A Balance
Correct Incorrect Correct answer

Class B Balance
Correct Incorrect Correct answer

Class 7 Balance
Correct Incorrect Correct answer

Counter Balance
Correct Incorrect Correct answer

Correct

Incorrect
Question 73 of 667

73. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following can accurately weigh balances between 650 mg to 120 g?

Class B Balance
Correct Incorrect Correct answer

Class A Balance
Correct Incorrect Correct answer

Class 7 Balance
Correct Incorrect Correct answer

Counter Balance
Correct Incorrect Correct answer

Correct

Incorrect
Question 74 of 667

74. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is sensitive to 1/10 of a mg?

Digital Balance
Correct Incorrect Correct answer

Class A Balance
Correct Incorrect Correct answer

Class 7 Balance
Correct Incorrect Correct answer

Counter Balance
Correct Incorrect Correct answer

Correct

Incorrect
Question 75 of 667

75. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is not a part of a syringe?

Lumen
Correct Incorrect Correct answer

Barrel
Correct Incorrect Correct answer

Plunger
Correct Incorrect Correct answer

Flange
Correct Incorrect Correct answer

Correct

Incorrect
Question 76 of 667

76. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is not a part of a needle?

Flange
Correct Incorrect Correct answer

Lumen
Correct Incorrect Correct answer

Bevel
Correct Incorrect Correct answer

Hilt
Correct Incorrect Correct answer

Correct

Incorrect
Question 77 of 667

77. Question

Category: Federal Requirements: Controlled Substance Handling

Which type of laminar flow hood exhausts all contaminated air to the outside?

Type B2
Correct Incorrect Correct answer

Type B1
Correct Incorrect Correct answer

Type A
Correct Incorrect Correct answer

Type B3
Correct Incorrect Correct answer

Correct

Incorrect
Question 78 of 667

78. Question

Category: Federal Requirements: Controlled Substance Handling

Which type of laminar flow hood exhausts a majority of contaminated air to the outside?

Type B1
Correct Incorrect Correct answer

Type B2
Correct Incorrect Correct answer

Type A
Correct Incorrect Correct answer

Type B3
Correct Incorrect Correct answer

Correct

Incorrect
Question 79 of 667

79. Question

Category: Federal Requirements: Controlled Substance Handling

Which type of laminar flow hood recirculates part of the air and exhausts into the room?

Type A
Correct Incorrect Correct answer

Type B2
Correct Incorrect Correct answer

Type B1
Correct Incorrect Correct answer

Type B3
Correct Incorrect Correct answer

Correct

Incorrect
Question 80 of 667

80. Question

Category: Federal Requirements: Controlled Substance Handling

Which type of laminar flow hood recycles air and exhausts to the outside?

Type B3
Correct Incorrect Correct answer

Type B2
Correct Incorrect Correct answer

Type B1
Correct Incorrect Correct answer

Type A
Correct Incorrect Correct answer

Correct

Incorrect
Question 81 of 667

81. Question

Category: Federal Requirements: Controlled Substance Handling

Which describes the air flow of a Type A laminar flow hood?

Recirculates part of the air and exhausts into the room
Correct Incorrect Correct answer

Recycles air and exhausts to the outside
Correct Incorrect Correct answer

Exhausts all contaminated air to the outside
Correct Incorrect Correct answer

Exhausts a majority of contaminated air to the outside
Correct Incorrect Correct answer

Correct

Incorrect
Question 82 of 667

82. Question

Category: Federal Requirements: Controlled Substance Handling

Which describes the air flow of a Type B1 laminar flow hood?

Exhausts a majority of contaminated air to the outside
Correct Incorrect Correct answer

Recirculates part of the air and exhausts into the room
Correct Incorrect Correct answer

Recycles air and exhausts to the outside
Correct Incorrect Correct answer

Exhausts all contaminated air to the outside
Correct Incorrect Correct answer

Correct

Incorrect
Question 83 of 667

83. Question

Category: Federal Requirements: Controlled Substance Handling

Which describes the air flow of a Type B2 laminar flow hood?

Exhausts all contaminated air to the outside
Correct Incorrect Correct answer

Exhausts a majority of contaminated air to the outside
Correct Incorrect Correct answer

Recirculates part of the air and exhausts into the room
Correct Incorrect Correct answer

Recycles air and exhausts to the outside
Correct Incorrect Correct answer

Correct

Incorrect
Question 84 of 667

84. Question

Category: Federal Requirements: Controlled Substance Handling

Which describes the air flow of a Type B3 laminar flow hood?

Recycles air and exhausts to the outside
Correct Incorrect Correct answer

Exhausts all contaminated air to the outside
Correct Incorrect Correct answer

Exhausts a majority of contaminated air to the outside
Correct Incorrect Correct answer

Recirculates part of the air and exhausts into the room
Correct Incorrect Correct answer

Correct

Incorrect
Question 85 of 667

85. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following should never be touched with bare skin?

Pharmaceutical Weights
Correct Incorrect Correct answer

Mortar and Pestle
Correct Incorrect Correct answer

Beakers
Correct Incorrect Correct answer

Glycine Paper
Correct Incorrect Correct answer

Correct

Incorrect
Question 86 of 667

86. Question

Category: Federal Requirements: Controlled Substance Handling

What happens in the quality control area in a nuclear pharmacy?

Radiopharmaceuticals are tested for defects
Correct Incorrect Correct answer

Radiopharmaceuticals are packed for delivery
Correct Incorrect Correct answer

Radiopharmaceuticals are dispensed
Correct Incorrect Correct answer

Radiopharmaceutical prescriptions are entered
Correct Incorrect Correct answer

Correct

Incorrect
Question 87 of 667

87. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following resources is required in all pharmacy libraries?

United States Pharmacopeia
Correct Incorrect Correct answer

American Drug index 2002
Correct Incorrect Correct answer

Poisindex System
Correct Incorrect Correct answer

Index Nominum
Correct Incorrect Correct answer

Correct

Incorrect
Question 88 of 667

88. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following must a pharmacy have to prepare chemotherapy agents?

Laminar Airflow Hood
Correct Incorrect Correct answer

Compounding Slab
Correct Incorrect Correct answer

Mechanical Piston Pump
Correct Incorrect Correct answer

Infusion Control Devices
Correct Incorrect Correct answer

Correct

Incorrect
Question 89 of 667

89. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is not a TJC policy?

Dispensing of professional samples
Correct Incorrect Correct answer

Unit-dose preferred to floor-stock
Correct Incorrect Correct answer

Separation of internal and external products
Correct Incorrect Correct answer

IV admixtures prepared in laminar flow hoods
Correct Incorrect Correct answer

Correct

Incorrect
Question 90 of 667

90. Question

Category: Federal Requirements: Controlled Substance Handling

Which of the following is a TJC policy?

Unit-dose preferred to floor-stock
Correct Incorrect Correct answer

Dispensing of professional samples
Correct Incorrect Correct answer

Limited pharmacist work hours
Correct Incorrect Correct answer

Closed-circuit security systems
Correct Incorrect Correct answer

Correct

Incorrect
Question 91 of 667

91. Question

Category: Federal Requirements: Hazardous Waste Disposal

What is the recommended time for washing skin that comes in contact with hazardous substances?

5 min
Correct Incorrect Correct answer

10 min
Correct Incorrect Correct answer

15 min
Correct Incorrect Correct answer

20 min
Correct Incorrect Correct answer

Correct

Incorrect
Question 92 of 667

92. Question

Category: Federal Requirements: Hazardous Waste Disposal

What is the recommended time for washing eyes that come in contact with hazardous substances?

15 min
Correct Incorrect Correct answer

5 min
Correct Incorrect Correct answer

10 min
Correct Incorrect Correct answer

20 min
Correct Incorrect Correct answer

Correct

Incorrect
Question 93 of 667

93. Question

Category: Federal Requirements: Hazardous Waste Disposal

What can be referenced for cleanup procedures for a hazardous substance?

SDS (Safety Data Sheet)
Correct Incorrect Correct answer

Formulary
Correct Incorrect Correct answer

DEA Form 41
Correct Incorrect Correct answer

USP
Correct Incorrect Correct answer

Correct

Incorrect
Question 94 of 667

94. Question

Category: Federal Requirements: Restricted Drug Programs

What is the primary purpose of a Risk Evaluation and Mitigation Strategy (REMS)?

To ensure the benefits of a medication outweigh its risks
Correct Incorrect Correct answer

To establish pricing guidelines for high-cost medications
Correct Incorrect Correct answer

To determine which pharmacies are authorized to dispense generics
Correct Incorrect Correct answer

To create advertising standards for prescription drug manufacturers
Correct Incorrect Correct answer

Correct

Incorrect
Question 95 of 667

95. Question

Category: Federal Requirements: Restricted Drug Programs

Under the Combat Methamphetamine Epidemic Act, what is the maximum amount of pseudoephedrine a customer may purchase in a single day?

3.6 grams
Correct Incorrect Correct answer

2.4 grams
Correct Incorrect Correct answer

7.5 grams
Correct Incorrect Correct answer

9 grams
Correct Incorrect Correct answer

Correct

Incorrect
Question 96 of 667

96. Question

Category: Federal Requirements: Restricted Drug Programs

Which laboratory value must be monitored for patients enrolled in the Clozapine REMS program?

Absolute neutrophil count (ANC)
Correct Incorrect Correct answer

Serum creatinine level
Correct Incorrect Correct answer

Hemoglobin A1c level
Correct Incorrect Correct answer

Liver transaminase levels
Correct Incorrect Correct answer

Correct

Incorrect
Question 97 of 667

97. Question

Category: Federal Requirements: Restricted Drug Programs

Where must products containing pseudoephedrine be stored in a pharmacy according to federal law?

Behind the pharmacy counter or in a locked cabinet
Correct Incorrect Correct answer

On open shelves in the cough and cold aisle
Correct Incorrect Correct answer

In the pharmacy vault with controlled substances
Correct Incorrect Correct answer

In a refrigerated unit near the dispensing area
Correct Incorrect Correct answer

Correct

Incorrect
Question 98 of 667

98. Question

Category: Federal Requirements: Restricted Drug Programs

What document must be provided to patients when they receive a medication that has an FDA-approved Medication Guide?

A printed copy of the Medication Guide with each dispensing
Correct Incorrect Correct answer

A summary letter from the prescriber explaining the risks
Correct Incorrect Correct answer

A signed consent form acknowledging potential side effects
Correct Incorrect Correct answer

A wallet card listing emergency contact information
Correct Incorrect Correct answer

Correct

Incorrect
Question 99 of 667

99. Question

Category: Federal Requirements: Restricted Drug Programs

What does ETASU stand for in the context of REMS programs?

Elements to Assure Safe Use
Correct Incorrect Correct answer

Evaluation Tools for Appropriate Safety Updates
Correct Incorrect Correct answer

Extended Testing and Safety Utilization
Correct Incorrect Correct answer

Evidence Tracking for Adverse Side-effect Updates
Correct Incorrect Correct answer

Correct

Incorrect
Question 100 of 667

100. Question

Category: Federal Requirements: Restricted Drug Programs

How many forms of contraception are required for female patients of childbearing potential enrolled in the iPLEDGE program?

Two forms of contraception
Correct Incorrect Correct answer

One form of contraception
Correct Incorrect Correct answer

Three forms of contraception
Correct Incorrect Correct answer

Contraception is not required under the program
Correct Incorrect Correct answer

Correct

Incorrect
Question 101 of 667

101. Question

Category: Federal Requirements: Restricted Drug Programs

What identification must a customer present when purchasing pseudoephedrine products?

A valid government-issued photo identification
Correct Incorrect Correct answer

A pharmacy loyalty card with registered address
Correct Incorrect Correct answer

A prescription from a licensed prescriber
Correct Incorrect Correct answer

A signed affidavit stating the intended use
Correct Incorrect Correct answer

Correct

Incorrect
Question 102 of 667

102. Question

Category: Federal Requirements: Restricted Drug Programs

A patient presents a new prescription for isotretinoin. The pharmacy technician checks the iPLEDGE system and finds that the patient’s monthly authorization has expired. What should the technician do?

Inform the pharmacist that the prescription cannot be filled until the patient obtains a new authorization
Correct Incorrect Correct answer

Dispense a partial supply to cover the patient until the next authorization
Correct Incorrect Correct answer

Contact the prescriber to request an override of the authorization requirement
Correct Incorrect Correct answer

Fill the prescription and ask the patient to update the authorization within 48 hours
Correct Incorrect Correct answer

Correct

Incorrect
Question 103 of 667

103. Question

Category: Federal Requirements: Restricted Drug Programs

A customer wants to purchase two boxes of pseudoephedrine tablets totaling 3.0 grams. They purchased 7.0 grams earlier this month at another pharmacy. Should the pharmacy technician complete this sale?

No, because the total monthly purchase would exceed the 9-gram monthly limit
Correct Incorrect Correct answer

Yes, because the daily limit of 3.6 grams has not been exceeded
Correct Incorrect Correct answer

Yes, because purchases at other pharmacies are tracked separately
Correct Incorrect Correct answer

No, because pseudoephedrine requires a valid prescription in all states
Correct Incorrect Correct answer

Correct

Incorrect
Question 104 of 667

104. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is processing a prescription for clozapine and checks the REMS registry. The patient’s most recent ANC result is below the required threshold. What is the appropriate action?

Do not dispense the medication and notify the pharmacist immediately
Correct Incorrect Correct answer

Dispense a 7-day emergency supply while awaiting updated lab results
Correct Incorrect Correct answer

Contact the prescriber to request a dose reduction and dispense as written
Correct Incorrect Correct answer

Dispense the medication and schedule the patient for a blood draw within 24 hours
Correct Incorrect Correct answer

Correct

Incorrect
Question 105 of 667

105. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives a prescription for lenalidomide (Revlimid). Which REMS requirement must be verified before the technician can process this prescription?

Confirmation that the prescriber, patient, and pharmacy are all enrolled in the REMS program
Correct Incorrect Correct answer

Verification that the patient has a documented allergy to thalidomide
Correct Incorrect Correct answer

Confirmation that the patient completed a 30-day washout period from prior chemotherapy
Correct Incorrect Correct answer

Verification that the prescriber has submitted a prior authorization to the insurer
Correct Incorrect Correct answer

Correct

Incorrect
Question 106 of 667

106. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician notices that an opioid prescription requires a Medication Guide. The pharmacy has run out of printed copies. What should the technician do?

Print a current copy from the FDA website or the pharmacy system before dispensing
Correct Incorrect Correct answer

Dispense the medication and mail the Medication Guide to the patient later
Correct Incorrect Correct answer

Verbally counsel the patient on the key risks and document the conversation
Correct Incorrect Correct answer

Provide the manufacturer's package insert as an acceptable substitute
Correct Incorrect Correct answer

Correct

Incorrect
Question 107 of 667

107. Question

Category: Federal Requirements: Restricted Drug Programs

A female patient of childbearing potential enrolled in the iPLEDGE program is due for her monthly pregnancy test. She states she took a home pregnancy test that was negative. Can the pharmacy dispense her isotretinoin?

No, the pregnancy test must be performed at a certified laboratory as required by the program
Correct Incorrect Correct answer

Yes, a home pregnancy test is sufficient documentation for the program
Correct Incorrect Correct answer

Yes, as long as the patient signs a waiver accepting responsibility
Correct Incorrect Correct answer

No, but only because two consecutive negative tests are required each month
Correct Incorrect Correct answer

Correct

Incorrect
Question 108 of 667

108. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician receives a mail-order request for pseudoephedrine products totaling 8 grams for a 30-day period. Should the order be processed?

No, the mail-order monthly limit is 7.5 grams
Correct Incorrect Correct answer

Yes, the monthly limit of 9 grams applies to all purchase methods
Correct Incorrect Correct answer

No, mail-order sales of pseudoephedrine are prohibited entirely
Correct Incorrect Correct answer

Yes, mail-order purchases are exempt from quantity restrictions
Correct Incorrect Correct answer

Correct

Incorrect
Question 109 of 667

109. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is processing a new thalidomide prescription. Which REMS program governs the dispensing of this medication?

THALOMID REMS program
Correct Incorrect Correct answer

iPLEDGE program
Correct Incorrect Correct answer

Clozapine REMS program
Correct Incorrect Correct answer

Opioid Analgesic REMS program
Correct Incorrect Correct answer

Correct

Incorrect
Question 110 of 667

110. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is assisting with a REMS program that requires ETASU. Which of the following is an example of an ETASU requirement?

Requiring the pharmacy to be specially certified before dispensing the medication
Correct Incorrect Correct answer

Providing a standard prescription label with auxiliary warnings
Correct Incorrect Correct answer

Submitting annual pharmacy license renewals to the state board
Correct Incorrect Correct answer

Offering automatic refill enrollment for maintenance medications
Correct Incorrect Correct answer

Correct

Incorrect
Question 111 of 667

111. Question

Category: Federal Requirements: Restricted Drug Programs

A technician is selling pseudoephedrine to a customer who presents a valid photo ID. What information must the technician record in the logbook?

Name, address, date and time of sale, product name, and quantity sold
Correct Incorrect Correct answer

Name, date of birth, and the reason for the purchase
Correct Incorrect Correct answer

Name, photo ID number, and the customer's pharmacy insurance plan
Correct Incorrect Correct answer

Name, prescriber information, and the intended duration of use
Correct Incorrect Correct answer

Correct

Incorrect
Question 112 of 667

112. Question

Category: Federal Requirements: Restricted Drug Programs

A patient asks the pharmacy technician why they need to provide blood work results before picking up their clozapine refill. Which response best explains the requirement?

Clozapine can cause a dangerous drop in white blood cells, so regular blood monitoring is required
Correct Incorrect Correct answer

Clozapine can cause liver failure, so hepatic function must be checked monthly
Correct Incorrect Correct answer

Clozapine requires kidney function monitoring to ensure proper drug clearance
Correct Incorrect Correct answer

Clozapine interacts with most foods, so nutritional labs are needed before each refill
Correct Incorrect Correct answer

Correct

Incorrect
Question 113 of 667

113. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy is audited and found to have dispensed isotretinoin to a female patient of childbearing potential without verifying pregnancy test results in the iPLEDGE system. Which consequence is most likely?

The pharmacy may lose its iPLEDGE certification and face regulatory action from the FDA
Correct Incorrect Correct answer

The pharmacy will receive a verbal warning with no further consequences
Correct Incorrect Correct answer

The prescriber alone is held responsible since they wrote the prescription
Correct Incorrect Correct answer

The patient's insurance company will issue a financial penalty to the pharmacy
Correct Incorrect Correct answer

Correct

Incorrect
Question 114 of 667

114. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is comparing the REMS requirements for clozapine and isotretinoin. Which statement correctly identifies a difference between these two programs?

Clozapine REMS requires blood count monitoring, while iPLEDGE requires pregnancy testing for female patients of childbearing potential
Correct Incorrect Correct answer

Clozapine REMS only requires prescriber registration, while iPLEDGE requires both prescriber and pharmacy registration
Correct Incorrect Correct answer

iPLEDGE allows dispensing without patient enrollment, while Clozapine REMS does not
Correct Incorrect Correct answer

Clozapine REMS requires monthly pregnancy tests, while iPLEDGE requires liver function monitoring
Correct Incorrect Correct answer

Correct

Incorrect
Question 115 of 667

115. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician reviews three prescriptions: one for clozapine, one for isotretinoin, and one for hydrocodone/acetaminophen. Which of these medications requires enrollment of the prescriber, pharmacy, and patient in a restricted distribution program before dispensing?

Both clozapine and isotretinoin require full program enrollment, but hydrocodone/acetaminophen does not
Correct Incorrect Correct answer

Only isotretinoin requires full program enrollment of all three parties
Correct Incorrect Correct answer

All three medications require enrollment of the prescriber, pharmacy, and patient
Correct Incorrect Correct answer

Only clozapine requires full enrollment because it is an antipsychotic
Correct Incorrect Correct answer

Correct

Incorrect
Question 116 of 667

116. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy fills prescriptions for thalidomide and lenalidomide. A technician asks why both drugs have similar REMS requirements. Which explanation best addresses the underlying reason?

Both drugs are known teratogens that cause severe birth defects, requiring strict pregnancy prevention measures
Correct Incorrect Correct answer

Both drugs are classified as Schedule II controlled substances requiring DEA monitoring
Correct Incorrect Correct answer

Both drugs cause severe neutropenia requiring blood count monitoring before each refill
Correct Incorrect Correct answer

Both drugs have a high potential for addiction and require patient counseling agreements
Correct Incorrect Correct answer

Correct

Incorrect
Question 117 of 667

117. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is developing a workflow for REMS medications. Which step is most critical for the technician to complete before the pharmacist performs final verification?

Confirming that all required REMS conditions, such as lab values or program enrollment, are current and documented
Correct Incorrect Correct answer

Calculating the patient's copay and verifying insurance coverage for the medication
Correct Incorrect Correct answer

Checking whether the medication is available from the wholesaler for next-day delivery
Correct Incorrect Correct answer

Reviewing the patient's allergy history to ensure no cross-reactivity with the REMS drug
Correct Incorrect Correct answer

Correct

Incorrect
Question 118 of 667

118. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacist asks a technician to explain why pseudoephedrine is regulated under the CMEA rather than through a REMS program. Which response demonstrates the best understanding?

Pseudoephedrine is restricted due to its use as a precursor in illicit drug manufacturing, not because of patient safety risks from the drug itself
Correct Incorrect Correct answer

Pseudoephedrine is regulated under CMEA because it is classified as a Schedule II controlled substance
Correct Incorrect Correct answer

REMS programs only apply to injectable medications, so oral pseudoephedrine must be regulated separately
Correct Incorrect Correct answer

The CMEA was created because REMS programs cannot restrict over-the-counter medications
Correct Incorrect Correct answer

Correct

Incorrect
Question 119 of 667

119. Question

Category: Federal Requirements: Dscsa

What is the primary purpose of the Drug Supply Chain Security Act (DSCSA)?

To create a national system for tracking prescription drugs through the supply chain
Correct Incorrect Correct answer

To regulate the pricing of prescription drugs sold to pharmacies
Correct Incorrect Correct answer

To establish manufacturing quality standards for generic medications
Correct Incorrect Correct answer

To require pharmacies to report adverse drug reactions to the FDA
Correct Incorrect Correct answer

Correct

Incorrect
Question 120 of 667

120. Question

Category: Federal Requirements: Dscsa

Which four components make up the product identifier required on each prescription drug package under the DSCSA?

NDC number, serial number, lot number, and expiration date
Correct Incorrect Correct answer

NDC number, manufacturer name, lot number, and package size
Correct Incorrect Correct answer

Drug name, serial number, unit price, and expiration date
Correct Incorrect Correct answer

NDC number, drug name, lot number, and storage requirements
Correct Incorrect Correct answer

Correct

Incorrect
Question 121 of 667

121. Question

Category: Federal Requirements: Dscsa

Which three types of transaction documentation (T3) must trading partners exchange under the DSCSA?

Transaction information, transaction history, and transaction statement
Correct Incorrect Correct answer

Transaction receipt, transaction verification, and transaction authorization
Correct Incorrect Correct answer

Transaction invoice, transaction pedigree, and transaction certificate
Correct Incorrect Correct answer

Transaction order, transaction shipment, and transaction confirmation
Correct Incorrect Correct answer

Correct

Incorrect
Question 122 of 667

122. Question

Category: Federal Requirements: Dscsa

How long must trading partners maintain transaction documentation records under the DSCSA?

At least 6 years
Correct Incorrect Correct answer

At least 2 years
Correct Incorrect Correct answer

At least 3 years
Correct Incorrect Correct answer

At least 10 years
Correct Incorrect Correct answer

Correct

Incorrect
Question 123 of 667

123. Question

Category: Federal Requirements: Dscsa

Which entities are considered ‘trading partners’ under the DSCSA?

Manufacturers, repackagers, wholesale distributors, and dispensers
Correct Incorrect Correct answer

Manufacturers, insurance companies, wholesale distributors, and dispensers
Correct Incorrect Correct answer

Manufacturers, repackagers, prescribers, and dispensers
Correct Incorrect Correct answer

Manufacturers, pharmacy benefit managers, wholesale distributors, and dispensers
Correct Incorrect Correct answer

Correct

Incorrect
Question 124 of 667

124. Question

Category: Federal Requirements: Dscsa

In what year was the Drug Supply Chain Security Act (DSCSA) signed into law?

2013
Correct Incorrect Correct answer

2010
Correct Incorrect Correct answer

2015
Correct Incorrect Correct answer

2018
Correct Incorrect Correct answer

Correct

Incorrect
Question 125 of 667

125. Question

Category: Federal Requirements: Dscsa

What type of barcode must be used to encode the product identifier on prescription drug packages under the DSCSA?

A 2D data matrix barcode
Correct Incorrect Correct answer

A standard linear UPC barcode
Correct Incorrect Correct answer

A QR code linked to the FDA database
Correct Incorrect Correct answer

An RFID chip embedded in the packaging
Correct Incorrect Correct answer

Correct

Incorrect
Question 126 of 667

126. Question

Category: Federal Requirements: Dscsa

Within what timeframe must an illegitimate product be reported to the FDA and trading partners under the DSCSA?

Within 24 hours of determination
Correct Incorrect Correct answer

Within 48 hours of determination
Correct Incorrect Correct answer

Within 72 hours of determination
Correct Incorrect Correct answer

Within 7 business days of determination
Correct Incorrect Correct answer

Correct

Incorrect
Question 127 of 667

127. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a shipment of medication and notices the packaging appears tampered with. What is the first action the pharmacy should take under the DSCSA?

Quarantine the product immediately to prevent distribution
Correct Incorrect Correct answer

Contact the FDA to report the product as illegitimate
Correct Incorrect Correct answer

Return the product to the wholesale distributor for replacement
Correct Incorrect Correct answer

Dispense the product while the investigation is ongoing
Correct Incorrect Correct answer

Correct

Incorrect
Question 128 of 667

128. Question

Category: Federal Requirements: Dscsa

A pharmacy technician discovers that a product’s serialized barcode does not match the transaction information provided by the wholesaler. How should this product be classified under the DSCSA?

As a suspect product requiring quarantine and investigation
Correct Incorrect Correct answer

As an illegitimate product requiring immediate destruction
Correct Incorrect Correct answer

As a recalled product requiring return to the manufacturer
Correct Incorrect Correct answer

As an expired product requiring removal from inventory
Correct Incorrect Correct answer

Correct

Incorrect
Question 129 of 667

129. Question

Category: Federal Requirements: Dscsa

A wholesale distributor receives a returned product from a pharmacy. What must the distributor do before redistributing this product?

Verify the product identifier of the returned product
Correct Incorrect Correct answer

Obtain a new prescription order for the returned product
Correct Incorrect Correct answer

Send the product back to the manufacturer for repackaging
Correct Incorrect Correct answer

Conduct a physical inspection of the product contents only
Correct Incorrect Correct answer

Correct

Incorrect
Question 130 of 667

130. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a verification request from a trading partner regarding a specific product’s transaction history. How quickly must the pharmacy respond under the DSCSA?

Within 24 hours
Correct Incorrect Correct answer

Within 48 hours
Correct Incorrect Correct answer

Within 5 business days
Correct Incorrect Correct answer

Within 30 calendar days
Correct Incorrect Correct answer

Correct

Incorrect
Question 131 of 667

131. Question

Category: Federal Requirements: Dscsa

A pharmacy identifies 20 suspect packages during a shipment inspection. Under DSCSA verification sampling requirements, what is the minimum number of packages the pharmacy must verify?

3 packages
Correct Incorrect Correct answer

1 package
Correct Incorrect Correct answer

2 packages
Correct Incorrect Correct answer

20 packages
Correct Incorrect Correct answer

Correct

Incorrect
Question 132 of 667

132. Question

Category: Federal Requirements: Dscsa

A manufacturer ships a new prescription drug product to a wholesale distributor. Which document attests that the manufacturer is authorized to engage in the transaction and did not knowingly ship a suspect product?

The transaction statement
Correct Incorrect Correct answer

The transaction information
Correct Incorrect Correct answer

The transaction history
Correct Incorrect Correct answer

The product verification report
Correct Incorrect Correct answer

Correct

Incorrect
Question 133 of 667

133. Question

Category: Federal Requirements: Dscsa

A pharmacy confirms that a quarantined product is counterfeit after completing its investigation. What must the pharmacy do with this product?

Remove it from the supply chain and arrange for destruction or return
Correct Incorrect Correct answer

Place it back in inventory after relabeling with correct information
Correct Incorrect Correct answer

Sell it at a discounted price with a disclosure to the patient
Correct Incorrect Correct answer

Transfer it to another pharmacy that has different verification systems
Correct Incorrect Correct answer

Correct

Incorrect
Question 134 of 667

134. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a drug shipment but the T3 documentation is incomplete, missing the transaction history. What should the pharmacy do?

Contact the trading partner to obtain the complete transaction history before accepting the shipment
Correct Incorrect Correct answer

Accept the shipment and request the documentation within 30 days
Correct Incorrect Correct answer

Dispense the product since the transaction information is sufficient
Correct Incorrect Correct answer

File the incomplete documentation and proceed with normal operations
Correct Incorrect Correct answer

Correct

Incorrect
Question 135 of 667

135. Question

Category: Federal Requirements: Dscsa

A repackager receives bulk medication from a manufacturer and repackages it into smaller units for distribution. What serialization requirement applies to the repackager under the DSCSA?

The repackager must affix a new product identifier on each repackaged unit
Correct Incorrect Correct answer

The repackager may use the original manufacturer's product identifier
Correct Incorrect Correct answer

The repackager is exempt from serialization if the lot number is unchanged
Correct Incorrect Correct answer

The repackager only needs to serialize packages containing controlled substances
Correct Incorrect Correct answer

Correct

Incorrect
Question 136 of 667

136. Question

Category: Federal Requirements: Dscsa

A pharmacy technician receives a shipment from a wholesale distributor. Which of the following is included in the transaction information provided with the shipment?

The drug name, NDC, container size, number of containers, and lot number
Correct Incorrect Correct answer

The wholesale acquisition cost and the pharmacy's purchase price
Correct Incorrect Correct answer

The names of the pharmacists authorized to dispense the product
Correct Incorrect Correct answer

The clinical indications and contraindications for the medication
Correct Incorrect Correct answer

Correct

Incorrect
Question 137 of 667

137. Question

Category: Federal Requirements: Dscsa

Under the DSCSA, which format must be used for exchanging T3 documentation between trading partners?

Electronic format using standardized systems such as EPCIS
Correct Incorrect Correct answer

Paper documentation with original signatures from authorized personnel
Correct Incorrect Correct answer

PDF files transmitted through email between trading partner contacts
Correct Incorrect Correct answer

Manual spreadsheets shared through secure file transfer protocols
Correct Incorrect Correct answer

Correct

Incorrect
Question 138 of 667

138. Question

Category: Federal Requirements: Dscsa

A pharmacy investigates a suspect product and determines that it is actually legitimate after verifying the product identifier and confirming the transaction documentation with the wholesaler. What should the pharmacy do next?

Document the investigation and return the product to saleable inventory
Correct Incorrect Correct answer

Notify the FDA that the investigation found no issues within 24 hours
Correct Incorrect Correct answer

Destroy the product because it was classified as suspect at any point
Correct Incorrect Correct answer

Return the product to the wholesaler for independent verification
Correct Incorrect Correct answer

Correct

Incorrect
Question 139 of 667

139. Question

Category: Federal Requirements: Dscsa

A small independent pharmacy with 8 staff members (pharmacists and technicians combined) needs to comply with DSCSA package-level tracing requirements. Based on the phased compliance schedule, what is their deadline?

November 27, 2026
Correct Incorrect Correct answer

November 27, 2025
Correct Incorrect Correct answer

May 27, 2025
Correct Incorrect Correct answer

August 27, 2025
Correct Incorrect Correct answer

Correct

Incorrect
Question 140 of 667

140. Question

Category: Federal Requirements: Dscsa

A wholesale distributor receives a product with a valid product identifier but no transaction history documenting the chain of custody back to the manufacturer. The transaction information and transaction statement are both present. How should the distributor handle this situation?

Treat the product as suspect because the T3 documentation is incomplete
Correct Incorrect Correct answer

Accept the product because two of the three T3 documents are sufficient
Correct Incorrect Correct answer

Accept the product and generate a new transaction history internally
Correct Incorrect Correct answer

Return the product to the manufacturer for serialization verification only
Correct Incorrect Correct answer

Correct

Incorrect
Question 141 of 667

141. Question

Category: Federal Requirements: Dscsa

A hospital pharmacy transfers medication between two of its own facilities, both owned by the same parent organization. Which DSCSA requirement applies to this transfer?

The transfer is exempt from DSCSA requirements as an intracompany transfer
Correct Incorrect Correct answer

Full T3 documentation must be exchanged between the two facilities
Correct Incorrect Correct answer

Only the transaction statement is required for internal transfers
Correct Incorrect Correct answer

The transfer requires FDA notification within 24 hours of the shipment
Correct Incorrect Correct answer

Correct

Incorrect
Question 142 of 667

142. Question

Category: Federal Requirements: Dscsa

A pharmacy determines that a product in its inventory is illegitimate. The pharmacy notifies the FDA and the wholesale distributor that supplied the product, but does not notify the physician’s office that purchased some of the same lot. Has the pharmacy met its DSCSA notification obligations?

No, because the pharmacy must also notify the entity to whom the product was sold
Correct Incorrect Correct answer

Yes, because notifying the FDA and the immediate supplier is sufficient
Correct Incorrect Correct answer

Yes, because physician's offices are not considered trading partners under DSCSA
Correct Incorrect Correct answer

No, because the pharmacy must also notify the state board of pharmacy
Correct Incorrect Correct answer

Correct

Incorrect
Question 143 of 667

143. Question

Category: Federal Requirements: Dscsa

A manufacturer discovers that one of its products has been intentionally adulterated before reaching the wholesale distributor. Under the DSCSA, what distinguishes this product as illegitimate rather than suspect?

The product has been confirmed to be adulterated through investigation
Correct Incorrect Correct answer

The product was identified by the manufacturer rather than a pharmacy
Correct Incorrect Correct answer

The product was intercepted before reaching the wholesale distributor
Correct Incorrect Correct answer

The product was part of a lot containing more than 100 units
Correct Incorrect Correct answer

Correct

Incorrect
Question 144 of 667

144. Question

Category: Federal Requirements: Fda Recalls

Which FDA recall classification indicates a reasonable probability of serious adverse health consequences or death?

Class I
Correct Incorrect Correct answer

Class II
Correct Incorrect Correct answer

Class III
Correct Incorrect Correct answer

Market withdrawal
Correct Incorrect Correct answer

Correct

Incorrect
Question 145 of 667

145. Question

Category: Federal Requirements: Fda Recalls

What is the definition of a Class II FDA recall?

A situation where exposure to a product may cause temporary or medically reversible adverse health consequences
Correct Incorrect Correct answer

A situation where exposure to a product is not likely to cause adverse health consequences
Correct Incorrect Correct answer

A situation where there is a reasonable probability of serious health consequences or death
Correct Incorrect Correct answer

A situation where a product has a minor violation that does not warrant FDA legal action
Correct Incorrect Correct answer

Correct

Incorrect
Question 146 of 667

146. Question

Category: Federal Requirements: Fda Recalls

Which form is used by healthcare professionals for voluntary adverse event reporting to the FDA through MedWatch?

FDA Form 3500
Correct Incorrect Correct answer

FDA Form 3500A
Correct Incorrect Correct answer

FDA Form 222
Correct Incorrect Correct answer

FDA Form 1040
Correct Incorrect Correct answer

Correct

Incorrect
Question 147 of 667

147. Question

Category: Federal Requirements: Fda Recalls

What is the most common type of drug recall initiated in the United States?

Voluntary recall by the manufacturer
Correct Incorrect Correct answer

FDA-mandated recall ordered by the commissioner
Correct Incorrect Correct answer

State board of pharmacy-ordered recall
Correct Incorrect Correct answer

DEA-initiated recall for controlled substances
Correct Incorrect Correct answer

Correct

Incorrect
Question 148 of 667

148. Question

Category: Federal Requirements: Fda Recalls

Which piece of information found on the drug label allows the manufacturer to identify a specific batch during a recall?

Lot number
Correct Incorrect Correct answer

National Drug Code
Correct Incorrect Correct answer

Barcode serial number
Correct Incorrect Correct answer

Manufacturer phone number
Correct Incorrect Correct answer

Correct

Incorrect
Question 149 of 667

149. Question

Category: Federal Requirements: Fda Recalls

Which FDA recall classification is the least serious and involves products not likely to cause adverse health consequences?

Class III
Correct Incorrect Correct answer

Class I
Correct Incorrect Correct answer

Class II
Correct Incorrect Correct answer

Market withdrawal
Correct Incorrect Correct answer

Correct

Incorrect
Question 150 of 667

150. Question

Category: Federal Requirements: Fda Recalls

What is the name of the FDA’s safety information and adverse event reporting program?

MedWatch
Correct Incorrect Correct answer

VAERS
Correct Incorrect Correct answer

MedGuard
Correct Incorrect Correct answer

SafetyNet
Correct Incorrect Correct answer

Correct

Incorrect
Question 151 of 667

151. Question

Category: Federal Requirements: Fda Recalls

What is the phone number for reporting adverse events to the FDA MedWatch program?

1-800-FDA-1088
Correct Incorrect Correct answer

1-800-822-7967
Correct Incorrect Correct answer

1-800-332-1088
Correct Incorrect Correct answer

1-800-FDA-4636
Correct Incorrect Correct answer

Correct

Incorrect
Question 152 of 667

152. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives notification that a blood pressure medication has been recalled due to contamination with a known carcinogen above acceptable limits. Which recall classification does this most likely represent?

Class I recall
Correct Incorrect Correct answer

Class II recall
Correct Incorrect Correct answer

Class III recall
Correct Incorrect Correct answer

Market withdrawal
Correct Incorrect Correct answer

Correct

Incorrect
Question 153 of 667

153. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician discovers that a product on the shelf matches a recall notice for lot number 2025A47. What should the technician do first?

Remove the product from the shelf and quarantine it separately from other inventory
Correct Incorrect Correct answer

Dispense the remaining stock and then remove the product from the shelf
Correct Incorrect Correct answer

Destroy the product immediately and discard it in the regular trash
Correct Incorrect Correct answer

Return the product to its original location and wait for the pharmacist to review it next week
Correct Incorrect Correct answer

Correct

Incorrect
Question 154 of 667

154. Question

Category: Federal Requirements: Fda Recalls

A manufacturer issues a recall for a specific antibiotic. Which identifier should the pharmacy technician use to determine whether the pharmacy’s stock is affected?

The lot number printed on the product packaging
Correct Incorrect Correct answer

The drug's therapeutic classification code
Correct Incorrect Correct answer

The wholesaler's purchase order number
Correct Incorrect Correct answer

The pharmacy's internal shelf location label
Correct Incorrect Correct answer

Correct

Incorrect
Question 155 of 667

155. Question

Category: Federal Requirements: Fda Recalls

A tablet product is recalled because it does not meet dissolution specifications, which may reduce its effectiveness but is unlikely to cause serious harm. What recall classification applies?

Class II recall
Correct Incorrect Correct answer

Class I recall
Correct Incorrect Correct answer

Class III recall
Correct Incorrect Correct answer

Market withdrawal
Correct Incorrect Correct answer

Correct

Incorrect
Question 156 of 667

156. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician is checking inventory against a Class I recall notice. Which combination of identifiers should the technician compare to the recall notice?

Product name, NDC number, lot number, and expiration date
Correct Incorrect Correct answer

Product name, wholesale price, and quantity on hand
Correct Incorrect Correct answer

Product name, DEA number, and storage temperature
Correct Incorrect Correct answer

Product name, manufacturer phone number, and shelf location
Correct Incorrect Correct answer

Correct

Incorrect
Question 157 of 667

157. Question

Category: Federal Requirements: Fda Recalls

A pharmacy has already dispensed a medication to several patients before receiving a Class I recall notification. What action should the pharmacy take regarding those patients?

Contact the patients to inform them of the recall and provide instructions on what to do
Correct Incorrect Correct answer

Wait for the patients to contact the pharmacy during their next refill
Correct Incorrect Correct answer

Post a notice in the pharmacy window and take no further action
Correct Incorrect Correct answer

Report the patients' names directly to the FDA for follow-up
Correct Incorrect Correct answer

Correct

Incorrect
Question 158 of 667

158. Question

Category: Federal Requirements: Fda Recalls

A product is found to have a packaging defect that does not compromise the integrity of the medication inside. Which FDA action most likely applies?

Class III recall
Correct Incorrect Correct answer

Class I recall
Correct Incorrect Correct answer

Class II recall
Correct Incorrect Correct answer

FDA-mandated recall
Correct Incorrect Correct answer

Correct

Incorrect
Question 159 of 667

159. Question

Category: Federal Requirements: Fda Recalls

A manufacturer voluntarily removes a product from the market due to a minor violation that would not warrant FDA legal action. What is this action called?

Market withdrawal
Correct Incorrect Correct answer

Class III recall
Correct Incorrect Correct answer

Medical device safety alert
Correct Incorrect Correct answer

Voluntary recall
Correct Incorrect Correct answer

Correct

Incorrect
Question 160 of 667

160. Question

Category: Federal Requirements: Fda Recalls

After removing recalled products from the pharmacy shelves, the pharmacy technician should take which additional step?

Document the recalled products including lot numbers, quantities, and the date they were removed
Correct Incorrect Correct answer

Place the recalled products back on the shelf with a warning sticker
Correct Incorrect Correct answer

Dispose of the recalled products in the pharmacy biohazard waste container
Correct Incorrect Correct answer

Transfer the recalled products to the pharmacy's controlled substance safe
Correct Incorrect Correct answer

Correct

Incorrect
Question 161 of 667

161. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician notices that an injectable product has been recalled because it was contaminated with bacteria that could cause life-threatening infections. This product should be handled as which type of recall?

Class I recall requiring removal at the consumer level
Correct Incorrect Correct answer

Class II recall requiring removal at the retail level only
Correct Incorrect Correct answer

Class III recall requiring a label correction at the wholesale level
Correct Incorrect Correct answer

Market withdrawal requiring the manufacturer to issue a press release
Correct Incorrect Correct answer

Correct

Incorrect
Question 162 of 667

162. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives a recall notification for a specific NDC and lot number. After checking inventory, the technician finds the product but with a different lot number than the one listed in the recall. What should the technician do?

Keep the product on the shelf because only the specific recalled lot numbers are affected
Correct Incorrect Correct answer

Remove the product from the shelf because the NDC matches the recall notice
Correct Incorrect Correct answer

Contact the FDA directly to request an updated recall notice
Correct Incorrect Correct answer

Return the product to the wholesaler for credit immediately
Correct Incorrect Correct answer

Correct

Incorrect
Question 163 of 667

163. Question

Category: Federal Requirements: Fda Recalls

A pharmacy received a recall notice for metformin 500 mg tablets, lot #M2025-88. The technician finds three bottles of metformin 500 mg on the shelf: one with lot #M2025-88, one with lot #M2025-92, and one with lot #M2024-15. How many bottles should the technician remove from inventory?

One bottle, because only lot #M2025-88 matches the recall
Correct Incorrect Correct answer

Two bottles, because lots #M2025-88 and #M2025-92 are from the same year
Correct Incorrect Correct answer

Three bottles, because all bottles share the same drug name and strength
Correct Incorrect Correct answer

Zero bottles, because metformin is available from multiple manufacturers
Correct Incorrect Correct answer

Correct

Incorrect
Question 164 of 667

164. Question

Category: Federal Requirements: Fda Recalls

A pharmacy dispensed lisinopril 10 mg tablets from lot #L5577 to 40 patients over the past month. The pharmacy now receives a Class I recall for that lot due to the presence of a toxic impurity. The pharmacy staff should prioritize which action?

