MCQ Quiz: Pharmacy Law

A deep understanding of pharmacy law and ethics is the essential framework that governs every aspect of pharmacy practice, ensuring public health and safety. This knowledge, a cornerstone of the Principles of Pharmacy Law and Ethics course “, is a non-negotiable requirement for every pharmacist to practice legally and ethically. This comprehensive quiz will test your knowledge on key federal acts, the roles of regulatory agencies like the FDA, DEA, and State Boards, and the legal requirements for dispensing, counseling, and managing controlled substances.

1. Which federal agency is primarily responsible for enforcing the Controlled Substances Act (CSA)?

• a. The Food and Drug Administration (FDA)
• b. The Centers for Disease Control and Prevention (CDC)
• c. The Drug Enforcement Administration (DEA)
• d. The Federal Trade Commission (FTC)

Answer: c. The Drug Enforcement Administration (DEA)

2. The Durham-Humphrey Amendment of 1951 is most famous for:

• a. Requiring all drugs to be proven effective.
• b. Establishing the two classes of drugs: prescription (legend) and over-the-counter (OTC).
• c. Creating the five schedules for controlled substances.
• d. Mandating child-resistant packaging.

Answer: b. Establishing the two classes of drugs: prescription (legend) and over-the-counter (OTC).

3. The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) established a federal mandate for pharmacists to __________ for Medicaid patients.

• a. perform a prospective drug utilization review and offer to counsel
• b. administer all immunizations
• c. compound all sterile products
• d. provide free medications

Answer: a. perform a prospective drug utilization review and offer to counsel

4. A prescription for oxycodone, a Schedule II medication, can be refilled how many times?

• a. One time
• b. Up to 5 times in 6 months
• c. Zero times
• d. As many times as the prescriber authorizes.

Answer: c. Zero times

5. Which DEA form must a pharmacy use to order Schedule II controlled substances like morphine or methylphenidate?

• a. DEA Form 41
• b. DEA Form 106
• c. DEA Form 222
• d. DEA Form 224

Answer: c. DEA Form 222

6. The “Principles of Pharmacy Law and Ethics” is a core course in the curriculum.

• a. True
• b. False

Answer: a. True

7. The Health Insurance Portability and Accountability Act (HIPAA) primarily governs:

• a. The pricing of medications.
• b. The privacy and security of protected health information (PHI).
• c. The manufacturing of drugs.
• d. The transfer of a pharmacist’s license between states.

Answer: b. The privacy and security of protected health information (PHI).

8. The Kefauver-Harris Amendment of 1962 was passed in response to a tragedy involving thalidomide and required drugs to be proven not only safe but also:

• a. Effective
• b. Inexpensive
• c. Easy to swallow
• d. Palatable

Answer: a. Effective

9. The “scope of practice” for a pharmacist is primarily defined by:

• a. Federal law
• b. The pharmacist’s employer
• c. National pharmacy organizations
• d. State law and the State Board of Pharmacy

Answer: d. State law and the State Board of Pharmacy

10. A pharmacist dispenses a prescription with the wrong directions. Under the Food, Drug, and Cosmetic Act, this product is considered:

• a. Adulterated
• b. A counterfeit
• c. Misbranded
• d. A controlled substance

Answer: c. Misbranded

11. Counseling patients on the appropriate use of medications is a key objective in the IPPE curriculum.

• a. True
• b. False

Answer: a. True

12. A biennial inventory of all controlled substances must be performed every:

• a. 6 months
• b. 1 year
• c. 2 years
• d. 5 years

Answer: c. 2 years

13. Which of the following is a Schedule I controlled substance?

• a. Cocaine
• b. Heroin
• c. Morphine
• d. Diazepam

Answer: b. Heroin

14. A pharmacist’s “corresponding responsibility” is the legal duty to ensure that a(n) _________ prescription is for a legitimate medical purpose.

• a. generic
• b. brand name
• c. compounded
• d. controlled substance

Answer: d. controlled substance

15. A pharmacy must report a significant loss or theft of controlled substances to the DEA using which form?

• a. DEA Form 41
• b. DEA Form 106
• c. DEA Form 222
• d. DEA Form 224

Answer: b. DEA Form 106

16. The Poison Prevention Packaging Act (PPPA) requires most prescription drugs to be dispensed in:

• a. Amber vials
• b. Child-resistant containers
• c. Easy-open containers
• d. Blister packs

Answer: b. Child-resistant containers

17. The new drug approval process is a topic in the Medicinal Chemistry and Pharmacology I course.

• a. True
• b. False

Answer: a. True

18. A prescription for a Schedule III medication like testosterone is valid for how long from the date of issue?

• a. 30 days
• b. 60 days
• c. 6 months
• d. 1 year

Answer: c. 6 months

19. Under HIPAA, a pharmacy can disclose a patient’s PHI without their authorization for TPO. The “T” stands for:

• a. Triage
• b. Transfer
• c. Treatment
• d. Toxicology

Answer: c. Treatment

20. A pharmacist who fails to provide the established standard of care, resulting in patient harm, may be accused of:

• a. Malpractice/Negligence
• b. Libel
• c. Slander
• d. Fraud

Answer: a. Malpractice/Negligence

21. A pharmacy must obtain a new permit from the State Board of Pharmacy if it:

• a. Hires a new technician.
• b. Changes its physical location.
• c. Starts a new marketing campaign.
• d. Changes its hours of operation.

Answer: b. Changes its physical location.

22. An oral prescription from a prescriber is acceptable for which of the following?

• a. A Schedule II medication in a non-emergency situation.
• b. A Schedule III medication.
• c. A Schedule I medication.
• d. None of the above.