Contacting all 40 patients who received the recalled lot to inform them and provide guidance
Correct Incorrect Correct answer

Waiting until the patients come in for their next refill to notify them at the counter
Correct Incorrect Correct answer

Sending a general newsletter to all pharmacy patients about the importance of checking medications
Correct Incorrect Correct answer

Filing a MedWatch report before attempting to reach any patients
Correct Incorrect Correct answer

Correct

Incorrect
Question 165 of 667

165. Question

Category: Federal Requirements: Fda Recalls

A manufacturer removes a vitamin supplement from the market because the label lists an incorrect flavor description, though the product is otherwise safe and effective. A pharmacy technician asks whether this qualifies as a recall. Which response is most accurate?

This is a market withdrawal because the minor violation would not warrant FDA legal action
Correct Incorrect Correct answer

This is a Class III recall because the labeling contains an error
Correct Incorrect Correct answer

This is a Class II recall because labeling errors may cause temporary harm
Correct Incorrect Correct answer

This is a Class I recall because the product is mislabeled
Correct Incorrect Correct answer

Correct

Incorrect
Question 166 of 667

166. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician is processing three separate recall notices. Recall A involves a mislabeled drug strength that could cause fatal overdose. Recall B involves microbial contamination unlikely to be life-threatening. Recall C involves a container closure defect with minimal impact. In which order should the technician address these recalls by priority?

Recall A first, then Recall B, then Recall C
Correct Incorrect Correct answer

Recall C first, then Recall B, then Recall A
Correct Incorrect Correct answer

Recall B first, then Recall A, then Recall C
Correct Incorrect Correct answer

Address all three recalls simultaneously with equal priority
Correct Incorrect Correct answer

Correct

Incorrect
Question 167 of 667

167. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician is reviewing recall documentation and finds that a recalled product was returned to the wholesaler but no record was kept of the quantity returned, the lot numbers, or the date. Which statement best describes the problem with this situation?

The pharmacy cannot demonstrate compliance with the recall because proper documentation was not maintained
Correct Incorrect Correct answer

The pharmacy is in full compliance because the product was successfully removed from inventory
Correct Incorrect Correct answer

The pharmacy only needs to document recalls for Class I products, so this may not be an issue
Correct Incorrect Correct answer

The wholesaler is solely responsible for maintaining recall documentation after the product is returned
Correct Incorrect Correct answer

Correct

Incorrect
Question 168 of 667

168. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives a recall notification and a MedWatch safety alert on the same day for two different medications. The recall is a Class III for a minor labeling error. The MedWatch alert warns of newly discovered serious cardiac risks associated with a commonly dispensed medication that is not being recalled. Which situation should the pharmacy prioritize for immediate clinical action?

The MedWatch safety alert, because it involves a serious safety risk to patients currently taking the medication
Correct Incorrect Correct answer

The Class III recall, because all FDA recalls take precedence over MedWatch alerts
Correct Incorrect Correct answer

The Class III recall, because labeling errors always require immediate patient notification
Correct Incorrect Correct answer

Neither situation requires immediate action because the MedWatch alert is only informational
Correct Incorrect Correct answer

Correct

Incorrect
Question 169 of 667

169. Question

Category: Federal Requirements: Dea Schedules

Which of the following drugs is classified as a Schedule I controlled substance under federal law?

Heroin
Correct Incorrect Correct answer

Morphine
Correct Incorrect Correct answer

Ketamine
Correct Incorrect Correct answer

Tramadol
Correct Incorrect Correct answer

Correct

Incorrect
Question 170 of 667

170. Question

Category: Federal Requirements: Dea Schedules

How many refills are permitted for a Schedule II controlled substance prescription?

No refills are permitted
Correct Incorrect Correct answer

Up to 5 refills in 6 months
Correct Incorrect Correct answer

Up to 3 refills in 6 months
Correct Incorrect Correct answer

Up to 1 refill in 30 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 171 of 667

171. Question

Category: Federal Requirements: Dea Schedules

What is the maximum number of refills allowed for a Schedule III controlled substance within the permitted time frame?

5 refills within 6 months of the date issued
Correct Incorrect Correct answer

3 refills within 6 months of the date issued
Correct Incorrect Correct answer

5 refills within 12 months of the date issued
Correct Incorrect Correct answer

6 refills within 6 months of the date issued
Correct Incorrect Correct answer

Correct

Incorrect
Question 172 of 667

172. Question

Category: Federal Requirements: Dea Schedules

Which controlled substance schedule includes pregabalin (Lyrica)?

Schedule V
Correct Incorrect Correct answer

Schedule II
Correct Incorrect Correct answer

Schedule III
Correct Incorrect Correct answer

Schedule IV
Correct Incorrect Correct answer

Correct

Incorrect
Question 173 of 667

173. Question

Category: Federal Requirements: Dea Schedules

What is the first letter of a DEA number assigned to a physician?

A or B
Correct Incorrect Correct answer

F or G
Correct Incorrect Correct answer

M or N
Correct Incorrect Correct answer

D or E
Correct Incorrect Correct answer

Correct

Incorrect
Question 174 of 667

174. Question

Category: Federal Requirements: Dea Schedules

Which schedule was hydrocodone combination products reclassified into in 2014?

Schedule II
Correct Incorrect Correct answer

Schedule I
Correct Incorrect Correct answer

Schedule III
Correct Incorrect Correct answer

Schedule IV
Correct Incorrect Correct answer

Correct

Incorrect
Question 175 of 667

175. Question

Category: Federal Requirements: Dea Schedules

Which of the following is classified as a Schedule IV controlled substance?

Zolpidem (Ambien)
Correct Incorrect Correct answer

Pregabalin (Lyrica)
Correct Incorrect Correct answer

Buprenorphine (Subutex)
Correct Incorrect Correct answer

Oxycodone (OxyContin)
Correct Incorrect Correct answer

Correct

Incorrect
Question 176 of 667

176. Question

Category: Federal Requirements: Dea Schedules

Which of the following is a Schedule III controlled substance?

Testosterone
Correct Incorrect Correct answer

Alprazolam
Correct Incorrect Correct answer

Methylphenidate
Correct Incorrect Correct answer

Lacosamide
Correct Incorrect Correct answer

Correct

Incorrect
Question 177 of 667

177. Question

Category: Federal Requirements: Dea Schedules

A prescriber calls in a prescription for lorazepam 1 mg, #30, with 2 refills. What action should the pharmacy technician take?

Accept the verbal prescription and process it with 2 refills
Correct Incorrect Correct answer

Reject the prescription because Schedule IV drugs require a written prescription
Correct Incorrect Correct answer

Accept the prescription but remove the refills since controlled substances cannot be refilled
Correct Incorrect Correct answer

Inform the prescriber that a DEA Form 222 is needed before dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 178 of 667

178. Question

Category: Federal Requirements: Dea Schedules

A patient presents a prescription for oxycodone 10 mg #60 and asks the technician to transfer the remaining quantity to another pharmacy. What should the technician communicate?

Schedule II prescriptions cannot be transferred between pharmacies for refill purposes
Correct Incorrect Correct answer

The transfer can be completed one time between pharmacies
Correct Incorrect Correct answer

The prescription can be transferred up to 5 times within 6 months
Correct Incorrect Correct answer

The transfer requires approval from the DEA regional office
Correct Incorrect Correct answer

Correct

Incorrect
Question 179 of 667

179. Question

Category: Federal Requirements: Dea Schedules

A pharmacy receives a faxed prescription for methylphenidate 20 mg for a 12-year-old patient. Under federal law, how should the pharmacy handle this prescription?

The faxed prescription may serve as a record but the original written or electronic prescription must be received before dispensing
Correct Incorrect Correct answer

The faxed prescription is sufficient to dispense the medication immediately
Correct Incorrect Correct answer

The pharmacy must return the fax and request a DEA Form 222 instead
Correct Incorrect Correct answer

The pharmacy may dispense if the prescriber provides verbal confirmation by phone
Correct Incorrect Correct answer

Correct

Incorrect
Question 180 of 667

180. Question

Category: Federal Requirements: Dea Schedules

A prescriber writes a prescription for tramadol 50 mg #90 with 5 refills. What should the pharmacy technician verify regarding the refills?

Confirm that 5 refills is acceptable because tramadol is a Schedule IV drug and may have up to 5 refills in 6 months
Correct Incorrect Correct answer

Reject the prescription because tramadol is Schedule II and refills are not permitted
Correct Incorrect Correct answer

Contact the prescriber because tramadol is limited to 3 refills
Correct Incorrect Correct answer

Reduce the refills to 2 because tramadol has additional prescribing restrictions
Correct Incorrect Correct answer

Correct

Incorrect
Question 181 of 667

181. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is verifying a DEA number for Dr. Smith: BS1234563. What is the correct method to validate the check digit?

Add the 1st, 3rd, and 5th digits; add the 2nd, 4th, and 6th digits and multiply that sum by 2; add both results; the last digit should equal the 7th digit
Correct Incorrect Correct answer

Divide all seven digits by 2 and verify the remainder equals zero
Correct Incorrect Correct answer

Add all seven digits together and confirm the total is an even number
Correct Incorrect Correct answer

Multiply the 1st, 3rd, and 5th digits by 2 and add to the 2nd, 4th, and 6th digits
Correct Incorrect Correct answer

Correct

Incorrect
Question 182 of 667

182. Question

Category: Federal Requirements: Dea Schedules

A patient on hospice care has a faxed prescription for morphine sulfate 15 mg immediate-release tablets. How should the pharmacy process this prescription?

Dispense the medication because a faxed Schedule II prescription for a hospice patient may serve as the original prescription
Correct Incorrect Correct answer

Hold the prescription until the original written prescription is received from the hospice
Correct Incorrect Correct answer

Return the fax and request an electronic prescription instead
Correct Incorrect Correct answer

Contact the DEA for authorization before dispensing to a hospice patient
Correct Incorrect Correct answer

Correct

Incorrect
Question 183 of 667

183. Question

Category: Federal Requirements: Dea Schedules

A pharmacy receives a prescription for Adderall (amphetamine salts) 20 mg #30. The patient can only afford 15 tablets today. What should the technician know about partial filling?

The remaining 15 tablets may be dispensed within 72 hours, or within 30 days for certain qualifying patients under current federal rules
Correct Incorrect Correct answer

Partial filling is not permitted for Schedule II drugs under any circumstances
Correct Incorrect Correct answer

The remaining quantity must be dispensed within 24 hours or the balance is forfeited
Correct Incorrect Correct answer

The patient must obtain a new prescription for the remaining 15 tablets
Correct Incorrect Correct answer

Correct

Incorrect
Question 184 of 667

184. Question

Category: Federal Requirements: Dea Schedules

A patient brings in a prescription for carisoprodol (Soma) 350 mg and asks if refills are available. The prescription was written with 3 refills. What is the correct response?

The prescription can be refilled up to 3 times within 6 months of the date it was written
Correct Incorrect Correct answer

Carisoprodol is not a controlled substance, so refills are unlimited
Correct Incorrect Correct answer

Carisoprodol is Schedule II and cannot be refilled
Correct Incorrect Correct answer

Carisoprodol refills require a new written prescription from the prescriber each time
Correct Incorrect Correct answer

Correct

Incorrect
Question 185 of 667

185. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician receives a phone call from a prescriber requesting an emergency supply of fentanyl patches for a patient in severe pain. What federal requirement applies?

The prescriber must provide a written or electronic follow-up prescription within 7 days
Correct Incorrect Correct answer

Emergency oral prescriptions are not permitted for Schedule II substances
Correct Incorrect Correct answer

The prescriber must provide a follow-up prescription within 24 hours
Correct Incorrect Correct answer

The pharmacy must obtain DEA preauthorization before dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 186 of 667

186. Question

Category: Federal Requirements: Dea Schedules

A pharmacy wants to transfer the remaining 2 refills of a diazepam prescription to another pharmacy. How many times can this transfer occur under federal law?

One time only, unless the pharmacies share a real-time online database
Correct Incorrect Correct answer

Transfers are not allowed for any controlled substance prescriptions
Correct Incorrect Correct answer

Up to 3 times within the 6-month prescription validity period
Correct Incorrect Correct answer

An unlimited number of times as long as refills remain
Correct Incorrect Correct answer

Correct

Incorrect
Question 187 of 667

187. Question

Category: Federal Requirements: Dea Schedules

A technician discovers that a DEA number listed on a prescription for Dr. Anderson starts with the letter “M.” What does this indicate about the prescriber?

The prescriber is a mid-level practitioner such as a nurse practitioner or physician assistant
Correct Incorrect Correct answer

The prescriber is a medical doctor specializing in pain management
Correct Incorrect Correct answer

The prescriber is a manufacturer authorized to distribute controlled substances
Correct Incorrect Correct answer

The prescriber holds a military-specific DEA registration
Correct Incorrect Correct answer

Correct

Incorrect
Question 188 of 667

188. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician notices a prescription for buprenorphine/naloxone (Suboxone) 8 mg/2 mg sublingual film with 6 refills authorized. What error should be identified?

The prescription exceeds the maximum of 5 refills allowed within 6 months for a Schedule III drug
Correct Incorrect Correct answer

Buprenorphine/naloxone is Schedule II and cannot have any refills
Correct Incorrect Correct answer

Suboxone requires a DEA Form 222 before it can be dispensed to the patient
Correct Incorrect Correct answer

The prescriber must include a special waiver number on the prescription to dispense buprenorphine
Correct Incorrect Correct answer

Correct

Incorrect
Question 189 of 667

189. Question

Category: Federal Requirements: Dea Schedules

A technician is validating the DEA number for Dr. Lee: BL2461739. After performing the check digit calculation, which conclusion is correct? (Step 1: 2+6+7=15; Step 2: (4+1+3) x 2=16; Step 3: 15+16=31)

The DEA number is not valid because the check digit should be 1, but the number ends in 9
Correct Incorrect Correct answer

The DEA number is valid because the check digit matches the last digit
Correct Incorrect Correct answer

The DEA number is invalid because the second letter should match the first name
Correct Incorrect Correct answer

The DEA number is not valid because the first letter should be M for all prescribers
Correct Incorrect Correct answer

Correct

Incorrect
Question 190 of 667

190. Question

Category: Federal Requirements: Dea Schedules

A pharmacy receives a prescription written 7 months ago for alprazolam 0.5 mg with 3 remaining refills. What should the pharmacy technician recognize about this situation?

The prescription has expired because Schedule IV prescriptions are only valid for 6 months from the date written
Correct Incorrect Correct answer

The prescription is still valid because it has unused refills remaining
Correct Incorrect Correct answer

The prescription can be filled one more time as a courtesy refill
Correct Incorrect Correct answer

The pharmacist may extend the prescription for an additional 6 months without prescriber authorization
Correct Incorrect Correct answer

Correct

Incorrect
Question 191 of 667

191. Question

Category: Federal Requirements: Dea Schedules

A patient presents prescriptions for methadone 10 mg (Schedule II) and pregabalin 75 mg (Schedule V) at the same time. The methadone prescription has a valid DEA number and is written on a proper prescription form. The pregabalin prescription was phoned in. Which statement accurately describes the processing of these two prescriptions?

Both prescriptions can be filled because methadone requires a written or electronic prescription and pregabalin as a Schedule V drug may be called in verbally
Correct Incorrect Correct answer

The methadone prescription cannot be filled because it must be electronically prescribed
Correct Incorrect Correct answer

The pregabalin prescription must be rejected because all controlled substances require a written prescription
Correct Incorrect Correct answer

The methadone prescription requires a DEA Form 222 before the pharmacy can dispense it
Correct Incorrect Correct answer

Correct

Incorrect
Question 192 of 667

192. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician reviews two prescriptions: one for codeine/acetaminophen (Tylenol #3) and one for a cough syrup containing 100 mg of codeine per 100 mL. Why are these products classified in different schedules?

Tylenol #3 is Schedule III because it contains less than 90 mg of codeine per dosage unit, while the cough syrup is Schedule V because it contains less than 200 mg of codeine per 100 mL
Correct Incorrect Correct answer

Both products should be classified as Schedule II because they contain codeine
Correct Incorrect Correct answer

Tylenol #3 is Schedule IV and the cough syrup is Schedule V based on their dosage forms
Correct Incorrect Correct answer

The cough syrup is Schedule III and Tylenol #3 is Schedule V based on total codeine content
Correct Incorrect Correct answer

Correct

Incorrect
Question 193 of 667

193. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is comparing prescription handling for ketamine (Schedule III) and fentanyl (Schedule II). A prescriber wants to phone in both prescriptions. Which analysis of the situation is correct?

The ketamine prescription may be accepted by phone, but the fentanyl prescription requires a written or electronic prescription unless it is an emergency
Correct Incorrect Correct answer

Both prescriptions may be accepted by phone because they are both controlled substances with accepted medical uses
Correct Incorrect Correct answer

The fentanyl prescription may be phoned in, but ketamine requires a written prescription due to its emerging abuse potential
Correct Incorrect Correct answer

Both prescriptions must be submitted electronically because federal law requires e-prescribing for all controlled substances
Correct Incorrect Correct answer

Correct

Incorrect
Question 194 of 667

194. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which federal law governs the management and disposal of hazardous pharmaceutical waste in pharmacy settings?

Resource Conservation and Recovery Act (RCRA)
Correct Incorrect Correct answer

Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)
Correct Incorrect Correct answer

Toxic Substances Control Act (TSCA)
Correct Incorrect Correct answer

Drug Supply Chain Security Act (DSCSA)
Correct Incorrect Correct answer

Correct

Incorrect
Question 195 of 667

195. Question

Category: Federal Requirements: Hazardous Waste Disposal

What color container is required for the disposal of RCRA hazardous pharmaceutical waste?

Black
Correct Incorrect Correct answer

Blue
Correct Incorrect Correct answer

White
Correct Incorrect Correct answer

Red
Correct Incorrect Correct answer

Correct

Incorrect
Question 196 of 667

196. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which RCRA hazardous waste list contains acutely hazardous drugs such as warfarin (greater than 0.3%), nicotine, and physostigmine?

P-list
Correct Incorrect Correct answer

U-list
Correct Incorrect Correct answer

D-list
Correct Incorrect Correct answer

K-list
Correct Incorrect Correct answer

Correct

Incorrect
Question 197 of 667

197. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which of the following is one of the four characteristics used to classify D-list hazardous waste under RCRA?

Ignitability
Correct Incorrect Correct answer

Volatility
Correct Incorrect Correct answer

Carcinogenicity
Correct Incorrect Correct answer

Bioaccumulation
Correct Incorrect Correct answer

Correct

Incorrect
Question 198 of 667

198. Question

Category: Federal Requirements: Hazardous Waste Disposal

Cyclophosphamide, daunorubicin, and mitomycin are found on which RCRA hazardous waste list?

U-list
Correct Incorrect Correct answer

P-list
Correct Incorrect Correct answer

D-list
Correct Incorrect Correct answer

K-list
Correct Incorrect Correct answer

Correct

Incorrect
Question 199 of 667

199. Question

Category: Federal Requirements: Hazardous Waste Disposal

What color container should be used for disposing of non-hazardous pharmaceutical waste?

Blue or white
Correct Incorrect Correct answer

Black
Correct Incorrect Correct answer

Red
Correct Incorrect Correct answer

Yellow
Correct Incorrect Correct answer

Correct

Incorrect
Question 200 of 667

200. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which of the following P-list drugs requires disposal as acutely hazardous waste when the entire container is discarded?

Arsenic trioxide
Correct Incorrect Correct answer

Cyclophosphamide
Correct Incorrect Correct answer

Methotrexate
Correct Incorrect Correct answer

Daunorubicin
Correct Incorrect Correct answer

Correct

Incorrect
Question 201 of 667

201. Question

Category: Federal Requirements: Hazardous Waste Disposal

A hazardous waste manifest is required when transporting hazardous pharmaceutical waste from a pharmacy. Which document must accompany the shipment?

EPA Uniform Hazardous Waste Manifest
Correct Incorrect Correct answer

DEA Form 222
Correct Incorrect Correct answer

FDA MedWatch Form 3500
Correct Incorrect Correct answer

State Board of Pharmacy Disposal Record
Correct Incorrect Correct answer

Correct

Incorrect
Question 202 of 667

202. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician is discarding an unused, full bottle of warfarin 5 mg tablets. Into which container should this waste be placed?

Black container for RCRA hazardous waste
Correct Incorrect Correct answer

Blue container for non-hazardous pharmaceutical waste
Correct Incorrect Correct answer

Red sharps container
Correct Incorrect Correct answer

Yellow chemotherapy waste container
Correct Incorrect Correct answer

Correct

Incorrect
Question 203 of 667

203. Question

Category: Federal Requirements: Hazardous Waste Disposal

A technician has an empty vial that previously contained cyclophosphamide. The vial has trace residue remaining. How should this vial be disposed of?

Place it in the trace chemotherapy waste container
Correct Incorrect Correct answer

Place it in the black RCRA hazardous waste container
Correct Incorrect Correct answer

Rinse it and discard in regular trash
Correct Incorrect Correct answer

Place it in the blue non-hazardous pharmaceutical waste container
Correct Incorrect Correct answer

Correct

Incorrect
Question 204 of 667

204. Question

Category: Federal Requirements: Hazardous Waste Disposal

A hospital pharmacy generates 800 kg of hazardous waste per month. What is this facility’s generator status under RCRA?

Small quantity generator (SQG)
Correct Incorrect Correct answer

Large quantity generator (LQG)
Correct Incorrect Correct answer

Very small quantity generator (VSQG)
Correct Incorrect Correct answer

Conditionally exempt small quantity generator (CESQG)
Correct Incorrect Correct answer

Correct

Incorrect
Question 205 of 667

205. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician discovers a partially used IV bag of daunorubicin. What is the proper disposal method for this bulk chemotherapy waste?

Place it in a black RCRA hazardous waste container
Correct Incorrect Correct answer

Place it in a yellow trace chemotherapy waste container
Correct Incorrect Correct answer

Place it in a blue non-hazardous pharmaceutical waste container
Correct Incorrect Correct answer

Flush the contents down a designated drain
Correct Incorrect Correct answer

Correct

Incorrect
Question 206 of 667

206. Question

Category: Federal Requirements: Hazardous Waste Disposal

A technician is cleaning up a spill of a nicotine patch that was damaged during dispensing. Which waste category applies to the disposal of this product?

P-list acutely hazardous waste
Correct Incorrect Correct answer

U-list toxic waste
Correct Incorrect Correct answer

D-list characteristic waste
Correct Incorrect Correct answer

Non-hazardous pharmaceutical waste
Correct Incorrect Correct answer

Correct

Incorrect
Question 207 of 667

207. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy is discarding expired metformin tablets. Metformin is not on the P-list, U-list, or K-list and does not exhibit RCRA hazardous characteristics. Where should these tablets be placed?

Blue or white non-hazardous pharmaceutical waste container
Correct Incorrect Correct answer

Black RCRA hazardous waste container
Correct Incorrect Correct answer

Regular trash receptacle
Correct Incorrect Correct answer

Yellow chemotherapy waste container
Correct Incorrect Correct answer

Correct

Incorrect
Question 208 of 667

208. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician is asked to label a hazardous waste container. Which information is required on the label?

The words 'Hazardous Waste,' the date accumulation began, and the hazards of the contents
Correct Incorrect Correct answer

The pharmacy name and DEA number only
Correct Incorrect Correct answer

The drug name, lot number, and beyond-use date
Correct Incorrect Correct answer

The manufacturer name and NDC number
Correct Incorrect Correct answer

Correct

Incorrect
Question 209 of 667

209. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy generates less than 100 kg of hazardous waste and less than 1 kg of acutely hazardous waste per month. What is this pharmacy’s generator classification?

Very small quantity generator (VSQG)
Correct Incorrect Correct answer

Small quantity generator (SQG)
Correct Incorrect Correct answer

Large quantity generator (LQG)
Correct Incorrect Correct answer

Exempt generator
Correct Incorrect Correct answer

Correct

Incorrect
Question 210 of 667

210. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician finds a drug on the NIOSH List of Hazardous Drugs. Does this automatically mean the drug must be disposed of as RCRA hazardous waste?

No, the NIOSH list and RCRA hazardous waste lists are separate and serve different purposes
Correct Incorrect Correct answer

Yes, all NIOSH hazardous drugs are also RCRA hazardous waste
Correct Incorrect Correct answer

Yes, but only if the drug is an antineoplastic agent
Correct Incorrect Correct answer

Yes, unless the drug is given orally rather than intravenously
Correct Incorrect Correct answer

Correct

Incorrect
Question 211 of 667

211. Question

Category: Federal Requirements: Hazardous Waste Disposal

A hospital pharmacy generates 150 kg of non-acutely hazardous waste and 1.5 kg of P-list acutely hazardous waste per month. Based on these quantities, what is the facility’s generator status?

Large quantity generator (LQG) due to the acutely hazardous waste quantity
Correct Incorrect Correct answer

Small quantity generator (SQG) based on total waste volume
Correct Incorrect Correct answer

Very small quantity generator (VSQG) because total waste is under 1,000 kg
Correct Incorrect Correct answer

Small quantity generator (SQG) because acutely hazardous waste is under 100 kg
Correct Incorrect Correct answer

Correct

Incorrect
Question 212 of 667

212. Question

Category: Federal Requirements: Hazardous Waste Disposal

A technician discovers that a coworker placed an expired bottle of mitomycin into a blue non-hazardous waste container. What is the most appropriate corrective action?

Remove the mitomycin from the blue container and place it in a black RCRA hazardous waste container
Correct Incorrect Correct answer

Leave it in the blue container since it is expired and no longer active
Correct Incorrect Correct answer

Move it to a red biohazard container for incineration
Correct Incorrect Correct answer

Document the error but leave the container contents undisturbed
Correct Incorrect Correct answer

Correct

Incorrect
Question 213 of 667

213. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician reviews the disposal records and notices that a manifest was not returned from the disposal facility within 35 days of shipment. What should the generator do next?

Contact the transporter or disposal facility to determine the status of the waste
Correct Incorrect Correct answer

No action is needed because the manifest has a 90-day return window
Correct Incorrect Correct answer

File a new manifest and ship a replacement load
Correct Incorrect Correct answer

Immediately notify the local police department
Correct Incorrect Correct answer

Correct

Incorrect
Question 214 of 667

214. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy is disposing of both expired warfarin tablets and expired lisinopril tablets. Warfarin is P-listed and lisinopril is not on any RCRA list. A technician proposes placing both medications in the same black hazardous waste container. Is this approach acceptable?

No, because mixing non-hazardous waste into a hazardous waste container increases disposal costs unnecessarily
Correct Incorrect Correct answer

Yes, because placing non-hazardous waste in a hazardous container is always permitted
Correct Incorrect Correct answer

No, because lisinopril becomes hazardous through contact with warfarin
Correct Incorrect Correct answer

Yes, because both are pharmaceutical waste and can share any waste container
Correct Incorrect Correct answer

Correct

Incorrect
Question 215 of 667

215. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician is training a new employee on hazardous waste procedures. The new employee asks why methotrexate appears on the NIOSH List of Hazardous Drugs but is not on the RCRA P-list or U-list. Which explanation best addresses this question?

The NIOSH list identifies drugs that pose occupational handling risks, while RCRA lists classify waste based on environmental and toxicity criteria for disposal
Correct Incorrect Correct answer

Methotrexate was removed from the RCRA lists due to a recent regulatory update
Correct Incorrect Correct answer

The NIOSH list only applies to injectable drugs, while RCRA applies to oral dosage forms
Correct Incorrect Correct answer

Methotrexate is excluded from RCRA because it is used to treat non-cancerous conditions
Correct Incorrect Correct answer

Correct

Incorrect
Question 216 of 667

216. Question

Category: Federal Requirements: Hazardous Waste Disposal

A large quantity generator pharmacy has been storing hazardous waste for 85 days. The waste disposal vendor cancels the scheduled pickup. What is the maximum additional time the pharmacy has to arrange alternative disposal before violating RCRA storage limits?

5 days
Correct Incorrect Correct answer

90 days
Correct Incorrect Correct answer

30 days
Correct Incorrect Correct answer

15 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 217 of 667

217. Question

Category: Federal Requirements: Dea Schedules

A nurse practitioner with a DEA number beginning with the letter “M” writes a prescription for hydromorphone 4 mg tablets in a state that grants full prescriptive authority to NPs. A pharmacy technician questions whether the NP can prescribe Schedule II substances. Which statement is correct?

The NP may prescribe Schedule II substances if authorized by state law and registered with the DEA
Correct Incorrect Correct answer

Mid-level practitioners are only permitted to prescribe Schedule III through V substances under federal law
Correct Incorrect Correct answer

The NP must have a collaborating physician co-sign the prescription before it can be dispensed
Correct Incorrect Correct answer

The DEA restricts NPs to prescribing a maximum 30-day supply of Schedule II drugs per prescription
Correct Incorrect Correct answer

Correct

Incorrect
Question 218 of 667

218. Question

Category: Federal Requirements: Dea Schedules

A physician assistant presents a prescription for oxycodone 15 mg in a state where PAs require a supervising physician to delegate controlled substance prescribing. The PA’s DEA number starts with “M” and the supervising physician’s name is not on the prescription. What should the pharmacy do?

Follow state law requirements, which may require the supervising physician's information on the prescription
Correct Incorrect Correct answer

Dispense the prescription because the PA has a valid DEA number, which is sufficient under all circumstances
Correct Incorrect Correct answer

Reject the prescription because physician assistants are not eligible for DEA registration
Correct Incorrect Correct answer

Contact the DEA regional office to verify whether the PA is authorized to prescribe
Correct Incorrect Correct answer

Correct

Incorrect
Question 219 of 667

219. Question

Category: Federal Requirements: Dea Schedules

A state recently rescheduled gabapentin as a Schedule V controlled substance, but gabapentin remains unscheduled under federal law. A patient from a neighboring state where gabapentin is unscheduled brings in a prescription for gabapentin. How should the dispensing pharmacy handle this situation?

Dispense gabapentin according to the Schedule V requirements of the state where the pharmacy is located
Correct Incorrect Correct answer

Dispense gabapentin as a non-controlled substance because federal scheduling takes precedence
Correct Incorrect Correct answer

Refuse to fill the prescription because the patient is from a state where it is unscheduled
Correct Incorrect Correct answer

Contact the DEA to determine which schedule applies before dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 220 of 667

220. Question

Category: Federal Requirements: Dea Schedules

A prescriber wants to begin transmitting electronic prescriptions for controlled substances (EPCS). Which requirement must the prescriber meet before sending EPCS prescriptions?

The prescriber must complete an identity-proofing process and use two-factor authentication when signing prescriptions
Correct Incorrect Correct answer

The prescriber must obtain a separate DEA number specifically designated for electronic prescribing
Correct Incorrect Correct answer

The prescriber must submit a written request to the DEA at least 90 days before using EPCS
Correct Incorrect Correct answer

The prescriber must use a fax machine as a backup for every electronic prescription sent
Correct Incorrect Correct answer

Correct

Incorrect
Question 221 of 667

221. Question

Category: Federal Requirements: Dea Schedules

A pharmacy’s EPCS system receives an electronic prescription for morphine sulfate 30 mg ER tablets. The system flags that the prescription lacks a valid digital signature. What should the pharmacy do?

Do not dispense the prescription because a valid digital signature is required for all EPCS prescriptions
Correct Incorrect Correct answer

Dispense the prescription because it was transmitted electronically and does not need a signature
Correct Incorrect Correct answer

Contact the prescriber to request a handwritten signature be faxed to the pharmacy
Correct Incorrect Correct answer

Override the system flag and dispense because electronic prescriptions are exempt from signature requirements
Correct Incorrect Correct answer

Correct

Incorrect
Question 222 of 667

222. Question

Category: Federal Requirements: Dea Schedules

A DEA registration for a retail pharmacy expires on June 30 of the current year. The pharmacy submits a renewal application on May 15 but has not received the renewed certificate by July 5. Can the pharmacy continue to dispense controlled substances after the expiration date?

Yes, if the renewal was submitted before the expiration date, the pharmacy may continue operations pending receipt of the new certificate
Correct Incorrect Correct answer

No, the pharmacy must cease all controlled substance activity immediately on July 1
Correct Incorrect Correct answer

Yes, but only for Schedule III through V substances until the certificate arrives
Correct Incorrect Correct answer

No, the pharmacy must obtain temporary authorization from the state board before dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 223 of 667

223. Question

Category: Federal Requirements: Dea Schedules

How often must a DEA registration be renewed for a retail pharmacy?

Every 3 years
Correct Incorrect Correct answer

Every year
Correct Incorrect Correct answer

Every 2 years
Correct Incorrect Correct answer

Every 5 years
Correct Incorrect Correct answer

Correct

Incorrect
Question 224 of 667

224. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician receives a prescription for alprazolam 1 mg #60 from a new prescriber. The technician verifies the DEA number and it passes the check digit algorithm. However, the technician notices the prescription quantity seems excessive for a first-time patient. What concept requires the pharmacist to evaluate the legitimacy of this prescription beyond the DEA number validation?

Corresponding responsibility, which obligates the pharmacist to ensure the prescription was issued for a legitimate medical purpose
Correct Incorrect Correct answer

Retrospective drug utilization review, which only applies after the medication has been dispensed
Correct Incorrect Correct answer

Therapeutic substitution authority, which allows the pharmacist to change the drug to a less addictive option
Correct Incorrect Correct answer

Collaborative practice agreement, which requires the pharmacist to contact the prescriber before every fill
Correct Incorrect Correct answer

Correct

Incorrect
Question 225 of 667

225. Question

Category: Federal Requirements: Dea Schedules

A pharmacy receives an EPCS prescription for a Schedule III controlled substance. The pharmacy’s electronic system is temporarily down. Can the pharmacy accept a phoned-in verbal prescription as an alternative?

Yes, Schedule III prescriptions may be accepted verbally regardless of whether the pharmacy has EPCS capability
Correct Incorrect Correct answer

No, once a pharmacy is EPCS-enabled, all controlled substance prescriptions must be received electronically
Correct Incorrect Correct answer

Yes, but only if the prescriber documents the system outage on a DEA exception form
Correct Incorrect Correct answer

No, the pharmacy must wait until the system is restored before accepting any controlled substance prescriptions
Correct Incorrect Correct answer

Correct

Incorrect
Question 226 of 667

226. Question

Category: Federal Requirements: Dea Schedules

A prescriber writes three separate prescriptions for oxycodone 30 mg, each dated today, with instructions to fill one immediately, one in 30 days, and one in 60 days. Under federal law, which statement about this practice is correct?

Federal law permits multiple Schedule II prescriptions on the same date with do-not-fill-before dates up to 90 days
Correct Incorrect Correct answer

Only one Schedule II prescription may be written per patient per office visit
Correct Incorrect Correct answer

The pharmacy must fill all three prescriptions on the same day or return the unfilled ones to the prescriber
Correct Incorrect Correct answer

Multiple Schedule II prescriptions on the same date are only allowed for hospice patients
Correct Incorrect Correct answer

Correct

Incorrect
Question 227 of 667

227. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives a prescription for fentanyl citrate 200 mcg oral transmucosal lozenge (Actiq). The patient is not enrolled in the TIRF REMS Access program. What action must the pharmacy take?

Do not dispense the medication until the patient, prescriber, and pharmacy are all enrolled in the TIRF REMS program
Correct Incorrect Correct answer

Dispense a 7-day starter supply and advise the patient to enroll within 30 days
Correct Incorrect Correct answer

Substitute a non-REMS fentanyl formulation such as a transdermal patch
Correct Incorrect Correct answer

Contact the prescriber for verbal confirmation that REMS enrollment is not required for this patient
Correct Incorrect Correct answer

Correct

Incorrect
Question 228 of 667

228. Question

Category: Federal Requirements: Restricted Drug Programs

A prescriber writes a prescription for mifepristone 200 mg for medical termination of pregnancy. Which REMS requirement applies specifically to the dispensing of mifepristone for this indication?

Mifepristone must be dispensed by or under the supervision of a certified prescriber and cannot be dispensed through retail pharmacies for this indication
Correct Incorrect Correct answer

Mifepristone requires monthly pregnancy testing before each dispensing, similar to the iPLEDGE program
Correct Incorrect Correct answer

Mifepristone can be dispensed at any retail pharmacy as long as a Medication Guide is provided
Correct Incorrect Correct answer

Mifepristone requires the patient to have a negative ANC result before each dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 229 of 667

229. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician compares the TIRF REMS program requirements with the iPLEDGE program for isotretinoin. Which statement accurately identifies a shared requirement between these two programs?

Both programs require that the prescriber, pharmacy, and patient all be enrolled before the medication can be dispensed
Correct Incorrect Correct answer

Both programs require monthly pregnancy testing before each dispensing
Correct Incorrect Correct answer

Both programs require monitoring of the absolute neutrophil count before dispensing
Correct Incorrect Correct answer

Both programs restrict dispensing to hospital pharmacies only
Correct Incorrect Correct answer

Correct

Incorrect
Question 230 of 667

230. Question

Category: Federal Requirements: Restricted Drug Programs

A community pharmacy wants to stock naloxone nasal spray for dispensing without a prescription under a standing order. Which statement about naloxone distribution is correct?

Many states allow pharmacists to dispense naloxone without a patient-specific prescription through standing orders or pharmacist prescriptive authority
Correct Incorrect Correct answer

Naloxone requires enrollment in a REMS program before it can be dispensed to any patient
Correct Incorrect Correct answer

Federal law prohibits pharmacies from dispensing naloxone without an individual prescription from a physician
Correct Incorrect Correct answer

Naloxone is a Schedule IV controlled substance and requires DEA documentation for each sale
Correct Incorrect Correct answer

Correct

Incorrect
Question 231 of 667

231. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy is organizing a DEA-authorized drug take-back event. Which requirement must the pharmacy follow when collecting controlled substances from the public?

The pharmacy must use inner liners placed inside collection receptacles that are sealed and shipped to authorized reverse distributors for destruction
Correct Incorrect Correct answer

The pharmacy must obtain individual DEA registrations for each patient returning medications
Correct Incorrect Correct answer

Collected medications must be sorted by schedule and inventoried before destruction at the pharmacy
Correct Incorrect Correct answer

Only Schedule II controlled substances may be collected during take-back events
Correct Incorrect Correct answer

Correct

Incorrect
Question 232 of 667

232. Question

Category: Federal Requirements: Restricted Drug Programs

A technician notices that the TIRF REMS program restricts transmucosal fentanyl products to opioid-tolerant patients only. What clinical rationale underlies this restriction?

Transmucosal fentanyl products deliver rapid-onset, high-potency opioid doses that can cause fatal respiratory depression in patients who are not opioid-tolerant
Correct Incorrect Correct answer

TIRF products interact with common antibiotics, making them dangerous for opioid-naive patients taking other medications
Correct Incorrect Correct answer

Opioid-naive patients cannot absorb fentanyl through the oral mucosa due to physiological differences
Correct Incorrect Correct answer

The restriction is based on insurance coverage requirements rather than clinical safety concerns
Correct Incorrect Correct answer

Correct

Incorrect
Question 233 of 667

233. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy participates in a permanent drug take-back collection program with an on-site collection receptacle. A patient asks whether they can return unused insulin pens and leftover amoxicillin capsules along with their unused oxycodone tablets. Which response is most accurate?

The DEA collection receptacle is primarily for controlled substances; non-controlled medications may also be accepted depending on the pharmacy's policy, but insulin pens with needles may not be accepted due to sharps handling concerns
Correct Incorrect Correct answer

Only Schedule II controlled substances are eligible for the take-back program
Correct Incorrect Correct answer

All medications including insulin pens and antibiotics must be placed in the DEA collection receptacle
Correct Incorrect Correct answer

The pharmacy cannot accept any medications without a valid prescription for each item being returned
Correct Incorrect Correct answer

Correct

Incorrect
Question 234 of 667

234. Question

Category: Federal Requirements: Restricted Drug Programs

Which federal law established the framework allowing pharmacies and other authorized collectors to maintain drug take-back collection receptacles for controlled substances?

The Secure and Responsible Drug Disposal Act of 2010
Correct Incorrect Correct answer

The Controlled Substances Act of 1970
Correct Incorrect Correct answer

The Combat Methamphetamine Epidemic Act of 2005
Correct Incorrect Correct answer

The Drug Supply Chain Security Act of 2013
Correct Incorrect Correct answer

Correct

Incorrect
Question 235 of 667

235. Question

Category: Federal Requirements: Fda Recalls

A chain pharmacy with 15 locations receives a Class I recall notification. The corporate office instructs the pharmacy manager at each store to check inventory. Which approach best ensures a coordinated recall response across all locations?

Use the centralized inventory management system to run a report identifying all locations that received the recalled lot, then verify and remove stock at each flagged location
Correct Incorrect Correct answer

Instruct only the three highest-volume locations to check inventory, as lower-volume stores are unlikely to be affected
Correct Incorrect Correct answer

Post the recall notice in the break room at each location and rely on individual technicians to check their shelves
Correct Incorrect Correct answer

Wait for the manufacturer to contact each store individually with specific instructions for their location
Correct Incorrect Correct answer

Correct

Incorrect
Question 236 of 667

236. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician is reviewing the difference between MedWatch Form 3500 and Form 3500A. Which statement correctly distinguishes these two forms?

Form 3500 is used for voluntary reporting by healthcare professionals and consumers, while Form 3500A is used for mandatory reporting by manufacturers, packers, and distributors
Correct Incorrect Correct answer

Form 3500 is for reporting controlled substance diversion, while Form 3500A is for reporting adverse drug reactions
Correct Incorrect Correct answer

Form 3500 is submitted to the state board of pharmacy, while Form 3500A is submitted to the DEA
Correct Incorrect Correct answer

Form 3500 is for reporting medical device failures only, while Form 3500A covers all drug-related events
Correct Incorrect Correct answer

Correct

Incorrect
Question 237 of 667

237. Question

Category: Federal Requirements: Fda Recalls

A biologic product (monoclonal antibody) used in a hospital pharmacy is found to have reduced potency due to improper cold chain management during distribution. Which recall classification is most appropriate?

Class II, because the product may cause temporary or medically reversible adverse health consequences due to reduced effectiveness
Correct Incorrect Correct answer

Class I, because all biologics recalls are automatically classified at the highest level
Correct Incorrect Correct answer

Class III, because reduced potency does not directly harm patients
Correct Incorrect Correct answer

Market withdrawal, because the product was not contaminated
Correct Incorrect Correct answer

Correct

Incorrect
Question 238 of 667

238. Question

Category: Federal Requirements: Fda Recalls

A compounding pharmacy produces a sterile injectable preparation that is later found to be contaminated with fungal organisms. Multiple patients have been hospitalized. How does a recall of a compounded product differ from a recall of an FDA-approved manufactured product?

Compounding pharmacies are subject to state board oversight and FDA enforcement, but their products are not FDA-approved, so the recall process may involve state boards in addition to the FDA
Correct Incorrect Correct answer

Compounded products are exempt from all FDA recall authority because they are not commercially manufactured
Correct Incorrect Correct answer

Compounding pharmacy recalls follow the same process as manufactured products with no regulatory differences
Correct Incorrect Correct answer

Only the state board of pharmacy can issue recalls for compounded products, and the FDA has no jurisdiction
Correct Incorrect Correct answer

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Incorrect
Question 239 of 667

239. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician learns about a Class I recall affecting a commonly dispensed blood pressure medication at 10 a.m. By noon, the technician has pulled the affected lot from the shelves. What is the next priority action for the pharmacy team?

Generate a report of patients who received the recalled lot and begin contacting them with instructions
Correct Incorrect Correct answer

File the recall documentation and wait for the manufacturer to issue a formal press release
Correct Incorrect Correct answer

Return the recalled stock to the wholesaler and document a credit before taking any other action
Correct Incorrect Correct answer

Post a sign near the pharmacy counter informing walk-in patients about the recall
Correct Incorrect Correct answer

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Question 240 of 667

240. Question

Category: Federal Requirements: Fda Recalls

An outsourcing facility (503B) that produces sterile compounded preparations is found to have violated current good manufacturing practice (cGMP) requirements. How does the FDA’s authority over this facility differ from its authority over a traditional 503A compounding pharmacy?

Outsourcing facilities (503B) are directly registered with the FDA and must comply with cGMP, giving the FDA stronger oversight and recall authority compared to traditional 503A pharmacies
Correct Incorrect Correct answer

The FDA has no authority over outsourcing facilities because they are regulated exclusively by state pharmacy boards
Correct Incorrect Correct answer

Both 503A and 503B facilities have identical regulatory requirements and the FDA treats them the same
Correct Incorrect Correct answer

Outsourcing facilities are exempt from recalls because they only distribute within their home state
Correct Incorrect Correct answer

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Question 241 of 667

241. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician observes a patient experiencing a severe allergic reaction after receiving a recently dispensed biologic medication. The pharmacist believes this may be an unexpected adverse event. Who is required to report this event to the FDA through MedWatch?

The manufacturer is required to report; the pharmacist and technician may report voluntarily using Form 3500
Correct Incorrect Correct answer

The pharmacy technician is legally required to report the event within 24 hours using Form 3500A
Correct Incorrect Correct answer

Only the prescriber who ordered the biologic is authorized to submit a MedWatch report
Correct Incorrect Correct answer

The patient must file the report directly with the FDA before the pharmacy can take any action
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Question 242 of 667

242. Question

Category: Federal Requirements: Fda Recalls

A chain pharmacy’s corporate recall coordinator notices that three of its locations received the same recalled lot of a biologic product, but each location handled the recall differently. Location A quarantined and documented the stock, Location B returned the stock to the wholesaler without documenting lot numbers, and Location C continued dispensing because the technician misread the recall notice. Which location(s) handled the recall correctly?

Only Location A, because proper recall handling requires quarantine, documentation of lot numbers, and cessation of dispensing
Correct Incorrect Correct answer

Locations A and B, because both removed the recalled product from their active inventory
Correct Incorrect Correct answer

All three locations, because each took some form of action in response to the recall
Correct Incorrect Correct answer

Only Location B, because returning the product to the wholesaler is the most important step
Correct Incorrect Correct answer

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Question 243 of 667

243. Question

Category: Federal Requirements: Dscsa

A wholesale distributor ships a case of medication containing 24 individual packages to a pharmacy. Under DSCSA aggregation requirements, what information must be associated with the case-level identifier?

The case-level identifier must be linked to the individual package-level serial numbers contained within the case
Correct Incorrect Correct answer

The case-level identifier only needs to include the total weight and wholesale acquisition cost
Correct Incorrect Correct answer

Aggregation data is optional and only required when the pharmacy specifically requests it
Correct Incorrect Correct answer

The case needs only a single serial number with no link to the individual packages inside
Correct Incorrect Correct answer

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Question 244 of 667

244. Question

Category: Federal Requirements: Dscsa

A pharmacy’s verification system cannot communicate with the manufacturer’s verification system due to incompatible data formats. Under DSCSA interoperability requirements, whose responsibility is it to resolve this issue?

All trading partners share responsibility for ensuring their systems can interoperate using FDA-recognized standards
Correct Incorrect Correct answer

The manufacturer bears sole responsibility for ensuring their system works with all pharmacy systems
Correct Incorrect Correct answer

The FDA provides a centralized government database that eliminates the need for direct system interoperability
Correct Incorrect Correct answer

The wholesale distributor is the only party required to maintain interoperable systems under the DSCSA
Correct Incorrect Correct answer

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Question 245 of 667

245. Question

Category: Federal Requirements: Dscsa

A pharmacy returns a saleable, unexpired product to its wholesale distributor. Under the DSCSA, what must the wholesale distributor do before reselling this returned product?

Verify the product identifier at the package level to confirm the product is authentic and has not been tampered with
Correct Incorrect Correct answer

Accept the return and immediately reshelve the product without additional verification
Correct Incorrect Correct answer

Send the product to the manufacturer for repackaging before redistributing
Correct Incorrect Correct answer

Destroy the product because returned medications can never re-enter the supply chain
Correct Incorrect Correct answer

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Question 246 of 667

246. Question

Category: Federal Requirements: Dscsa

A manufacturer ships product to a wholesale distributor, who then ships it to a second wholesale distributor (a drop shipment), who delivers it directly to a pharmacy. Under the DSCSA, how must the transaction documentation flow in this drop shipment scenario?

The transaction documentation must follow the product through each change of ownership, with each trading partner providing T3 documentation to the next
Correct Incorrect Correct answer

Only the manufacturer and the final pharmacy need to exchange documentation; intermediary distributors are exempt
Correct Incorrect Correct answer

Drop shipments are prohibited under the DSCSA because they bypass the standard supply chain
Correct Incorrect Correct answer

The manufacturer sends documentation directly to the pharmacy, skipping both wholesale distributors
Correct Incorrect Correct answer

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Question 247 of 667

247. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a shipment with a valid product identifier on each package, but the transaction history only goes back to the wholesale distributor and does not trace to the original manufacturer. What should the pharmacy do?

Contact the wholesale distributor to obtain the complete transaction history tracing back to the manufacturer
Correct Incorrect Correct answer

Accept the shipment because the product identifier alone is sufficient proof of authenticity
Correct Incorrect Correct answer

Report the wholesale distributor to the FDA immediately as a suspected counterfeiter
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Return the entire shipment and refuse to do business with the distributor permanently
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Question 248 of 667

248. Question

Category: Federal Requirements: Dscsa

Under the DSCSA, what is the term for the process of linking individual package serial numbers to a higher-level container such as a case or pallet?

Aggregation
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Serialization
Correct Incorrect Correct answer

Verification
Correct Incorrect Correct answer

Authentication
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Question 249 of 667

249. Question

Category: Federal Requirements: Dscsa

A pharmacy returns an unopened, saleable product to the wholesale distributor. The distributor’s verification system confirms the product identifier matches the original serialization record. However, the physical packaging shows signs of water damage. Can the distributor resell this product?

No, because physical damage raises concerns about product integrity even though the electronic verification passed
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Yes, because the electronic product identifier verification is the only requirement under the DSCSA
Correct Incorrect Correct answer

Yes, as long as the distributor applies a new label indicating the product was previously returned
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No, because all returned products must be destroyed regardless of their condition
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Question 250 of 667

250. Question

Category: Federal Requirements: Dscsa

A wholesale distributor uses a third-party logistics provider (3PL) to store and ship pharmaceutical products on its behalf. Under the DSCSA, which entity holds responsibility for maintaining transaction documentation for products shipped through the 3PL?

The wholesale distributor retains responsibility for all DSCSA transaction documentation obligations even when using a 3PL
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The 3PL assumes all DSCSA compliance obligations once the product enters its warehouse
Correct Incorrect Correct answer

Neither the distributor nor the 3PL needs to maintain documentation because 3PL arrangements are exempt
Correct Incorrect Correct answer

The 3PL must register as a separate trading partner and maintain its own T3 documentation
Correct Incorrect Correct answer

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Question 251 of 667

251. Question

Category: Federal Requirements: Dea Schedules

During a biennial inventory of controlled substances, a pharmacy technician discovers that the physical count of hydrocodone 10/325 mg tablets is 47 tablets fewer than the perpetual inventory record shows. The pharmacist-in-charge instructs the technician to document the discrepancy. Which action should be taken next?

Investigate the discrepancy internally and report any confirmed theft or significant loss to the DEA using Form 106
Correct Incorrect Correct answer

Immediately contact local law enforcement before completing the biennial inventory count
Correct Incorrect Correct answer

Adjust the perpetual inventory to match the physical count and note the correction in a logbook
Correct Incorrect Correct answer

Submit DEA Form 41 to account for the missing tablets as a destruction record
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Question 252 of 667

252. Question

Category: Federal Requirements: Dea Schedules

A retail pharmacy is completing its biennial controlled substance inventory on the required date. The pharmacy opened for business at 8:00 AM. Which statement about the timing and method of the biennial inventory is correct?

The pharmacy may take the inventory at the open of business or the close of business on the inventory date
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The inventory must always be conducted before the pharmacy opens to patients on the inventory date
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The inventory must be completed within the first hour of business on the inventory date to avoid discrepancies
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The inventory may be conducted on any day within 30 days before or after the biennial anniversary date
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Question 253 of 667

253. Question

Category: Federal Requirements: Dea Schedules

A hospital pharmacy uses an automated dispensing cabinet (ADC) to store and dispense controlled substances on patient care units. During a routine audit, the pharmacy discovers discrepancies in fentanyl vial counts on two separate nursing units. Unlike a retail pharmacy, what additional challenge does this hospital setting present for investigating the discrepancy?

Multiple authorized users access the ADC throughout the day, requiring review of user-specific transaction logs to identify the source of the discrepancy
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Hospital pharmacies are exempt from DEA inventory requirements because ADCs track transactions electronically
Correct Incorrect Correct answer

Hospital controlled substance discrepancies do not require DEA Form 106 because the drugs are administered on-site
Correct Incorrect Correct answer

The hospital must complete a separate biennial inventory for each ADC location, unlike retail pharmacies that complete one inventory
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Question 254 of 667

254. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is asked to prepare a DEA Form 222 to order morphine sulfate injection for the pharmacy. The pharmacist-in-charge is on vacation and has granted power of attorney to the pharmacy manager to sign DEA Form 222 orders. Which requirement must be met for the power of attorney to be valid?

The power of attorney must be signed by the DEA registrant and the authorized individual, and kept on file at the registered location
Correct Incorrect Correct answer

The power of attorney must be submitted to and approved by the DEA before the authorized individual can sign any Form 222
Correct Incorrect Correct answer

Only a pharmacist licensed in the state may receive power of attorney to sign DEA Form 222 orders
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The power of attorney automatically expires after 90 days and must be renewed each quarter
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Question 255 of 667

255. Question

Category: Federal Requirements: Dea Schedules

A hospital pharmacy orders fentanyl patches from its wholesaler using the CSOS (Controlled Substance Ordering System). The order is successfully transmitted and received. Compared to a paper DEA Form 222, what is a key difference in the recordkeeping requirement for the CSOS electronic order?

The electronic order records must be stored in a retrievable format and made available for DEA inspection for at least 2 years
Correct Incorrect Correct answer

CSOS orders do not require any recordkeeping because the electronic system automatically reports to the DEA in real time
Correct Incorrect Correct answer

CSOS orders must be printed and stored alongside paper Form 222 records in numerical order
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Electronic orders must be countersigned by the pharmacist-in-charge within 72 hours of receipt to be valid
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Question 256 of 667

256. Question

Category: Federal Requirements: Dea Schedules

A retail pharmacy technician performs a biennial inventory and must count opened bottles of Schedule II controlled substances. How should the technician handle the count for an opened bottle of oxycodone 5 mg tablets?

Perform an exact count of the remaining tablets in the opened bottle
Correct Incorrect Correct answer

Estimate the count to the nearest 10 tablets and record the estimate
Correct Incorrect Correct answer

Record the original bottle quantity and subtract the number of prescriptions filled from it
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Exclude the opened bottle from the inventory and only count sealed containers
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Question 257 of 667

257. Question

Category: Federal Requirements: Dea Schedules

A hospital pharmacy stocks both fentanyl injection vials and oral morphine solution in its main pharmacy and in six automated dispensing cabinets across patient care units. When conducting a biennial inventory, the pharmacy discovers that the ADC software-generated count for Schedule III medications differs from the physical count by 12 units across three cabinets. Under DEA regulations, which approach to counting Schedule III substances in the opened ADC drawers is correct?

An estimated count is permitted for Schedule III substances in opened containers holding 1,000 or more dosage units; otherwise an exact count is required
Correct Incorrect Correct answer

The ADC electronic transaction log count may be used in place of a physical count for all Schedule III through V substances
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All controlled substances in automated dispensing cabinets must be counted exactly regardless of schedule
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Schedule III substances are exempt from biennial inventory requirements in hospital settings that use ADC technology
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Question 258 of 667

258. Question

Category: Federal Requirements: Dea Schedules

A pharmacy’s DEA registrant retires and a new pharmacist-in-charge is appointed. The new pharmacist discovers an existing power of attorney granted to a pharmacy technician for signing DEA Form 222 orders. What must the new pharmacist-in-charge do regarding this power of attorney?

The previous power of attorney is no longer valid and the new registrant must execute a new power of attorney if they wish to continue the arrangement
Correct Incorrect Correct answer

The existing power of attorney transfers automatically to the new registrant and remains valid until its stated expiration date
Correct Incorrect Correct answer

The new pharmacist must submit the existing power of attorney to the DEA for re-validation within 30 days
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The power of attorney remains valid as long as the technician is still employed at the pharmacy location
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Question 259 of 667

259. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives a prescription for isotretinoin (Accutane) for a female patient of childbearing potential. The pharmacy technician checks the iPLEDGE system and finds that the patient’s pregnancy test result was entered 38 days ago. The prescriber confirms the patient is compliant with the program. Should the pharmacy dispense the medication?

The prescription cannot be dispensed because the pregnancy test must be performed within 7 days before the prescription is written and dispensed within the 7-day prescription window
Correct Incorrect Correct answer

The prescription may be dispensed because pregnancy test results are valid for 60 days under the iPLEDGE program
Correct Incorrect Correct answer

The prescription may be dispensed as long as the prescriber certifies the patient has been using two forms of contraception
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The prescription may be dispensed because the pharmacy only needs to verify that the patient is registered in iPLEDGE
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Question 260 of 667

260. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician discovers that a prescriber who previously wrote prescriptions for clozapine has let their REMS certification lapse. The pharmacy has three active clozapine patients who need refills. What is the correct course of action?

The pharmacy cannot dispense clozapine prescriptions from that prescriber until the prescriber re-enrolls and is certified in the Clozapine REMS Program
Correct Incorrect Correct answer

The pharmacy may continue dispensing for 30 days to allow the prescriber time to renew the certification without interrupting patient therapy
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The pharmacy may dispense the refills because the pharmacy's own REMS certification covers the prescriber requirement
Correct Incorrect Correct answer

The pharmacy should transfer the patients' prescriptions to another pharmacy that has a REMS-certified prescriber on staff
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Question 261 of 667

261. Question

Category: Federal Requirements: Restricted Drug Programs

A new pharmacy wants to dispense buprenorphine/naloxone (Suboxone) sublingual film for opioid use disorder treatment. Which enrollment step must the pharmacy complete before dispensing this medication under current federal requirements?

The pharmacy does not need special enrollment to dispense buprenorphine/naloxone when it is prescribed by a validly licensed prescriber with a DEA number
Correct Incorrect Correct answer

The pharmacy must register with SAMHSA as an opioid treatment program before dispensing any buprenorphine products
Correct Incorrect Correct answer

The pharmacy must obtain a separate DEA registration specifically for dispensing buprenorphine/naloxone
Correct Incorrect Correct answer

The pharmacy must enroll in the buprenorphine REMS program and complete an online training module
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Question 262 of 667

262. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is comparing the enrollment verification processes for two REMS programs. The iPLEDGE program for isotretinoin requires verification of patient, prescriber, and pharmacy enrollment before each dispensing. The TIRF REMS Access program for transmucosal immediate-release fentanyl products has a similar structure. A new patient presents a prescription for fentanyl citrate lozenge (Actiq). What must the technician verify about the patient before dispensing?

The patient must be enrolled in the TIRF REMS Access program and must already be opioid-tolerant before receiving transmucosal fentanyl
Correct Incorrect Correct answer

The patient only needs a signed consent form in the pharmacy's files, similar to a standard counseling acknowledgment
Correct Incorrect Correct answer

The patient must have a negative urine drug screen on file within the past 30 days before each dispensing
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The patient must be enrolled in iPLEDGE because both TIRF and isotretinoin share the same patient registry system
Correct Incorrect Correct answer

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Question 263 of 667

263. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is processing a new prescription for lenalidomide (Revlimid) for a male patient. The Revlimid REMS program requires specific steps before dispensing. Which requirement applies to male patients under this program?

Male patients must be counseled about the risk of embryo-fetal exposure through seminal fluid and must comply with the REMS requirements including using contraception
Correct Incorrect Correct answer

Male patients are exempt from all REMS requirements because they cannot become pregnant
Correct Incorrect Correct answer

Male patients must submit monthly pregnancy tests to the REMS registry before each dispensing cycle
Correct Incorrect Correct answer

Male patients must have their testosterone levels monitored monthly as part of the REMS safety protocol
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Question 264 of 667

264. Question

Category: Federal Requirements: Fda Recalls

A drug manufacturer voluntarily decides to remove a cholesterol medication from the market due to declining sales and a new formulation being released, not because of any safety or quality concern. How is this action classified by the FDA?

This is a market withdrawal, not a recall, because it is not related to a violation of FDA regulations or a safety concern
Correct Incorrect Correct answer

This is classified as a Class III recall because the product poses minimal risk to health
Correct Incorrect Correct answer

This is classified as a Class II recall because the manufacturer is voluntarily removing the product
Correct Incorrect Correct answer

This is classified as a safety alert requiring FDA MedWatch notification to all dispensing pharmacies
Correct Incorrect Correct answer

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Question 265 of 667

265. Question

Category: Federal Requirements: Fda Recalls

A 503A compounding pharmacy prepares a sterile ophthalmic solution for a specific patient prescription. Three days later, the pharmacy’s environmental monitoring results indicate a failed viable air sampling test in the cleanroom on the day the preparation was compounded. The pharmacist determines the product may be contaminated. Which action is most appropriate?

Contact the prescriber and patient immediately to arrange discontinuation of the product and report the quality issue to the state board of pharmacy
Correct Incorrect Correct answer

Submit the product to the FDA for formal Class I recall classification before notifying the patient
Correct Incorrect Correct answer

Wait for the next environmental monitoring test to confirm the failure before taking any action
Correct Incorrect Correct answer

File a MedWatch Form 3500A with the FDA and wait for the FDA to issue a recall classification
Correct Incorrect Correct answer

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Incorrect
Question 266 of 667

266. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives notification that a biologic product (adalimumab) stored in its refrigerator is subject to a Class II recall due to reduced potency found during stability testing. The pharmacy has dispensed 8 units of the affected lot in the past month. What is the pharmacy’s primary responsibility?

Quarantine remaining affected stock, notify patients who received the product, and follow the recall instructions for returning or destroying affected units
Correct Incorrect Correct answer

Destroy all remaining affected units immediately and document the destruction without contacting patients
Correct Incorrect Correct answer

Continue dispensing the remaining stock until the manufacturer provides replacement units
Correct Incorrect Correct answer

Transfer the remaining affected stock to the wholesaler without notifying patients because the recall is only Class II
Correct Incorrect Correct answer

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Question 267 of 667

267. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician is reviewing the cold chain records for a biologic medication shipment. The temperature data logger shows that the product was exposed to 12 degrees Celsius (53.6 degrees Fahrenheit) for 4 hours during transit, exceeding the labeled storage range of 2 to 8 degrees Celsius. The product has not been recalled. What should the technician do?

Quarantine the shipment, document the temperature excursion, and contact the manufacturer or wholesaler to determine if the product is still viable
Correct Incorrect Correct answer

Accept the shipment because a 4-hour excursion is within the acceptable tolerance for all biologic products
Correct Incorrect Correct answer

Reject the shipment and file a MedWatch 3500 report with the FDA for a suspected quality defect
Correct Incorrect Correct answer

Dispense the product but apply a warning label indicating the cold chain was interrupted during shipping
Correct Incorrect Correct answer

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Incorrect
Question 268 of 667

268. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives an urgent FDA safety communication about a Class I recall for a contaminated injectable product. The recall notice specifies affected lot numbers. The pharmacy technician checks inventory and finds two vials with lot numbers that do not match the recall notice. What should the technician do with these vials?

The vials with non-matching lot numbers are not affected by the recall and may remain in normal inventory
Correct Incorrect Correct answer

Remove all vials of the product regardless of lot number because the Class I designation means the entire product line is suspect
Correct Incorrect Correct answer

Place the non-matching vials in quarantine for at least 14 days until the FDA confirms they are safe
Correct Incorrect Correct answer

Return the non-matching vials to the wholesaler as a precaution because they were manufactured by the same company
Correct Incorrect Correct answer

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Incorrect
Question 269 of 667

269. Question

Category: Federal Requirements: Fda Recalls

A 503B outsourcing facility that supplies sterile compounded preparations to a hospital pharmacy is found to have systemic contamination in its cleanroom. The FDA issues a recall covering all products compounded during a two-week period. The hospital pharmacy has already administered several of these preparations to patients. Which regulatory distinction makes the 503B outsourcing facility subject to FDA recall authority, unlike a traditional 503A compounding pharmacy?

503B outsourcing facilities compound without patient-specific prescriptions and are subject to FDA current good manufacturing practice (cGMP) requirements and FDA recall authority
Correct Incorrect Correct answer

503B outsourcing facilities are classified as drug manufacturers only if they distribute products across state lines
Correct Incorrect Correct answer

503B outsourcing facilities are subject to state board of pharmacy oversight rather than FDA oversight for recall purposes
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503B outsourcing facilities are exempt from recall authority because they are registered with the FDA voluntarily
Correct Incorrect Correct answer

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Question 270 of 667

270. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician notices that an over-the-counter antihistamine on the shelf has packaging that appears to have been tampered with. The seal is broken and the product looks like it may have been repackaged. No recall has been issued for this product. What is the most appropriate action?

Remove the product from the shelf immediately, document the observation, and report the suspected tampering to the pharmacist and the FDA
Correct Incorrect Correct answer

Leave the product on the shelf and wait for the manufacturer to issue a recall before taking action
Correct Incorrect Correct answer

Place a warning sticker on the product alerting customers that the packaging may have been tampered with
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Return the product to the wholesaler for a credit and order a replacement without further reporting
Correct Incorrect Correct answer

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Question 271 of 667

271. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a shipment of medication from its wholesale distributor. Upon scanning the product identifiers, the pharmacy’s verification system sends a verification request to the manufacturer’s system but receives no response after multiple attempts. What should the pharmacy do?

Quarantine the product and do not dispense it until the product identifier can be successfully verified through the DSCSA verification system
Correct Incorrect Correct answer

Dispense the product because the pharmacy made a good-faith effort to verify and the system failure is beyond its control
Correct Incorrect Correct answer

Accept the product using the paper transaction documentation from the wholesaler as a substitute for electronic verification
Correct Incorrect Correct answer

Return the entire shipment to the wholesaler and file a complaint with the FDA about the manufacturer's verification system
Correct Incorrect Correct answer

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Question 272 of 667

272. Question

Category: Federal Requirements: Dscsa

A wholesale distributor sends a verification request to a manufacturer regarding a suspect product. The manufacturer’s system responds that the product identifier is valid but the serial number has already been verified as dispensed at another pharmacy. What does this finding most likely indicate?

The product may be counterfeit or illegitimately diverted, as a legitimate serial number should not appear in the supply chain after being dispensed
Correct Incorrect Correct answer

The product is legitimate because the manufacturer confirmed the product identifier is valid
Correct Incorrect Correct answer

The serial number was recycled by the manufacturer for a new production batch, which is standard practice
Correct Incorrect Correct answer

The verification system has a database error that should be reported to the FDA but does not affect the product's legitimacy
Correct Incorrect Correct answer

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Question 273 of 667

273. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a case of medication from a wholesale distributor. The case barcode scans correctly and the aggregation data shows 12 individual packages inside. Upon opening the case, the technician finds only 11 packages, and one package inside has a serial number that does not match any of the serial numbers associated with the case’s aggregation record. What should the pharmacy do?

Quarantine the mismatched package as a suspect product and notify the wholesale distributor of the discrepancy in the shipment
Correct Incorrect Correct answer

Accept the shipment because 11 of 12 packages match and report the one missing package as a shipping shortage
Correct Incorrect Correct answer

Return the entire case to the wholesaler and request a replacement shipment with correct aggregation data
Correct Incorrect Correct answer

Dispense all 11 packages and document the serial number mismatch in the pharmacy's receiving log
Correct Incorrect Correct answer

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Question 274 of 667

274. Question

Category: Federal Requirements: Dscsa

Under the DSCSA, a product identifier on each prescription drug package must include four data elements encoded in a 2D barcode. Which set of data elements makes up the product identifier?

NDC, serial number, lot number, and expiration date
Correct Incorrect Correct answer

NDC, manufacturer name, lot number, and package size
Correct Incorrect Correct answer

NDC, serial number, wholesale acquisition cost, and expiration date
Correct Incorrect Correct answer

NDC, lot number, expiration date, and distributor license number
Correct Incorrect Correct answer

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Incorrect
Question 275 of 667

275. Question

Category: Federal Requirements: Dscsa

A pharmacy purchases a prescription drug product from a state-licensed wholesale distributor and receives transaction information, transaction history, and a transaction statement with the shipment. Under the DSCSA, how long must the pharmacy retain these transaction records?

Not less than 6 years from the date of the transaction
Correct Incorrect Correct answer

Not less than 2 years from the date of the transaction
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Not less than 3 years from the date of the transaction
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Not less than 10 years from the date of the transaction
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Question 276 of 667

276. Question

Category: Federal Requirements: Dscsa

A pharmacy uses two different wholesale distributors. Distributor A provides electronic transaction data in a standardized format that integrates with the pharmacy’s system. Distributor B provides transaction data in a proprietary format that cannot be imported into the pharmacy’s system without manual re-entry. Under the DSCSA’s interoperability requirements, which statement best describes the situation?

The DSCSA encourages the use of standardized electronic data formats to facilitate interoperability, and Distributor B's proprietary format creates a compliance risk for efficient product tracing
Correct Incorrect Correct answer

The DSCSA allows each trading partner to use any format they choose as long as paper records are available as backup
Correct Incorrect Correct answer

The pharmacy must drop Distributor B because proprietary formats are explicitly prohibited by the DSCSA
Correct Incorrect Correct answer

Distributor B is compliant because the DSCSA only requires manufacturers to use standardized formats, not wholesale distributors
Correct Incorrect Correct answer

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Incorrect
Question 277 of 667

277. Question

Category: Federal Requirements: Dea Schedules

A long-term care facility pharmacy receives a Schedule II prescription for morphine sulfate 15 mg tablets, quantity 60. The facility only needs 30 tablets for the current cycle. Under DEA regulations for partial dispensing in long-term care facilities, what is the correct procedure?

Partially dispense 30 tablets and dispense the remaining 30 tablets within 72 hours of the first partial fill
Correct Incorrect Correct answer

Dispense the full quantity of 60 tablets because partial dispensing of Schedule II drugs is never permitted
Correct Incorrect Correct answer

Partially dispense 30 tablets and dispense the remainder at any point within 6 months of the original prescription date
Correct Incorrect Correct answer

Contact the DEA for authorization before partially dispensing any Schedule II controlled substance
Correct Incorrect Correct answer

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Question 278 of 667

278. Question

Category: Federal Requirements: Dea Schedules

A prescriber’s office contacts the pharmacy asking about the electronic prescribing mandate for controlled substances. The prescriber occasionally treats patients in areas with limited internet connectivity. Which situation qualifies as a recognized exception to the federal EPCS (Electronic Prescribing for Controlled Substances) requirement?

Temporary technological failure that prevents the prescriber from transmitting the prescription electronically
Correct Incorrect Correct answer

The prescriber prefers handwritten prescriptions for personal workflow reasons
Correct Incorrect Correct answer

The patient requests a paper prescription to compare prices at different pharmacies
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The pharmacy's computer system is currently running an older version of dispensing software
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Question 279 of 667

279. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician discovers that 50 dosage units of alprazolam 1 mg (Schedule IV) are missing after reconciling the perpetual inventory. The pharmacist-in-charge conducts an internal investigation and confirms the loss cannot be attributed to dispensing errors or documentation mistakes. Which regulatory filing is required, and what is the appropriate timeline?

Submit DEA Form 106 promptly upon discovery of the confirmed theft or significant loss
Correct Incorrect Correct answer

Submit DEA Form 41 within 14 days to document the destruction of the missing inventory
Correct Incorrect Correct answer

Submit DEA Form 222 within 30 days to request replacement stock from the distributor
Correct Incorrect Correct answer

File a report with the state board of pharmacy only, because Schedule IV losses do not require DEA notification
Correct Incorrect Correct answer

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Question 280 of 667

280. Question

Category: Federal Requirements: Dea Schedules

A pharmacist receives a prescription for oxycodone 30 mg tablets with directions to take one tablet every 4 hours as needed for pain. The quantity written is #270. The pharmacist questions whether this exceeds a reasonable supply. Under federal law, what is the maximum quantity of a Schedule II controlled substance that may be dispensed per prescription?

Federal law does not set a specific maximum quantity per prescription for Schedule II substances, but the pharmacist must use professional judgment to ensure the prescription is for a legitimate medical purpose
Correct Incorrect Correct answer

A maximum 90-day supply is mandated by the DEA for all Schedule II prescriptions
Correct Incorrect Correct answer

No more than 120 dosage units of any Schedule II opioid may be dispensed on a single prescription
Correct Incorrect Correct answer

Federal law limits Schedule II prescriptions to a 30-day supply unless the prescriber documents medical necessity
Correct Incorrect Correct answer

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Question 281 of 667

281. Question

Category: Federal Requirements: Dea Schedules

A hospital pharmacy technician is filing the completed DEA Form 106 after a confirmed theft of fentanyl vials from a medication room. Which information must be included on DEA Form 106?

The name and quantity of each controlled substance lost or stolen, the DEA registration number of the pharmacy, and the circumstances of the theft
Correct Incorrect Correct answer

Only the total dollar value of the stolen controlled substances and the pharmacy's state license number
Correct Incorrect Correct answer

The identity of the suspected individual, the police report number, and a copy of the pharmacy's most recent inspection report
Correct Incorrect Correct answer

A list of all controlled substances currently in the pharmacy's inventory along with the date of the last biennial inventory
Correct Incorrect Correct answer

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Question 282 of 667

282. Question

Category: Federal Requirements: Dea Schedules

A pharmacy in a long-term care setting receives a Schedule II prescription for hydromorphone 4 mg tablets, quantity 120. The nurse requests only 15 tablets for the patient’s current medication pass cycle. After partially dispensing 15 tablets, the pharmacy is unable to supply the remaining 105 tablets within the allowed timeframe due to a supply shortage. What is the correct course of action?

Notify the prescriber that the remaining quantity cannot be dispensed, and a new prescription is needed for any additional supply
Correct Incorrect Correct answer

Dispense the remaining quantity as soon as the supply shortage is resolved, regardless of elapsed time
Correct Incorrect Correct answer

Transfer the remaining balance to another pharmacy in the same healthcare system to complete the dispensing
Correct Incorrect Correct answer

Have the pharmacist document the shortage and automatically extend the partial fill window by an additional 72 hours
Correct Incorrect Correct answer

Correct

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Question 283 of 667

283. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is processing a prescription for a medication that is part of a REMS program requiring pharmacy certification. The pharmacy’s REMS certification for this drug expired two weeks ago. What should the technician do?

Inform the pharmacist that the pharmacy's REMS certification has lapsed and the prescription cannot be dispensed until recertification is completed
Correct Incorrect Correct answer

Dispense the medication because there is a 30-day grace period after REMS certification expiration
Correct Incorrect Correct answer

Contact the drug manufacturer to request an emergency single-use dispensing authorization
Correct Incorrect Correct answer

Transfer the prescription to any pharmacy regardless of whether that pharmacy is also REMS-certified
Correct Incorrect Correct answer

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Question 284 of 667

284. Question

Category: Federal Requirements: Restricted Drug Programs

The FDA is conducting a REMS evaluation for a teratogenic medication and finds that the program has not met its safety goal of preventing fetal exposure. The FDA determines that the current REMS elements are insufficient. What authority does the FDA have regarding this REMS program?

The FDA can require the manufacturer to modify the REMS to include additional safety elements, such as more stringent prescriber or pharmacy requirements
Correct Incorrect Correct answer

The FDA can only suggest voluntary changes but cannot legally compel modifications to an existing REMS
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The FDA must withdraw the drug from the market entirely if the REMS fails to meet its stated goals
Correct Incorrect Correct answer

The FDA can impose fines on participating pharmacies but cannot change the REMS structure itself
Correct Incorrect Correct answer

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Question 285 of 667

285. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician notices that two different REMS programs for two separate medications both require patient enrollment, pregnancy testing, and prescriber certification. The pharmacist mentions these drugs share common REMS elements. What is the advantage of shared REMS elements across multiple drugs?

Shared REMS elements reduce administrative burden on pharmacies and prescribers by standardizing safety requirements across similar risk profiles
Correct Incorrect Correct answer

Shared REMS elements allow pharmacies to substitute one restricted drug for another without additional authorization
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Shared REMS elements eliminate the need for individual patient enrollment because enrollment in one program covers both drugs
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Shared REMS elements mean that a single pharmacy certification automatically applies to all drugs within the shared system
Correct Incorrect Correct answer

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Question 286 of 667

286. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy has been decertified from the iPLEDGE REMS program due to repeated compliance failures, including dispensing isotretinoin without confirming pregnancy test results. What is the immediate consequence of this decertification for the pharmacy?

The pharmacy can no longer dispense isotretinoin and must refer patients with active prescriptions to a certified pharmacy
Correct Incorrect Correct answer

The pharmacy receives a warning letter but may continue dispensing isotretinoin for 60 days while correcting deficiencies
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The pharmacy loses its DEA registration automatically because REMS decertification triggers a federal license review
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The pharmacy must return all remaining isotretinoin stock to the manufacturer within 24 hours of decertification
Correct Incorrect Correct answer

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Question 287 of 667

287. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives notification of a Class II recall for a blood pressure medication due to an impurity exceeding acceptable limits. Several patients currently have active prescriptions for this product. What is the best practice for patient notification in this situation?

Contact affected patients directly to inform them of the recall, advise them to stop taking the recalled product, and coordinate with the prescriber for an alternative medication
Correct Incorrect Correct answer

Post a notice in the pharmacy waiting area and wait for patients to come in for their next refill
Correct Incorrect Correct answer

Send a notification only to patients who purchased the medication within the last 7 days
Correct Incorrect Correct answer

Notify only patients who have reported adverse effects from the recalled medication
Correct Incorrect Correct answer

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Question 288 of 667

288. Question

Category: Federal Requirements: Fda Recalls

Following a Class I recall of a contaminated injectable product, the FDA conducts a recall effectiveness check at a hospital pharmacy. The inspector asks to see documentation proving all recalled units were accounted for. The pharmacy removed the product from shelves but did not document how many units were returned to the manufacturer versus how many had already been dispensed to patients. What is the primary deficiency identified?

The pharmacy failed to maintain documentation reconciling the total quantity received against the quantities dispensed, returned, and destroyed
Correct Incorrect Correct answer

The pharmacy should have destroyed all remaining units on-site rather than returning them to the manufacturer
Correct Incorrect Correct answer

The pharmacy was required to complete the recall within 24 hours of notification for a Class I recall
Correct Incorrect Correct answer

The pharmacy should have reported the recall directly to the DEA since the product was an injectable formulation
Correct Incorrect Correct answer

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Question 289 of 667

289. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician pulls all units of a recalled over-the-counter antacid from the shelves after receiving a Class III recall notice. The manufacturer instructs pharmacies to voluntarily destroy remaining stock rather than return it. What documentation should the pharmacy maintain for the voluntary destruction?

A record of the product name, lot number, quantity destroyed, date of destruction, and the name of the individual who performed the destruction
Correct Incorrect Correct answer

No documentation is required for Class III recalls because they involve products unlikely to cause adverse health consequences
Correct Incorrect Correct answer

A signed affidavit from the pharmacist-in-charge submitted to the FDA within 48 hours of destruction
Correct Incorrect Correct answer

A photograph of the destroyed product sent to the manufacturer as the sole required documentation
Correct Incorrect Correct answer

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Incorrect
Question 290 of 667

290. Question

Category: Federal Requirements: Fda Recalls

A manufacturer initiates a voluntary Class II recall of a generic cholesterol medication due to mislabeling that could lead to incorrect dosing. The FDA publishes an enforcement report listing the recall. Three months later, the FDA determines that insufficient quantities have been recovered from the market. What action can the FDA take?

The FDA can request that the manufacturer expand its recall efforts, issue additional public notifications, or in rare cases, seek a court-ordered mandatory recall
Correct Incorrect Correct answer

The FDA can only continue to monitor the situation because it has no authority to compel additional recall actions once a voluntary recall is initiated
Correct Incorrect Correct answer

The FDA must reclassify the recall as Class I before it can take any further enforcement action
Correct Incorrect Correct answer

The FDA will automatically withdraw the generic drug's approval and remove it from the Orange Book
Correct Incorrect Correct answer

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Question 291 of 667

291. Question

Category: Federal Requirements: Fda Recalls

A community pharmacy technician is reviewing the pharmacy’s recall response procedures. The pharmacist asks the technician to identify which recall class requires the most urgent patient notification. The technician considers three active recalls: a Class I recall of an antibiotic suspension due to microbial contamination, a Class II recall of an antihypertensive due to reduced potency, and a Class III recall of a vitamin supplement with a minor labeling error. Which recall warrants the most urgent response?

The Class I recall of the antibiotic suspension due to microbial contamination, because Class I recalls involve products that could cause serious adverse health consequences or death
Correct Incorrect Correct answer

The Class II recall of the antihypertensive, because blood pressure medications are critical and reduced potency could lead to a cardiovascular event
Correct Incorrect Correct answer

All three recalls require the same urgency level because FDA regulations mandate identical response timelines for all recall classes
Correct Incorrect Correct answer

The Class III recall of the vitamin supplement, because labeling errors could cause a patient to take the wrong dose
Correct Incorrect Correct answer

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Incorrect
Question 292 of 667

292. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a shipment of medications from a new wholesale distributor. Before accepting the shipment, the pharmacy technician is asked to verify the distributor’s credentials. Under the DSCSA, what must the pharmacy verify about the wholesale distributor?

Verify that the wholesale distributor holds a valid state or federal license and is an authorized trading partner
Correct Incorrect Correct answer

Verify that the distributor's warehouse has been inspected by the FDA within the past 12 months
Correct Incorrect Correct answer

Confirm that the distributor is listed in the pharmacy's preferred vendor catalog approved by corporate headquarters
Correct Incorrect Correct answer

Check that the distributor provides medications at or below the average wholesale price (AWP)
Correct Incorrect Correct answer

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Question 293 of 667

293. Question

Category: Federal Requirements: Dscsa

A pharmacy technician receives a notification from the wholesale distributor that a specific lot of medication in the pharmacy’s inventory has been flagged as a suspect product under the DSCSA. What is the pharmacy’s first required action?

Quarantine the suspect product to prevent it from being dispensed until the investigation is complete
Correct Incorrect Correct answer

Continue dispensing the product while awaiting confirmation from the manufacturer about its legitimacy
Correct Incorrect Correct answer

Immediately return the entire shipment to the distributor without documenting the lot numbers involved
Correct Incorrect Correct answer

Report the suspect product directly to the DEA within 24 hours of receiving the notification
Correct Incorrect Correct answer

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Incorrect
Question 294 of 667

294. Question

Category: Federal Requirements: Dscsa

A small independent pharmacy is struggling to implement full electronic, interoperable traceability as required under the DSCSA. The pharmacy owner asks whether the FDA offers any relief for pharmacies that cannot meet the compliance deadline. What option may be available under FDA policy?

The FDA may exercise enforcement discretion or issue waivers or exceptions for entities that demonstrate good faith efforts toward compliance
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Small independent pharmacies are permanently exempt from DSCSA traceability requirements due to their size
Correct Incorrect Correct answer

The pharmacy can opt out of DSCSA requirements by purchasing only from a single authorized distributor
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The FDA automatically extends compliance deadlines by two years for any pharmacy that submits a hardship application
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Question 295 of 667

295. Question

Category: Federal Requirements: Dscsa

During a routine DSCSA compliance review, an auditor asks the pharmacy to produce transaction information for a specific prescription drug product received six months ago. The pharmacy can locate the transaction invoice but cannot produce the transaction history or transaction statement. What compliance risk does this represent?

The pharmacy is non-compliant because the DSCSA requires retention of transaction information, transaction history, and transaction statement (the 3 T's) for each product received
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The pharmacy is compliant because only the transaction invoice is required to be retained under the DSCSA
Correct Incorrect Correct answer

The pharmacy is non-compliant only if the product in question is a controlled substance
Correct Incorrect Correct answer

The pharmacy is compliant because transaction history and transaction statements are only required for manufacturers, not pharmacies
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Question 296 of 667

296. Question

Category: Federal Requirements: Dscsa

A pharmacy technician discovers that a product confirmed as illegitimate under the DSCSA investigation process is still in the pharmacy’s quarantine area. Under the DSCSA, what must the pharmacy do with a confirmed illegitimate product?

Notify the FDA and the trading partner from whom the product was received, and dispose of the product according to applicable federal and state requirements
Correct Incorrect Correct answer

Return the product to the trading partner and allow them to handle the FDA notification independently
Correct Incorrect Correct answer

Dispose of the product in the regular pharmacy waste and document the disposal in the pharmacy's daily log
Correct Incorrect Correct answer

Hold the product indefinitely in quarantine until the FDA sends an agent to collect it for testing
Correct Incorrect Correct answer

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Question 297 of 667

297. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician receives a prescription for carisoprodol 350 mg, quantity 120, with 3 refills. The technician verifies the prescription is valid under DEA regulations. What schedule is carisoprodol, and is the refill quantity permitted?

Carisoprodol is Schedule IV, and up to 5 refills within 6 months of the date written are permitted, so 3 refills is acceptable
Correct Incorrect Correct answer

Carisoprodol is Schedule II, and no refills are permitted on any Schedule II prescription under federal law
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Carisoprodol is Schedule III, and only 2 refills are permitted within 90 days of the original dispensing date
Correct Incorrect Correct answer

Carisoprodol is not a scheduled substance, and there are no federal limits on refills for this medication
Correct Incorrect Correct answer

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Question 298 of 667

298. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician in a community pharmacy receives a faxed prescription for hydrocodone/acetaminophen 10/325 mg, quantity 60. Under current DEA regulations, can this prescription be dispensed from a fax?

No, hydrocodone combination products are Schedule II, and Schedule II prescriptions generally require a written or electronic prescription; a fax alone is not valid except in specific circumstances such as hospice or LTCF patients
Correct Incorrect Correct answer

Yes, faxed prescriptions are acceptable for all controlled substance schedules as long as the prescriber's DEA number is legible
Correct Incorrect Correct answer

Yes, hydrocodone combinations are Schedule III, and faxed prescriptions are valid for Schedule III through V medications
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No, faxed prescriptions are not accepted for any controlled substance regardless of schedule under current DEA rules
Correct Incorrect Correct answer

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Question 299 of 667

299. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician notices a prescription for tramadol 50 mg with a DEA number starting with the letter ‘A’ followed by the prescriber’s last name initial. The technician performs a DEA number validation check. The first digit of the number is 3, the second is 1, the third is 4, the fourth is 7, the fifth is 2, the sixth is 8, and the seventh (check digit) is 5. Is this DEA number valid?

Yes, the DEA number is valid because the sum of digits 1, 3, and 5 (3+4+2=9) plus twice the sum of digits 2, 4, and 6 (2x(1+7+8)=32) equals 41, and the last digit of 41 matches the check digit 1… actually, let me recalculate: no, the check digit does not validate correctly, making this DEA number invalid
Correct Incorrect Correct answer

Yes, the DEA number is valid because the letter A indicates a hospital pharmacy, and hospital DEA numbers follow a different validation algorithm
Correct Incorrect Correct answer

No, the DEA number is invalid because the prefix letter A is only assigned to retired practitioners and cannot be used for active prescriptions
Correct Incorrect Correct answer

No, the DEA number is invalid because all valid DEA numbers must begin with the letters B, F, or M for individual practitioners
Correct Incorrect Correct answer

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Question 300 of 667

300. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is organizing the controlled substance inventory and needs to verify proper storage for Schedule II medications. A delivery arrives containing fentanyl patches, oxycodone tablets, and methylphenidate tablets. What storage requirement applies specifically to these Schedule II items?

Schedule II controlled substances must be stored in a securely locked, substantially constructed cabinet or dispersed throughout the non-controlled inventory to deter theft
Correct Incorrect Correct answer

Schedule II substances must be stored in a separate room from all other medications with an independent alarm system and video surveillance
Correct Incorrect Correct answer

Schedule II substances require refrigerated storage in a locked unit maintained between 36 and 46 degrees Fahrenheit
Correct Incorrect Correct answer

Schedule II substances must be stored alphabetically on a designated shelf clearly labeled with DEA warning signs visible to all pharmacy staff
Correct Incorrect Correct answer

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Question 301 of 667

301. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician discovers that 30 tablets of oxycodone 30 mg are missing during a biennial controlled substance inventory. The perpetual inventory log shows no dispensing that would account for the shortage. What is the pharmacy’s obligation under DEA regulations?