Answer: b. A Schedule III medication.

23. The “Introduction to Medication Errors” is a module within the Professional Practice Skills Lab II curriculum.

• a. True
• b. False

Answer: a. True

24. An active learning session on pharmacy law is a key part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

25. A Risk Evaluation and Mitigation Strategy (REMS) is a program required by the ____ for certain drugs with serious safety concerns.

• a. DEA
• b. State Board of Pharmacy
• c. FDA
• d. The Joint Commission

Answer: c. The FDA

26. Which of the following is NOT required on a dispensed prescription label?

• a. The patient’s name
• b. The name and strength of the drug
• c. The patient’s diagnosis
• d. The name and address of the pharmacy

Answer: c. The patient’s diagnosis

27. The pharmacist who is legally responsible for the overall operation of a pharmacy is the:

• a. Staff Pharmacist
• b. Pharmacy Intern
• c. Pharmacy Technician
• d. Pharmacist-in-Charge (PIC)

Answer: d. Pharmacist-in-Charge (PIC)

28. An active learning session on pharmacy law is part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

29. The term “adulteration” refers to a problem with a drug’s:

• a. Labeling or promotion.
• b. Purity, strength, or quality.
• c. Price.
• d. Therapeutic equivalence.

Answer: b. Purity, strength, or quality.

30. The “Principles of Pharmacy Law and Ethics” course provides the knowledge base for the MPJE.

• a. True
• b. False

Answer: a. True

31. A patient can make a blanket request for all of their medications to be in easy-open containers.

• a. True
• b. False

Answer: a. True

32. A pharmacist’s “scope of practice” is determined at the federal level, ensuring uniformity across all states.

• a. True
• b. False

Answer: b. False

33. The transfer of an original prescription for a C-III drug with refills is permissible:

• a. An unlimited number of times.
• b. It is not allowed.
• c. On a one-time basis between two licensed pharmacists.
• d. Only if the patient provides written authorization.

Answer: c. On a one-time basis between two licensed pharmacists.

34. The “closed system” of controlled substance distribution is designed to create an accountability trail to prevent:

• a. High prices
• b. Drug interactions
• c. Diversion
• d. Side effects

Answer: c. Diversion

35. A pharmacist must complete Continuing Pharmacy Education (CPE) hours to:

• a. Get their initial license.
• b. Renew their license.
• c. Be promoted to manager.
• d. Join a professional organization.

Answer: b. Renew their license.

36. A key part of the pharmacist’s role, established by OBRA ’90, is to screen for:

• a. Financial issues
• b. Potential drug therapy problems
• c. The patient’s insurance eligibility
• d. The patient’s literacy level

Answer: b. Potential drug therapy problems

37. Which of the following is an example of misbranding?

• a. A bottle of 100 tablets contains only 98 tablets.
• b. A pharmacist dispenses a refill without authorization from the prescriber.
• c. A drug contains a substance that makes it filthy or putrid.
• d. A drug’s strength is lower than what is stated on the label.

Answer: b. A pharmacist dispenses a refill without authorization from the prescriber.

38. The HIPPE curriculum requires students to adhere to institutional policies and procedures, which are based on laws and regulations.

• a. True
• b. False

Answer: a. True

39. A valid DEA number for Dr. Jane Doe (JD) would have what as the second letter?

• a. A
• b. B
• c. J
• d. D

Answer: d. D

40. An active learning session covering pharmacy law is part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

41. The Food, Drug, and Cosmetic Act of 1938 required that new drugs be proven safe before marketing.

• a. True
• b. False

Answer: a. True

42. Which of the following is NOT one of the four elements of negligence a plaintiff must prove?

• a. Duty
• b. Breach
• c. Malice
• d. Damages

Answer: c. Malice

43. A pharmacist’s professional ethics often require a higher standard of conduct than the minimum required by law.

• a. True
• b. False

Answer: a. True

44. A key responsibility of a Pharmacist-in-Charge (PIC) is to:

• a. Ensure the pharmacy is compliant with all state and federal laws.
• b. Counsel every patient personally.
• c. Compound all sterile products.
• d. Set the prices for OTC products.

Answer: a. Ensure the pharmacy is compliant with all state and federal laws.

45. A patient’s right to privacy regarding their health information is protected by:

• a. The Controlled Substances Act
• b. HIPAA
• c. OBRA ’90
• d. The PPPA

Answer: b. HIPAA

46. A prescription for a C-II medication for a patient in a long-term care facility can be partially filled for up to:

• a. 72 hours
• b. 30 days
• c. 60 days
• d. 6 months

Answer: c. 60 days

47. The curriculum includes a dedicated course on Pharmacy Law and Ethics.

• a. True
• b. False

Answer: a. True

48. An active learning session on pharmacy law is part of which course module?

• a. The PHA5703 course itself.
• b. The Diabetes Mellitus Module
• c. The Women’s Health Module
• d. The Geriatrics Module

Answer: a. The PHA5703 course itself.

49. The overall purpose of pharmacy law is to:

• a. Make the practice of pharmacy difficult and complex.
• b. Protect the health and safety of the public.
• c. Ensure pharmacists are well-paid.
• d. Increase the profits of pharmaceutical companies.

Answer: b. Protect the health and safety of the public.

50. The ultimate reason to master pharmacy law is to:

• a. Be able to practice pharmacy legally, ethically, and competently.
• b. Pass the MPJE.
• c. Avoid disciplinary action from the Board of Pharmacy.
• d. All of the above.

Answer: d. All of the above.