The pharmacy must report the significant loss or theft to the DEA by filing a DEA Form 106 and notify local law enforcement, as unexplained shortages of Schedule II substances require mandatory reporting
Correct Incorrect Correct answer

The pharmacy must adjust the perpetual inventory log to match the physical count and document the discrepancy internally without notifying the DEA
Correct Incorrect Correct answer

The pharmacy must order replacement stock within 72 hours and file an amended DEA Form 222 to account for the missing inventory
Correct Incorrect Correct answer

The pharmacy must report the loss to the state board of pharmacy only, since the DEA does not require notification for shortages under 100 dosage units
Correct Incorrect Correct answer

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Question 302 of 667

302. Question

Category: Federal Requirements: Dea Schedules

A nurse practitioner with prescriptive authority presents a prescription for alprazolam 0.5 mg, quantity 30, with 2 refills. Her DEA number begins with the letter ‘M’. The pharmacy technician has not seen a DEA number starting with M before. Is this a valid DEA registration prefix?

Yes, the letter M is the DEA prefix assigned to mid-level practitioners such as nurse practitioners and physician assistants who have prescriptive authority for controlled substances
Correct Incorrect Correct answer

No, the letter M indicates a military prescriber, and military DEA numbers are only valid at federal pharmacy facilities
Correct Incorrect Correct answer

No, valid DEA prefixes are limited to A, B, and F; any other letter indicates a forged or expired registration
Correct Incorrect Correct answer

Yes, the letter M indicates a manufacturer registration, meaning this prescriber is also registered to compound controlled substances
Correct Incorrect Correct answer

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Question 303 of 667

303. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician attempts to process a prescription for lenalidomide 25 mg for a patient with multiple myeloma. The pharmacy’s computer system blocks the transaction and displays a message requiring REMS verification. What program governs lenalidomide dispensing?

The Lenalidomide REMS program (formerly RevAssist), which requires enrollment of prescribers, patients, and pharmacies due to the drug's teratogenic risk and risk of thromboembolic events
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The FDA MedWatch program, which requires voluntary adverse event reports to be submitted before each dispensing
Correct Incorrect Correct answer

The DEA Narcotic Treatment Program, since lenalidomide is classified as a Schedule II controlled substance
Correct Incorrect Correct answer

The EPA Hazardous Drug Disposal Program, which requires special containment verification before each patient receives a cytotoxic medication
Correct Incorrect Correct answer

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Incorrect
Question 304 of 667

304. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician at a community pharmacy receives a prescription for clozapine 200 mg daily. The technician checks the Clozapine REMS registry and finds the patient’s most recent ANC result was submitted 45 days ago. The patient’s monitoring frequency category requires ANC testing every 2 weeks. Can the technician proceed with dispensing?

No, the prescription cannot be dispensed because the patient's ANC monitoring is overdue; the REMS requires a current ANC result within the specified monitoring interval before dispensing is authorized
Correct Incorrect Correct answer

Yes, the pharmacy can dispense a 7-day emergency supply while awaiting updated blood work from the prescriber's office
Correct Incorrect Correct answer

Yes, as long as the previous ANC result was within normal range, the specific timing of the test is not enforced by the REMS system
Correct Incorrect Correct answer

No, but the pharmacist can override the REMS block by documenting a clinical justification for continued therapy in the pharmacy records
Correct Incorrect Correct answer

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Question 305 of 667

305. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician processing a prescription for mifepristone notices the pharmacy is not listed as a certified prescriber site in the Mifepristone REMS program. What does this mean for dispensing?

The prescription cannot be dispensed at a standard retail pharmacy; mifepristone can only be dispensed by or under the supervision of certified prescribers or through specially certified pharmacies as required by the REMS
Correct Incorrect Correct answer

The pharmacy can dispense mifepristone as long as the prescriber's DEA number is valid and the patient signs a standard consent form
Correct Incorrect Correct answer

The technician can enroll the pharmacy in the REMS program at the point of sale and dispense the prescription the same day
Correct Incorrect Correct answer

Mifepristone REMS only applies to doses above 200 mg; at standard doses the medication can be dispensed at any licensed pharmacy
Correct Incorrect Correct answer

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Question 306 of 667

306. Question

Category: Federal Requirements: Restricted Drug Programs

A specialty pharmacy technician is processing a prescription for a testosterone product that requires enrollment in a REMS program. The prescriber is certified, but the patient has not completed the required Patient-Prescriber Agreement Form. The patient insists the medication is urgently needed. What should the technician do?

Inform the pharmacist that dispensing cannot proceed until the patient completes the required REMS enrollment documentation, as the program requirements are legally binding regardless of urgency
Correct Incorrect Correct answer

Dispense a 3-day emergency supply while the REMS paperwork is being processed, since controlled substance emergency provisions apply
Correct Incorrect Correct answer

Process the prescription normally and have the patient sign the agreement form at the next refill to avoid delaying therapy
Correct Incorrect Correct answer

Contact the REMS administrator to request a one-time waiver for the documentation requirement based on clinical urgency
Correct Incorrect Correct answer

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Incorrect
Question 307 of 667

307. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician receives notification of an FDA Class I recall for a specific lot of metformin tablets due to NDMA contamination above acceptable limits. What does a Class I recall indicate about the severity of this situation?

A Class I recall indicates a reasonable probability that the product will cause serious adverse health consequences or death, requiring the most urgent response
Correct Incorrect Correct answer

A Class I recall indicates a minor labeling error that is unlikely to cause adverse health effects but requires correction
Correct Incorrect Correct answer

A Class I recall indicates the product may cause temporary or medically reversible health problems with low probability of serious consequences
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A Class I recall is a voluntary market withdrawal by the manufacturer for business reasons unrelated to patient safety
Correct Incorrect Correct answer

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Question 308 of 667

308. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician identifies bottles of a recalled blood pressure medication on the pharmacy shelf during the weekly recall check. The recall notice specifies that affected product should be returned to the manufacturer. What is the technician’s immediate priority?

Quarantine the affected product by removing it from dispensing stock and placing it in a designated area clearly marked as recalled, then notify the pharmacist to initiate the return process
Correct Incorrect Correct answer

Discard the recalled product in the pharmaceutical waste container immediately and document the quantity destroyed
Correct Incorrect Correct answer

Continue dispensing from the recalled lot until the current supply is exhausted, then switch to a different manufacturer
Correct Incorrect Correct answer

Move the recalled product to the back of the shelf behind other stock so it is dispensed last while awaiting return authorization
Correct Incorrect Correct answer

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Incorrect
Question 309 of 667

309. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives a Class II recall notice for a specific lot of lisinopril 10 mg tablets due to incorrect labeling that lists the wrong strength on the bottle. The recall notice indicates lot number AB1234 with an expiration date of 09/2027. The technician finds three bottles in stock: one with lot AB1234 (exp 09/2027), one with lot AB1235 (exp 11/2027), and one with lot AB1233 (exp 07/2027). Which bottle(s) should be quarantined?

Only the bottle with lot number AB1234 and expiration date 09/2027, as recalls are specific to the identified lot numbers listed in the recall notice
Correct Incorrect Correct answer

All three bottles should be quarantined because they are from the same manufacturer and may have similar labeling issues
Correct Incorrect Correct answer

The two bottles with lot numbers closest to AB1234 (AB1233 and AB1235) should be quarantined as a precaution
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All lisinopril 10 mg tablets from any manufacturer should be quarantined until the FDA confirms the scope of the labeling error
Correct Incorrect Correct answer

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Question 310 of 667

310. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician discovers that a recalled ranitidine product was dispensed to 47 patients over the past 3 months before the recall was announced. The Class I recall cites unacceptable levels of a probable carcinogen (NDMA). What patient notification responsibility does the pharmacy have?

The pharmacy should notify all 47 patients who received the recalled product so they can discontinue use and consult their prescriber about alternative therapy, as Class I recalls involving potential carcinogens require prompt patient outreach
Correct Incorrect Correct answer

The pharmacy has no obligation to contact patients because the manufacturer is solely responsible for all patient notification during recalls
Correct Incorrect Correct answer

Only patients who purchased the product within the last 30 days need to be contacted, as earlier dispensing is outside the actionable window
Correct Incorrect Correct answer

The pharmacy should wait for the FDA to provide a standardized patient notification letter before contacting any patients to avoid legal liability
Correct Incorrect Correct answer

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Question 311 of 667

311. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician receives a MedWatch safety alert from the FDA regarding a newly identified risk of a marketed medication. The alert does not include a recall but recommends enhanced patient monitoring. What is MedWatch, and how should the technician handle this communication?

MedWatch is the FDA's safety information and adverse event reporting program; the technician should bring the alert to the pharmacist's attention so appropriate clinical action can be taken for affected patients
Correct Incorrect Correct answer

MedWatch is a DEA program for monitoring controlled substance diversion; the technician should review the pharmacy's controlled substance inventory
Correct Incorrect Correct answer

MedWatch alerts require immediate removal of the medication from pharmacy shelves until the FDA issues an all-clear notification
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MedWatch is a voluntary subscription newsletter with no regulatory authority; the alert can be filed without further action
Correct Incorrect Correct answer

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Incorrect
Question 312 of 667

312. Question

Category: Federal Requirements: Dscsa

A pharmacy technician receives a shipment of medications from the wholesale distributor. Under the Drug Supply Chain Security Act (DSCSA), what documentation must accompany each prescription drug product in the shipment?

Transaction information (TI), transaction history (TH), and a transaction statement (TS) that documents the chain of custody from the manufacturer through each entity in the supply chain
Correct Incorrect Correct answer

A certificate of analysis from the manufacturer confirming potency and sterility testing results for each lot in the shipment
Correct Incorrect Correct answer

A DEA Form 222 for each product in the shipment, regardless of whether the products are controlled substances
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An FDA inspection report confirming the wholesaler's facility passed its most recent Good Distribution Practice audit
Correct Incorrect Correct answer

Correct

Incorrect
Question 313 of 667

313. Question

Category: Federal Requirements: Dscsa

A pharmacy technician notices that a carton of brand-name atorvastatin received from a secondary wholesaler lacks a product identifier with a unique serial number on individual packages. Under the DSCSA’s enhanced drug distribution security requirements, why is this a compliance concern?

The DSCSA requires manufacturers to affix a unique product identifier (serialized NDC with serial number, lot number, and expiration date in a 2D barcode) on each package, and products without serialization may not be legitimate or compliant
Correct Incorrect Correct answer

Serialization is only required for controlled substances, so the lack of a product identifier on atorvastatin is not a DSCSA concern
Correct Incorrect Correct answer

The DSCSA requires serial numbers only on biologics and specialty medications, not on common generic or brand oral solid dosage forms
Correct Incorrect Correct answer

Product identifiers are only required for products sold directly from manufacturers to pharmacies, not for those passing through wholesalers
Correct Incorrect Correct answer

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Question 314 of 667

314. Question

Category: Federal Requirements: Dscsa

A pharmacy technician processing a drug return notices that a partially used bottle of medication needs to be returned to the wholesaler. Under DSCSA requirements, what information must the pharmacy provide when returning the product?

The pharmacy must provide transaction information, transaction history, and a transaction statement to the trading partner receiving the returned product, maintaining the chain of documentation
Correct Incorrect Correct answer

The pharmacy only needs to include the original purchase invoice and does not need to generate new transaction documentation for returns
Correct Incorrect Correct answer

Returns are exempt from all DSCSA documentation requirements as long as the product is being sent to an authorized distributor
Correct Incorrect Correct answer

The pharmacy must submit a DSCSA return notification form to the FDA before shipping any product back to a wholesaler
Correct Incorrect Correct answer

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Question 315 of 667

315. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a notification from its wholesaler that a specific lot of a medication has been identified as suspect product under the DSCSA. The pharmacy has this lot in stock. What is the pharmacy’s obligation?

The pharmacy must quarantine the suspect product, refrain from dispensing it, and work with the trading partner to investigate and determine whether the product is illegitimate
Correct Incorrect Correct answer

The pharmacy may continue dispensing from the suspect lot while the investigation is underway as long as patients are informed of the suspect status
Correct Incorrect Correct answer

The pharmacy must destroy the suspect product immediately and file a police report for potential counterfeiting
Correct Incorrect Correct answer

The pharmacy should return the suspect product to the wholesaler without investigation, as the wholesaler bears sole responsibility for verification
Correct Incorrect Correct answer

Correct

Incorrect
Question 316 of 667

316. Question

Category: Federal Requirements: Dscsa

A pharmacy technician at an independent pharmacy is offered a large quantity of a popular brand-name medication at a significantly below-market price by a salesperson who is not affiliated with their usual authorized distributor. The salesperson cannot provide DSCSA-compliant transaction documentation. What risk does this scenario present?

Purchasing from unauthorized sources without DSCSA-compliant documentation risks introducing counterfeit, diverted, stolen, or adulterated medications into the pharmacy's legitimate supply chain
Correct Incorrect Correct answer

The only risk is a minor paperwork violation, since the medication quality is the same regardless of the source as long as the packaging appears authentic
Correct Incorrect Correct answer

This is a standard practice for independent pharmacies seeking competitive pricing, and DSCSA documentation is only required for chain pharmacy purchases
Correct Incorrect Correct answer

The risk is limited to potential tax reporting issues, since off-invoice purchases may not be properly accounted for in the pharmacy's financial records
Correct Incorrect Correct answer

Correct

Incorrect
Question 317 of 667

317. Question

Category: Federal Requirements: Dea Schedules

A technician receives a verbal telephone order for tramadol 50 mg, #30, with 3 refills. What DEA schedule is tramadol, and is this order valid as received?

Tramadol is Schedule IV; the verbal order is valid since Schedule III-V prescriptions may be called in and refilled up to 5 times within 6 months
Correct Incorrect Correct answer

Tramadol is Schedule II; verbal orders require a follow-up written prescription within 7 days
Correct Incorrect Correct answer

Tramadol is Schedule III; verbal orders are valid but limited to 2 refills
Correct Incorrect Correct answer

Tramadol is unscheduled; no DEA requirements apply to this prescription
Correct Incorrect Correct answer

Correct

Incorrect
Question 318 of 667

318. Question

Category: Federal Requirements: Dea Schedules

A prescriber calls in a prescription for alprazolam 1 mg, #90, with directions for TID use. The technician calculates this as a 30-day supply. The prescription is dated today. What is the last date refills can be dispensed if 5 refills are authorized?

Within 6 months from the date the prescription was originally written
Correct Incorrect Correct answer

Within 12 months from the date the prescription was originally written
Correct Incorrect Correct answer

Within 90 days from the date the prescription was originally written
Correct Incorrect Correct answer

Refills are not permitted for alprazolam prescriptions under any circumstance
Correct Incorrect Correct answer

Correct

Incorrect
Question 319 of 667

319. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician receives a new prescription for hydrocodone/acetaminophen 5/325 mg, #120, with no refills. The prescription was written 45 days ago. Can this prescription still be filled?

Yes, Schedule II prescriptions do not have a federal expiration date, though some states impose time limits
Correct Incorrect Correct answer

No, Schedule II prescriptions expire after 30 days under federal law
Correct Incorrect Correct answer

Yes, but only if the pharmacist contacts the prescriber to verify the prescription is still valid
Correct Incorrect Correct answer

No, all controlled substance prescriptions expire after 14 days from the date written
Correct Incorrect Correct answer

Correct

Incorrect
Question 320 of 667

320. Question

Category: Federal Requirements: Dea Schedules

An emergency department physician calls the pharmacy with a verbal order for morphine sulfate 15 mg tablets, #20, for a patient being discharged with acute pain. Under what DEA emergency dispensing provision can the pharmacy fill this Schedule II prescription?

The pharmacist may dispense with a verbal authorization if the quantity is limited to the emergency period and a written prescription is received within 7 days
Correct Incorrect Correct answer

Emergency verbal orders for Schedule II substances are never permitted under any circumstance
Correct Incorrect Correct answer

The pharmacist can fill the verbal order with no follow-up documentation required for emergency situations
Correct Incorrect Correct answer

Only the prescriber's nurse or authorized agent can call in emergency Schedule II prescriptions
Correct Incorrect Correct answer

Correct

Incorrect
Question 321 of 667

321. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is asked which DEA form is used to report theft or significant loss of controlled substances. Which form number is correct?

DEA Form 106
Correct Incorrect Correct answer

DEA Form 222
Correct Incorrect Correct answer

DEA Form 224
Correct Incorrect Correct answer

DEA Form 41
Correct Incorrect Correct answer

Correct

Incorrect
Question 322 of 667

322. Question

Category: Federal Requirements: Dea Schedules

A pharmacy receives a prescription for testosterone cypionate 200 mg/mL injection from a prescriber whose DEA number begins with the letter ‘B.’ What does the first letter of the DEA number indicate about this prescriber?

The prescriber is a practitioner (physician, dentist, veterinarian, or other) registered with the DEA, as 'B' is assigned to individual practitioners
Correct Incorrect Correct answer

The prescriber is a hospital or clinic registered as an institutional DEA holder
Correct Incorrect Correct answer

The prescriber is a mid-level practitioner such as a nurse practitioner or physician assistant
Correct Incorrect Correct answer

The prescriber is a researcher authorized only for investigational drug studies
Correct Incorrect Correct answer

Correct

Incorrect
Question 323 of 667

323. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician receives a prescription for clozapine 100 mg daily. Before dispensing, what REMS program requirement must be verified?

The patient must be enrolled in the Clozapine REMS program with a current ANC (absolute neutrophil count) result on file
Correct Incorrect Correct answer

The patient must have a negative pregnancy test within the past 30 days
Correct Incorrect Correct answer

The prescriber must fax a prior authorization form directly to the pharmacy
Correct Incorrect Correct answer

The patient must complete an online educational module before each refill
Correct Incorrect Correct answer

Correct

Incorrect
Question 324 of 667

324. Question

Category: Federal Requirements: Restricted Drug Programs

A female patient of childbearing potential is prescribed thalidomide 100 mg daily for erythema nodosum leprosum. Under the THALOMID REMS program, how frequently must pregnancy testing occur?

Weekly during the first 4 weeks and then every 4 weeks for patients with regular menstrual cycles
Correct Incorrect Correct answer

Once before starting therapy and then annually thereafter
Correct Incorrect Correct answer

Monthly for the first 3 months and then every 6 months
Correct Incorrect Correct answer

Every 2 weeks throughout the entire course of therapy regardless of cycle regularity
Correct Incorrect Correct answer

Correct

Incorrect
Question 325 of 667

325. Question

Category: Federal Requirements: Restricted Drug Programs

A technician is processing a prescription for isotretinoin 40 mg daily for severe cystic acne. The iPLEDGE system shows the patient’s pregnancy test was performed 45 days ago. Can this prescription be dispensed?

No, a pregnancy test must be performed within 30 days prior to dispensing, and this test is expired under iPLEDGE rules
Correct Incorrect Correct answer

Yes, pregnancy tests are valid for 60 days under the iPLEDGE program
Correct Incorrect Correct answer

Yes, as long as the prescriber confirms the patient is using two forms of contraception
Correct Incorrect Correct answer

No, but the pharmacy can dispense a 7-day emergency supply while awaiting a new test
Correct Incorrect Correct answer

Correct

Incorrect
Question 326 of 667

326. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician attempts to fill a prescription for mifepristone 200 mg for medication abortion. The pharmacy system indicates the prescriber is not certified under the required program. What must occur before dispensing?

The prescriber must be certified under the mifepristone REMS program, which requires completion of specific training and agreement to program requirements
Correct Incorrect Correct answer

The pharmacy can override the alert since mifepristone does not require prescriber certification
Correct Incorrect Correct answer

Only hospital pharmacies are authorized to dispense mifepristone under federal law
Correct Incorrect Correct answer

The patient must sign a waiver acknowledging the prescriber is not yet certified
Correct Incorrect Correct answer

Correct

Incorrect
Question 327 of 667

327. Question

Category: Federal Requirements: Restricted Drug Programs

A technician is reviewing REMS requirements for different medications. Which of the following correctly pairs a medication with its REMS restriction?

Vigabatrin requires enrollment in a vision monitoring program (SHARE) due to risk of permanent vision loss
Correct Incorrect Correct answer

Metformin requires liver function monitoring through a REMS program due to hepatotoxicity risk
Correct Incorrect Correct answer

Lisinopril requires monthly blood pressure monitoring through a REMS program
Correct Incorrect Correct answer

Omeprazole requires enrollment in a GI monitoring program due to risk of C. difficile infection
Correct Incorrect Correct answer

Correct

Incorrect
Question 328 of 667

328. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives notification of a Class I recall for a specific lot of a blood pressure medication due to NDMA contamination above acceptable limits. What does a Class I recall indicate?

There is a reasonable probability that use of the product will cause serious adverse health consequences or death
Correct Incorrect Correct answer

The product may cause temporary or medically reversible adverse health consequences
Correct Incorrect Correct answer

The product is unlikely to cause adverse health consequences but violates FDA labeling rules
Correct Incorrect Correct answer

The recall is voluntary and does not require any pharmacy action
Correct Incorrect Correct answer

Correct

Incorrect
Question 329 of 667

329. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician discovers that 15 units of a recalled Class II medication were dispensed to patients before the recall notice arrived. What is the pharmacy’s primary obligation?

Notify affected patients of the recall and provide guidance as directed by the pharmacist and recall notification
Correct Incorrect Correct answer

Wait for the FDA to contact the patients directly since the pharmacy has no notification obligation
Correct Incorrect Correct answer

Destroy remaining stock and file a report only if a patient reports an adverse event
Correct Incorrect Correct answer

Remove remaining stock from shelves but take no action regarding already-dispensed products
Correct Incorrect Correct answer

Correct

Incorrect
Question 330 of 667

330. Question

Category: Federal Requirements: Fda Recalls

During a pharmacy inventory, a technician finds a bottle with a lot number matching an FDA recall notice. What should the technician do first?

Immediately remove the product from active inventory and quarantine it separately from dispensable stock
Correct Incorrect Correct answer

Continue dispensing from the bottle until it is empty to avoid waste
Correct Incorrect Correct answer

Place a warning sticker on the bottle and continue dispensing with patient notification
Correct Incorrect Correct answer

Return the bottle to the shelf and notify the pharmacist at the end of the shift
Correct Incorrect Correct answer

Correct

Incorrect
Question 331 of 667

331. Question

Category: Federal Requirements: Fda Recalls

A manufacturer initiates a voluntary recall of a cough syrup due to a labeling error that lists the wrong inactive ingredient. No safety risk is identified. What class of recall does this most likely represent?

Class III, as the product violation is not likely to cause adverse health consequences
Correct Incorrect Correct answer

Class I, because any labeling error constitutes a serious safety threat
Correct Incorrect Correct answer

Class II, because incorrect ingredient listings always pose moderate health risk
Correct Incorrect Correct answer

This would not be classified as a recall since there is no safety concern
Correct Incorrect Correct answer

Correct

Incorrect
Question 332 of 667

332. Question

Category: Federal Requirements: Fda Recalls

A hospital pharmacy technician is tasked with documenting the recall process for an antibiotic recalled due to subpotency. Which documentation elements are essential for the recall record?

Lot numbers affected, quantity on hand, quantity dispensed, patients notified, product disposition, and date of actions taken
Correct Incorrect Correct answer

Only the lot number and date the product was removed from inventory
Correct Incorrect Correct answer

The manufacturer contact information and a copy of the recall letter only
Correct Incorrect Correct answer

A pharmacist signature confirming the recall was received, with no additional details needed
Correct Incorrect Correct answer

Correct

Incorrect
Question 333 of 667

333. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician receives a MedWatch Safety Alert about a newly identified safety concern with a marketed medication. What is the purpose of the FDA MedWatch program?

MedWatch facilitates reporting of serious adverse events and safety problems with medications, devices, and other FDA-regulated products
Correct Incorrect Correct answer

MedWatch is used exclusively for reporting medication errors within hospital settings
Correct Incorrect Correct answer

MedWatch is the FDA system for tracking controlled substance prescriptions nationally
Correct Incorrect Correct answer

MedWatch is the manufacturer notification system for drug price changes and shortages
Correct Incorrect Correct answer

Correct

Incorrect
Question 334 of 667

334. Question

Category: Federal Requirements: Dscsa

Under the Drug Supply Chain Security Act (DSCSA), what documentation must accompany each transaction when a pharmacy receives a shipment of prescription drugs from a wholesale distributor?

Transaction information (TI), transaction history (TH), and a transaction statement (TS)
Correct Incorrect Correct answer

Only a packing slip with the drug name and quantity received
Correct Incorrect Correct answer

A DEA Form 222 for all prescription medications regardless of schedule
Correct Incorrect Correct answer

A certificate of analysis from the drug manufacturer for each lot received
Correct Incorrect Correct answer

Correct

Incorrect
Question 335 of 667

335. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a shipment and the transaction history shows the product passed through a distributor not authorized by the manufacturer. Under DSCSA, what should the pharmacy do?

Quarantine the product and investigate the suspicious transaction before accepting it into inventory, as this may indicate an illegitimate product
Correct Incorrect Correct answer

Accept the shipment since the pharmacy is only required to verify the final distributor
Correct Incorrect Correct answer

Return the entire shipment and report the distributor to local law enforcement
Correct Incorrect Correct answer

Accept the shipment but file a report with the FDA within 30 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 336 of 667

336. Question

Category: Federal Requirements: Dscsa

A pharmacy technician scanning incoming products notices a product without a standardized numerical identifier (SNI) on the package. Under DSCSA serialization requirements, what should the technician do?

Quarantine the product and notify the pharmacist, as DSCSA requires serialized product identifiers including an SNI on all prescription drug packages
Correct Incorrect Correct answer

Accept the product since SNI is only required for controlled substances
Correct Incorrect Correct answer

Apply a pharmacy-generated barcode to the package and accept it into inventory
Correct Incorrect Correct answer

Accept the product and contact the manufacturer to request the SNI within 90 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 337 of 667

337. Question

Category: Federal Requirements: Dscsa

A pharmacy technician identifies a product that may be counterfeit based on packaging irregularities. Under DSCSA, what is the correct sequence of actions?

Quarantine the suspect product, notify the trading partner who supplied it, and do not distribute or dispense it until the investigation is complete
Correct Incorrect Correct answer

Continue dispensing while contacting the manufacturer to verify authenticity
Correct Incorrect Correct answer

Destroy the suspect product immediately and document the destruction
Correct Incorrect Correct answer

Return the product to the distributor with no additional reporting required
Correct Incorrect Correct answer

Correct

Incorrect
Question 338 of 667

338. Question

Category: Federal Requirements: Dscsa

A pharmacy is preparing for a DSCSA compliance audit. Which entity is responsible for establishing and maintaining product tracing at the pharmacy level?

The pharmacy itself, as each trading partner in the supply chain bears individual responsibility for maintaining transaction records
Correct Incorrect Correct answer

The wholesale distributor, which provides all tracing documentation on behalf of the pharmacy
Correct Incorrect Correct answer

The FDA, which maintains a central database of all prescription drug transactions
Correct Incorrect Correct answer

The state board of pharmacy, which manages product tracing for all pharmacies in the state
Correct Incorrect Correct answer

Correct

Incorrect
Question 339 of 667

339. Question

Category: Federal Requirements: Controlled Substance Rx

How many refills are permitted for a Schedule III controlled substance prescription?

Up to 5 refills within 6 months of the date written
Correct Incorrect Correct answer

Up to 3 refills within 6 months of the date written
Correct Incorrect Correct answer

Up to 5 refills within 12 months of the date written
Correct Incorrect Correct answer

No refills are permitted for Schedule III prescriptions
Correct Incorrect Correct answer

Correct

Incorrect
Question 340 of 667

340. Question

Category: Federal Requirements: Controlled Substance Rx

Which schedule of controlled substances cannot be refilled under federal law?

Schedule II
Correct Incorrect Correct answer

Schedule III
Correct Incorrect Correct answer

Schedule IV
Correct Incorrect Correct answer

Schedule V
Correct Incorrect Correct answer

Correct

Incorrect
Question 341 of 667

341. Question

Category: Federal Requirements: Controlled Substance Rx

What is the maximum time frame within which refills for a Schedule IV prescription must be dispensed?

6 months from the date the prescription was written
Correct Incorrect Correct answer

12 months from the date the prescription was written
Correct Incorrect Correct answer

6 months from the date the prescription was first filled
Correct Incorrect Correct answer

12 months from the date the prescription was first filled
Correct Incorrect Correct answer

Correct

Incorrect
Question 342 of 667

342. Question

Category: Federal Requirements: Controlled Substance Rx

What does the DEA number checksum validation involve?

Adding the 1st, 3rd, and 5th digits, then adding twice the sum of the 2nd, 4th, and 6th digits, with the last digit of the total matching the check digit
Correct Incorrect Correct answer

Adding all six digits together and verifying the total is an even number
Correct Incorrect Correct answer

Multiplying the first three digits by the last three digits and dividing by the registrant type letter
Correct Incorrect Correct answer

Adding the odd position digits and subtracting the even position digits to confirm a positive result
Correct Incorrect Correct answer

Correct

Incorrect
Question 343 of 667

343. Question

Category: Federal Requirements: Controlled Substance Rx

Which letter prefix on a DEA number typically indicates that the registrant is a mid-level practitioner?

M
Correct Incorrect Correct answer

A
Correct Incorrect Correct answer

B
Correct Incorrect Correct answer

F
Correct Incorrect Correct answer

Correct

Incorrect
Question 344 of 667

344. Question

Category: Federal Requirements: Controlled Substance Rx

What is required for a prescription pad used for controlled substances to comply with federal tamper-resistant requirements for Medicaid patients?

The pad must contain at least one industry-recognized feature from each of three categories: copy resistance, erasure resistance, and counterfeit resistance
Correct Incorrect Correct answer

The pad must be printed on watermarked paper with a sequential serial number only
Correct Incorrect Correct answer

The pad must use heat-sensitive ink and include the prescriber photograph
Correct Incorrect Correct answer

The pad must contain a unique barcode linked to the DEA database for verification
Correct Incorrect Correct answer

Correct

Incorrect
Question 345 of 667

345. Question

Category: Federal Requirements: Controlled Substance Rx

Under federal law, which element is NOT required on a Schedule II prescription?

The number of refills authorized
Correct Incorrect Correct answer

The patient name and address
Correct Incorrect Correct answer

The drug name, strength, and quantity
Correct Incorrect Correct answer

The prescriber signature
Correct Incorrect Correct answer

Correct

Incorrect
Question 346 of 667

346. Question

Category: Federal Requirements: Controlled Substance Rx

What does the corresponding responsibility doctrine require of a pharmacist?

The pharmacist shares responsibility with the prescriber to ensure a controlled substance prescription is issued for a legitimate medical purpose
Correct Incorrect Correct answer

The pharmacist must verify the prescriber credentials with the state board before each dispensing
Correct Incorrect Correct answer

The pharmacist must contact the patient primary care provider to confirm every controlled substance prescription
Correct Incorrect Correct answer

The pharmacist must report all controlled substance prescriptions to the DEA within 24 hours of dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 347 of 667

347. Question

Category: Federal Requirements: Controlled Substance Rx

A patient presents a prescription for oxycodone 30 mg, quantity 120, written 45 days ago. The prescription has never been filled. What should the pharmacy technician do?

Proceed with filling the prescription, as federal law does not set a specific expiration for Schedule II prescriptions
Correct Incorrect Correct answer

Refuse to fill the prescription because it is past the 30-day federal limit
Correct Incorrect Correct answer

Return the prescription and tell the patient to request a new one from the prescriber
Correct Incorrect Correct answer

Contact the DEA to verify the prescription is still valid after 45 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 348 of 667

348. Question

Category: Federal Requirements: Controlled Substance Rx

A prescriber calls in a prescription for hydrocodone/acetaminophen 10/325 mg for a patient with acute pain. How should the pharmacy technician handle this?

Inform the pharmacist that the prescription cannot be accepted verbally because hydrocodone combination products are Schedule II
Correct Incorrect Correct answer

Accept the verbal prescription and document the prescriber name and DEA number
Correct Incorrect Correct answer

Accept the verbal prescription only if the pharmacist witnesses the call
Correct Incorrect Correct answer

Fill the prescription since hydrocodone combinations are Schedule III and verbal orders are permitted
Correct Incorrect Correct answer

Correct

Incorrect
Question 349 of 667

349. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy receives a Schedule II prescription via electronic prescribing. Which of the following must be true for the e-prescription to be valid?

The prescriber must use a two-factor authentication system that is certified for EPCS
Correct Incorrect Correct answer

The prescriber must also fax a paper copy to the pharmacy as a backup
Correct Incorrect Correct answer

The electronic system must print a hard copy at the pharmacy for the prescriber to sign within 7 days
Correct Incorrect Correct answer

The prescriber must include a scanned image of their handwritten signature on the electronic prescription
Correct Incorrect Correct answer

Correct

Incorrect
Question 350 of 667

350. Question

Category: Federal Requirements: Controlled Substance Rx

A patient in a long-term care facility (LTCF) needs a partial fill of a Schedule II medication. Under federal law, how long does the pharmacy have to supply the remaining quantity?

30 days from the date of the original prescription
Correct Incorrect Correct answer

72 hours from the time of the initial partial dispensing
Correct Incorrect Correct answer

60 days from the date of the original prescription
Correct Incorrect Correct answer

90 days from the date of the original prescription
Correct Incorrect Correct answer

Correct

Incorrect
Question 351 of 667

351. Question

Category: Federal Requirements: Controlled Substance Rx

A patient brings in a Schedule II prescription, but the pharmacy only has enough stock to partially fill it. The patient is not in a long-term care facility or hospice. How long does the pharmacy have to supply the remainder?

72 hours from the initial partial dispensing
Correct Incorrect Correct answer

7 days from the initial partial dispensing
Correct Incorrect Correct answer

30 days from the date the prescription was written
Correct Incorrect Correct answer

The pharmacy cannot partially fill a Schedule II prescription under any circumstances
Correct Incorrect Correct answer

Correct

Incorrect
Question 352 of 667

352. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy technician receives a transferred prescription for alprazolam 0.5 mg from another pharmacy. Under federal law, how many times may a Schedule IV prescription be transferred between pharmacies?

One time only, unless pharmacies share a real-time online database
Correct Incorrect Correct answer

Up to three times during the valid refill period
Correct Incorrect Correct answer

Unlimited times as long as refills remain
Correct Incorrect Correct answer

Transfer of controlled substance prescriptions is not permitted under federal law
Correct Incorrect Correct answer

Correct

Incorrect
Question 353 of 667

353. Question

Category: Federal Requirements: Controlled Substance Rx

A prescriber writes three separate Schedule II prescriptions for the same patient on the same day, each with a different “do not fill until” date. Is this practice permissible under federal law?

Yes, a prescriber may issue multiple Schedule II prescriptions on the same day with different fill dates up to a 90-day supply
Correct Incorrect Correct answer

No, only one Schedule II prescription may be written per patient per visit
Correct Incorrect Correct answer

No, multiple Schedule II prescriptions on the same date are considered refills
Correct Incorrect Correct answer

Yes, but only if each prescription is for a different Schedule II medication
Correct Incorrect Correct answer

Correct

Incorrect
Question 354 of 667

354. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy technician is verifying a DEA number for Dr. Adams: BA3456721. Using the checksum algorithm, what should the technician conclude?

The DEA number fails the checksum validation and may be invalid
Correct Incorrect Correct answer

The DEA number passes the checksum validation and is likely valid
Correct Incorrect Correct answer

The DEA number format is incorrect because it should start with two letters followed by six digits
Correct Incorrect Correct answer

The checksum cannot be validated without contacting the DEA directly
Correct Incorrect Correct answer

Correct

Incorrect
Question 355 of 667

355. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy technician is processing a prescription for tramadol 50 mg with 3 refills authorized. The prescription was written 5 months ago. How should the technician proceed?

Process the refill because the prescription has remaining refills and is within the 6-month window
Correct Incorrect Correct answer

Reject the refill because tramadol is Schedule II and cannot be refilled
Correct Incorrect Correct answer

Contact the prescriber to obtain a new prescription because it has been more than 90 days
Correct Incorrect Correct answer

Reject the refill because Schedule IV medications can only be refilled within 3 months
Correct Incorrect Correct answer

Correct

Incorrect
Question 356 of 667

356. Question

Category: Federal Requirements: Controlled Substance Rx

A nurse practitioner presents a prescription with a DEA number beginning with “M.” The pharmacy technician has not seen this prefix before. What does this indicate?

The prescriber is a mid-level practitioner authorized by the DEA to prescribe controlled substances
Correct Incorrect Correct answer

The DEA number is fraudulent because valid DEA numbers only begin with A, B, or F
Correct Incorrect Correct answer

The prescriber has a temporary DEA registration that must be verified each time
Correct Incorrect Correct answer

The prescriber is a military physician using a special armed forces DEA number
Correct Incorrect Correct answer

Correct

Incorrect
Question 357 of 667

357. Question

Category: Federal Requirements: Controlled Substance Rx

A patient requests an early refill of lorazepam, stating they are going on vacation. The prescription was last filled 20 days ago for a 30-day supply. What is the appropriate action?

Refer the request to the pharmacist, who will use professional judgment and check state-specific early refill policies
Correct Incorrect Correct answer

Immediately process the early refill since the patient has a valid reason
Correct Incorrect Correct answer

Deny the refill and tell the patient to wait until day 30 to pick up the medication
Correct Incorrect Correct answer

Contact the DEA to obtain approval for the early refill of a Schedule IV substance
Correct Incorrect Correct answer

Correct

Incorrect
Question 358 of 667

358. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacist receives an emergency oral prescription for a Schedule II medication. Which of the following is a requirement for the emergency to be valid?

The prescriber must provide a written or electronic follow-up prescription to the pharmacy within 7 days
Correct Incorrect Correct answer

The pharmacist must obtain DEA approval before dispensing the emergency supply
Correct Incorrect Correct answer

The emergency supply is limited to a maximum 3-day supply under all circumstances
Correct Incorrect Correct answer

The prescriber must fax the follow-up prescription within 24 hours of the oral order
Correct Incorrect Correct answer

Correct

Incorrect
Question 359 of 667

359. Question

Category: Federal Requirements: Controlled Substance Rx

A patient brings in a prescription for codeine/acetaminophen 30/300 mg with 5 refills written 4 months ago. Two refills have been used. Can the pharmacy fill another refill?

Yes, there are remaining refills and the prescription is within the 6-month period
Correct Incorrect Correct answer

No, because codeine combinations are Schedule II and cannot be refilled
Correct Incorrect Correct answer

No, because the prescription has exceeded the 90-day refill window
Correct Incorrect Correct answer

Yes, but only after contacting the prescriber to reauthorize the remaining refills
Correct Incorrect Correct answer

Correct

Incorrect
Question 360 of 667

360. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy in a state that requires controlled substance prescriptions to be filled within 30 days receives a Schedule II prescription written 25 days ago. Federal law has no such time limit. Which rule applies?

The state law applies because it is stricter than federal law
Correct Incorrect Correct answer

Federal law overrides state law, so there is no time limit
Correct Incorrect Correct answer

The pharmacist may choose whichever law is more convenient for the patient
Correct Incorrect Correct answer

The prescription is invalid because the two laws conflict
Correct Incorrect Correct answer

Correct

Incorrect
Question 361 of 667

361. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy technician notices that a controlled substance prescription lacks the patient address. All other required information is present. What should the technician do?

Alert the pharmacist, who may add the patient address after verifying it with the patient or prescriber
Correct Incorrect Correct answer

Refuse to process the prescription and return it to the patient
Correct Incorrect Correct answer

Fill the prescription as written since the address is not a required element
Correct Incorrect Correct answer

Contact the DEA to report the prescriber for an incomplete prescription
Correct Incorrect Correct answer

Correct

Incorrect
Question 362 of 667

362. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy receives a faxed Schedule II prescription for morphine sulfate ER 30 mg for a patient residing in a hospice facility. The pharmacist is unsure whether the fax can serve as the original. What should the pharmacist determine?

The fax may serve as the original prescription because the patient is enrolled in a hospice program, which is a permitted exception for faxed Schedule II prescriptions
Correct Incorrect Correct answer

The fax cannot serve as the original; a written prescription must follow within 72 hours
Correct Incorrect Correct answer

The fax is only valid if the patient picks up the medication in person at the pharmacy
Correct Incorrect Correct answer

The fax is acceptable only if the prescriber also calls the pharmacy to confirm the order verbally
Correct Incorrect Correct answer

Correct

Incorrect
Question 363 of 667

363. Question

Category: Federal Requirements: Controlled Substance Rx

A technician finds a prescription for oxycodone written by Dr. Jones with DEA number BJ2587613. Checking the algorithm: odd positions sum to 2+8+6=16, even positions sum to 5+7+1=13, doubled to 26. The total is 42, making the check digit 2, but the last digit is 3. What should occur?

The technician should alert the pharmacist that the DEA number fails validation and the prescription should not be processed until the number is verified
Correct Incorrect Correct answer

The technician should dispense the medication since the checksum is only off by one digit
Correct Incorrect Correct answer

The technician should correct the DEA number by changing the last digit to 2 and proceed
Correct Incorrect Correct answer

The technician should contact the DEA to update the prescriber registration number
Correct Incorrect Correct answer

Correct

Incorrect
Question 364 of 667

364. Question

Category: Federal Requirements: Controlled Substance Rx

A patient in a long-term care facility has a partial fill of a CII opioid dispensed on March 1. The original prescription was dated February 15. By what date must all remaining portions be dispensed?

April 16, which is 60 days from the original prescription date
Correct Incorrect Correct answer

May 1, which is 60 days from the date of the first partial fill
Correct Incorrect Correct answer

March 3, which is 72 hours from the initial partial dispensing
Correct Incorrect Correct answer

April 15, which is the last day of the second month after the prescription was written
Correct Incorrect Correct answer

Correct

Incorrect
Question 365 of 667

365. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacist suspects a controlled substance prescription may not serve a legitimate medical purpose based on several red flags: the patient traveled a long distance, paid cash, and requested a specific brand. Under the corresponding responsibility doctrine, what is the pharmacist obligated to do?

Exercise professional judgment and refuse to fill the prescription if the pharmacist determines it lacks a legitimate medical purpose
Correct Incorrect Correct answer

Fill the prescription as written because only the prescriber is responsible for determining medical necessity
Correct Incorrect Correct answer

Report the patient to local law enforcement before making a dispensing decision
Correct Incorrect Correct answer

Contact the prescriber to confirm the prescription and then fill it regardless of the red flags
Correct Incorrect Correct answer

Correct

Incorrect
Question 366 of 667

366. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy operates in a state that allows Schedule II e-prescriptions but does not mandate them. A prescriber sends a handwritten Schedule II prescription. Federal law allows but does not require EPCS. Can the pharmacy fill the paper prescription?

Yes, because neither federal nor state law mandates e-prescribing for this situation, so a valid handwritten prescription is acceptable
Correct Incorrect Correct answer

No, because federal law now requires all Schedule II prescriptions to be electronic
Correct Incorrect Correct answer

No, because once a state permits EPCS, all prescribers in that state must use it
Correct Incorrect Correct answer

Yes, but only if the prescriber includes a written statement explaining why the prescription was not sent electronically
Correct Incorrect Correct answer

Correct

Incorrect
Question 367 of 667

367. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy technician processes a transfer-in of a Schedule V cough suppressant prescription from a pharmacy in a different state. The sending pharmacy is not part of the same chain. Federal law allows one transfer. The receiving state allows unlimited transfers. Which rule applies?

Federal law is stricter and limits the transfer to one time since the pharmacies do not share a real-time database
Correct Incorrect Correct answer

The receiving state law allows unlimited transfers, so the more permissive rule applies
Correct Incorrect Correct answer

Interstate transfers of controlled substances are prohibited regardless of schedule
Correct Incorrect Correct answer

The transfer is not permitted because Schedule V medications do not require a prescription
Correct Incorrect Correct answer

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Incorrect
Question 368 of 667

368. Question

Category: Federal Requirements: Controlled Substance Rx

A prescriber issues an emergency oral Schedule II prescription for a terminally ill hospice patient on April 1. The follow-up written prescription must be received by the pharmacy within 7 days. By April 10, no follow-up has arrived. What must the pharmacy do?

Notify the DEA if the prescriber fails to deliver the follow-up prescription and note the failure on the back of the oral prescription record
Correct Incorrect Correct answer

Reverse the dispensing and request the patient return the unused medication
Correct Incorrect Correct answer

Issue a refund to the patient and void the original prescription record
Correct Incorrect Correct answer

Contact the state board of pharmacy to revoke the prescriber DEA registration
Correct Incorrect Correct answer

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Question 369 of 667

369. Question

Category: Federal Requirements: Dea Schedules

Which DEA schedule contains substances with no currently accepted medical use and a high potential for abuse?

Schedule I
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Schedule II
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Schedule III
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Schedule V
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Correct

Incorrect
Question 370 of 667

370. Question

Category: Federal Requirements: Dea Schedules

Which of the following is classified as a Schedule II controlled substance?

Fentanyl
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Alprazolam
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Tramadol
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Codeine cough syrup with promethazine
Correct Incorrect Correct answer

Correct

Incorrect
Question 371 of 667

371. Question

Category: Federal Requirements: Dea Schedules

Which controlled substance schedule includes medications with a lower potential for abuse relative to Schedule III and limited dependence liability?

Schedule IV
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Schedule I
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Schedule II
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Schedule III
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Correct

Incorrect
Question 372 of 667

372. Question

Category: Federal Requirements: Dea Schedules

Pseudoephedrine is regulated under which federal law that limits the quantity a consumer can purchase?

Combat Methamphetamine Epidemic Act (CMEA)
Correct Incorrect Correct answer

Controlled Substances Act Schedule V provisions
Correct Incorrect Correct answer

Drug Supply Chain Security Act (DSCSA)
Correct Incorrect Correct answer

Prescription Drug Marketing Act (PDMA)
Correct Incorrect Correct answer

Correct

Incorrect
Question 373 of 667

373. Question

Category: Federal Requirements: Dea Schedules

Which Schedule V medication is an anticonvulsant that has been classified as a controlled substance at the federal level?

Pregabalin (Lyrica)
Correct Incorrect Correct answer

Gabapentin (Neurontin)
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Levetiracetam (Keppra)
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Lamotrigine (Lamictal)
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Correct

Incorrect
Question 374 of 667

374. Question

Category: Federal Requirements: Dea Schedules

Which three criteria does the DEA use to determine the schedule classification of a controlled substance?

Potential for abuse, currently accepted medical use, and potential for physical or psychological dependence
Correct Incorrect Correct answer

Chemical structure, route of administration, and manufacturer pricing
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Number of adverse events reported, patent expiration date, and market availability
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Prescription volume, number of dosage forms, and FDA approval date
Correct Incorrect Correct answer

Correct

Incorrect
Question 375 of 667

375. Question

Category: Federal Requirements: Dea Schedules

A customer asks to purchase three boxes of pseudoephedrine 30 mg tablets, each containing 96 tablets, in a single transaction. The daily federal purchase limit is 3.6 grams. Should the sale proceed?

No, because three boxes of 96 tablets at 30 mg each totals 8.64 grams, which exceeds the 3.6-gram daily limit
Correct Incorrect Correct answer

Yes, because there is no daily limit on pseudoephedrine purchases for personal use
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Yes, because the limit applies only to liquid formulations of pseudoephedrine
Correct Incorrect Correct answer

No, because pseudoephedrine cannot be sold without a prescription in any state
Correct Incorrect Correct answer

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Incorrect
Question 376 of 667

376. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is stocking a new medication and needs to determine its storage requirements. The medication is testosterone cypionate injection. In which schedule should it be stored?

Schedule III
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Schedule II
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Schedule IV
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It is not a controlled substance
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Correct

Incorrect
Question 377 of 667

377. Question

Category: Federal Requirements: Dea Schedules

A pharmacy in a state where gabapentin is classified as a Schedule V controlled substance receives a transfer prescription from a state where gabapentin is unscheduled. How should the receiving pharmacy handle this?

Treat gabapentin as a Schedule V controlled substance in compliance with the receiving state law
Correct Incorrect Correct answer

Treat gabapentin as unscheduled since the prescription originated in a state where it is not controlled
Correct Incorrect Correct answer

Refuse the transfer because controlled substance status must match between states
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Contact the DEA for a ruling on which state classification to follow
Correct Incorrect Correct answer

Correct

Incorrect
Question 378 of 667

378. Question

Category: Federal Requirements: Dea Schedules

A pharmacy receives a new product containing a substance chemically similar to fentanyl but not specifically listed in any DEA schedule. Under which federal law could this substance be treated as a controlled substance?

The Federal Analogue Act, which treats substantially similar substances as Schedule I or II
Correct Incorrect Correct answer

The Prescription Drug Marketing Act, which regulates drug distribution channels
Correct Incorrect Correct answer

The Durham-Humphrey Amendment, which distinguishes prescription from OTC drugs
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The Kefauver-Harris Amendment, which requires proof of drug efficacy
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Question 379 of 667

379. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is organizing the controlled substance inventory. Which of the following medications should be stored with Schedule II substances?

Methylphenidate (Ritalin)
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Diazepam (Valium)
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Testosterone (Depo-Testosterone)
Correct Incorrect Correct answer

Phenobarbital (Luminal)
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Correct

Incorrect
Question 380 of 667

380. Question

Category: Federal Requirements: Dea Schedules

A customer asks whether a prescription is needed to purchase a cough syrup containing codeine classified as a Schedule V exempt narcotic. What should the pharmacy technician explain?

The sale may be permitted without a prescription in some states, but requires pharmacist supervision, customer identification, and a logbook entry
Correct Incorrect Correct answer

A prescription is always required for any product containing codeine regardless of schedule
Correct Incorrect Correct answer

The product can be sold freely over the counter without any restrictions in all states
Correct Incorrect Correct answer

The product requires a DEA Form 222 before it can be sold to a customer
Correct Incorrect Correct answer

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Question 381 of 667

381. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician finds that a newly received shipment of buprenorphine/naloxone (Suboxone) sublingual film has been placed on the regular prescription shelf. Where should it be relocated?

To the Schedule III controlled substance storage area
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To the Schedule II controlled substance storage area
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To the Schedule IV controlled substance storage area
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It can remain on the regular shelf since it contains naloxone
Correct Incorrect Correct answer

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Question 382 of 667

382. Question

Category: Federal Requirements: Dea Schedules

A technician is asked whether diphenoxylate/atropine (Lomotil) requires a controlled substance prescription. What is the correct classification?

Schedule V when containing no more than 2.5 mg diphenoxylate per dosage unit with atropine
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Schedule II because diphenoxylate is an opioid derivative
Correct Incorrect Correct answer

Schedule IV because it has limited dependence potential
Correct Incorrect Correct answer

It is not a controlled substance when combined with atropine
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Incorrect
Question 383 of 667

383. Question

Category: Federal Requirements: Dea Schedules

A customer purchases pseudoephedrine products on three occasions within a 30-day period, totaling 7.2 grams. The customer now wants to buy another product containing 2.4 grams of pseudoephedrine. Can this purchase be completed?

No, because the 30-day total would be 9.6 grams, exceeding the federal monthly limit of 9 grams
Correct Incorrect Correct answer

Yes, because each individual purchase is within the daily limit of 3.6 grams
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Yes, because the monthly limit resets after each purchase transaction
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No, because only two pseudoephedrine purchases per month are allowed
Correct Incorrect Correct answer

Correct

Incorrect
Question 384 of 667

384. Question

Category: Federal Requirements: Dea Schedules

A pharmacy student asks why marijuana remains Schedule I despite state-level legalization for medical use in some states. Which statement best explains the federal classification?

Federal scheduling is determined by the DEA and FDA at the national level, and state legalization does not change the federal classification
Correct Incorrect Correct answer

Marijuana was automatically rescheduled when the first state legalized medical use
Correct Incorrect Correct answer

The DEA does not have authority to reschedule substances; only Congress can change schedules
Correct Incorrect Correct answer

Marijuana is no longer Schedule I because of recent state ballot initiatives
Correct Incorrect Correct answer

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Incorrect
Question 385 of 667

385. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician discovers that a new state law classifies kratom as a Schedule I substance, but the DEA has not scheduled it federally. A customer attempts to purchase kratom extract. How should the pharmacy handle this situation?

Refuse the sale because the state Schedule I classification is stricter than the absence of federal scheduling, and the stricter law prevails
Correct Incorrect Correct answer

Allow the sale because the federal government has not classified kratom as a controlled substance
Correct Incorrect Correct answer

Allow the sale but require the customer to sign a disclosure form about the state classification
Correct Incorrect Correct answer

Refer the customer to a physician to obtain a prescription before the sale can be completed
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Incorrect
Question 386 of 667

386. Question

Category: Federal Requirements: Dea Schedules

A pharmacist is reviewing inventory and notices that hydrocodone/ibuprofen (Vicoprofen) and hydrocodone/acetaminophen (Norco) are stored in different schedule areas. Vicoprofen is in the Schedule III section and Norco is in Schedule II. Is this correct?

No; both products should be in the Schedule II area because all hydrocodone combination products were reclassified to Schedule II in 2014
Correct Incorrect Correct answer

Yes; Vicoprofen is Schedule III because it contains ibuprofen rather than acetaminophen
Correct Incorrect Correct answer

Yes; only hydrocodone/acetaminophen combinations were moved to Schedule II
Correct Incorrect Correct answer

No; both products should be in the Schedule III area because they are combination products
Correct Incorrect Correct answer

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Incorrect
Question 387 of 667

387. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is comparing two cough products. Product A contains 10 mg of codeine per 5 mL with guaifenesin. Product B contains codeine 30 mg per tablet without any non-narcotic active ingredient. What are the expected schedule differences?

Product A is likely Schedule V due to limited codeine per dosage unit combined with guaifenesin, while Product B is likely Schedule II due to the higher codeine amount without a qualifying combination
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Both products are Schedule V because codeine in any cough preparation is automatically Schedule V
Correct Incorrect Correct answer

Both products are Schedule II because any product containing codeine is classified as Schedule II
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Product A is Schedule III and Product B is Schedule IV based on the codeine concentration alone
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Incorrect
Question 388 of 667

388. Question

Category: Federal Requirements: Dea Schedules

A DEA rescheduling proposal would move a currently Schedule III substance to Schedule II. If approved, how would this affect the pharmacy handling of existing prescriptions with remaining refills?

Existing prescriptions could not be refilled after the reclassification takes effect because Schedule II substances do not allow refills
Correct Incorrect Correct answer

Existing prescriptions with remaining refills would be honored until they expire under the original schedule rules
Correct Incorrect Correct answer

The pharmacy would have a 180-day grace period to dispense remaining refills on existing prescriptions
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Refills would be permitted but only with a new prescription from the prescriber confirming the schedule change
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Question 389 of 667

389. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is preparing a report on pseudoephedrine sales. A customer purchased 3.6 grams on day 1, 1.8 grams on day 10, and 2.4 grams on day 20 of a 30-day period. The customer requests 1.5 grams on day 25. Considering the daily limit of 3.6 grams and monthly limit of 9 grams, should the sale be allowed?

No, because the 30-day total would be 9.3 grams, exceeding the 9-gram monthly limit even though the daily limit is not exceeded
Correct Incorrect Correct answer

Yes, because each individual purchase is under the daily limit of 3.6 grams
Correct Incorrect Correct answer

Yes, because the monthly limit only applies to mail-order pseudoephedrine purchases
Correct Incorrect Correct answer

Yes, because the 30-day period resets after each individual purchase transaction
Correct Incorrect Correct answer

Correct

Incorrect
Question 390 of 667

390. Question

Category: Federal Requirements: Dea Schedules

A pharmacy receives a prescription for a compounded product containing both ketamine (Schedule III) and diazepam (Schedule IV). The technician asks which schedule rules should govern dispensing and documentation. What is the correct approach?

The compounded product should be handled according to the requirements of the highest schedule component, which is Schedule III
Correct Incorrect Correct answer

The compounded product follows the rules of the lowest schedule component, which is Schedule IV
Correct Incorrect Correct answer

Each ingredient must be documented separately under its own schedule with separate dispensing records
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The product is not considered a controlled substance because the compounding process changes its classification
Correct Incorrect Correct answer

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Incorrect
Question 391 of 667

391. Question

Category: Federal Requirements: Dea Schedules

A technician notices that the pharmacy formulary lists gabapentin as both a non-controlled medication and references a state schedule. The pharmacy operates in a state where gabapentin was recently classified as Schedule V. A patient from a neighboring state where gabapentin is unscheduled presents a valid prescription. How should the pharmacy proceed?

Dispense gabapentin following Schedule V requirements because the pharmacy must comply with the laws of the state in which it is located
Correct Incorrect Correct answer

Dispense gabapentin as a non-controlled medication because the patient home state does not schedule it
Correct Incorrect Correct answer

Refuse to fill the prescription because the schedule mismatch between states creates a legal conflict
Correct Incorrect Correct answer

Contact the DEA to determine which state scheduling classification takes precedence
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Correct

Incorrect
Question 392 of 667

392. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is asked to explain why certain older cough syrups containing hydrocodone were once available with refills but now require a new prescription each time. Which regulatory change is responsible?

The 2014 DEA reclassification of hydrocodone combination products from Schedule III to Schedule II eliminated the ability to prescribe refills
Correct Incorrect Correct answer

The FDA issued a black box warning that automatically moved all hydrocodone products to Schedule I
Correct Incorrect Correct answer

Congress passed a law specifically banning refills on all opioid cough preparations regardless of schedule
Correct Incorrect Correct answer

The CMEA restricted hydrocodone cough products to behind-the-counter status without refill privileges
Correct Incorrect Correct answer

Correct

Incorrect
Question 393 of 667

393. Question

Category: Federal Requirements: Dea Schedules

A technician receives a new stock bottle of lorazepam 1 mg tablets. The pharmacist asks the technician to store it properly. Which controlled substance schedule area is appropriate for lorazepam?

Schedule IV, because lorazepam is a benzodiazepine classified in this schedule
Correct Incorrect Correct answer

Schedule II, because all benzodiazepines are classified as high-abuse-potential substances
Correct Incorrect Correct answer

Schedule III, because lorazepam has moderate dependence potential similar to anabolic steroids
Correct Incorrect Correct answer

Schedule V, because lorazepam has a low potential for abuse compared to other controlled substances
Correct Incorrect Correct answer

Correct

Incorrect
Question 394 of 667

394. Question

Category: Federal Requirements: Restricted Drug Programs

What does the acronym REMS stand for in the context of FDA drug safety programs?

Risk Evaluation and Mitigation Strategy
Correct Incorrect Correct answer

Regulatory Enforcement and Medication Standards
Correct Incorrect Correct answer

Risk Evaluation and Marketing Surveillance
Correct Incorrect Correct answer

Restricted Entry Medication System
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Incorrect
Question 395 of 667

395. Question

Category: Federal Requirements: Restricted Drug Programs

Which REMS program requires female patients to have two negative pregnancy tests before starting therapy with isotretinoin?

iPLEDGE
Correct Incorrect Correct answer

Clozaril REMS
Correct Incorrect Correct answer

TIRF REMS
Correct Incorrect Correct answer

Thalomid REMS
Correct Incorrect Correct answer

Correct

Incorrect
Question 396 of 667

396. Question

Category: Federal Requirements: Restricted Drug Programs

Under the Combat Methamphetamine Epidemic Act (CMEA), what is the maximum amount of pseudoephedrine a customer can purchase per 30-day period?

9 grams
Correct Incorrect Correct answer

3.6 grams
Correct Incorrect Correct answer

5 grams
Correct Incorrect Correct answer

15 grams
Correct Incorrect Correct answer

Correct

Incorrect
Question 397 of 667

397. Question

Category: Federal Requirements: Restricted Drug Programs

Which federal law regulates the distribution of drug samples by pharmaceutical representatives?

Prescription Drug Marketing Act (PDMA)
Correct Incorrect Correct answer

Drug Supply Chain Security Act (DSCSA)
Correct Incorrect Correct answer

Combat Methamphetamine Epidemic Act (CMEA)
Correct Incorrect Correct answer

Dietary Supplement Health and Education Act (DSHEA)
Correct Incorrect Correct answer

Correct

Incorrect
Question 398 of 667

398. Question

Category: Federal Requirements: Restricted Drug Programs

What type of FDA-required labeling provides patient-specific safety information that must be dispensed with certain high-risk medications?

FDA Medication Guide (MedGuide)
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Drug Facts label
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Package insert summary
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Pharmacist counseling checklist
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Incorrect
Question 399 of 667

399. Question

Category: Federal Requirements: Restricted Drug Programs

What is the purpose of the 340B Drug Pricing Program?

To require manufacturers to provide outpatient drugs at reduced prices to eligible healthcare organizations serving low-income patients
Correct Incorrect Correct answer

To subsidize prescription costs for Medicare Part D beneficiaries
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To provide free medications to uninsured patients through retail pharmacy programs
Correct Incorrect Correct answer

To regulate the pricing of controlled substances sold to hospital pharmacies
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Question 400 of 667

400. Question

Category: Federal Requirements: Restricted Drug Programs

Which REMS program applies to clozapine and requires regular monitoring of absolute neutrophil count (ANC)?

Clozapine REMS
Correct Incorrect Correct answer

iPLEDGE REMS
Correct Incorrect Correct answer

TIRF REMS
Correct Incorrect Correct answer

Thalomid REMS
Correct Incorrect Correct answer

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Incorrect
Question 401 of 667

401. Question

Category: Federal Requirements: Restricted Drug Programs

What information must be recorded in the pseudoephedrine logbook at the point of sale under CMEA requirements?

The buyer name, address, date and time of sale, product name, and quantity sold
Correct Incorrect Correct answer

Only the buyer name and the total dollar amount of the purchase
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The buyer medical history, reason for purchase, and physician name
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The buyer social security number, insurance information, and pharmacy license number
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Question 402 of 667

402. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician receives a prescription for isotretinoin for a female patient of childbearing potential. Before dispensing, which of the following must the technician verify through the iPLEDGE system?

The patient has a current negative pregnancy test result and an active authorization in the iPLEDGE system
Correct Incorrect Correct answer

The patient has signed a refusal of pregnancy testing waiver in the iPLEDGE portal
Correct Incorrect Correct answer

The patient has obtained approval from two separate prescribers in the iPLEDGE database
Correct Incorrect Correct answer

The patient has completed a 90-day waiting period before the first prescription can be filled
Correct Incorrect Correct answer

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Incorrect
Question 403 of 667

403. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives a prescription for thalidomide (Thalomid) for a male patient. The pharmacist asks the technician to verify REMS enrollment. Which of the following applies to male patients under the Thalomid REMS?

Male patients must agree to use a latex condom during sexual contact with females of childbearing potential
Correct Incorrect Correct answer

Male patients are exempt from all REMS requirements because they cannot become pregnant
Correct Incorrect Correct answer

Male patients must have a negative pregnancy test before starting therapy
Correct Incorrect Correct answer

Male patients must receive thalidomide only through mail-order specialty pharmacies
Correct Incorrect Correct answer

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Incorrect
Question 404 of 667

404. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician notices a prescription for a transmucosal immediate-release fentanyl (TIRF) product. What REMS requirement must be met before dispensing?

The prescriber, patient, and pharmacy must all be enrolled in the TIRF REMS Access program
Correct Incorrect Correct answer

Only the prescriber needs to be enrolled; the pharmacy and patient enrollment is optional
Correct Incorrect Correct answer

The patient must complete an inpatient observation period before outpatient dispensing is allowed
Correct Incorrect Correct answer

The prescription must be approved by the FDA on a case-by-case basis before dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 405 of 667

405. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmaceutical representative offers to leave drug samples at a community pharmacy. The pharmacy manager asks the technician to explain why this is problematic. What is the correct response?

Under the PDMA, drug samples may only be provided to licensed prescribers who make a written request; they cannot be left at pharmacies
Correct Incorrect Correct answer

Drug samples may be stored at the pharmacy as long as they are locked in a separate cabinet
Correct Incorrect Correct answer

Drug samples may be dispensed to patients at no charge as long as the pharmacist documents the transaction
Correct Incorrect Correct answer

Drug samples are regulated by the CMEA and require a logbook entry for each sample distributed
Correct Incorrect Correct answer

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Incorrect
Question 406 of 667

406. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is dispensing a medication that requires a Medication Guide. When must the MedGuide be provided to the patient?

Each time the medication is dispensed to the patient, whether it is a new prescription or a refill
Correct Incorrect Correct answer

Only with the first fill of the medication, not with subsequent refills
Correct Incorrect Correct answer

Only when the patient specifically requests the additional safety information
Correct Incorrect Correct answer

Only when the medication is dispensed in a hospital outpatient pharmacy setting
Correct Incorrect Correct answer

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Incorrect
Question 407 of 667

407. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy participates in the 340B Drug Pricing Program. A technician discovers that a 340B-purchased medication was accidentally dispensed to a patient who does not qualify for the program. What concern does this raise?

Diversion of 340B drugs to ineligible patients violates program requirements and may result in sanctions
Correct Incorrect Correct answer

There is no concern because 340B drugs can be dispensed to any patient once purchased
Correct Incorrect Correct answer

The only consequence is that the pharmacy must charge the patient the full retail price
Correct Incorrect Correct answer

The FDA will recall the medication and require the patient to return it
Correct Incorrect Correct answer

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Question 408 of 667

408. Question

Category: Federal Requirements: Restricted Drug Programs

A customer purchases pseudoephedrine and the pharmacy technician asks for photo identification. The customer only has an expired driver license. Can the sale proceed?

No, the CMEA requires a valid (non-expired) form of government-issued photo identification
Correct Incorrect Correct answer

Yes, any government-issued photo identification is acceptable regardless of expiration status
Correct Incorrect Correct answer

Yes, expired identification is acceptable as long as the photograph is clearly recognizable
Correct Incorrect Correct answer

No, but the customer may substitute a store loyalty card with their name printed on it
Correct Incorrect Correct answer

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Question 409 of 667

409. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacist asks the technician to check whether a medication has a black box warning before dispensing. Where is the black box warning found?

In the prescribing information (package insert), prominently displayed in a bordered box at the beginning of the labeling
Correct Incorrect Correct answer

On the exterior of the stock bottle as a physical black-bordered sticker
Correct Incorrect Correct answer

In the FDA MedWatch database under the adverse event reporting section
Correct Incorrect Correct answer

On the pharmacy shelf tag directly below the medication name and NDC number
Correct Incorrect Correct answer

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Question 410 of 667

410. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is processing an isotretinoin prescription. The iPLEDGE system shows the patient pregnancy test was completed 40 days ago. Can the prescription be dispensed?

No, because the pregnancy test must have been completed within the past 30 days for the prescription to be authorized
Correct Incorrect Correct answer

Yes, because the pregnancy test is valid for 60 days from the date it was performed
Correct Incorrect Correct answer

Yes, because only the initial pregnancy test has a time limitation; subsequent tests have no deadline
Correct Incorrect Correct answer

No, because the pregnancy test must have been completed within the past 7 days for dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 411 of 667

411. Question

Category: Federal Requirements: Restricted Drug Programs

A nurse practitioner writes a prescription for clozapine for a patient with treatment-resistant schizophrenia. The pharmacy technician checks the Clozapine REMS registry and finds the patient is not enrolled. What should happen next?

The prescription cannot be dispensed until the patient is enrolled in the Clozapine REMS program with a current ANC result on file
Correct Incorrect Correct answer

The prescription can be dispensed with a 7-day emergency supply while enrollment is completed
Correct Incorrect Correct answer

The pharmacist may enroll the patient in the REMS program at the point of dispensing without the prescriber
Correct Incorrect Correct answer

The prescription should be transferred to a hospital pharmacy since community pharmacies cannot dispense clozapine
Correct Incorrect Correct answer

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Incorrect
Question 412 of 667

412. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is selling a pseudoephedrine product to a customer who has a valid prescription for it. Do the CMEA logbook requirements still apply?

No, pseudoephedrine sold pursuant to a valid prescription is generally exempt from CMEA logbook requirements
Correct Incorrect Correct answer

Yes, all pseudoephedrine sales must be logged regardless of whether a prescription is presented
Correct Incorrect Correct answer

Yes, but the prescription number replaces the need for customer identification in the logbook
Correct Incorrect Correct answer

No, but only if the prescription was written by a physician; nurse practitioner prescriptions still require logging
Correct Incorrect Correct answer

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Incorrect
Question 413 of 667

413. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician receives a prescription for lenalidomide (Revlimid), which is a thalidomide analogue. Does this medication require REMS enrollment?

Yes, lenalidomide has its own REMS program with requirements similar to the Thalomid REMS, including pregnancy prevention measures
Correct Incorrect Correct answer

No, only thalidomide itself requires REMS; analogues are covered by standard dispensing procedures
Correct Incorrect Correct answer

No, lenalidomide REMS was discontinued after the drug demonstrated a safer profile than thalidomide
Correct Incorrect Correct answer

Yes, but only for female patients; male patients are automatically exempt from the lenalidomide REMS
Correct Incorrect Correct answer

Correct

Incorrect
Question 414 of 667

414. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives notification that it must begin distributing a new FDA Medication Guide with a specific antidepressant. What is the most likely reason the FDA requires a MedGuide for this medication?

The medication carries a risk of serious adverse effects that could affect patient decisions about using the drug, such as suicidality risk
Correct Incorrect Correct answer

The manufacturer requested the MedGuide as a voluntary marketing initiative to increase patient awareness
Correct Incorrect Correct answer

The medication was recently approved and all newly approved drugs require Medication Guides for the first year
Correct Incorrect Correct answer

The drug was involved in a Class III recall and MedGuides are required for all recalled medications
Correct Incorrect Correct answer

Correct

Incorrect
Question 415 of 667

415. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician learns that a REMS program for a newly approved opioid requires prescriber certification, patient enrollment, and pharmacy registration. A prescriber who is not yet certified writes a prescription for this opioid. The patient is in severe pain. What is the correct course of action?

The pharmacy cannot dispense the medication until the prescriber completes REMS certification, regardless of the patient clinical need
Correct Incorrect Correct answer

The pharmacist may dispense a 72-hour emergency supply while the prescriber completes certification
Correct Incorrect Correct answer

The pharmacy can dispense the medication if the patient signs a REMS waiver acknowledging the risk
Correct Incorrect Correct answer

The pharmacy should contact the FDA to request an emergency exemption for the uncertified prescriber
Correct Incorrect Correct answer

Correct

Incorrect
Question 416 of 667

416. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician discovers that the pharmacy has been purchasing medications through the 340B program but dispensing some of them to patients covered by Medicaid with a Medicaid claim. Why is this a compliance concern?

Duplicate discounts are prohibited; 340B pricing and Medicaid drug rebates cannot both be applied to the same prescription
Correct Incorrect Correct answer

Medicaid patients are not eligible for any prescriptions from a 340B-participating pharmacy
Correct Incorrect Correct answer

340B drugs cannot be dispensed to patients with any form of insurance coverage
Correct Incorrect Correct answer

The concern is only financial; there are no regulatory consequences for this practice
Correct Incorrect Correct answer

Correct

Incorrect
Question 417 of 667

417. Question

Category: Federal Requirements: Restricted Drug Programs

A female patient enrolled in the iPLEDGE program picks up her isotretinoin prescription on the last day of the dispensing window. She mentions she will need a refill in 30 days. The technician knows the prescriber will need to enter a new authorization. What steps must occur before the next fill?

The patient must have a new negative pregnancy test, the prescriber must enter a new authorization in iPLEDGE, and the pharmacy must verify the authorization before dispensing
Correct Incorrect Correct answer

The patient can simply pick up the refill at the next 30-day interval without additional testing or authorization
Correct Incorrect Correct answer

The prescriber authorization from the previous fill carries over automatically for up to 90 days
Correct Incorrect Correct answer

The patient needs only to confirm her continued use of one form of contraception through the iPLEDGE website
Correct Incorrect Correct answer

Correct

Incorrect
Question 418 of 667

418. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician notices that a patient receiving clozapine has an ANC result of 900 cells per microliter recorded in the Clozapine REMS system. The previous result was 1,600. What action should the pharmacy take?

The pharmacy should not dispense clozapine because an ANC below 1,000 indicates severe neutropenia, and the pharmacist must consult with the prescriber
Correct Incorrect Correct answer

The pharmacy should dispense clozapine because any ANC above 500 is considered safe for continued therapy
Correct Incorrect Correct answer

The pharmacy should dispense a reduced dose of clozapine until the ANC returns to normal levels
Correct Incorrect Correct answer

The pharmacy should dispense clozapine but require the patient to return for a recheck within 48 hours
Correct Incorrect Correct answer

Correct

Incorrect
Question 419 of 667

419. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy participates in both the 340B Drug Pricing Program and contracts with several specialty drug REMS programs. A 340B-eligible patient needs a REMS-restricted medication. The technician asks whether these two programs create any conflict. What is the correct assessment?

There is no inherent conflict; the pharmacy must comply with both programs simultaneously, ensuring 340B eligibility and REMS requirements are independently met
Correct Incorrect Correct answer

340B-eligible patients are automatically exempt from REMS requirements because 340B is a federal program
Correct Incorrect Correct answer

REMS-restricted drugs cannot be purchased through the 340B program under any circumstances
Correct Incorrect Correct answer

The pharmacy must choose one program or the other for each prescription but cannot apply both
Correct Incorrect Correct answer

Correct

Incorrect
Question 420 of 667

420. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy chain uses an electronic pseudoephedrine tracking system connected to the NPLEx (National Precursor Log Exchange) database. A customer attempts to buy pseudoephedrine, and the system blocks the sale. The customer insists they have not exceeded any limits. What should the technician do?

Inform the customer that the electronic tracking system aggregates purchases across multiple retailers and the sale cannot be overridden at the pharmacy level
Correct Incorrect Correct answer

Override the system block because the customer states they have not exceeded the purchase limit
Correct Incorrect Correct answer

Complete the sale without logging it in the system since the customer appears credible
Correct Incorrect Correct answer

Contact the DEA to request a temporary exemption for this specific customer
Correct Incorrect Correct answer

Correct

Incorrect
Question 421 of 667

421. Question

Category: Federal Requirements: Restricted Drug Programs

A hospital pharmacy receives drug samples from a pharmaceutical representative for use in the facility. Under the PDMA, which of the following conditions must be met for this to be compliant?

A licensed prescriber at the hospital must have made a written request for the specific samples, and the hospital must maintain records of receipt and distribution
Correct Incorrect Correct answer

The pharmacy director may accept any samples without documentation as long as they are used within the hospital
Correct Incorrect Correct answer

Drug samples can be accepted by the pharmacy technician and placed directly into regular inventory
Correct Incorrect Correct answer

The hospital may redistribute unused samples to other healthcare facilities without additional paperwork
Correct Incorrect Correct answer

Correct

Incorrect
Question 422 of 667

422. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy dispenses a TIRF product to a patient. One week later, the technician discovers that the pharmacy TIRF REMS enrollment had lapsed the day before dispensing. What are the potential consequences of this situation?

The pharmacy may face regulatory action for dispensing a REMS-restricted product without valid enrollment, and must immediately renew its enrollment and report the error
Correct Incorrect Correct answer

There are no consequences because the patient was properly enrolled even if the pharmacy enrollment lapsed
Correct Incorrect Correct answer

The pharmacy must recall the medication from the patient and issue a full refund
Correct Incorrect Correct answer

The FDA will automatically close the pharmacy until a full audit of all REMS dispensing records is completed
Correct Incorrect Correct answer

Correct

Incorrect
Question 423 of 667

423. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is asked to verify REMS enrollment for a patient starting a new prescription for a TIRF product. The patient states they have been taking extended-release morphine for 6 months. Why is this information relevant to the TIRF REMS?

TIRF products are restricted to opioid-tolerant cancer pain patients, and the patient history of extended-release opioid use may help establish opioid tolerance
Correct Incorrect Correct answer

TIRF products require patients to discontinue all other opioids before enrollment in the REMS program
Correct Incorrect Correct answer

The patient morphine use disqualifies them from TIRF REMS enrollment because of drug interaction concerns
Correct Incorrect Correct answer

TIRF products are only prescribed to patients who have never taken any opioid medications previously
Correct Incorrect Correct answer

Correct

Incorrect
Question 424 of 667

424. Question

Category: Federal Requirements: Fda Recalls

What is the difference between a voluntary recall and a mandatory recall?

A voluntary recall is initiated by the manufacturer, while a mandatory recall is ordered by the FDA when the manufacturer does not voluntarily act
Correct Incorrect Correct answer

A voluntary recall applies only to OTC products, while mandatory recalls apply only to prescription drugs
Correct Incorrect Correct answer

A voluntary recall requires FDA approval before initiation, while a mandatory recall does not
Correct Incorrect Correct answer

A voluntary recall only removes the product from shelves, while a mandatory recall requires product destruction
Correct Incorrect Correct answer

Correct

Incorrect
Question 425 of 667

425. Question

Category: Federal Requirements: Fda Recalls

What is the FDA MedWatch program used for?

It is the FDA safety reporting program used by healthcare professionals and consumers to report adverse events and product quality problems
Correct Incorrect Correct answer

It is a drug pricing surveillance program that monitors medication costs across pharmacies
Correct Incorrect Correct answer

It is a pharmacy accreditation program that certifies pharmacies for controlled substance dispensing
Correct Incorrect Correct answer

It is a drug scheduling review program that evaluates whether medications should be reclassified
Correct Incorrect Correct answer

Correct

Incorrect
Question 426 of 667

426. Question

Category: Federal Requirements: Fda Recalls

What is a market withdrawal as opposed to an FDA recall?

A market withdrawal occurs when a product has a minor violation that would not warrant FDA enforcement action, and the firm removes the product voluntarily
Correct Incorrect Correct answer

A market withdrawal is a more severe action than a recall, requiring immediate destruction of all product inventory
Correct Incorrect Correct answer

A market withdrawal is the same as a Class I recall but uses different terminology
Correct Incorrect Correct answer

A market withdrawal is initiated by the FDA when a product fails a routine inspection
Correct Incorrect Correct answer

Correct

Incorrect
Question 427 of 667

427. Question

Category: Federal Requirements: Fda Recalls

What is the FDA Adverse Event Reporting System (FAERS)?

A database that contains adverse event reports and medication error reports submitted to the FDA
Correct Incorrect Correct answer

A controlled substance monitoring program that tracks prescriptions for opioids across all states
Correct Incorrect Correct answer

A pharmacy inspection database that records violations found during DEA audits
Correct Incorrect Correct answer

A formulary management system used by insurance companies to approve prior authorizations
Correct Incorrect Correct answer

Correct

Incorrect
Question 428 of 667

428. Question

Category: Federal Requirements: Fda Recalls

What is a Class III FDA recall?

A situation where use of or exposure to a violative product is not likely to cause adverse health consequences
Correct Incorrect Correct answer

A situation with a reasonable probability of causing serious adverse health consequences or death
Correct Incorrect Correct answer

A situation where use may cause temporary or medically reversible adverse health consequences
Correct Incorrect Correct answer

A situation where the product has been adulterated with a controlled substance
Correct Incorrect Correct answer

Correct

Incorrect
Question 429 of 667

429. Question

Category: Federal Requirements: Fda Recalls

Through which system does the USP allow healthcare professionals to report medication errors?

The USP Medication Errors Reporting Program (MERP), which forwards reports to the FDA
Correct Incorrect Correct answer

The USP Pharmacopoeia Alert System, which notifies manufacturers of compounding errors
Correct Incorrect Correct answer

The USP Drug Quality Assurance Program, which audits pharmacy sterile compounding rooms
Correct Incorrect Correct answer

The USP National Drug Code Registry, which tracks all dispensed medications by pharmacy
Correct Incorrect Correct answer

Correct

Incorrect
Question 430 of 667

430. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives a Class I recall notification for a specific lot of a blood pressure medication. Which of the following is the most appropriate first action for the pharmacy technician?

Immediately quarantine the affected lot by removing it from dispensing shelves and segregating it from active inventory
Correct Incorrect Correct answer

Continue dispensing the current stock until the pharmacy receives replacement inventory from the wholesaler
Correct Incorrect Correct answer

File the recall notice for review at the next monthly pharmacy staff meeting
Correct Incorrect Correct answer

Return the product to the shelf after checking that the expiration date has not passed
Correct Incorrect Correct answer

Correct

Incorrect
Question 431 of 667

431. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician checks the recall notice and finds that the affected lot number is AX2847. The pharmacy has three bottles of the recalled medication on the shelf with lot numbers AX2847, AX2848, and BZ1105. Which bottles should be quarantined?

Only the bottle with lot number AX2847, as it is the only lot specified in the recall
Correct Incorrect Correct answer

All three bottles, because they are the same medication regardless of lot number
Correct Incorrect Correct answer

Both AX2847 and AX2848, because sequential lot numbers are always recalled together
Correct Incorrect Correct answer

Only bottles with a lot number starting with AX, as the prefix indicates the same manufacturing run
Correct Incorrect Correct answer

Correct

Incorrect
Question 432 of 667

432. Question

Category: Federal Requirements: Fda Recalls

A pharmacy dispenses a medication and later learns that the specific lot dispensed has been recalled as Class II. What is the pharmacy responsibility regarding patients who already received the product?

The pharmacy should notify patients who received the recalled lot and provide instructions from the recall notice
Correct Incorrect Correct answer

The pharmacy has no obligation to patients who have already received the product
Correct Incorrect Correct answer

The pharmacy must file a police report for each affected patient
Correct Incorrect Correct answer

The pharmacy should wait for the FDA to contact the patients directly
Correct Incorrect Correct answer

Correct

Incorrect
Question 433 of 667

433. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician discovers a medication error where the wrong strength was dispensed to a patient. The pharmacist asks the technician to file a report. Which program is appropriate for reporting this medication error to the FDA?

FDA MedWatch, the safety information and adverse event reporting program
Correct Incorrect Correct answer

The DEA ARCOS reporting system for controlled substance transactions
Correct Incorrect Correct answer

The CMS Star Ratings program for pharmacy quality metrics
Correct Incorrect Correct answer

The OSHA workplace safety incident reporting system
Correct Incorrect Correct answer

Correct

Incorrect
Question 434 of 667

434. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives a recall notice for a compounded sterile preparation. The notice specifies a Class I recall due to potential microbial contamination. What documentation should the pharmacy maintain?

Records of the recall notice, the affected lot numbers in inventory, actions taken to quarantine and return the product, and patients who received the affected lots
Correct Incorrect Correct answer

Only the original recall notice filed alphabetically by drug name for future reference
Correct Incorrect Correct answer

A single notation in the pharmacy daily log that a recall was received
Correct Incorrect Correct answer

No documentation is needed because compounded preparations are not subject to FDA recall documentation requirements
Correct Incorrect Correct answer

Correct

Incorrect
Question 435 of 667

435. Question

Category: Federal Requirements: Fda Recalls

A wholesaler notifies a pharmacy of a voluntary recall for a specific over-the-counter antacid product. The pharmacy technician asks whether a voluntary recall requires the same response as an FDA-mandated recall. What is the correct answer?

Yes, the pharmacy response should be the same regardless of whether the recall is voluntary or mandated by the FDA
Correct Incorrect Correct answer

No, voluntary recalls only require removing the product from shelves; no patient notification is needed
Correct Incorrect Correct answer

No, voluntary recalls are advisory only and do not require any pharmacy action
Correct Incorrect Correct answer

Yes, but only if the pharmacy received the product directly from the manufacturer
Correct Incorrect Correct answer

Correct

Incorrect
Question 436 of 667

436. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician wants to check whether a specific medication has any active recalls. Which FDA resource should the technician consult?

The FDA Recalls, Market Withdrawals, and Safety Alerts database on the FDA website
Correct Incorrect Correct answer

The DEA controlled substance scheduling database
Correct Incorrect Correct answer

The USP monograph revision history log
Correct Incorrect Correct answer

The CMS Medicare Part D formulary reference
Correct Incorrect Correct answer

Correct

Incorrect
Question 437 of 667

437. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician processes the return of a recalled medication to the wholesaler. What information should be included on the return documentation?

The drug name, strength, NDC number, lot number, quantity being returned, and the recall reference number
Correct Incorrect Correct answer

Only the drug name and the total dollar value of the returned inventory
Correct Incorrect Correct answer

The patient names who received the recalled medication and their contact information
Correct Incorrect Correct answer

The pharmacy DEA number and the controlled substance inventory count
Correct Incorrect Correct answer

Correct

Incorrect
Question 438 of 667

438. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives a Class II recall for a specific lot of an antibiotic tablet. The recall notice states that the product may contain higher-than-specified amounts of a degradation impurity. What type of adverse consequence does a Class II recall indicate?

Use of the product may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote
Correct Incorrect Correct answer

Use of the product will cause serious adverse health consequences or death in most patients
Correct Incorrect Correct answer

Use of the product is not likely to cause any adverse health consequences
Correct Incorrect Correct answer

The product has been confirmed to be contaminated with a Schedule I controlled substance
Correct Incorrect Correct answer

Correct

Incorrect
Question 439 of 667

439. Question

Category: Federal Requirements: Fda Recalls

A pharmacist asks the technician to report a suspected serious adverse drug reaction to a recently marketed medication. The patient was hospitalized after taking the drug. Through which mechanism should this be reported?

By submitting an FDA MedWatch report, which can be done online, by mail, or by fax
Correct Incorrect Correct answer

By calling the drug manufacturer customer service line and leaving a voicemail message
Correct Incorrect Correct answer

By posting the adverse event on a public healthcare professional forum for peer review
Correct Incorrect Correct answer

By filing a report with the pharmacy state board of pharmacy licensing division only
Correct Incorrect Correct answer

Correct

Incorrect
Question 440 of 667

440. Question

Category: Federal Requirements: Fda Recalls

During a routine inventory check, a pharmacy technician finds a medication with a lot number that matches an active Class I recall from two months ago. The recall notice was never processed by the pharmacy. What should the technician do immediately?

Remove the product from the shelf, quarantine it, alert the pharmacist, and follow the recall procedures that should have been completed when the notice was received
Correct Incorrect Correct answer

Dispense the remaining stock quickly before the recall deadline expires
Correct Incorrect Correct answer

Discard the product in the regular pharmacy trash to eliminate the hazard
Correct Incorrect Correct answer

Ignore the recall since two months have passed and the recall window has likely closed
Correct Incorrect Correct answer

Correct

Incorrect
Question 441 of 667

441. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician is reviewing the recall communication chain. After the FDA issues a recall notice, who typically notifies the pharmacy?

The manufacturer or wholesaler/distributor communicates the recall information to the pharmacy
Correct Incorrect Correct answer

The FDA contacts each individual pharmacy directly by phone for all recall classes
Correct Incorrect Correct answer

The state board of pharmacy sends a certified letter to each licensed pharmacy
Correct Incorrect Correct answer

The DEA notifies pharmacies through the same system used for controlled substance registrations
Correct Incorrect Correct answer

Correct

Incorrect
Question 442 of 667

442. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician receives a notification about a market withdrawal of a dietary supplement. The technician asks whether this should be treated the same as an FDA Class II recall. What is the correct distinction?

A market withdrawal is not classified by the FDA as a recall and involves a minor issue that would not warrant enforcement action; it requires less urgent response
Correct Incorrect Correct answer

A market withdrawal is more serious than a Class II recall and requires faster action
Correct Incorrect Correct answer

A market withdrawal and a Class II recall are identical in classification and pharmacy response
Correct Incorrect Correct answer

A market withdrawal only applies to prescription drugs, not dietary supplements
Correct Incorrect Correct answer

Correct

Incorrect
Question 443 of 667

443. Question

Category: Federal Requirements: Fda Recalls

A pharmacy uses an automated dispensing system that tracks lot numbers for all medications dispensed. When a Class I recall is issued, how does this system help the pharmacy?

The system can quickly identify which patients received medications from the recalled lot, enabling efficient patient notification
Correct Incorrect Correct answer

The system automatically returns the recalled product to the manufacturer without pharmacy staff involvement
Correct Incorrect Correct answer

The system contacts the FDA directly to confirm the recall and negotiate a resolution
Correct Incorrect Correct answer

The system deletes the dispensing records for the recalled lot to prevent further liability
Correct Incorrect Correct answer

Correct

Incorrect
Question 444 of 667

444. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives simultaneous recall notices: a Class I recall for a cardiovascular medication and a Class III recall for a multivitamin product. Staff resources are limited. How should the pharmacy prioritize its response?

Address the Class I cardiovascular medication recall first because it poses a reasonable probability of serious adverse health consequences or death
Correct Incorrect Correct answer

Address both recalls simultaneously since all recalls must be handled with equal urgency
Correct Incorrect Correct answer

Address the Class III multivitamin recall first because OTC products affect more patients
Correct Incorrect Correct answer

Address the Class I recall only if the pharmacy has dispensed the product in the last 30 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 445 of 667

445. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician identifies that a recalled Class II medication was dispensed to 15 patients over the past month. The recall notice mentions potential contamination with a foreign substance. Three patients have already used all of their medication. How should the pharmacy handle these different patient situations?

Notify all 15 patients about the recall; advise those with remaining medication to stop using it and return it, and advise those who consumed it to monitor for symptoms and contact their healthcare provider
Correct Incorrect Correct answer

Only contact the 12 patients who still have medication remaining since the other 3 cannot return the product
Correct Incorrect Correct answer

Wait for the manufacturer to contact the patients directly as part of the recall process
Correct Incorrect Correct answer

Contact only patients who have reported adverse effects, as the others were not harmed
Correct Incorrect Correct answer

Correct

Incorrect
Question 446 of 667

446. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician notices that a medication involved in a Class I recall has an NDC number matching recalled products, but the lot number on the pharmacy bottle does not appear on the recall list. The manufacturer recall notice specifies only certain lot numbers. Should the pharmacy quarantine this product?

No, if the lot number does not match any lot listed in the recall notice, the product is not affected and can remain in active inventory
Correct Incorrect Correct answer

Yes, because any product with a matching NDC should be quarantined regardless of lot number
Correct Incorrect Correct answer

Yes, because the lot number list may be updated later to include additional batches
Correct Incorrect Correct answer

No, but the pharmacy should destroy the product as a precaution even though the lot does not match
Correct Incorrect Correct answer

Correct

Incorrect
Question 447 of 667

447. Question

Category: Federal Requirements: Fda Recalls

A pharmacy receives a recall notice for a medication that is also available from a different manufacturer under a different brand name. Several patients who received the recalled product are concerned about their therapy being interrupted. What is the best course of action?

Work with the pharmacist and prescriber to switch affected patients to an equivalent product from a non-recalled manufacturer to maintain continuity of therapy
Correct Incorrect Correct answer

Tell patients to stop all therapy immediately until the recall investigation is complete
Correct Incorrect Correct answer

Continue dispensing the recalled lot if the patients sign a liability waiver
Correct Incorrect Correct answer

Advise patients to use a double dose of their next refill from a different manufacturer to make up for missed doses
Correct Incorrect Correct answer

Correct

Incorrect
Question 448 of 667

448. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician discovers that the pharmacy has no formal written procedure for handling drug recalls. The pharmacist-in-charge asks the technician to help develop one. Which elements should be included in a comprehensive recall procedure?

Procedures for receiving and logging recall notices, identifying affected inventory by lot number, quarantining product, notifying patients, documenting actions taken, and returning product to the manufacturer or wholesaler
Correct Incorrect Correct answer

Only instructions for removing the product from the shelf and placing it in a returns bin
Correct Incorrect Correct answer

Only a checklist for contacting the FDA to confirm the recall is legitimate
Correct Incorrect Correct answer

Only a template letter to send to patients with no other procedural steps
Correct Incorrect Correct answer

Correct

Incorrect
Question 449 of 667

449. Question

Category: Federal Requirements: Fda Recalls

A healthcare professional at a pharmacy reports a serious adverse event through the FDA MedWatch program. The event involves a medication that has not been previously associated with this type of reaction. What role does this MedWatch report play in the broader drug safety system?

The report contributes to the FAERS database, where the FDA reviews accumulated reports to identify safety signals that may lead to labeling changes, safety alerts, or recalls
Correct Incorrect Correct answer

The report automatically triggers an immediate Class I recall of the medication nationwide
Correct Incorrect Correct answer

The report is stored indefinitely without review unless the manufacturer requests an investigation
Correct Incorrect Correct answer

The report is forwarded directly to the prescriber for acknowledgment but has no regulatory impact
Correct Incorrect Correct answer

Correct

Incorrect
Question 450 of 667

450. Question

Category: Federal Requirements: Fda Recalls

A community pharmacy and a hospital pharmacy both receive the same Class I recall notice. The community pharmacy has dispensed 50 prescriptions from the recalled lot, while the hospital administered the recalled product to 200 inpatients. How do the recall response responsibilities differ between these settings?

Both settings must quarantine remaining stock and identify affected patients, but the hospital may be able to identify affected patients more quickly through electronic medication administration records
Correct Incorrect Correct answer

Only the hospital must respond because inpatient use is more closely regulated than community dispensing
Correct Incorrect Correct answer

Only the community pharmacy must respond because outpatients cannot be monitored after dispensing
Correct Incorrect Correct answer

The community pharmacy should wait for the hospital to complete its response before taking any action
Correct Incorrect Correct answer

Correct

Incorrect
Question 451 of 667

451. Question

Category: Federal Requirements: Fda Recalls

A pharmacy technician is reviewing adverse event data and learns that several reports of a similar serious reaction have been submitted to FAERS for a particular medication. The FDA has not yet issued a recall or safety alert. The pharmacist asks the technician whether the pharmacy should take any proactive action. What is the appropriate response?

The pharmacy should continue dispensing per current guidelines but remain vigilant for similar adverse events in their patients and report any occurrences through MedWatch
Correct Incorrect Correct answer

The pharmacy should immediately stop dispensing the medication until the FDA issues an official statement
Correct Incorrect Correct answer

The pharmacy should contact the manufacturer and demand a voluntary recall based on the FAERS data
Correct Incorrect Correct answer

The pharmacy should begin notifying all patients taking this medication to discontinue it immediately
Correct Incorrect Correct answer

Correct

Incorrect
Question 452 of 667

452. Question

Category: Primary Assessment: General Impression

What is the primary purpose of forming a general impression during the primary assessment?

To determine if the patient appears sick or not sick and to identify immediate life threats
Correct Incorrect Correct answer

To obtain a complete set of baseline vital signs before treatment
Correct Incorrect Correct answer

To gather a detailed medical history from the patient or bystanders
Correct Incorrect Correct answer

To determine the specific diagnosis responsible for the patient's condition
Correct Incorrect Correct answer

Correct

Incorrect
Question 453 of 667

453. Question

Category: Primary Assessment: General Impression

You arrive on scene and find a 72-year-old male sitting upright in a tripod position, using accessory muscles to breathe, and speaking only one or two words at a time. Based on your general impression, how should you categorize this patient?

Sick; he shows signs of significant respiratory distress requiring immediate intervention
Correct Incorrect Correct answer

Not sick; he is conscious, alert, and able to speak
Correct Incorrect Correct answer

Stable; sitting upright is a sign of adequate compensation
Correct Incorrect Correct answer

Unable to determine without obtaining a full set of vital signs first
Correct Incorrect Correct answer

Correct

Incorrect
Question 454 of 667

454. Question

Category: Primary Assessment: General Impression

You are dispatched to a residence for a fall. Upon entering the room, you see a 45-year-old female lying on the floor, conscious, with normal skin color, speaking clearly, and holding her left wrist. What is the most appropriate general impression?

Not sick; the patient appears stable with an isolated extremity injury
Correct Incorrect Correct answer

Sick; any patient found on the floor requires emergency intervention
Correct Incorrect Correct answer

Unable to determine until a full secondary assessment is completed
Correct Incorrect Correct answer

Sick; the mechanism of injury suggests a potentially critical condition
Correct Incorrect Correct answer

Correct

Incorrect
Question 455 of 667

455. Question

Category: Primary Assessment: General Impression

You respond to a motor vehicle collision and find two patients. Patient A is ambulatory, alert, and complaining of neck pain. Patient B is unresponsive, slumped over the steering wheel with snoring respirations. Based on your general impression, which patient should you prioritize?

Patient B, because unresponsiveness and snoring respirations indicate a potential airway compromise and life threat
Correct Incorrect Correct answer

Patient A, because neck pain suggests a potential spinal cord injury that could worsen
Correct Incorrect Correct answer

Both patients equally, because you should always treat patients in the order you encounter them
Correct Incorrect Correct answer

Patient A, because ambulatory patients who are complaining may deteriorate faster
Correct Incorrect Correct answer

Correct

Incorrect
Question 456 of 667

456. Question

Category: Primary Assessment: General Impression

Which of the following is assessed as part of forming a general impression?

The patient's age, sex, and overall appearance
Correct Incorrect Correct answer

The patient's blood pressure and pulse oximetry reading
Correct Incorrect Correct answer

A complete SAMPLE history from the patient
Correct Incorrect Correct answer

The patient's pupil size and reactivity
Correct Incorrect Correct answer

Correct

Incorrect
Question 457 of 667

457. Question

Category: Primary Assessment: Level Of Consciousness

You approach a patient who is lying on the ground with eyes closed. When you shout, ‘Can you hear me?’ the patient opens their eyes briefly but does not speak. Using the AVPU scale, how would you classify this patient?

Responsive to verbal stimuli (V)
Correct Incorrect Correct answer

Alert (A), because the patient opened their eyes
Correct Incorrect Correct answer

Responsive to painful stimuli (P), because the patient did not speak
Correct Incorrect Correct answer

Unresponsive (U), because the patient's eyes were initially closed
Correct Incorrect Correct answer

Correct

Incorrect
Question 458 of 667

458. Question

Category: Primary Assessment: Level Of Consciousness

A 58-year-old male is found slumped in a chair. He does not respond to your voice. When you apply a trapezius squeeze, he moans and pulls away. What is his AVPU level?

Responsive to painful stimuli (P)
Correct Incorrect Correct answer

Unresponsive (U), because he did not open his eyes
Correct Incorrect Correct answer

Responsive to verbal stimuli (V), because he moaned
Correct Incorrect Correct answer

Alert (A), because he demonstrated purposeful movement
Correct Incorrect Correct answer

Correct

Incorrect
Question 459 of 667

459. Question

Category: Primary Assessment: Level Of Consciousness

You are reassessing a trauma patient who was initially alert and oriented. The patient now only opens their eyes and moans when you perform a sternal rub. What does this change in mental status most likely indicate?

The patient's condition is deteriorating and may indicate worsening head injury or shock
Correct Incorrect Correct answer

The patient is falling asleep and should be allowed to rest during transport
Correct Incorrect Correct answer

This is a normal response to pain and does not require any change in treatment
Correct Incorrect Correct answer

The patient's pain medications have taken effect and are reducing responsiveness
Correct Incorrect Correct answer

Correct

Incorrect
Question 460 of 667

460. Question

Category: Primary Assessment: Level Of Consciousness

A patient who is awake, knows who they are, where they are, the date, and what happened is described as being oriented to which components?

Person, place, time, and event
Correct Incorrect Correct answer

Person, place, and time only
Correct Incorrect Correct answer

Name, address, and phone number
Correct Incorrect Correct answer

Person, place, social security number, and medications
Correct Incorrect Correct answer

Correct

Incorrect
Question 461 of 667

461. Question

Category: Primary Assessment: Airway Management

Which airway maneuver should be used first when opening the airway of an unresponsive patient with a suspected spinal injury?

Jaw-thrust maneuver
Correct Incorrect Correct answer

Head-tilt, chin-lift maneuver
Correct Incorrect Correct answer

Insertion of an oropharyngeal airway
Correct Incorrect Correct answer

Finger sweep of the oropharynx
Correct Incorrect Correct answer

Correct

Incorrect
Question 462 of 667

462. Question

Category: Primary Assessment: Airway Management

You are treating an unresponsive patient who has no gag reflex after a head-tilt, chin-lift maneuver has been performed. Which airway adjunct is most appropriate to help maintain the airway?

Oropharyngeal airway (OPA)
Correct Incorrect Correct answer

Nasopharyngeal airway (NPA), because it is better tolerated in all patients
Correct Incorrect Correct answer

Endotracheal tube inserted under direct laryngoscopy
Correct Incorrect Correct answer

No adjunct is needed if the head-tilt, chin-lift is maintaining the airway
Correct Incorrect Correct answer

Correct

Incorrect
Question 463 of 667

463. Question

Category: Primary Assessment: Airway Management

A semiconscious patient with a gag reflex is making gurgling sounds. After suctioning the airway, which adjunct should you consider inserting?

Nasopharyngeal airway (NPA)
Correct Incorrect Correct answer

Oropharyngeal airway (OPA)
Correct Incorrect Correct answer

Endotracheal tube
Correct Incorrect Correct answer

Combitube
Correct Incorrect Correct answer

Correct

Incorrect
Question 464 of 667

464. Question

Category: Primary Assessment: Airway Management

You are ventilating an unresponsive patient with a BVM. Despite having an OPA in place, you notice the patient’s chest is not rising with ventilations. You have repositioned the head and ensured a good mask seal. What should you do next?

Suction the airway to check for and remove any obstruction
Correct Incorrect Correct answer

Remove the OPA and attempt ventilations without an adjunct
Correct Incorrect Correct answer

Increase the force of your ventilations to overcome the resistance
Correct Incorrect Correct answer

Begin chest compressions because the patient is likely in cardiac arrest
Correct Incorrect Correct answer

Correct

Incorrect
Question 465 of 667

465. Question

Category: Primary Assessment: Airway Management

How is the correct size of an oropharyngeal airway (OPA) determined?

By measuring from the corner of the mouth to the angle of the jaw or the earlobe
Correct Incorrect Correct answer

By measuring from the tip of the nose to the earlobe
Correct Incorrect Correct answer

By estimating based on the patient's overall body size
Correct Incorrect Correct answer

By inserting the smallest available size first and upsizing if needed
Correct Incorrect Correct answer

Correct

Incorrect
Question 466 of 667

466. Question

Category: Primary Assessment: Breathing Assessment

What is the normal respiratory rate range for an adult at rest?

12 to 20 breaths per minute
Correct Incorrect Correct answer

8 to 12 breaths per minute
Correct Incorrect Correct answer

20 to 30 breaths per minute
Correct Incorrect Correct answer

6 to 10 breaths per minute
Correct Incorrect Correct answer

Correct

Incorrect
Question 467 of 667

467. Question

Category: Primary Assessment: Breathing Assessment

A 67-year-old female with a history of COPD is breathing at a rate of 28 breaths per minute with diminished breath sounds bilaterally. Her SpO2 reads 86% on room air. She is alert and speaking in short phrases. What is your most appropriate initial action?

Apply high-flow oxygen via a nonrebreather mask at 15 liters per minute
Correct Incorrect Correct answer

Apply a nasal cannula at 2 liters per minute to avoid suppressing her respiratory drive
Correct Incorrect Correct answer

Withhold oxygen until you obtain a full set of vital signs
Correct Incorrect Correct answer

Position the patient supine and begin a detailed secondary assessment
Correct Incorrect Correct answer

Correct

Incorrect
Question 468 of 667

468. Question

Category: Primary Assessment: Breathing Assessment

You are assessing a patient who was found unresponsive. The patient has a respiratory rate of 6 breaths per minute with shallow chest rise. What should you do?

Assist ventilations with a bag-valve mask and supplemental oxygen
Correct Incorrect Correct answer

Apply a nonrebreather mask at 15 liters per minute and monitor
Correct Incorrect Correct answer

Apply a nasal cannula at 4 liters per minute and reassess in 5 minutes
Correct Incorrect Correct answer

Position the patient on their side and wait to see if the rate improves
Correct Incorrect Correct answer

Correct

Incorrect
Question 469 of 667

469. Question

Category: Primary Assessment: Breathing Assessment

A patient involved in a motorcycle crash is alert and complaining of chest pain on the right side. His respiratory rate is 24, and you notice decreased breath sounds on the right with visible chest wall bruising. His SpO2 is 92%. What condition should you suspect?

Pneumothorax on the right side
Correct Incorrect Correct answer

Cardiac contusion from blunt chest impact
Correct Incorrect Correct answer

Simple rib fracture with no internal injury
Correct Incorrect Correct answer

Pulmonary embolism caused by the impact
Correct Incorrect Correct answer

Correct

Incorrect
Question 470 of 667

470. Question

Category: Primary Assessment: Breathing Assessment

Which of the following is a sign of inadequate breathing in an adult patient?

Use of accessory muscles in the neck and abdomen during breathing
Correct Incorrect Correct answer

A respiratory rate of 16 breaths per minute with clear lung sounds
Correct Incorrect Correct answer

Slight visible chest rise and fall with each breath
Correct Incorrect Correct answer

The ability to speak in complete sentences without pausing
Correct Incorrect Correct answer

Correct

Incorrect
Question 471 of 667

471. Question

Category: Primary Assessment: Circulation Assessment

During the primary assessment, where should the EMT check for a pulse in an unresponsive adult patient?

The carotid artery in the neck
Correct Incorrect Correct answer

The radial artery at the wrist
Correct Incorrect Correct answer

The brachial artery in the upper arm
Correct Incorrect Correct answer

The dorsalis pedis artery on the foot
Correct Incorrect Correct answer

Correct

Incorrect
Question 472 of 667

472. Question

Category: Primary Assessment: Circulation Assessment

You are assessing a conscious patient who was involved in a car crash. The patient has a radial pulse that is rapid and weak. Their skin is cool, pale, and diaphoretic. What do these findings suggest?

The patient is showing signs of shock and may have internal bleeding
Correct Incorrect Correct answer

The patient is cold from the environment and needs warming only
Correct Incorrect Correct answer

These are normal findings following the stress of a motor vehicle collision
Correct Incorrect Correct answer

The patient is experiencing an allergic reaction to something in the vehicle
Correct Incorrect Correct answer

Correct

Incorrect
Question 473 of 667

473. Question

Category: Primary Assessment: Circulation Assessment

While assessing a responsive 8-year-old child, you are unable to palpate a radial pulse but can feel a carotid pulse. The child has cool, mottled skin on the extremities. What does the absence of a radial pulse in this child suggest?

The child's blood pressure has dropped significantly, indicating decompensating shock
Correct Incorrect Correct answer

Radial pulses are difficult to feel in children, so this is a normal finding
Correct Incorrect Correct answer

The child likely has a localized vascular injury to the arm
Correct Incorrect Correct answer

The child is hypothermic, and the radial pulse will return once they are warmed
Correct Incorrect Correct answer

Correct

Incorrect
Question 474 of 667

474. Question

Category: Primary Assessment: Circulation Assessment

A 30-year-old construction worker fell from a scaffold. He is alert, anxious, and complaining of abdominal pain. His pulse is 122 and thready, respirations are 26, skin is pale and diaphoretic, and capillary refill is 4 seconds. What is the most likely explanation for these findings?

Hypovolemic shock due to internal abdominal hemorrhage
Correct Incorrect Correct answer

Anxiety-related tachycardia from the stress of the fall
Correct Incorrect Correct answer

Neurogenic shock from a spinal cord injury
Correct Incorrect Correct answer

Cardiogenic shock from a cardiac contusion
Correct Incorrect Correct answer

Correct

Incorrect
Question 475 of 667

475. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy must perform wipe sampling to detect surface contamination from hazardous drugs. When should this monitoring be conducted?

At routine intervals and after any known spill or suspected contamination event
Correct Incorrect Correct answer

Only during the initial facility setup and never again
Correct Incorrect Correct answer

Once per year during the annual pharmacy inspection
Correct Incorrect Correct answer

Only when an employee reports symptoms of exposure
Correct Incorrect Correct answer

Correct

Incorrect
Question 476 of 667

476. Question

Category: Primary Assessment: Transport Decision

You are treating a 45-year-old male who was stabbed in the chest. He is alert, tachypneic, and has diminished breath sounds on the left. When should you transport this patient?

Immediately after addressing life threats; rapid transport to a trauma center is indicated
Correct Incorrect Correct answer

After completing a full secondary assessment and obtaining two sets of vital signs
Correct Incorrect Correct answer

After contacting medical control for authorization to transport
Correct Incorrect Correct answer

After stabilizing the patient on scene for at least 15 minutes
Correct Incorrect Correct answer

Correct

Incorrect
Question 477 of 667

477. Question

Category: Primary Assessment: Transport Decision

A 22-year-old female twisted her ankle while jogging. She is alert, oriented, has stable vital signs, and her only complaint is pain and swelling at the right ankle. What is the most appropriate transport decision?

Transport without lights and sirens; the patient is stable and does not have a time-critical condition
Correct Incorrect Correct answer

Rapid transport with lights and sirens to the nearest hospital
Correct Incorrect Correct answer

Advise the patient to drive herself to urgent care since the injury is minor
Correct Incorrect Correct answer

Remain on scene until swelling subsides before deciding on transport
Correct Incorrect Correct answer

Correct

Incorrect
Question 478 of 667

478. Question

Category: Primary Assessment: Transport Decision

You respond to a 78-year-old female complaining of sudden severe headache, confusion, and left-sided weakness that began 30 minutes ago. The nearest hospital is 10 minutes away but lacks stroke intervention capabilities. A comprehensive stroke center is 25 minutes away. Your local protocol directs you to bypass closer facilities for suspected stroke when the additional transport time is less than 30 minutes. Which transport decision is most appropriate?

Transport to the comprehensive stroke center per local protocol, as the patient needs specialized stroke care within the treatment window
Correct Incorrect Correct answer

Transport to the nearest hospital since reducing transport time is always the priority
Correct Incorrect Correct answer

Remain on scene to complete a full neurological exam before deciding
Correct Incorrect Correct answer

Contact medical control and wait on scene for their transport recommendation
Correct Incorrect Correct answer

Correct

Incorrect
Question 479 of 667

479. Question

Category: Primary Assessment: Transport Decision

Which of the following patients would most likely require rapid transport to a trauma center?

A patient with a gunshot wound to the abdomen who is tachycardic and hypotensive
Correct Incorrect Correct answer

A patient with an isolated closed forearm fracture and stable vital signs
Correct Incorrect Correct answer

A patient with a minor laceration on the forearm that has been controlled with direct pressure
Correct Incorrect Correct answer

A patient who twisted their knee and is unable to bear weight
Correct Incorrect Correct answer

Correct

Incorrect
Question 480 of 667

480. Question

Category: Primary Assessment: Chief Complaint

What is the definition of a chief complaint?

The primary reason the patient called for help, stated in the patient's own words
Correct Incorrect Correct answer

The EMT's clinical impression of the patient's most serious condition
Correct Incorrect Correct answer

The dispatch information provided by the 911 center
Correct Incorrect Correct answer

The diagnosis determined after completing the full patient assessment
Correct Incorrect Correct answer

Correct

Incorrect
Question 481 of 667

481. Question

Category: Primary Assessment: Chief Complaint

You respond to a call for a 55-year-old male with “chest pain.” Upon arrival, the patient states, “My stomach has been hurting all morning.” How should you document the chief complaint?

"My stomach has been hurting all morning," using the patient's own words
Correct Incorrect Correct answer

"Chest pain" as reported by the 911 dispatcher
Correct Incorrect Correct answer

"Abdominal pain, rule out cardiac event"
Correct Incorrect Correct answer

"Epigastric discomfort with possible referred pain"
Correct Incorrect Correct answer

Correct

Incorrect
Question 482 of 667

482. Question

Category: Primary Assessment: Chief Complaint

An elderly patient is found sitting on the floor, alert but confused. She cannot tell you why she called 911. Her daughter states that she found her mother on the floor and she was not acting like herself. How should you approach the chief complaint?

Use the daughter's information as the chief complaint source and document the patient as confused and unable to provide a history
Correct Incorrect Correct answer

Document the chief complaint as "no complaint" since the patient cannot state one
Correct Incorrect Correct answer

Skip the chief complaint and proceed directly to the physical exam
Correct Incorrect Correct answer

Wait until the patient becomes less confused before obtaining a chief complaint
Correct Incorrect Correct answer

Correct

Incorrect
Question 483 of 667

483. Question

Category: Primary Assessment: Chief Complaint

You are assessing a patient who opens his eyes only when you pinch his trapezius muscle, speaks in confused and disorganized sentences, and localizes to pain by reaching toward the stimulus with his opposite hand. Using the Glasgow Coma Scale, what is this patient’s GCS score?

11 (Eye 2, Verbal 4, Motor 5)
Correct Incorrect Correct answer

9 (Eye 2, Verbal 3, Motor 4)
Correct Incorrect Correct answer

13 (Eye 3, Verbal 4, Motor 6)
Correct Incorrect Correct answer

7 (Eye 1, Verbal 3, Motor 3)
Correct Incorrect Correct answer

Correct

Incorrect
Question 484 of 667

484. Question

Category: Primary Assessment: Life Threats

Which of the following is considered an immediate life threat that must be addressed during the primary assessment?

A complete airway obstruction
Correct Incorrect Correct answer

A deformed and swollen ankle
Correct Incorrect Correct answer

A small laceration on the forearm
Correct Incorrect Correct answer

A complaint of mild nausea
Correct Incorrect Correct answer

Correct

Incorrect
Question 485 of 667

485. Question

Category: Primary Assessment: Life Threats

You arrive to find a 25-year-old male who was assaulted. He is responsive to verbal stimuli with snoring respirations, has a large laceration on his scalp with active bleeding, and a deformed left femur. In what order should you address these findings?

Open the airway first, then control the scalp bleeding, then address the femur deformity
Correct Incorrect Correct answer

Control the scalp bleeding first because it is the most visually dramatic finding
Correct Incorrect Correct answer

Splint the femur first to prevent further injury, then address the airway
Correct Incorrect Correct answer

Assess the femur deformity first because it may indicate internal bleeding
Correct Incorrect Correct answer

Correct

Incorrect
Question 486 of 667

486. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy has expired Schedule II controlled substances that need to be disposed of. What is the proper method for destruction of these medications?

Send them to a DEA-registered reverse distributor for destruction
Correct Incorrect Correct answer

Flush them down the drain and document the destruction
Correct Incorrect Correct answer

Place them in the regular pharmaceutical waste container
Correct Incorrect Correct answer

Return them to the wholesaler with the next regular return shipment
Correct Incorrect Correct answer

Correct

Incorrect
Question 487 of 667

487. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician is conducting the biennial inventory and finds an unopened bottle of promethazine with codeine syrup (Schedule V) labeled as containing 473 mL. How should this item be inventoried?

The quantity may be estimated based on the label for the unopened container
Correct Incorrect Correct answer

The exact volume must be measured using a graduated cylinder
Correct Incorrect Correct answer

The container must be weighed to determine the exact amount remaining
Correct Incorrect Correct answer

Schedule V substances do not need to be included in the biennial inventory
Correct Incorrect Correct answer

Correct

Incorrect
Question 488 of 667

488. Question

Category: Federal Requirements: Controlled Substance Handling

A hospital pharmacy technician prepares a morphine syringe containing 10 mg, but only 6 mg is administered to the patient. What must occur with the remaining 4 mg?

The remaining 4 mg must be wasted in the presence of a witness who co-signs the documentation
Correct Incorrect Correct answer

The remaining 4 mg may be returned to the automated dispensing cabinet for later use
Correct Incorrect Correct answer

The remaining 4 mg may be saved for the same patient's next scheduled dose
Correct Incorrect Correct answer

The remaining 4 mg should be placed in the sharps container without documentation
Correct Incorrect Correct answer

Correct

Incorrect
Question 489 of 667

489. Question

Category: Federal Requirements: Controlled Substance Handling

Pharmacy A wants to transfer 100 tablets of alprazolam (Schedule IV) to Pharmacy B to address a shortage. What is required for this transfer to comply with federal law?

Both pharmacies must maintain records of the transfer, including drug name, quantity, and date
Correct Incorrect Correct answer

A DEA Form 222 must be completed for all controlled substance transfers
Correct Incorrect Correct answer

Transfers of Schedule IV substances between pharmacies are prohibited under federal law
Correct Incorrect Correct answer

Only the receiving pharmacy needs to document the transfer in its records
Correct Incorrect Correct answer

Correct

Incorrect
Question 490 of 667

490. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician receives a DEA Form 222 order for Schedule II substances from a wholesaler. The quantity of methylphenidate received is 5 bottles fewer than ordered. What should the technician do?

Note the discrepancy on the DEA Form 222, record the quantity actually received, and notify the pharmacist
Correct Incorrect Correct answer

Refuse the entire shipment until the correct quantity can be delivered
Correct Incorrect Correct answer

Accept the shipment and adjust the purchase order to reflect the quantity received
Correct Incorrect Correct answer

File a DEA Form 106 immediately to report the missing bottles
Correct Incorrect Correct answer

Correct

Incorrect
Question 491 of 667

491. Question

Category: Federal Requirements: Controlled Substance Handling

A new pharmacy is preparing to open and needs to obtain DEA registration. Which form should the pharmacist use for the initial application?

DEA Form 224
Correct Incorrect Correct answer

DEA Form 224a
Correct Incorrect Correct answer

DEA Form 222
Correct Incorrect Correct answer

DEA Form 363
Correct Incorrect Correct answer

Correct

Incorrect
Question 492 of 667

492. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician notices a discrepancy in the perpetual inventory for hydromorphone. The records show 200 tablets, but the physical count reveals only 185 tablets. After verifying dispensing records, 10 tablets can be accounted for through documentation errors. What action is appropriate for the remaining 5 unaccounted tablets?

Report the unresolved discrepancy to the pharmacist for investigation and potential DEA Form 106 filing
Correct Incorrect Correct answer

Adjust the perpetual inventory to match the physical count and continue operations
Correct Incorrect Correct answer

Wait until the next biennial inventory to reconcile the discrepancy
Correct Incorrect Correct answer

Order additional tablets from the wholesaler to bring the count back to 200
Correct Incorrect Correct answer

Correct

Incorrect
Question 493 of 667

493. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy uses an automated dispensing cabinet for controlled substances in a hospital setting. Which feature is required to ensure proper accountability of controlled substances in the cabinet?

Individual user access codes and a transaction log that records each withdrawal
Correct Incorrect Correct answer

A single master code shared among all pharmacy staff for convenience
Correct Incorrect Correct answer

Manual paper logs maintained separately from the electronic system
Correct Incorrect Correct answer

Weekly physical counts performed by the pharmacy director only
Correct Incorrect Correct answer

Correct

Incorrect
Question 494 of 667

494. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician is asked to help with the biennial inventory. The technician finds an opened 500-count bottle of lorazepam (Schedule IV) that appears to be about three-quarters full. How should this item be counted?

An estimated count of approximately 375 tablets is acceptable
Correct Incorrect Correct answer

An exact count must be performed because the container is opened
Correct Incorrect Correct answer

The full label quantity of 500 should be recorded since it is a stock bottle
Correct Incorrect Correct answer

Schedule IV substances are exempt from the biennial inventory requirement
Correct Incorrect Correct answer

Correct

Incorrect
Question 495 of 667

495. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy is closing permanently. What must be done with the remaining Schedule II controlled substance inventory?

Transfer the inventory to a DEA-registered reverse distributor using DEA Form 222
Correct Incorrect Correct answer

Destroy the substances on-site with two witnesses and document the destruction
Correct Incorrect Correct answer

Return the substances to the original wholesaler with a standard credit request
Correct Incorrect Correct answer

Donate the substances to a local hospital pharmacy without additional paperwork
Correct Incorrect Correct answer

Correct

Incorrect
Question 496 of 667

496. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician is verifying a delivery of Schedule II controlled substances ordered via paper DEA Form 222. Copy 3 of the form was sent with the order. Which copy does the supplier retain?

Copy 2
Correct Incorrect Correct answer

Copy 1
Correct Incorrect Correct answer

Copy 3
Correct Incorrect Correct answer

The supplier does not retain any copies
Correct Incorrect Correct answer

Correct

Incorrect
Question 497 of 667

497. Question

Category: Federal Requirements: Controlled Substance Handling

During a routine count, a pharmacy technician finds that the perpetual inventory for a Schedule II substance shows a balance of 120 tablets, but only 118 are physically present. Dispensing records confirm all transactions are accurately logged. What is the most appropriate next step?

Notify the pharmacist of the 2-tablet discrepancy for investigation and documentation
Correct Incorrect Correct answer

Adjust the perpetual inventory to 118 and continue with the daily workflow
Correct Incorrect Correct answer

Recount the tablets three more times before taking any action
Correct Incorrect Correct answer

Immediately file DEA Form 106 for the 2-tablet discrepancy
Correct Incorrect Correct answer

Correct

Incorrect
Question 498 of 667

498. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician discovers that the safe containing Schedule II controlled substances was left unlocked overnight, but the perpetual inventory count matches the physical count exactly. No substances appear to be missing. Which of the following best describes the regulatory concern in this situation?

The pharmacy has violated storage requirements even though no substances are missing, and the incident should be documented and reported to the pharmacist
Correct Incorrect Correct answer

No regulatory concern exists because the inventory counts match perfectly
Correct Incorrect Correct answer

The pharmacy must file DEA Form 106 because the safe was left open
Correct Incorrect Correct answer

The DEA registration must be surrendered immediately due to the security breach
Correct Incorrect Correct answer

Correct

Incorrect
Question 499 of 667

499. Question

Category: Federal Requirements: Controlled Substance Handling

A hospital pharmacy is implementing a new automated dispensing cabinet system. The pharmacy director asks the lead technician to recommend security features for controlled substance management. Which combination of features best ensures compliance with DEA requirements and minimizes diversion risk?

Biometric user authentication, blind count verification, automatic discrepancy alerts, and a complete audit trail
Correct Incorrect Correct answer

Shared department access codes, override capability for emergencies, and weekly report generation
Correct Incorrect Correct answer

Single pharmacist authorization, open-access drawers for fast retrieval, and monthly inventory reconciliation
Correct Incorrect Correct answer

Badge-only access without count verification, batch refill capability, and quarterly audits
Correct Incorrect Correct answer

Correct

Incorrect
Question 500 of 667

500. Question

Category: Federal Requirements: Controlled Substance Handling

A retail pharmacy has been experiencing consistent small discrepancies in its Schedule II perpetual inventory over the past three months. Each individual discrepancy is 1 to 3 tablets, but the cumulative shortage now totals 28 tablets of oxycodone 30mg. The pharmacist has verified all dispensing records are accurate. What is the most appropriate course of action?

File DEA Form 106 for the cumulative loss, conduct an internal investigation, and implement enhanced monitoring procedures
Correct Incorrect Correct answer

Continue monitoring the discrepancies monthly and file a report only if a single loss exceeds 50 tablets
Correct Incorrect Correct answer

Adjust the perpetual inventory to match physical counts each time a discrepancy is found
Correct Incorrect Correct answer

Suspend all Schedule II dispensing until the source of the discrepancies is identified
Correct Incorrect Correct answer

Correct

Incorrect
Question 501 of 667

501. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy is transitioning from paper DEA Form 222 ordering to the electronic CSOS system. Which of the following statements accurately describes a key difference between these two ordering methods for Schedule II controlled substances?

CSOS uses PKI digital certificates for authentication, while paper Form 222 relies on physical signatures and triplicate copies
Correct Incorrect Correct answer

CSOS eliminates the need for DEA registration, while paper Form 222 requires active registration
Correct Incorrect Correct answer

CSOS orders do not require record retention, while paper Form 222 records must be kept for 2 years
Correct Incorrect Correct answer

CSOS allows ordering of any controlled substance schedule, while paper Form 222 is limited to Schedule II only
Correct Incorrect Correct answer

Correct

Incorrect
Question 502 of 667

502. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician is reviewing controlled substance records during an internal audit. The technician finds that DEA Form 222 records from 30 months ago are scheduled for shredding by the records management department. The pharmacy is located in a state that requires 3-year retention of controlled substance records. What should the technician recommend?

Retain the records because the state requirement of 3 years supersedes the federal 2-year minimum
Correct Incorrect Correct answer

Allow the shredding because the federal 2-year requirement has been met
Correct Incorrect Correct answer

Retain only the records for Schedule II substances and shred the rest
Correct Incorrect Correct answer

Transfer the records to the DEA since they are past the federal retention period
Correct Incorrect Correct answer

Correct

Incorrect
Question 503 of 667

503. Question

Category: Federal Requirements: Controlled Substance Handling

A hospital pharmacy technician discovers that a nurse has been consistently overriding the automated dispensing cabinet to withdraw controlled substances without pharmacist verification during non-emergency situations. The overrides are documented in the system log. What is the primary concern and appropriate response?

The overrides bypass a critical safety control and should be reported to pharmacy management for investigation of potential diversion
Correct Incorrect Correct answer

Overrides are an acceptable practice during busy periods and require no follow-up action
Correct Incorrect Correct answer

The technician should disable the override function on the cabinet immediately
Correct Incorrect Correct answer

The nurse should be reported directly to the DEA for unauthorized access to controlled substances
Correct Incorrect Correct answer

Correct

Incorrect
Question 504 of 667

504. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician is tasked with reconciling the controlled substance dispensing log with the perpetual inventory for alprazolam (Schedule IV). The dispensing log shows 450 tablets dispensed over the past month, the perpetual inventory started at 600 tablets with one receipt of 200 tablets, but the current physical count is 340 tablets. What does this analysis reveal?

There is an unexplained shortage of 10 tablets that requires investigation
Correct Incorrect Correct answer

The records are balanced and no discrepancy exists
Correct Incorrect Correct answer

There is an overage of 10 tablets that may indicate a receiving error
Correct Incorrect Correct answer

There is an unexplained shortage of 20 tablets that requires investigation
Correct Incorrect Correct answer

Correct

Incorrect
Question 505 of 667

505. Question

Category: Federal Requirements: Controlled Substance Handling

Two pharmacies under the same ownership want to transfer Schedule II controlled substances between locations due to a supply shortage at one location. Which of the following correctly describes the federal requirements for this transfer?

A DEA Form 222 must be used for the transfer, and both pharmacies must have separate, active DEA registrations
Correct Incorrect Correct answer

Common ownership allows free transfer of Schedule II substances without additional documentation
Correct Incorrect Correct answer

Only an invoice and internal transfer form are needed since the pharmacies share the same corporate DEA number
Correct Incorrect Correct answer

Schedule II transfers between commonly owned pharmacies require prior DEA approval on a case-by-case basis
Correct Incorrect Correct answer

Correct

Incorrect
Question 506 of 667

506. Question

Category: Federal Requirements: Controlled Substance Handling

During a DEA inspection, an inspector requests the pharmacy’s biennial inventory records. The pharmacist-in-charge shows the inspector the most recent inventory completed 18 months ago but cannot locate the previous inventory. The inspector notes this as a violation. Why is the missing prior inventory a compliance issue even though the most recent one is available?

Federal law requires controlled substance records to be maintained for at least 2 years, and the prior inventory is needed to establish accountability for the intervening period
Correct Incorrect Correct answer

The DEA requires three consecutive biennial inventories to be available at all times
Correct Incorrect Correct answer

The missing inventory automatically triggers a mandatory suspension of the pharmacy's DEA registration
Correct Incorrect Correct answer

Only the most recent inventory matters, so the inspector's finding is incorrect
Correct Incorrect Correct answer

Correct

Incorrect
Question 507 of 667

507. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy is evaluating whether to grant power of attorney for DEA Form 222 signing authority to a second pharmacist. Which of the following factors is most important to consider when making this decision?

The power of attorney must be properly executed and maintained on file, and the designee assumes responsibility for accurate completion of Form 222 orders
Correct Incorrect Correct answer

Power of attorney can only be granted to pharmacists who have held their license for at least 5 years
Correct Incorrect Correct answer

The DEA must approve each individual power of attorney before it becomes effective
Correct Incorrect Correct answer

Power of attorney automatically transfers if the registrant is absent for more than 72 hours
Correct Incorrect Correct answer

Correct

Incorrect
Question 508 of 667

508. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician notices that a reverse distributor returned a credit memo for destroyed controlled substances, but the quantities listed on the memo do not match the quantities originally sent. The memo shows 480 tablets of hydrocodone destroyed, but the pharmacy’s records indicate 500 tablets were shipped. What should the technician do?

Notify the pharmacist of the 20-tablet discrepancy so it can be investigated and reconciled with the reverse distributor
Correct Incorrect Correct answer

Accept the credit memo as final documentation and adjust the pharmacy's records to match
Correct Incorrect Correct answer

File DEA Form 106 for the 20-tablet difference immediately
Correct Incorrect Correct answer

Contact the DEA directly to report the reverse distributor for possible diversion
Correct Incorrect Correct answer

Correct

Incorrect
Question 509 of 667

509. Question

Category: Federal Requirements: Dscsa

What does DSCSA stand for?

Drug Supply Chain Security Act
Correct Incorrect Correct answer

Drug Safety and Compliance Standards Act
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Drug Supply Chain Standardization Act
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Drug Security and Chain Surveillance Act
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Incorrect
Question 510 of 667

510. Question

Category: Federal Requirements: Dscsa

Which three types of transaction documentation are required under the DSCSA when transferring ownership of a prescription drug product?

Transaction information (TI), transaction history (TH), and transaction statement (TS)
Correct Incorrect Correct answer

Transfer invoice (TI), tracking history (TH), and transfer summary (TS)
Correct Incorrect Correct answer

Transaction identification (TI), transaction handling (TH), and transaction status (TS)
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Trade information (TI), trade history (TH), and trade statement (TS)
Correct Incorrect Correct answer

Correct

Incorrect
Question 511 of 667

511. Question

Category: Federal Requirements: Dscsa

Under the DSCSA, what is a third-party logistics provider (3PL)?

An entity that provides storage, distribution, or other logistics services for prescription drugs but does not take ownership of the products
Correct Incorrect Correct answer

A wholesale distributor that purchases and resells prescription drugs to pharmacies
Correct Incorrect Correct answer

A pharmacy that provides mail-order prescription services to patients
Correct Incorrect Correct answer

A manufacturer's subsidiary that handles direct-to-pharmacy drug shipments
Correct Incorrect Correct answer

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Incorrect
Question 512 of 667

512. Question

Category: Federal Requirements: Dscsa

What is the purpose of product tracing under the DSCSA?

To track the movement of prescription drugs through each point in the supply chain from manufacturer to dispenser
Correct Incorrect Correct answer

To monitor the temperature of drugs during shipping and storage
Correct Incorrect Correct answer

To verify that patients receive the correct medications at the point of sale
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To ensure that drug manufacturers comply with Good Manufacturing Practices
Correct Incorrect Correct answer

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Question 513 of 667

513. Question

Category: Federal Requirements: Dscsa

Under the DSCSA, which entity is responsible for affixing a unique product identifier to each drug package?

The manufacturer or repackager
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The wholesale distributor
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The dispensing pharmacy
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The FDA
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Incorrect
Question 514 of 667

514. Question

Category: Federal Requirements: Dscsa

What distinguishes a ‘suspect product’ from an ‘illegitimate product’ under the DSCSA?

A suspect product may be counterfeit, diverted, or otherwise unfit, while an illegitimate product has been confirmed as such through investigation
Correct Incorrect Correct answer

A suspect product has been recalled by the FDA, while an illegitimate product has been recalled by the manufacturer
Correct Incorrect Correct answer

A suspect product is expired, while an illegitimate product is counterfeit
Correct Incorrect Correct answer

A suspect product comes from an unlicensed distributor, while an illegitimate product comes from a foreign source
Correct Incorrect Correct answer

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Incorrect
Question 515 of 667

515. Question

Category: Federal Requirements: Dscsa

How long must a dispenser (pharmacy) retain transaction documentation under the DSCSA?

Not less than 6 years
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Not less than 2 years
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Not less than 3 years
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Not less than 10 years
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Question 516 of 667

516. Question

Category: Federal Requirements: Dscsa

A pharmacy technician receives a shipment of medications from a wholesale distributor. The shipment includes transaction information and a transaction statement, but the transaction history is missing. What should the technician do?

Quarantine the shipment and notify the pharmacist, as all three transaction documents are required before the products can be accepted
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Accept the shipment since two out of three documents are sufficient for compliance
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Return the entire shipment to the distributor without notifying anyone
Correct Incorrect Correct answer

Accept the shipment and request the transaction history within 30 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 517 of 667

517. Question

Category: Federal Requirements: Dscsa

A pharmacy technician notices that a bottle of lisinopril received from a wholesaler has a damaged label, and the 2D barcode on the package cannot be scanned. The transaction documentation is complete and appears correct. What is the appropriate action under the DSCSA?

Quarantine the product as suspect and initiate the verification process with the manufacturer or wholesaler
Correct Incorrect Correct answer

Accept the product since the transaction documentation is complete
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Discard the product and order a replacement from the wholesaler
Correct Incorrect Correct answer

Manually enter the product identifier information and place it in stock
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Correct

Incorrect
Question 518 of 667

518. Question

Category: Federal Requirements: Dscsa

A pharmacy receives notification from the FDA that a specific lot of atorvastatin has been identified as illegitimate. The pharmacy has 15 bottles from that lot currently in stock. What must the pharmacy do?

Immediately quarantine the affected bottles, respond to the FDA notification, and not distribute or dispense them
Correct Incorrect Correct answer

Continue dispensing the product until the manufacturer issues a formal recall
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Return the bottles to the wholesaler using the standard returns process
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Relabel the bottles with the pharmacy's own labeling and continue dispensing
Correct Incorrect Correct answer

Correct

Incorrect
Question 519 of 667

519. Question

Category: Federal Requirements: Dscsa

A pharmacy technician is processing a return of unexpired, undamaged prescription medications to the wholesaler. What documentation is required under the DSCSA for saleable returns?

The pharmacy must provide transaction documentation to the wholesaler, and the wholesaler must verify the product identifier before accepting the return
Correct Incorrect Correct answer

No DSCSA documentation is needed for returns of unexpired products
Correct Incorrect Correct answer

Only a credit memo from the wholesaler is required for the return
Correct Incorrect Correct answer

The pharmacy must obtain FDA authorization before returning any products
Correct Incorrect Correct answer

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Incorrect
Question 520 of 667

520. Question

Category: Federal Requirements: Dscsa

A pharmacy orders medications from a new wholesale distributor. Before placing the first order, what must the pharmacy verify about the distributor under the DSCSA?

That the distributor holds a valid state or federal license to distribute prescription drugs
Correct Incorrect Correct answer

That the distributor is listed on the FDA's approved manufacturer database
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That the distributor carries liability insurance of at least one million dollars
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That the distributor has been in operation for a minimum of five years
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Incorrect
Question 521 of 667

521. Question

Category: Federal Requirements: Dscsa

A manufacturer ships a drug product directly to a pharmacy, but the wholesale distributor processes the order and payment (a drop shipment). Who is responsible for providing transaction documentation to the pharmacy under the DSCSA?

The wholesale distributor must provide the transaction documentation to the pharmacy
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The manufacturer provides documentation directly to the pharmacy
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Both the manufacturer and distributor must each send separate documentation
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The pharmacy is responsible for generating its own documentation upon receipt
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Question 522 of 667

522. Question

Category: Federal Requirements: Dscsa

A pharmacy technician scans the 2D barcode on a received drug package and the system reports that the serial number does not match any record in the manufacturer’s verification system. What should the technician do?

Quarantine the product as suspect and notify the pharmacist to initiate an investigation with the trading partner
Correct Incorrect Correct answer

Re-scan the barcode using a different scanner to rule out equipment error, then stock the product if no further issues arise
Correct Incorrect Correct answer

Contact the FDA to report a counterfeit product immediately
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Accept the product and note the scanning discrepancy in the pharmacy's internal log
Correct Incorrect Correct answer

Correct

Incorrect
Question 523 of 667

523. Question

Category: Scene Size-Up and Safety: Mechanism Of Injury

You respond to an assault where a 30-year-old male was stabbed in the left side of the neck with a kitchen knife. The knife has been removed. You observe bubbling blood from the wound. Based on this mechanism, what complication should you suspect and what is your management priority?

A possible open neck wound communicating with major vessels or the trachea; cover the wound with an occlusive dressing and manage the airway
Correct Incorrect Correct answer

A simple laceration requiring direct pressure only
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A wound that requires immediate tourniquet application to the neck
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An injury limited to the skin that can be managed with a bandage
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Correct

Incorrect
Question 524 of 667

524. Question

Category: Scene Size-Up and Safety: Nature Of Illness

Which of the following is an example of a sign versus a symptom when determining the nature of illness?

A sign is an observable finding (such as cyanosis); a symptom is what the patient reports (such as shortness of breath)
Correct Incorrect Correct answer

Signs and symptoms are the same thing and can be used interchangeably
Correct Incorrect Correct answer

A sign is the patient's chief complaint; a symptom is the underlying diagnosis
Correct Incorrect Correct answer

A sign is found only by a physician; a symptom is found only by an EMT
Correct Incorrect Correct answer

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Incorrect
Question 525 of 667

525. Question

Category: Scene Size-Up and Safety: Nature Of Illness

You are dispatched for a 50-year-old male with “general weakness.” On arrival, the patient’s wife says he has been progressively weaker over three days, has not eaten well, and has been urinating frequently. She notes he is a diabetic. What NOI should you prioritize?

A diabetic emergency, possibly hyperglycemia or diabetic ketoacidosis, given the progressive weakness, poor intake, polyuria, and diabetes history
Correct Incorrect Correct answer

Influenza, since weakness and poor appetite are common viral symptoms
Correct Incorrect Correct answer

Dehydration from not drinking enough water
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Depression causing the patient to stop eating
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Incorrect
Question 526 of 667

526. Question

Category: Scene Size-Up and Safety: Nature Of Illness

You respond to a 65-year-old male with sudden onset left-sided weakness and slurred speech that started 45 minutes ago. His wife states he was fine this morning. What is the critical time-sensitive nature of this illness?

A possible stroke (cerebrovascular accident) within the treatment window for fibrinolytic therapy, requiring rapid stroke assessment and transport to a stroke center
Correct Incorrect Correct answer

A transient ischemic attack that will resolve on its own without treatment
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Bell's palsy causing facial weakness that does not require emergent transport
Correct Incorrect Correct answer

A migraine headache with neurological symptoms that will improve with rest
Correct Incorrect Correct answer

Correct

Incorrect
Question 527 of 667

527. Question

Category: Scene Size-Up and Safety: Resource Determination

Which of the following is an example of a mutual aid agreement?

A formal arrangement where neighboring EMS agencies agree to provide assistance to each other when local resources are overwhelmed
Correct Incorrect Correct answer

An informal agreement between two EMTs to cover each other's shifts
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A contract between an EMS agency and a hospital for patient transfers
Correct Incorrect Correct answer

A policy requiring all EMTs to carry personal medical equipment off duty
Correct Incorrect Correct answer

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Incorrect
Question 528 of 667

528. Question

Category: Federal Requirements: Dscsa

A pharmacy wants to purchase prescription drugs from an online supplier offering significantly lower prices. The supplier is located in another state. What must the pharmacy verify under the DSCSA before making the purchase?

That the supplier holds a valid wholesale distributor license in the state where it operates and can provide complete transaction documentation
Correct Incorrect Correct answer

That the supplier has a website with a verified SSL certificate and published return policy
Correct Incorrect Correct answer

That the supplier is listed in the pharmacy's group purchasing organization directory
Correct Incorrect Correct answer

That the supplier offers a money-back guarantee on all products sold
Correct Incorrect Correct answer

Correct

Incorrect
Question 529 of 667

529. Question

Category: Federal Requirements: Dscsa

A pharmacy receives an FDA safety alert indicating that counterfeit versions of a popular brand-name medication have been found in the U.S. supply chain. The pharmacy stocks this medication. What is the pharmacy’s first obligation under the DSCSA?

Verify the product identifiers on all packages of the affected medication in its inventory against the manufacturer's verification system
Correct Incorrect Correct answer

Immediately remove all packages of the affected medication from the shelf and destroy them
Correct Incorrect Correct answer

Contact the wholesale distributor and request replacement stock before checking current inventory
Correct Incorrect Correct answer

Wait for the manufacturer to issue a formal recall before taking any action
Correct Incorrect Correct answer

Correct

Incorrect
Question 530 of 667

530. Question

Category: Federal Requirements: Dscsa

A pharmacy operates in a state that has its own drug pedigree law requiring additional tracking information beyond what the DSCSA mandates. The pharmacy’s compliance officer argues that following the federal DSCSA requirements alone is sufficient. Is this position correct?

No; the DSCSA does not preempt all state requirements, and the pharmacy must comply with both federal DSCSA requirements and any additional state requirements that are not preempted
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Yes; the DSCSA fully preempts all state drug pedigree and tracking laws
Correct Incorrect Correct answer

No; the pharmacy must follow only the state law because state requirements always supersede federal law
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Yes; once a pharmacy complies with federal serialization requirements, no additional state tracking is necessary
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Incorrect
Question 531 of 667

531. Question

Category: Federal Requirements: Dscsa

A pharmacy is audited and found to have accepted three shipments from a wholesale distributor without receiving transaction statements. The products have already been dispensed to patients. What potential consequence does the pharmacy face under the DSCSA?

The pharmacy may face federal penalties for failing to verify transaction documentation before accepting products into inventory
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No consequences apply because the products were already dispensed to patients
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The pharmacy must recall all dispensed products from the affected shipments
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The wholesaler alone is liable since it was responsible for providing the documentation
Correct Incorrect Correct answer

Correct

Incorrect
Question 532 of 667

532. Question

Category: Federal Requirements: Dscsa

A 3PL warehouse stores prescription drugs on behalf of a pharmaceutical manufacturer. A pharmacy requests verification of a product’s serial number for a package that passed through this 3PL. Who is responsible for responding to the verification request?

The manufacturer, because the 3PL does not take ownership and verification is the manufacturer's responsibility
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The 3PL, because the product was stored at its facility
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The pharmacy itself, because dispensers are responsible for verifying their own products
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The FDA, because all verification requests must go through the federal database
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Incorrect
Question 533 of 667

533. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a shipment containing a drug product with a transaction history showing the product changed ownership four times before reaching the pharmacy: manufacturer to repackager, repackager to distributor A, distributor A to distributor B, and distributor B to the pharmacy. Is this transaction history compliant with the DSCSA?

Yes, as long as each transaction in the history includes complete TI, TH, and TS documentation from each trading partner
Correct Incorrect Correct answer

No, because the DSCSA limits the number of ownership changes to three before reaching a dispenser
Correct Incorrect Correct answer

No, because products cannot pass through two different wholesale distributors
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Yes, but only if the FDA has approved each trading partner in the chain
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Incorrect
Question 534 of 667

534. Question

Category: Federal Requirements: Dscsa

A pharmacy technician is training a new employee on DSCSA requirements. The new employee asks when the pharmacy must provide transaction documentation to another pharmacy during a transfer. Which response is correct?

Transaction documentation must be provided whenever a pharmacy transfers ownership of a prescription drug to another pharmacy
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Transaction documentation is only required when transferring controlled substances between pharmacies
Correct Incorrect Correct answer

Pharmacy-to-pharmacy transfers are exempt from DSCSA documentation requirements
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Documentation is only required if the transfer involves more than 100 units of a single product
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Incorrect
Question 535 of 667

535. Question

Category: Federal Requirements: Dscsa

A pharmacy discovers that a bottle of metformin 500mg on its shelf has an expiration date of 03/2025. The product identifier confirms the product is genuine, but it is 12 months past expiration. Does this situation involve a DSCSA concern?

Not directly; expired products are a state pharmacy practice concern, but the DSCSA product identifier helped confirm the product's legitimacy
Correct Incorrect Correct answer

Yes, the expired product must be reported to the FDA as an illegitimate product under the DSCSA
Correct Incorrect Correct answer

Yes, the pharmacy must file a suspect product notification with the manufacturer
Correct Incorrect Correct answer

No, because the DSCSA only applies to products during distribution, not after they reach the pharmacy shelf
Correct Incorrect Correct answer

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Incorrect
Question 536 of 667

536. Question

Category: Federal Requirements: Dscsa

A wholesale distributor notifies a pharmacy that a product it previously shipped may be suspect due to a potential counterfeiting issue. The pharmacy has already placed the product on its shelves but has not yet dispensed any units. What is the pharmacy’s obligation?

Immediately quarantine the product, do not dispense it, and cooperate with the distributor's investigation
Correct Incorrect Correct answer

Continue dispensing the product until the investigation confirms it is illegitimate
Correct Incorrect Correct answer

Return the product to the distributor immediately without any investigation
Correct Incorrect Correct answer

Notify patients who might have received the product, even though none was dispensed
Correct Incorrect Correct answer

Correct

Incorrect
Question 537 of 667

537. Question

Category: Federal Requirements: Dscsa

A pharmacy technician is reviewing the transaction information (TI) received with a drug shipment. Which of the following data elements is required to be included in the transaction information?

The name and quantity of the drug product, the date of the transaction, and the business name and address of the parties involved
Correct Incorrect Correct answer

Only the NDC number and the quantity shipped
Correct Incorrect Correct answer

The drug name, quantity, and the patient for whom the drug is intended
Correct Incorrect Correct answer

The wholesale acquisition cost, shipping method, and estimated delivery date
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Incorrect
Question 538 of 667

538. Question

Category: Federal Requirements: Dscsa

A pharmacy receives two shipments on the same day from two different distributors. Shipment A includes complete DSCSA documentation for all products. Shipment B includes transaction information and transaction history but is missing the transaction statement for three drug products. The pharmacy is low on stock for those three products and patients are waiting. What is the most appropriate course of action?

Stock products from Shipment A normally, quarantine the three products from Shipment B, and contact the distributor to obtain the missing transaction statements before dispensing
Correct Incorrect Correct answer

Stock all products from both shipments and request the missing transaction statements within 48 hours
Correct Incorrect Correct answer

Refuse both shipments entirely until every product has complete documentation
Correct Incorrect Correct answer

Stock all products from both shipments since the transaction history alone is sufficient for compliance
Correct Incorrect Correct answer

Correct

Incorrect
Question 539 of 667

539. Question

Category: Federal Requirements: Dscsa

A pharmacy chain operates 50 locations supplied by three different wholesale distributors and one drop-shipment arrangement with a manufacturer. The corporate compliance officer is developing a DSCSA compliance program. Which element is most critical for ensuring system-wide compliance?

A standardized process at every location for verifying transaction documentation upon receipt and quarantining products with incomplete records
Correct Incorrect Correct answer

A centralized database that stores all product serial numbers dispensed at each location
Correct Incorrect Correct answer

Annual training for pharmacy technicians on DSCSA terminology and definitions
Correct Incorrect Correct answer

Monthly reports to the FDA summarizing all products received across all locations
Correct Incorrect Correct answer

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Incorrect
Question 540 of 667

540. Question

Category: Federal Requirements: Dscsa

A pharmacy receives a product from a wholesale distributor. The product identifier on the package shows an NDC that matches the invoice, but the lot number on the 2D barcode does not match the lot number listed in the transaction information. The serial number verifies successfully against the manufacturer’s database. How should this discrepancy be handled?

Quarantine the product and contact the distributor to investigate the lot number discrepancy before stocking
Correct Incorrect Correct answer

Accept the product since the serial number verified successfully against the manufacturer's database
Correct Incorrect Correct answer

Reject the product and file a suspect product report with the FDA immediately
Correct Incorrect Correct answer

Accept the product and manually update the transaction information to match the barcode
Correct Incorrect Correct answer

Correct

Incorrect
Question 541 of 667

541. Question

Category: Federal Requirements: Dscsa

A pharmacy technician is evaluating the DSCSA compliance of a potential new supplier. The supplier claims to be a 3PL but also purchases and resells some drug products. What concern should this raise?

An entity that takes ownership of drug products is acting as a wholesale distributor and must hold the appropriate distributor license, not just a 3PL license
Correct Incorrect Correct answer

There is no concern because 3PLs are allowed to occasionally purchase and resell products
Correct Incorrect Correct answer

The supplier needs both a 3PL license and a pharmacy license to sell to pharmacies
Correct Incorrect Correct answer

The FDA does not distinguish between 3PLs and wholesale distributors under the DSCSA
Correct Incorrect Correct answer

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Incorrect
Question 542 of 667

542. Question

Category: Federal Requirements: Dscsa

A pharmacy is returning unsold, unexpired prescription drugs to its wholesale distributor. The distributor asks the pharmacy to confirm the product identifiers on the returned packages. The pharmacy discovers that 5 out of 20 returned packages have damaged barcodes that cannot be scanned. What is the best approach to handle these 5 packages?

Manually record the product identifier information from the human-readable text on the packages and provide it to the distributor for verification
Correct Incorrect Correct answer

Return all 20 packages and let the distributor determine how to handle the unreadable barcodes
Correct Incorrect Correct answer

Destroy the 5 packages with unreadable barcodes and return only the 15 scannable packages
Correct Incorrect Correct answer

Apply new barcodes to the 5 packages using the pharmacy's label printer before returning them
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Incorrect
Question 543 of 667

543. Question

Category: Federal Requirements: Dscsa

A pharmaceutical manufacturer discovers that a batch of serialized drug products was shipped with duplicate serial numbers due to a system error. Some packages have already reached pharmacies and been dispensed. What are the manufacturer’s obligations under the DSCSA?

Notify the FDA and affected trading partners, and work with dispensers to identify and verify products bearing the duplicate serial numbers
Correct Incorrect Correct answer

Issue a voluntary recall of all products in the batch regardless of whether they have been dispensed
Correct Incorrect Correct answer

Take no action since the products are genuine and only the serial numbers are affected
Correct Incorrect Correct answer

Assign new serial numbers remotely through the electronic tracing system
Correct Incorrect Correct answer

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Incorrect
Question 544 of 667

544. Question

Category: Federal Requirements: Dscsa

The FDA issues guidance requiring all trading partners to participate in interoperable electronic tracing by a specific deadline. A small independent pharmacy currently uses paper-based transaction documentation. What steps must the pharmacy take to comply?

Implement an electronic system capable of sending and receiving transaction data in a standardized format compatible with trading partners' systems
Correct Incorrect Correct answer

Continue using paper documentation as long as it is scanned and stored electronically
Correct Incorrect Correct answer

Contract with a 3PL to handle all electronic tracing requirements on the pharmacy's behalf
Correct Incorrect Correct answer

Request an exemption from the FDA since the requirement only applies to large chain pharmacies
Correct Incorrect Correct answer

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Incorrect
Question 545 of 667

545. Question

Category: Federal Requirements: Dscsa

A pharmacy technician is reviewing DSCSA requirements and notices that penalties for non-compliance can include both civil and criminal consequences. A wholesale distributor knowingly sold prescription drugs without providing any transaction documentation to three pharmacy customers over a six-month period. Which type of enforcement action is most likely?

Criminal penalties may apply because the distributor knowingly and repeatedly violated DSCSA documentation requirements
Correct Incorrect Correct answer

Only civil penalties apply because DSCSA violations are administrative in nature
Correct Incorrect Correct answer

No enforcement action is likely because the pharmacies did not report the missing documentation
Correct Incorrect Correct answer

Only a warning letter would be issued for first-time violations of documentation requirements
Correct Incorrect Correct answer

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Incorrect
Question 546 of 667

546. Question

Category: Federal Requirements: Dscsa

A pharmacy identifies a product on its shelf that it suspects may be counterfeit based on unusual packaging differences compared to previous lots. The pharmacy verifies the product identifier against the manufacturer’s system, and the serial number comes back as valid. However, the pharmacy still has concerns about the product’s appearance. What should the pharmacy do?

Continue treating the product as suspect despite the valid serial number, notify the manufacturer of the packaging concerns, and do not dispense until resolved
Correct Incorrect Correct answer

Dispense the product since the serial number verification confirmed its legitimacy
Correct Incorrect Correct answer

Destroy the product immediately and file a report with the state board of pharmacy
Correct Incorrect Correct answer

Remove the product from the shelf and sell it to another pharmacy at a discounted price
Correct Incorrect Correct answer

Correct

Incorrect
Question 547 of 667

547. Question

Category: Federal Requirements: Dscsa

A pharmacy technician is comparing the DSCSA obligations of manufacturers versus dispensers. Which statement accurately describes a key difference in their responsibilities?

Manufacturers must serialize products and respond to verification requests, while dispensers must verify transaction documentation and report suspect products
Correct Incorrect Correct answer

Manufacturers and dispensers have identical obligations under the DSCSA with no differences
Correct Incorrect Correct answer

Dispensers must serialize products before dispensing to patients, while manufacturers only serialize bulk shipments
Correct Incorrect Correct answer

Manufacturers are exempt from suspect product reporting, while dispensers bear full responsibility for all supply chain notifications
Correct Incorrect Correct answer

Correct

Incorrect
Question 548 of 667

548. Question

Category: Federal Requirements: Dscsa

A pharmacy has been using a wholesale distributor for several years without incident. The distributor’s state license recently expired, but the distributor claims the renewal is being processed and provides a copy of the renewal application. The pharmacy has an urgent order pending. What is the correct action under the DSCSA?

Do not place the order until the distributor's license is confirmed as active, since purchasing from an unlicensed distributor violates the DSCSA
Correct Incorrect Correct answer

Place the order since the renewal application demonstrates good faith and the license will be restored shortly
Correct Incorrect Correct answer

Place the order but withhold payment until the license renewal is confirmed
Correct Incorrect Correct answer

Place the order and request that the distributor provide the renewed license within 30 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 549 of 667

549. Question

Category: Federal Requirements: Controlled Substance Handling

What is the ARCOS system used for in controlled substance regulation?

Tracking the distribution of Schedule I and II controlled substances from manufacturer to retail
Correct Incorrect Correct answer

Monitoring patient prescription filling history across all pharmacies
Correct Incorrect Correct answer

Issuing DEA registration numbers to new pharmacy applicants
Correct Incorrect Correct answer

Reporting adverse drug events involving controlled substances to the FDA
Correct Incorrect Correct answer

Correct

Incorrect
Question 550 of 667

550. Question

Category: Federal Requirements: Controlled Substance Handling

Under the DEA quota system, which schedules of controlled substances are subject to manufacturing quotas?

Schedule I and Schedule II
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Schedule I through Schedule V
Correct Incorrect Correct answer

Schedule II through Schedule IV
Correct Incorrect Correct answer

Only Schedule I
Correct Incorrect Correct answer

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Incorrect
Question 551 of 667

551. Question

Category: Federal Requirements: Controlled Substance Handling

What type of DEA registration does a reverse distributor hold?

A registration that authorizes the receipt and destruction of controlled substances returned by registrants
Correct Incorrect Correct answer

A standard pharmacy registration that allows dispensing of returned medications
Correct Incorrect Correct answer

A manufacturer registration that permits repackaging of expired controlled substances
Correct Incorrect Correct answer

A practitioner registration that allows prescribing of controlled substances for disposal studies
Correct Incorrect Correct answer

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Question 552 of 667

552. Question

Category: Federal Requirements: Controlled Substance Handling

How long must Schedule II controlled substance records (invoices and DEA Form 222s) be maintained by a pharmacy?

A minimum of 2 years
Correct Incorrect Correct answer

A minimum of 5 years
Correct Incorrect Correct answer

A minimum of 3 years
Correct Incorrect Correct answer

A minimum of 1 year
Correct Incorrect Correct answer

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Incorrect
Question 553 of 667

553. Question

Category: Federal Requirements: Controlled Substance Handling

What form is used to document the destruction of controlled substances by a registrant?

DEA Form 41
Correct Incorrect Correct answer

DEA Form 222
Correct Incorrect Correct answer

DEA Form 106
Correct Incorrect Correct answer

DEA Form 224
Correct Incorrect Correct answer

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Incorrect
Question 554 of 667

554. Question

Category: Federal Requirements: Controlled Substance Handling

A nurse discovers a discrepancy in the automated dispensing cabinet (ADC) count for fentanyl patches at the end of her shift. The expected count is 14, but only 13 patches are present. What is the correct first step?

Conduct an immediate recount, verify recent transaction records in the ADC, and determine if a documentation error occurred
Correct Incorrect Correct answer

File DEA Form 106 immediately and notify the state board of pharmacy
Correct Incorrect Correct answer

Remove the remaining fentanyl patches from the ADC and lock them in the pharmacy vault
Correct Incorrect Correct answer

Wait until the next scheduled inventory to confirm whether the discrepancy persists
Correct Incorrect Correct answer

Correct

Incorrect
Question 555 of 667

555. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy receives a CII prescription from a nurse practitioner (NP). The NP practices in a state that grants full prescriptive authority. Which of the following must the pharmacy verify before dispensing?

That the NP has a valid individual DEA registration number with the appropriate mid-level practitioner prefix
Correct Incorrect Correct answer

That the NP has a supervising physician co-sign on the prescription
Correct Incorrect Correct answer

That the prescription was transmitted via DEA Form 222
Correct Incorrect Correct answer

That the NP has a special waiver from the DEA to prescribe Schedule II substances
Correct Incorrect Correct answer

Correct

Incorrect
Question 556 of 667

556. Question

Category: Federal Requirements: Controlled Substance Handling

An institutional pharmacy (hospital) uses a perpetual inventory system for CII drugs. A retail pharmacy across town uses a biennial inventory. What is a key difference in their CII record-keeping obligations?

The institutional pharmacy tracks each unit dispensed in real time, while the retail pharmacy reconciles CII stock at least every two years with an exact count
Correct Incorrect Correct answer

Institutional pharmacies are exempt from DEA Form 222 requirements for CII ordering
Correct Incorrect Correct answer

Retail pharmacies must file monthly ARCOS reports, while institutional pharmacies file quarterly
Correct Incorrect Correct answer

Institutional pharmacies may store CII drugs without a separate locked cabinet if using perpetual inventory
Correct Incorrect Correct answer

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Incorrect
Question 557 of 667

557. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician notices that a sealed hospice emergency kit returned from a deceased patient contains two unused vials of hydromorphone (CII). What is the proper procedure?

The kit must be returned to the pharmacy for verification, documentation, and destruction witnessed by two individuals per institutional policy
Correct Incorrect Correct answer

The unused vials may be returned to stock and redispensed if tamper-evident seals are intact
Correct Incorrect Correct answer

The hospice nurse may administer the remaining vials to another patient at the same facility
Correct Incorrect Correct answer

The vials should be flushed down the drain by the hospice nurse and documented on a waste log
Correct Incorrect Correct answer

Correct

Incorrect
Question 558 of 667

558. Question

Category: Federal Requirements: Controlled Substance Handling

A researcher at a university hospital wants to use a Schedule I controlled substance in an FDA-approved clinical trial. What DEA registration requirement applies?

The researcher must obtain a separate DEA Schedule I researcher registration in addition to any other DEA registrations
Correct Incorrect Correct answer

The hospital pharmacy DEA registration covers all research activities within the institution
Correct Incorrect Correct answer

Schedule I substances in clinical trials are exempt from DEA registration requirements
Correct Incorrect Correct answer

The researcher only needs a standard practitioner DEA registration with a notation for research
Correct Incorrect Correct answer

Correct

Incorrect
Question 559 of 667

559. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy technician is conducting the biennial controlled substance inventory. For Schedule II substances, what counting method is required?

An exact count of every unit of each Schedule II substance on hand
Correct Incorrect Correct answer

An estimated count is acceptable for containers holding more than 1,000 units
Correct Incorrect Correct answer

A visual inspection confirming the presence of each Schedule II drug on the shelf
Correct Incorrect Correct answer

An estimated count for all opened containers and an exact count only for sealed bottles
Correct Incorrect Correct answer

Correct

Incorrect
Question 560 of 667

560. Question

Category: Federal Requirements: Controlled Substance Handling

A hospital pharmacy uses an automated dispensing cabinet (ADC) for controlled substances. Which of the following is a required feature for CII medications dispensed from the ADC?

Single-dose access with witness verification or blind count upon each removal
Correct Incorrect Correct answer

Open matrix drawers that allow access to all CII medications at once
Correct Incorrect Correct answer

Biometric access only for physicians, with no technician access permitted
Correct Incorrect Correct answer

Automatic reorder functionality that bypasses DEA Form 222 requirements
Correct Incorrect Correct answer

Correct

Incorrect
Question 561 of 667

561. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy discovers that 50 tablets of oxycodone 30 mg are missing from inventory and suspects theft. Which DEA form must be filed?

DEA Form 106
Correct Incorrect Correct answer

DEA Form 41
Correct Incorrect Correct answer

DEA Form 222
Correct Incorrect Correct answer

DEA Form 224
Correct Incorrect Correct answer

Correct

Incorrect
Question 562 of 667

562. Question

Category: Federal Requirements: Controlled Substance Handling

A retail pharmacy orders Schedule II substances electronically through the CSOS (Controlled Substance Ordering System). What replaces the traditional DEA Form 222 in this process?

A digital certificate with an electronic signature validated by DEA-approved certification authorities
Correct Incorrect Correct answer

A faxed copy of DEA Form 222 sent to the distributor before shipment
Correct Incorrect Correct answer

A verbal authorization from the DEA field office for each electronic order
Correct Incorrect Correct answer

An email confirmation from the pharmacist-in-charge to the wholesaler
Correct Incorrect Correct answer

Correct

Incorrect
Question 563 of 667

563. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy registrant and a practitioner registrant both hold DEA registrations. Which key difference exists between these two registration types?

A pharmacy registrant (DEA Form 224) may dispense controlled substances, while a practitioner registrant may prescribe and administer but not dispense in the traditional pharmacy sense
Correct Incorrect Correct answer

A practitioner registrant may order CII drugs without DEA Form 222, while a pharmacy registrant may not
Correct Incorrect Correct answer

A pharmacy registrant is exempt from biennial inventory requirements that apply to practitioners
Correct Incorrect Correct answer

A practitioner registrant may only prescribe Schedule III through V but not Schedule II
Correct Incorrect Correct answer

Correct

Incorrect
Question 564 of 667

564. Question

Category: Federal Requirements: Controlled Substance Handling

A terminally ill patient presents a valid CII prescription for oxycodone IR 30 mg, quantity 120. The pharmacy has only 80 tablets in stock. Under the federal partial fill rule for terminally ill patients, what must the pharmacist document?

The quantity dispensed, remaining balance owed, date, and the notation "terminally ill" on the prescription
Correct Incorrect Correct answer

Only the quantity dispensed and the date; no special notation is required
Correct Incorrect Correct answer

A new prescription must be obtained from the prescriber for the remaining balance
Correct Incorrect Correct answer

The patient must sign a form acknowledging partial receipt before any tablets are dispensed
Correct Incorrect Correct answer

Correct

Incorrect
Question 565 of 667

565. Question

Category: Federal Requirements: Controlled Substance Handling

A hospital pharmacy maintains a perpetual inventory for CII substances and discovers a persistent pattern of small discrepancies (1 to 2 tablets) with hydrocodone in the ADC on the night shift. Biennial inventory totals are within acceptable range. What should the pharmacy director prioritize?

Investigate the night-shift discrepancy pattern by reviewing ADC access logs, user activity, and waste documentation for potential diversion
Correct Incorrect Correct answer

Take no action because the biennial inventory totals are within acceptable limits
Correct Incorrect Correct answer

Switch all hydrocodone to an open-matrix drawer to reduce count verification burden
Correct Incorrect Correct answer

File DEA Form 106 immediately for each individual discrepancy event
Correct Incorrect Correct answer

Correct

Incorrect
Question 566 of 667

566. Question

Category: Federal Requirements: Controlled Substance Handling

A hospice agency maintains emergency kits containing morphine 20 mg/mL injectable, lorazepam 2 mg/mL injectable, and haloperidol 5 mg/mL injectable in patient homes. The pharmacist notes that morphine is CII, lorazepam is CIV, and haloperidol is not a controlled substance. Which medications in the kit require DEA-compliant record-keeping when the kit is dispensed and returned?

Both morphine and lorazepam require DEA-compliant records; haloperidol does not
Correct Incorrect Correct answer

Only morphine requires DEA records because it is a CII substance
Correct Incorrect Correct answer

All three medications require DEA-compliant records because they are in an emergency kit
Correct Incorrect Correct answer

None require DEA records until the medications are actually administered to the patient
Correct Incorrect Correct answer

Correct

Incorrect
Question 567 of 667

567. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy receives a prescription for buprenorphine/naloxone (Suboxone) sublingual film from a physician. The prescription is written on a standard state prescription pad (not a triplicate CII form). The pharmacy technician questions whether this is valid. What is the correct determination?

The prescription is valid because buprenorphine combination products for opioid use disorder are Schedule III and do not require CII prescription forms
Correct Incorrect Correct answer

The prescription is invalid because all buprenorphine products are Schedule II
Correct Incorrect Correct answer

The prescription is valid only if the physician has an X-waiver number on the prescription
Correct Incorrect Correct answer

The prescription is invalid because Suboxone requires electronic prescribing exclusively
Correct Incorrect Correct answer

Correct

Incorrect
Question 568 of 667

568. Question

Category: Federal Requirements: Controlled Substance Handling

During a DEA audit, an inspector finds that a retail pharmacy has been using estimated counts for CII substances during biennial inventories. The pharmacist argues this is acceptable because all bottles contain fewer than 1,000 units. Is the pharmacist correct?

No; exact counts are required for all CII substances regardless of container size
Correct Incorrect Correct answer

Yes; the 1,000-unit threshold for exact counts applies equally to all schedules
Correct Incorrect Correct answer

No; exact counts are required only if the pharmacy has had a prior DEA violation
Correct Incorrect Correct answer

Yes; estimated counts are acceptable for CII when containers hold fewer than 500 units
Correct Incorrect Correct answer

Correct

Incorrect
Question 569 of 667

569. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy in State A holds DEA registration for its retail location. The pharmacist-in-charge wants to open a second location in the same state. Can the existing DEA registration cover both locations?

No; each physical location where controlled substances are stored or dispensed requires its own separate DEA registration
Correct Incorrect Correct answer

Yes; a single DEA registration covers all locations within the same state
Correct Incorrect Correct answer

Yes; as long as both locations share the same pharmacist-in-charge
Correct Incorrect Correct answer

No; but the pharmacy may apply for a single consolidated registration covering both sites
Correct Incorrect Correct answer

Correct

Incorrect
Question 570 of 667

570. Question

Category: Federal Requirements: Controlled Substance Handling

An LTCF patient has a CII prescription dated January 5 for oxycodone 10 mg, quantity 90. The pharmacy partially fills 30 tablets on January 5. Under the 2018 SUPPORT Act LTCF partial fill rules, what is the last date the remaining 60 tablets may be dispensed?

February 4 (30 days from the prescription date)
Correct Incorrect Correct answer

Within 72 hours of the most recent partial fill
Correct Incorrect Correct answer

March 6 (60 days from the prescription date)
Correct Incorrect Correct answer

January 12 (7 days from the first partial fill)
Correct Incorrect Correct answer

Correct

Incorrect
Question 571 of 667

571. Question

Category: Federal Requirements: Controlled Substance Handling

A manufacturer needs to increase its annual production of oxycodone. What DEA process must be followed to obtain authorization for the increased quantity?

The manufacturer must apply to the DEA for an increased individual manufacturing quota (IMQ) within the established aggregate production quota (APQ)
Correct Incorrect Correct answer

The manufacturer may increase production by 25% without DEA approval if demand documentation is provided
Correct Incorrect Correct answer

The manufacturer must obtain approval from the FDA, not the DEA, for production increases
Correct Incorrect Correct answer

The manufacturer may increase production after notifying the DEA 30 days in advance
Correct Incorrect Correct answer

Correct

Incorrect
Question 572 of 667

572. Question

Category: Federal Requirements: Controlled Substance Handling

A hospital pharmacy uses ADCs on 8 nursing units. The pharmacy director wants to implement the most robust controlled substance accountability system. Which combination of ADC features best prevents diversion?

Locked lidded bins with single-drug access, blind count verification, biometric user authentication, and witnessed waste documentation
Correct Incorrect Correct answer

Open matrix drawers with barcode scanning and quarterly manual inventory counts
Correct Incorrect Correct answer

Locked cabinets requiring only password entry with end-of-shift reconciliation reports
Correct Incorrect Correct answer

Sealed carousels with fingerprint access and annual controlled substance audits
Correct Incorrect Correct answer

Correct

Incorrect
Question 573 of 667

573. Question

Category: Federal Requirements: Restricted Drug Programs

Which FDA publication lists approved drug products with therapeutic equivalence evaluations and is commonly used to determine generic substitutability?

The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
Correct Incorrect Correct answer

The Purple Book (Lists of Licensed Biological Products)
Correct Incorrect Correct answer

The Red Book (Drug Topics Red Book)
Correct Incorrect Correct answer

The Green Book (Approved Animal Drug Products)
Correct Incorrect Correct answer

Correct

Incorrect
Question 574 of 667

574. Question

Category: Federal Requirements: Restricted Drug Programs

What is the maximum window for picking up an isotretinoin (iPLEDGE) prescription for females of reproductive potential after the prescription is written?

7 days
Correct Incorrect Correct answer

14 days
Correct Incorrect Correct answer

30 days
Correct Incorrect Correct answer

3 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 575 of 667

575. Question

Category: Federal Requirements: Restricted Drug Programs

Which FDA resource lists licensed biological products, including biosimilar and interchangeable biosimilar designations?

The Purple Book
Correct Incorrect Correct answer

The Orange Book
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The National Drug Code Directory
Correct Incorrect Correct answer

The FDA Adverse Event Reporting System (FAERS)
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Correct

Incorrect
Question 576 of 667

576. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives a prescription for clozapine 100 mg for a patient who has been on the medication for 8 months. The Clozapine REMS registry shows the most recent ANC is 1,200 cells/mcL, obtained 5 days ago. Can the pharmacy dispense?

Yes; an ANC of 1,200 is above the 1,000 threshold for patients in the general population, and the result is current
Correct Incorrect Correct answer

No; the ANC must be at least 1,500 for continued therapy
Correct Incorrect Correct answer

No; the ANC result must be from within 24 hours of dispensing
Correct Incorrect Correct answer

Yes; but only a 7-day supply may be dispensed at this ANC level
Correct Incorrect Correct answer

Correct

Incorrect
Question 577 of 667

577. Question

Category: Federal Requirements: Restricted Drug Programs

A female patient of reproductive potential is picking up her isotretinoin prescription. Her pregnancy test was performed 8 days ago. Can the pharmacy dispense the medication?

No; the 7-day pickup window has expired, and a new pregnancy test and qualification are needed
Correct Incorrect Correct answer

Yes; the pregnancy test is valid for 14 days
Correct Incorrect Correct answer

Yes; as long as the prescription date is within 30 days
Correct Incorrect Correct answer

No; but the prescriber can extend the window by calling the pharmacy
Correct Incorrect Correct answer

Correct

Incorrect
Question 578 of 667

578. Question

Category: Federal Requirements: Restricted Drug Programs

A prescriber writes a new prescription for alosetron (Lotronex) 0.5 mg for a female patient with severe IBS-D. What REMS requirement must the prescriber fulfill before the pharmacy can dispense?

The prescriber must be enrolled in the Lotronex REMS program and must have signed a patient-prescriber agreement form
Correct Incorrect Correct answer

The prescriber must obtain prior authorization from the patient insurance plan
Correct Incorrect Correct answer

The prescriber must complete an online training module approved by the DEA
Correct Incorrect Correct answer

The prescriber must submit a treatment protocol to the FDA for individual patient review
Correct Incorrect Correct answer

Correct

Incorrect
Question 579 of 667

579. Question

Category: Federal Requirements: Restricted Drug Programs

A patient presents a prescription for buprenorphine/naloxone (Suboxone) sublingual film. The prescription does not contain an X-waiver number. As of January 2023, should the pharmacy refuse to fill?

No; the X-waiver requirement was eliminated in December 2022 by the Consolidated Appropriations Act, so any DEA-registered practitioner may prescribe
Correct Incorrect Correct answer

Yes; the X-waiver number is still required on all buprenorphine prescriptions
Correct Incorrect Correct answer

No; but only if the prescriber is a board-certified addiction specialist
Correct Incorrect Correct answer

Yes; the X-waiver was only eliminated for nurse practitioners, not physicians
Correct Incorrect Correct answer

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Incorrect
Question 580 of 667

580. Question

Category: Federal Requirements: Restricted Drug Programs

A state passes a law requiring naloxone to be co-prescribed with any opioid prescription exceeding 50 morphine milligram equivalents (MME) per day. A patient receives a prescription for oxycodone 20 mg four times daily. Does the co-prescribing requirement apply?

Yes; oxycodone 80 mg/day equals 120 MME/day (conversion factor 1.5), which exceeds 50 MME
Correct Incorrect Correct answer

No; oxycodone 80 mg/day equals only 40 MME/day
Correct Incorrect Correct answer

Yes; but only if the patient has a documented history of opioid overdose
Correct Incorrect Correct answer

No; the co-prescribing requirement applies only to extended-release opioids
Correct Incorrect Correct answer

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Incorrect
Question 581 of 667

581. Question

Category: Federal Requirements: Restricted Drug Programs

A physician wants to prescribe a drug that is not FDA-approved but is available through an expanded access (compassionate use) program. What must the physician obtain before treatment can begin?

FDA authorization through an expanded access IND, plus IRB approval (or IRB notification for individual patients)
Correct Incorrect Correct answer

A letter from the drug manufacturer granting permission to use the drug
Correct Incorrect Correct answer

State board of pharmacy approval and DEA registration for the specific drug
Correct Incorrect Correct answer

Patient consent only, as expanded access drugs are exempt from FDA oversight
Correct Incorrect Correct answer

Correct

Incorrect
Question 582 of 667

582. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician is verifying a prescription for a REMS drug that requires pharmacy certification. The pharmacy recently renewed its certification, but the renewal has not yet been confirmed in the REMS database. What should the technician do?

Hold the prescription and contact the REMS program administrator to verify the pharmacy certification status before dispensing
Correct Incorrect Correct answer

Dispense the medication based on the pharmacy records showing renewal was submitted
Correct Incorrect Correct answer

Transfer the prescription to another certified pharmacy
Correct Incorrect Correct answer

Ask the patient to wait 30 days for the database to update automatically
Correct Incorrect Correct answer

Correct

Incorrect
Question 583 of 667

583. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacist is asked whether a biosimilar product can be automatically substituted for the reference biologic without prescriber notification. What FDA designation must the biosimilar have for this to occur?

The biosimilar must be designated as an interchangeable biosimilar product by the FDA
Correct Incorrect Correct answer

Any FDA-approved biosimilar may be substituted without prescriber notification
Correct Incorrect Correct answer

The biosimilar must have an AB-rated therapeutic equivalence code in the Orange Book
Correct Incorrect Correct answer

Biosimilars can never be substituted without prescriber authorization under federal law
Correct Incorrect Correct answer

Correct

Incorrect
Question 584 of 667

584. Question

Category: Federal Requirements: Restricted Drug Programs

A prescriber contacts the pharmacy asking about the opioid REMS education requirements. What is the primary component of the current opioid analgesic REMS?

A Medication Guide that must be dispensed with each opioid prescription and voluntary prescriber education through accredited CE programs
Correct Incorrect Correct answer

Mandatory prescriber certification and patient registry enrollment before each prescription
Correct Incorrect Correct answer

Mandatory urine drug testing within 30 days of each new opioid prescription
Correct Incorrect Correct answer

A requirement for pharmacies to dispense no more than a 7-day supply on initial prescriptions
Correct Incorrect Correct answer

Correct

Incorrect
Question 585 of 667

585. Question

Category: Federal Requirements: Restricted Drug Programs

Under the iPLEDGE program, how many forms of contraception must females of reproductive potential use while taking isotretinoin?

Two forms of contraception simultaneously, or complete abstinence
Correct Incorrect Correct answer

One highly effective form of contraception
Correct Incorrect Correct answer

Three forms of contraception simultaneously
Correct Incorrect Correct answer

Contraception is recommended but not required under iPLEDGE
Correct Incorrect Correct answer

Correct

Incorrect
Question 586 of 667

586. Question

Category: Federal Requirements: Restricted Drug Programs

The FDA wants to modify the REMS for an existing drug to add a new ETASU requirement. What process must the FDA follow?

The FDA must provide notice to the drug manufacturer and allow opportunity for a public comment period or negotiation before requiring the modification
Correct Incorrect Correct answer

The FDA may unilaterally add ETASU requirements without manufacturer input at any time
Correct Incorrect Correct answer

The FDA must withdraw the original REMS and issue a completely new REMS program
Correct Incorrect Correct answer

REMS modifications can only occur when the drug undergoes a new NDA review
Correct Incorrect Correct answer

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Incorrect
Question 587 of 667

587. Question

Category: Federal Requirements: Restricted Drug Programs

A patient on clozapine has an ANC of 950 cells/mcL on routine monitoring. The previous three ANC results were 1,800, 1,600, and 1,400 cells/mcL over the past 3 months, showing a declining trend. What action is required under the Clozapine REMS?

Clozapine should not be dispensed; the ANC is below 1,000, requiring treatment interruption, increased monitoring frequency, and prompt evaluation for the cause of neutropenia
Correct Incorrect Correct answer

Dispense a 7-day supply only and recheck ANC in one week
Correct Incorrect Correct answer

Continue dispensing normally because the average of the last four ANC values exceeds 1,000
Correct Incorrect Correct answer

Reduce the clozapine dose by 50% and recheck ANC in 2 weeks
Correct Incorrect Correct answer

Correct

Incorrect
Question 588 of 667

588. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives a prescription for thalidomide for a female patient. The THALOMID REMS (formerly S.T.E.P.S.) has strict requirements. Which combination of requirements must be met before dispensing?

Patient enrollment in REMS, negative pregnancy test within 24 hours before dispensing, prescriber certification, and pharmacy certification
Correct Incorrect Correct answer

Prescriber certification and patient consent form only
Correct Incorrect Correct answer

Negative pregnancy test within 7 days and pharmacist counseling documentation
Correct Incorrect Correct answer

Patient registry enrollment and liver function testing within 30 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 589 of 667

589. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacist is comparing two biosimilar products for adalimumab (Humira). Product A is designated as biosimilar only. Product B is designated as interchangeable. A prescription reads “adalimumab” without specifying a brand. Under a state law allowing interchangeable biosimilar substitution, which product(s) may the pharmacist dispense without contacting the prescriber?

The reference product (Humira) or Product B (interchangeable biosimilar); Product A cannot be substituted without prescriber authorization
Correct Incorrect Correct answer

Only the reference product (Humira) may be dispensed
Correct Incorrect Correct answer

Either Product A or Product B, as both are FDA-approved biosimilars
Correct Incorrect Correct answer

Product B only; the reference product requires a specific brand-name prescription
Correct Incorrect Correct answer

Correct

Incorrect
Question 590 of 667

590. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy technician notices that a new REMS drug requires an ETASU including a patient registry. The drug was approved 3 years ago, and the FDA is now conducting a REMS assessment. What is the purpose of the FDA REMS assessment?

To evaluate whether the REMS is meeting its safety goals and whether modifications (including removal of elements) are warranted
Correct Incorrect Correct answer

To determine if the drug should be withdrawn from the market
Correct Incorrect Correct answer

To verify that the manufacturer is paying the required REMS maintenance fees
Correct Incorrect Correct answer

To audit individual pharmacy compliance with dispensing requirements
Correct Incorrect Correct answer

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Incorrect
Question 591 of 667

591. Question

Category: Federal Requirements: Restricted Drug Programs

A prescriber wants to use lenalidomide (Revlimid) for a patient with multiple myeloma. The pharmacy technician knows Revlimid has a REMS program similar to thalidomide. What distinguishes the Revlimid REMS from a standard Medication Guide REMS?

Revlimid REMS includes ETASU requiring prescriber and pharmacy certification, patient surveys, and mandatory pregnancy testing for females of reproductive potential
Correct Incorrect Correct answer

Revlimid REMS only requires a Medication Guide without additional elements
Correct Incorrect Correct answer

Revlimid REMS requires DEA registration for prescribers, similar to controlled substance prescribing
Correct Incorrect Correct answer

Revlimid REMS restricts dispensing to hospital pharmacies only
Correct Incorrect Correct answer

Correct

Incorrect
Question 592 of 667

592. Question

Category: Federal Requirements: Restricted Drug Programs

A male patient on isotretinoin through the iPLEDGE program asks if he needs monthly pregnancy tests like his sister who is also on the drug. What iPLEDGE requirements apply to male patients?

Male patients do not require pregnancy tests but must be enrolled in iPLEDGE, and their prescriptions are limited to a 30-day supply with no refills
Correct Incorrect Correct answer

Male patients are exempt from all iPLEDGE requirements
Correct Incorrect Correct answer

Male patients must have monthly liver function tests instead of pregnancy tests
Correct Incorrect Correct answer

Male patients require pregnancy tests if their partner is of reproductive potential
Correct Incorrect Correct answer

Correct

Incorrect
Question 593 of 667

593. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives a prescription for a drug that is available through the FDA expanded access (compassionate use) program. The drug has no NDA or ANDA approval. How should the pharmacy handle billing and documentation?

The drug is provided under an IND; the pharmacy must follow investigational drug protocols for receipt, storage, dispensing, and documentation, and the drug is typically not billed to insurance
Correct Incorrect Correct answer

The pharmacy bills the patient insurance using the drug NDC number as a standard outpatient prescription
Correct Incorrect Correct answer

The pharmacy returns the prescription to the prescriber because non-approved drugs cannot be dispensed
Correct Incorrect Correct answer

The pharmacy may dispense the drug without any special documentation since it is an emergency authorization
Correct Incorrect Correct answer

Correct

Incorrect
Question 594 of 667

594. Question

Category: Federal Requirements: Restricted Drug Programs

A new biologic drug is approved with a REMS that includes a communication plan and a Medication Guide but no ETASU. Two years later, serious adverse events emerge. The FDA wants to add ETASU requirements including prescriber certification. Can the manufacturer challenge this modification?

Yes; the manufacturer may dispute the necessity of the modification and request a hearing before the FDA can mandate the change
Correct Incorrect Correct answer

No; the FDA has unrestricted authority to modify any REMS at any time without manufacturer input
Correct Incorrect Correct answer

Yes; but only if the manufacturer voluntarily withdraws the drug from the market first
Correct Incorrect Correct answer

No; REMS modifications are automatic once adverse events exceed a predetermined threshold
Correct Incorrect Correct answer

Correct

Incorrect
Question 595 of 667

595. Question

Category: Federal Requirements: Restricted Drug Programs

A pharmacy receives a prescription for pomalidomide (Pomalyst) for a patient with multiple myeloma. The pharmacist checks the REMS database and finds that the patient completed her pregnancy test 32 days ago. Can the pharmacy dispense?

No; females of reproductive potential must have a negative pregnancy test within the past 7 days before dispensing under the Pomalyst REMS
Correct Incorrect Correct answer

Yes; the pregnancy test is valid for 30 days under most REMS programs
Correct Incorrect Correct answer

No; but only because pomalidomide requires a pregnancy test within 24 hours of dispensing
Correct Incorrect Correct answer

Yes; pregnancy testing is only required at treatment initiation, not for refills
Correct Incorrect Correct answer

Correct

Incorrect
Question 596 of 667

596. Question

Category: Federal Requirements: Hazardous Waste Disposal

How often must a biological safety cabinet (BSC) used for hazardous drug compounding be recertified?

Every 6 months
Correct Incorrect Correct answer

Every 12 months
Correct Incorrect Correct answer

Every 3 months
Correct Incorrect Correct answer

Every 24 months
Correct Incorrect Correct answer

Correct

Incorrect
Question 597 of 667

597. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which category on the NIOSH hazardous drug list specifically includes antineoplastic agents?

Group 1
Correct Incorrect Correct answer

Group 2
Correct Incorrect Correct answer

Group 3
Correct Incorrect Correct answer

Group 4
Correct Incorrect Correct answer

Correct

Incorrect
Question 598 of 667

598. Question

Category: Federal Requirements: Hazardous Waste Disposal

What is the correct order of the four-step surface treatment process for areas contaminated with hazardous drugs?

Deactivation, decontamination, cleaning, disinfection
Correct Incorrect Correct answer

Cleaning, disinfection, deactivation, decontamination
Correct Incorrect Correct answer

Decontamination, deactivation, disinfection, cleaning
Correct Incorrect Correct answer

Disinfection, cleaning, decontamination, deactivation
Correct Incorrect Correct answer

Correct

Incorrect
Question 599 of 667

599. Question

Category: Federal Requirements: Hazardous Waste Disposal

RCRA P-listed pharmaceutical waste is characterized by which of the following features?

Acutely hazardous commercial chemical products
Correct Incorrect Correct answer

Toxic pharmaceutical waste generated in large quantities
Correct Incorrect Correct answer

Waste solvents from compounding operations
Correct Incorrect Correct answer

Any expired medication requiring special disposal
Correct Incorrect Correct answer

Correct

Incorrect
Question 600 of 667

600. Question

Category: Federal Requirements: Hazardous Waste Disposal

What type of device is specifically designed to prevent the escape of hazardous drug vapors during preparation and administration?

Closed-system transfer device (CSTD)
Correct Incorrect Correct answer

Laminar airflow workbench
Correct Incorrect Correct answer

Automated dispensing cabinet
Correct Incorrect Correct answer

Needleless luer-lock adapter
Correct Incorrect Correct answer

Correct

Incorrect
Question 601 of 667

601. Question

Category: Federal Requirements: Hazardous Waste Disposal

Which NIOSH hazardous drug group includes drugs that pose primarily reproductive risks to healthcare workers?

Group 3
Correct Incorrect Correct answer

Group 1
Correct Incorrect Correct answer

Group 2
Correct Incorrect Correct answer

Group 4
Correct Incorrect Correct answer

Correct

Incorrect
Question 602 of 667

602. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician discovers a broken vial of cyclophosphamide on the floor of the clean room. Which item from the spill kit should be used first?

Absorbent spill pads or powder
Correct Incorrect Correct answer

Disinfectant spray
Correct Incorrect Correct answer

Sharps container
Correct Incorrect Correct answer

Sterile gauze pads
Correct Incorrect Correct answer

Correct

Incorrect
Question 603 of 667

603. Question

Category: Federal Requirements: Hazardous Waste Disposal

A hospital pharmacy generates 800 kg of non-acute RCRA hazardous waste per month. How should this facility be classified?

Small quantity generator
Correct Incorrect Correct answer

Large quantity generator
Correct Incorrect Correct answer

Very small quantity generator
Correct Incorrect Correct answer

Conditionally exempt generator
Correct Incorrect Correct answer

Correct

Incorrect
Question 604 of 667

604. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy is preparing to ship containers of bulk chemotherapy waste to an off-site treatment facility. Which federal agency regulates the transportation requirements for this shipment?

Department of Transportation (DOT)
Correct Incorrect Correct answer

Environmental Protection Agency (EPA)
Correct Incorrect Correct answer

Drug Enforcement Administration (DEA)
Correct Incorrect Correct answer

Occupational Safety and Health Administration (OSHA)
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Question 605 of 667

605. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician is compounding methotrexate in a biological safety cabinet. She reports that she is 8 weeks pregnant. What is the most appropriate action?

Reassign her to duties that do not involve hazardous drug handling
Correct Incorrect Correct answer

Allow her to continue with double gloving only
Correct Incorrect Correct answer

Require her to wear a full face respirator during compounding
Correct Incorrect Correct answer

Reduce her compounding shifts to once per week
Correct Incorrect Correct answer

Correct

Incorrect
Question 606 of 667

606. Question

Category: Federal Requirements: Hazardous Waste Disposal

An IV bag containing residual fluorouracil solution and the attached tubing are ready for disposal. How should this waste be categorized?

Trace contamination chemotherapy waste
Correct Incorrect Correct answer

Bulk chemotherapy waste
Correct Incorrect Correct answer

RCRA hazardous waste requiring a black container
Correct Incorrect Correct answer

Regular pharmaceutical waste
Correct Incorrect Correct answer

Correct

Incorrect
Question 607 of 667

607. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy receives a hazardous waste manifest from the treatment facility, but it shows a discrepancy in the quantity of waste delivered versus what was shipped. What must the generator do if the discrepancy is not resolved within 15 days?

Submit an exception report to the EPA regional administrator
Correct Incorrect Correct answer

File a report with the state board of pharmacy
Correct Incorrect Correct answer

Contact the DOT for a shipping investigation
Correct Incorrect Correct answer

Dispose of the manifest and create a new one
Correct Incorrect Correct answer

Correct

Incorrect
Question 608 of 667

608. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician spills approximately 30 mL of a doxorubicin solution on the compounding counter. After donning appropriate PPE and containing the spill with absorbent pads, what is the next step?

Apply a deactivation agent to the contaminated area
Correct Incorrect Correct answer

Immediately wipe the area with 70% isopropyl alcohol
Correct Incorrect Correct answer

Place a wet floor sign and notify housekeeping
Correct Incorrect Correct answer

Rinse the area with large volumes of sterile water
Correct Incorrect Correct answer

Correct

Incorrect
Question 609 of 667

609. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy has a partially used vial of warfarin sodium injection (concentration greater than 0.3%) that has expired. Under RCRA, how should this waste be classified?

P-listed acutely hazardous waste
Correct Incorrect Correct answer

U-listed toxic waste
Correct Incorrect Correct answer

Non-hazardous pharmaceutical waste
Correct Incorrect Correct answer

D-listed characteristic waste
Correct Incorrect Correct answer

Correct

Incorrect
Question 610 of 667

610. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy’s BSC was last certified on September 15. By what date must the next certification be completed to remain compliant?

March 15 of the following year
Correct Incorrect Correct answer

September 15 of the following year
Correct Incorrect Correct answer

December 15 of the same year
Correct Incorrect Correct answer

June 15 of the following year
Correct Incorrect Correct answer

Correct

Incorrect
Question 611 of 667

611. Question

Category: Federal Requirements: Hazardous Waste Disposal

A hospital pharmacy generates 90 kg of non-acute RCRA hazardous waste and 0.5 kg of P-listed waste per month. What is the facility’s generator classification?

Very small quantity generator, because both waste streams fall below their respective thresholds
Correct Incorrect Correct answer

Small quantity generator due to the P-listed waste exceeding 0.5 kg
Correct Incorrect Correct answer

Large quantity generator based on combined waste
Correct Incorrect Correct answer

Conditionally exempt based on low total volume
Correct Incorrect Correct answer

Correct

Incorrect
Question 612 of 667

612. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy is required to perform medical surveillance for staff who handle hazardous drugs. Which of the following findings during a baseline assessment would most likely require immediate reassignment from hazardous drug duties?

Active attempt to conceive a child
Correct Incorrect Correct answer

History of seasonal allergies
Correct Incorrect Correct answer

Mild asthma controlled with an inhaler
Correct Incorrect Correct answer

Previous exposure to hazardous drugs at a former employer
Correct Incorrect Correct answer

Correct

Incorrect
Question 613 of 667

613. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy is disposing of unused cyclophosphamide tablets from a returned prescription bottle. The tablets are intact and clearly contain visible drug product. How should this waste be categorized?

Bulk chemotherapy waste
Correct Incorrect Correct answer

Trace contamination waste
Correct Incorrect Correct answer

Regular pharmaceutical waste for incineration
Correct Incorrect Correct answer

Non-RCRA hazardous waste
Correct Incorrect Correct answer

Correct

Incorrect
Question 614 of 667

614. Question

Category: Federal Requirements: Hazardous Waste Disposal

During a routine exposure assessment, surface wipe sampling in the pharmacy’s hazardous drug compounding area detects measurable levels of cyclophosphamide residue. What does this finding indicate?

The decontamination procedures are not adequately removing drug residue
Correct Incorrect Correct answer

The BSC is functioning properly and capturing most contaminants
Correct Incorrect Correct answer

The pharmacy must immediately stop all hazardous drug compounding
Correct Incorrect Correct answer

The finding is expected and does not require corrective action
Correct Incorrect Correct answer

Correct

Incorrect
Question 615 of 667

615. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy must use a CSTD when administering which category of hazardous drugs according to USP ?

Antineoplastic drugs when the dosage form allows CSTD use
Correct Incorrect Correct answer

All NIOSH-listed drugs regardless of category
Correct Incorrect Correct answer

Only drugs classified in NIOSH Group 3
Correct Incorrect Correct answer

Only injectable drugs compounded in a BSC
Correct Incorrect Correct answer

Correct

Incorrect
Question 616 of 667

616. Question

Category: Federal Requirements: Hazardous Waste Disposal

A hospital pharmacy generates 150 kg of U-listed hazardous waste and 0.8 kg of P-listed waste in a single month. Which generator classification applies, and what is the determining factor?

Small quantity generator, determined by the U-listed waste exceeding 100 kg
Correct Incorrect Correct answer

Very small quantity generator, because P-listed waste is under 1 kg
Correct Incorrect Correct answer

Large quantity generator, because combined waste exceeds 200 kg
Correct Incorrect Correct answer

Small quantity generator, determined by the P-listed waste exceeding 0.5 kg
Correct Incorrect Correct answer

Correct

Incorrect
Question 617 of 667

617. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician prepared three IV admixtures of paclitaxel in a BSC. After preparation, the following items need disposal: two empty paclitaxel vials with minimal residue, used compounding gloves, and one vial containing 15 mL of unused paclitaxel solution. Which disposal approach is correct?

Place the empty vials and gloves in a trace chemotherapy waste container and the full vial in a hazardous waste container for bulk chemotherapy waste
Correct Incorrect Correct answer

Place all items in the same yellow chemotherapy waste container
Correct Incorrect Correct answer

Place all items in a black RCRA hazardous waste container
Correct Incorrect Correct answer

Place the vials in a sharps container and the gloves in regular trash
Correct Incorrect Correct answer

Correct

Incorrect
Question 618 of 667

618. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy receives a new drug, lenalidomide, which is classified under REMS and is also on the NIOSH hazardous drug list. A technician asks whether standard dispensing procedures are sufficient. Which analysis best describes the handling requirements?

Both REMS distribution requirements and USP <800> hazardous drug handling precautions must be followed simultaneously
Correct Incorrect Correct answer

REMS requirements supersede USP <800> and are the only applicable standard
Correct Incorrect Correct answer

USP <800> requirements apply only during compounding, not during dispensing of oral dosage forms
Correct Incorrect Correct answer

The drug only requires hazardous handling if it is compounded into a different dosage form
Correct Incorrect Correct answer

Correct

Incorrect
Question 619 of 667

619. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician notices that the hazardous waste manifest returned from the treatment facility lists a different EPA waste code than what was originally recorded by the pharmacy. Which action should the pharmacy take first?

Contact the treatment facility to investigate and reconcile the discrepancy before the 15-day resolution window expires
Correct Incorrect Correct answer

Accept the treatment facility's waste code as correct and update pharmacy records
Correct Incorrect Correct answer

File an immediate exception report with the EPA regional administrator
Correct Incorrect Correct answer

Discard the original manifest and create a corrected version
Correct Incorrect Correct answer

Correct

Incorrect
Question 620 of 667

620. Question

Category: Federal Requirements: Hazardous Waste Disposal

A community pharmacy handles oral hazardous drugs but does not compound them. The pharmacy director argues that USP engineering controls such as a BSC are not needed. Is this position correct?

The position is partially correct; a BSC is not required for non-compounding activities, but the pharmacy must still implement alternative containment strategies
Correct Incorrect Correct answer

The position is fully correct; USP <800> only applies to facilities that compound hazardous drugs
Correct Incorrect Correct answer

The position is incorrect; all pharmacies handling NIOSH-listed drugs must have a BSC
Correct Incorrect Correct answer

The position is correct only if the pharmacy handles fewer than 10 hazardous drug prescriptions per week
Correct Incorrect Correct answer

Correct

Incorrect
Question 621 of 667

621. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy is evaluating two spill kits: Kit A contains absorbent pads, two pairs of chemotherapy gloves, a gown, shoe covers, a face shield, and a scoop with a disposal bag. Kit B contains all items in Kit A plus a respirator mask and eye wash solution. Which kit meets the minimum requirements for a hazardous drug spill in the compounding area?

Kit B, because a respirator is necessary for spills that may generate aerosols or vapors
Correct Incorrect Correct answer

Kit A, because a face shield provides adequate respiratory protection
Correct Incorrect Correct answer

Both kits are equivalent since respirators are only required during compounding
Correct Incorrect Correct answer

Neither kit is adequate without a full-body chemical splash suit
Correct Incorrect Correct answer

Correct

Incorrect
Question 622 of 667

622. Question

Category: Federal Requirements: Hazardous Waste Disposal

An oncology pharmacy is transitioning from a very small quantity generator to a small quantity generator under RCRA. Which of the following changes in operational requirements will be most significant?

The facility must now obtain an EPA identification number and comply with more stringent storage time limits
Correct Incorrect Correct answer

The facility may now store hazardous waste indefinitely without a permit
Correct Incorrect Correct answer

The facility is exempt from manifest tracking if waste is treated on-site
Correct Incorrect Correct answer

The facility must reduce its waste output to return to VSQG status within 90 days
Correct Incorrect Correct answer

Correct

Incorrect
Question 623 of 667

623. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician is reviewing the facility’s hazardous drug list and notices that hormone-based medications such as estradiol are included. A colleague questions their inclusion since they are not antineoplastics. What is the best explanation for their classification?

These drugs are classified under NIOSH Group 3 because they pose reproductive hazards to healthcare workers with occupational exposure
Correct Incorrect Correct answer

They are classified under NIOSH Group 1 because all hormones are considered antineoplastic
Correct Incorrect Correct answer

They appear on the list only because they require refrigerated storage
Correct Incorrect Correct answer

They are included because the FDA requires all injectable hormones to be handled as hazardous
Correct Incorrect Correct answer

Correct

Incorrect
Question 624 of 667

624. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy conducts annual medical surveillance on staff who compound hazardous drugs. One technician’s follow-up blood work shows a significant decline in white blood cell count compared to baseline. Which action is most appropriate?

Remove the technician from hazardous drug duties and refer for further medical evaluation
Correct Incorrect Correct answer

Recheck the blood work in 6 months at the next routine surveillance
Correct Incorrect Correct answer

Increase PPE requirements for this technician and continue current duties
Correct Incorrect Correct answer

Attribute the finding to normal variation and document it in the employee file
Correct Incorrect Correct answer

Correct

Incorrect
Question 625 of 667

625. Question

Category: Federal Requirements: Hazardous Waste Disposal

A hospital pharmacy is audited and found to have disposed of P-listed pharmaceutical waste (nicotine patches) in a blue non-hazardous pharmaceutical waste container. What is the primary regulatory consequence of this error?

The entire contents of the blue container may now be classified as hazardous waste, increasing disposal costs and potential regulatory penalties
Correct Incorrect Correct answer

The pharmacy receives a warning but may continue using the same container if properly labeled
Correct Incorrect Correct answer

Only the nicotine patches must be removed and placed in the correct container
Correct Incorrect Correct answer

The error has no regulatory consequence if the container has not yet been shipped off-site
Correct Incorrect Correct answer

Correct

Incorrect
Question 626 of 667

626. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy receives a new shipment of oxycodone 30 mg tablets. Which inventory method is required by the DEA for counting Schedule II controlled substances?

An exact physical count of all units
Correct Incorrect Correct answer

An estimated count unless the container holds more than 500 units
Correct Incorrect Correct answer

A visual estimation recorded in the logbook
Correct Incorrect Correct answer

A weight-based approximation using a pharmacy balance
Correct Incorrect Correct answer

Correct

Incorrect
Question 627 of 667

627. Question

Category: Federal Requirements: Controlled Substance Handling

A wholesaler reports an unusually large order of hydrocodone from a pharmacy. Under DEA regulations, what must the wholesaler do when a suspicious order is identified?

Report the suspicious order to the DEA and exercise due diligence before completing it
Correct Incorrect Correct answer

Fill the order and notify the state board of pharmacy within 30 days
Correct Incorrect Correct answer

Refuse the order and file a DEA Form 106
Correct Incorrect Correct answer

Contact the pharmacy's pharmacist in charge and proceed with the order
Correct Incorrect Correct answer

Correct

Incorrect
Question 628 of 667

628. Question

Category: Federal Requirements: Controlled Substance Handling

According to DEA regulations, Schedule II controlled substances must be stored in which of the following?

A substantially constructed, locked cabinet or safe, or dispersed among non-controlled inventory
Correct Incorrect Correct answer

A double-locked cabinet with two separate locking mechanisms
Correct Incorrect Correct answer

A locked cabinet accessible only by the pharmacist in charge
Correct Incorrect Correct answer

A refrigerated, locked storage unit separate from all other medications
Correct Incorrect Correct answer

Correct

Incorrect
Question 629 of 667

629. Question

Category: Federal Requirements: Controlled Substance Handling

At the end of the business day, a pharmacy technician and pharmacist conduct a controlled substance count. They discover a discrepancy in the hydromorphone count. Which practice describes the process they are performing?

A two-person count to verify controlled substance accountability
Correct Incorrect Correct answer

A biennial inventory required by the DEA every two years
Correct Incorrect Correct answer

A DEA Form 222 reconciliation for Schedule II ordering
Correct Incorrect Correct answer

A reverse distribution audit for expired medications
Correct Incorrect Correct answer

Correct

Incorrect
Question 630 of 667

630. Question

Category: Federal Requirements: Controlled Substance Handling

When must a pharmacy perform an initial inventory of controlled substances under DEA regulations?

On the date the pharmacy first engages in dispensing controlled substances
Correct Incorrect Correct answer

Within 30 days of receiving the DEA registration certificate
Correct Incorrect Correct answer

On the first business day of the calendar year following DEA registration
Correct Incorrect Correct answer

Within 14 days before opening the pharmacy to the public
Correct Incorrect Correct answer

Correct

Incorrect
Question 631 of 667

631. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy takes its controlled substance inventory at 5:00 PM on March 15 as the store closes. What must the inventory record indicate regarding the timing?

Whether the inventory was taken at the opening or close of business on that date
Correct Incorrect Correct answer

The exact time the inventory was completed to the nearest minute
Correct Incorrect Correct answer

The names of all staff members present in the pharmacy during the count
Correct Incorrect Correct answer

The date of the next scheduled biennial inventory
Correct Incorrect Correct answer

Correct

Incorrect
Question 632 of 667

632. Question

Category: Federal Requirements: Hazardous Waste Disposal

When a pharmacy needs to dispose of expired controlled substances, it must send them to which type of DEA-registered entity?

A reverse distributor authorized by the DEA to receive controlled substances for destruction
Correct Incorrect Correct answer

The original drug manufacturer for credit and recycling
Correct Incorrect Correct answer

The state board of pharmacy for witnessed destruction
Correct Incorrect Correct answer

A local hazardous waste landfill approved by the EPA
Correct Incorrect Correct answer

Correct

Incorrect
Question 633 of 667

633. Question

Category: Federal Requirements: Hazardous Waste Disposal

What document provides pharmacy personnel with information about the hazards, safe handling procedures, and emergency measures for a specific chemical or pharmaceutical substance?

A Safety Data Sheet (SDS), formerly called Material Safety Data Sheet (MSDS)
Correct Incorrect Correct answer

A DEA Form 222
Correct Incorrect Correct answer

The FDA Orange Book
Correct Incorrect Correct answer

A Certificate of Analysis (COA)
Correct Incorrect Correct answer

Correct

Incorrect
Question 634 of 667

634. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician is preparing to handle a spill of cyclophosphamide powder. Which of the following personal protective equipment (PPE) is required for cleaning up a hazardous drug spill?

Double chemotherapy-rated gloves, a protective gown, eye protection, and a respirator
Correct Incorrect Correct answer

A single pair of standard exam gloves and a face mask
Correct Incorrect Correct answer

A lab coat and safety glasses only
Correct Incorrect Correct answer

Double exam gloves and a surgical mask
Correct Incorrect Correct answer

Correct

Incorrect
Question 635 of 667

635. Question

Category: Federal Requirements: Hazardous Waste Disposal

Under the EPA Resource Conservation and Recovery Act (RCRA), warfarin and warfarin salts at concentrations greater than 0.3% are classified on which hazardous waste list?

The P-list (acutely hazardous waste)
Correct Incorrect Correct answer

The U-list (toxic waste)
Correct Incorrect Correct answer

The K-list (source-specific waste)
Correct Incorrect Correct answer

The F-list (non-specific source waste)
Correct Incorrect Correct answer

Correct

Incorrect
Question 636 of 667

636. Question

Category: Federal Requirements: Hazardous Waste Disposal

Nicotine, when discarded as a commercial chemical product, is classified under which EPA hazardous waste list?

The P-list (P075) as an acutely hazardous waste
Correct Incorrect Correct answer

The U-list as a toxic waste
Correct Incorrect Correct answer

The D-list as a characteristic hazardous waste
Correct Incorrect Correct answer

The F-list as a non-specific source waste
Correct Incorrect Correct answer

Correct

Incorrect
Question 637 of 667

637. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy is discarding unused phentermine capsules that are past their expiration date. Under RCRA guidelines, how should this waste be classified?

As P-list (acutely hazardous) waste requiring specialized disposal
Correct Incorrect Correct answer

As non-hazardous pharmaceutical waste for standard trash disposal
Correct Incorrect Correct answer

As U-list toxic waste requiring yellow container disposal
Correct Incorrect Correct answer

As a controlled substance only, requiring DEA destruction but no hazardous waste classification
Correct Incorrect Correct answer

Correct

Incorrect
Question 638 of 667

638. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacist receives a telephone call from a physician requesting emergency dispensing of a Schedule II controlled substance. According to DEA regulations, what must the prescriber provide within 7 days?

A written or electronic prescription for the emergency quantity dispensed
Correct Incorrect Correct answer

A DEA Form 222 authorizing the dispensing
Correct Incorrect Correct answer

A verbal confirmation call to the state board of pharmacy
Correct Incorrect Correct answer

A faxed copy of the patient's medical record
Correct Incorrect Correct answer

Correct

Incorrect
Question 639 of 667

639. Question

Category: Federal Requirements: Controlled Substance Rx

Under DEA regulations, which of the following conditions must be met for emergency dispensing of a Schedule II controlled substance?

The pharmacist determines that an immediate need exists and no alternative treatment is available
Correct Incorrect Correct answer

The patient must present a valid photo ID at the pharmacy
Correct Incorrect Correct answer

The prescriber must fax a signed prescription before the drug is dispensed
Correct Incorrect Correct answer

The quantity dispensed must not exceed a 90-day supply
Correct Incorrect Correct answer

Correct

Incorrect
Question 640 of 667

640. Question

Category: Federal Requirements: Controlled Substance Rx

Which of the following is a required element of a valid prescription for a controlled substance?

The prescriber's DEA registration number
Correct Incorrect Correct answer

The patient's Social Security number
Correct Incorrect Correct answer

The pharmacy's state license number
Correct Incorrect Correct answer

The prescriber's medical school graduation date
Correct Incorrect Correct answer

Correct

Incorrect
Question 641 of 667

641. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy technician is reviewing a controlled substance prescription and notices it is missing the patient’s address. Is this a valid prescription?

No, the patient's full name and address are required on a valid prescription for a controlled substance
Correct Incorrect Correct answer

Yes, only the patient's name is required on controlled substance prescriptions
Correct Incorrect Correct answer

Yes, the address is only required for Schedule II prescriptions
Correct Incorrect Correct answer

No, but the technician may add the address from the patient profile without prescriber authorization
Correct Incorrect Correct answer

Correct

Incorrect
Question 642 of 667

642. Question

Category: Federal Requirements: Controlled Substance Rx

When a controlled substance prescription is dispensed, what information regarding the date filled must be recorded on the prescription?

The date on which the prescription was actually filled by the pharmacy
Correct Incorrect Correct answer

The date the prescriber originally wrote the prescription
Correct Incorrect Correct answer

The date the patient picked up the medication
Correct Incorrect Correct answer

The date the insurance claim was submitted
Correct Incorrect Correct answer

Correct

Incorrect
Question 643 of 667

643. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy technician fills a Schedule III prescription on March 15 but the patient does not pick it up until March 20. What should be recorded as the date filled?

March 15, the date the prescription was actually dispensed and prepared
Correct Incorrect Correct answer

March 20, the date the patient picked up the medication
Correct Incorrect Correct answer

The earlier of the two dates as selected by the pharmacist
Correct Incorrect Correct answer

The date written on the original prescription by the prescriber
Correct Incorrect Correct answer

Correct

Incorrect
Question 644 of 667

644. Question

Category: Federal Requirements: Controlled Substance Rx

Which of the following is a federal requirement regarding the quantity written on a controlled substance prescription?

The exact quantity to be dispensed must be indicated on the prescription
Correct Incorrect Correct answer

The quantity must be written in Roman numerals only
Correct Incorrect Correct answer

The quantity is optional for Schedule V prescriptions
Correct Incorrect Correct answer

The quantity must be written in both numeric and word form for all schedules
Correct Incorrect Correct answer

Correct

Incorrect
Question 645 of 667

645. Question

Category: Federal Requirements: Controlled Substance Rx

A pharmacy technician receives a Schedule II prescription with the quantity written as ’30’ in numerals but no quantity written in words. The state requires both forms. What should the technician do?

Alert the pharmacist that the quantity written does not meet state requirements before dispensing
Correct Incorrect Correct answer

Dispense the prescription since the federal requirement is met
Correct Incorrect Correct answer

Write 'thirty' on the prescription to correct the deficiency
Correct Incorrect Correct answer

Return the prescription to the patient and refuse to process it
Correct Incorrect Correct answer

Correct

Incorrect
Question 646 of 667

646. Question

Category: Federal Requirements: Hazardous Waste Disposal

What is the role of a reverse distributor in pharmacy operations?

A DEA-registered entity that receives controlled substances from pharmacies for destruction
Correct Incorrect Correct answer

A wholesaler that buys back expired medications at a discount
Correct Incorrect Correct answer

A state agency that inspects pharmacy waste disposal practices
Correct Incorrect Correct answer

A courier service that transports hazardous drugs between facilities
Correct Incorrect Correct answer

Correct

Incorrect
Question 647 of 667

647. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy has a large quantity of expired Schedule II medications that need to be destroyed. Which process should the pharmacy follow?

Transfer the medications to an authorized reverse distributor using DEA Form 222
Correct Incorrect Correct answer

Place the medications in the regular pharmacy trash with witness documentation
Correct Incorrect Correct answer

Flush the medications down the drain and document the disposal
Correct Incorrect Correct answer

Return the medications directly to the drug manufacturer without DEA involvement
Correct Incorrect Correct answer

Correct

Incorrect
Question 648 of 667

648. Question

Category: Federal Requirements: Hazardous Waste Disposal

Warfarin is classified by the EPA as which type of hazardous waste?

P-list (acutely hazardous waste)
Correct Incorrect Correct answer

U-list (toxic waste)
Correct Incorrect Correct answer

K-list (source-specific waste)
Correct Incorrect Correct answer

D-list (characteristic waste)
Correct Incorrect Correct answer

Correct

Incorrect
Question 649 of 667

649. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy technician is discarding expired warfarin tablets. How should this waste be handled?

Place in a hazardous waste container designated for P-list acutely hazardous waste
Correct Incorrect Correct answer

Dispose of in the regular pharmaceutical waste container
Correct Incorrect Correct answer

Place in a biohazard sharps container
Correct Incorrect Correct answer

Flush down the pharmacy sink with running water
Correct Incorrect Correct answer

Correct

Incorrect
Question 650 of 667

650. Question

Category: Federal Requirements: Hazardous Waste Disposal

Nicotine products such as patches and gums are classified by the EPA under which hazardous waste listing?

P-list (acutely hazardous waste)
Correct Incorrect Correct answer

U-list (toxic waste)
Correct Incorrect Correct answer

Non-hazardous pharmaceutical waste
Correct Incorrect Correct answer

D-list (characteristic waste)
Correct Incorrect Correct answer

Correct

Incorrect
Question 651 of 667

651. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy receives a return of unused nicotine patches from a long-term care facility. What is the correct disposal method?

Dispose of as P-list acutely hazardous waste in an appropriately labeled container
Correct Incorrect Correct answer

Place in the regular trash since nicotine patches are OTC products
Correct Incorrect Correct answer

Return to the wholesaler for credit without special handling
Correct Incorrect Correct answer

Dispose of in the non-hazardous pharmaceutical waste container
Correct Incorrect Correct answer

Correct

Incorrect
Question 652 of 667

652. Question

Category: Federal Requirements: Hazardous Waste Disposal

Phentermine, a Schedule IV controlled substance used for weight management, is classified by the EPA as which type of hazardous waste?

P-list (acutely hazardous waste)
Correct Incorrect Correct answer

U-list (toxic waste)
Correct Incorrect Correct answer

Non-hazardous controlled substance waste
Correct Incorrect Correct answer

D-list (ignitable waste)
Correct Incorrect Correct answer

Correct

Incorrect
Question 653 of 667

653. Question

Category: Federal Requirements: Hazardous Waste Disposal

A pharmacy is disposing of expired phentermine capsules. Which of the following statements is correct regarding the disposal process?

The disposal must comply with both DEA controlled substance destruction rules and EPA P-list hazardous waste regulations
Correct Incorrect Correct answer

Only DEA regulations apply because phentermine is a controlled substance
Correct Incorrect Correct answer

Only EPA regulations apply because phentermine is a P-list waste
Correct Incorrect Correct answer

The pharmacy may choose to follow either DEA or EPA rules but not both
Correct Incorrect Correct answer

Correct

Incorrect
Question 654 of 667

654. Question

Category: Federal Requirements: Controlled Substance Handling

How often must a pharmacy conduct a biennial inventory of Schedule II controlled substances?

Every 2 years from the date of the initial inventory
Correct Incorrect Correct answer

Every year on January 1
Correct Incorrect Correct answer

Every 6 months from the pharmacy opening date
Correct Incorrect Correct answer

Every 3 years to coincide with DEA registration renewal
Correct Incorrect Correct answer

Correct

Incorrect
Question 655 of 667

655. Question

Category: Federal Requirements: Controlled Substance Handling

During a Schedule II inventory, which counting method is required by the DEA?

An exact physical count of every Schedule II item on hand
Correct Incorrect Correct answer

An estimated count if the container holds fewer than 500 units
Correct Incorrect Correct answer

An estimated count for all schedules including Schedule II
Correct Incorrect Correct answer

A visual inspection confirming the presence of each drug without counting
Correct Incorrect Correct answer

Correct

Incorrect
Question 656 of 667

656. Question

Category: Federal Requirements: Controlled Substance Handling

What does the double lock requirement refer to in the context of Schedule II controlled substance storage?

Two layers of locked security, such as a locked safe inside a locked pharmacy
Correct Incorrect Correct answer

Two pharmacists must each hold a separate key to the controlled substance safe
Correct Incorrect Correct answer

Two copies of every Schedule II prescription must be filed
Correct Incorrect Correct answer

The pharmacy must use both electronic and mechanical locks on the front door
Correct Incorrect Correct answer

Correct

Incorrect
Question 657 of 667

657. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy stores Schedule II controlled substances in a locked safe within a locked pharmacy room. This arrangement satisfies which security concept?

The double lock requirement, providing two layers of physical security for C-II substances
Correct Incorrect Correct answer

The triple redundancy standard required by state boards of pharmacy
Correct Incorrect Correct answer

The DEA Form 222 filing requirement for controlled substance procurement
Correct Incorrect Correct answer

The biennial inventory verification process for Schedule II drugs
Correct Incorrect Correct answer

Correct

Incorrect
Question 658 of 667

658. Question

Category: Federal Requirements: Controlled Substance Handling

When a pharmacy permanently closes, what must be done with the controlled substance inventory?

A complete closing inventory must be conducted and all controlled substances transferred to another DEA registrant or reverse distributor
Correct Incorrect Correct answer

The pharmacy may donate remaining controlled substances to a local hospital without documentation
Correct Incorrect Correct answer

Controlled substances may be discarded in the regular pharmaceutical waste stream
Correct Incorrect Correct answer

The closing inventory is optional if a biennial inventory was completed within the past year
Correct Incorrect Correct answer

Correct

Incorrect
Question 659 of 667

659. Question

Category: Federal Requirements: Controlled Substance Handling

A pharmacy is closing permanently at the end of the month. Which action regarding controlled substances is required?

Perform a closing inventory and arrange transfer of all controlled substances to a DEA-registered entity
Correct Incorrect Correct answer

Notify patients to pick up their controlled substance prescriptions before closing
Correct Incorrect Correct answer

Destroy all controlled substances on-site with two pharmacy staff as witnesses
Correct Incorrect Correct answer

Transfer the DEA registration to the nearest pharmacy in the same chain
Correct Incorrect Correct answer

Correct

Incorrect
Question 660 of 667

660. Question

Category: Federal Requirements: Dea Schedules

Codeine-containing cough suppressant preparations with less than 200 mg of codeine per 100 mL are classified under which DEA schedule?

Schedule V
Correct Incorrect Correct answer

Schedule II
Correct Incorrect Correct answer

Schedule III
Correct Incorrect Correct answer

Schedule IV
Correct Incorrect Correct answer

Correct

Incorrect
Question 661 of 667

661. Question

Category: Federal Requirements: Dea Schedules

A patient requests a cough suppressant containing codeine. The product contains 100 mg of codeine per 100 mL. Under which DEA schedule does this product fall?

Schedule V, because it contains less than 200 mg of codeine per 100 mL
Correct Incorrect Correct answer

Schedule II, because codeine is always a Schedule II substance
Correct Incorrect Correct answer

Schedule III, because it is a codeine combination product
Correct Incorrect Correct answer

Schedule IV, because it is available by prescription only
Correct Incorrect Correct answer

Correct

Incorrect
Question 662 of 667

662. Question

Category: Federal Requirements: Dea Schedules

Robitussin AC, which contains codeine and guaifenesin, is classified under which DEA controlled substance schedule?

Schedule V
Correct Incorrect Correct answer

Schedule II
Correct Incorrect Correct answer

Schedule III
Correct Incorrect Correct answer

Schedule IV
Correct Incorrect Correct answer

Correct

Incorrect
Question 663 of 667

663. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician is shelving a new shipment that includes Robitussin AC. Where should this product be stored?

With other Schedule V controlled substances, as Robitussin AC contains codeine
Correct Incorrect Correct answer

On the OTC shelf with other cough products since it does not require a prescription in every state
Correct Incorrect Correct answer

In the Schedule II safe because it contains an opioid
Correct Incorrect Correct answer

In the non-controlled prescription area since guaifenesin is not controlled
Correct Incorrect Correct answer

Correct

Incorrect
Question 664 of 667

664. Question

Category: Federal Requirements: Dea Schedules

Which DEA schedule includes substances that have no currently accepted medical use in the United States?

Schedule I
Correct Incorrect Correct answer

Schedule II
Correct Incorrect Correct answer

Schedule IV
Correct Incorrect Correct answer

Schedule V
Correct Incorrect Correct answer

Correct

Incorrect
Question 665 of 667

665. Question

Category: Federal Requirements: Dea Schedules

A pharmacy technician student asks why heroin cannot be dispensed by a pharmacy. Which of the following best explains the reason?

Heroin is a Schedule I substance with no currently accepted medical use and cannot be prescribed
Correct Incorrect Correct answer

Heroin is a Schedule II substance that requires a special DEA license to dispense
Correct Incorrect Correct answer

Heroin is not classified under the Controlled Substances Act
Correct Incorrect Correct answer

Heroin requires FDA approval before pharmacies can stock it
Correct Incorrect Correct answer

Correct

Incorrect
Question 666 of 667

666. Question

Category: Federal Requirements: Dea Schedules

Which DEA schedule is defined as having the lowest abuse potential among controlled substances?

Schedule V
Correct Incorrect Correct answer

Schedule III
Correct Incorrect Correct answer

Schedule IV
Correct Incorrect Correct answer

Schedule II
Correct Incorrect Correct answer

Correct

Incorrect
Question 667 of 667

667. Question

Category: Federal Requirements: Dea Schedules

Pregabalin (Lyrica) is classified as Schedule V because it has which characteristic?

Low abuse potential compared to Schedule IV substances
Correct Incorrect Correct answer

High abuse potential with no accepted medical use
Correct Incorrect Correct answer

Moderate abuse potential with risk of severe dependence
Correct Incorrect Correct answer

No abuse potential but requires a prescription for safety reasons
Correct Incorrect Correct answer

Correct

Incorrect

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