MCQ Quiz-Regulation

MCQ Quiz: Regulation

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Pharmacy is one of the most highly regulated professions, with a complex web of federal and state laws designed to protect public health. For PharmD students, a thorough understanding of these regulations—from the FDA’s drug approval process to the DEA’s rules for controlled substances and state board requirements—is non-negotiable for compliant and ethical practice. This quiz will test your knowledge of the key agencies, landmark acts, and practice-level rules that govern the pharmacy profession.

1. Which federal agency is primarily responsible for approving new drugs for the market and ensuring their safety and efficacy?

  • The Drug Enforcement Administration (DEA)
  • The Centers for Medicare & Medicaid Services (CMS)
  • The Food and Drug Administration (FDA)
  • The Environmental Protection Agency (EPA)

Answer: The Food and Drug Administration (FDA)

2. The Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act is most famous for:

  • Requiring all drugs to be proven effective.
  • Establishing the two classes of drugs: prescription and over-the-counter.
  • Creating the schedule for controlled substances.
  • Mandating child-resistant packaging.

Answer: Establishing the two classes of drugs: prescription and over-the-counter.

3. The Drug Enforcement Administration (DEA) is primarily responsible for regulating:

  • The advertising of prescription drugs.
  • The manufacturing and distribution of controlled substances.
  • The price of medications.
  • The standards for sterile compounding.

Answer: The manufacturing and distribution of controlled substances.

4. A prescription for which of the following controlled substance schedules cannot be refilled?

  • Schedule II
  • Schedule III
  • Schedule IV
  • Schedule V

Answer: Schedule II

5. Which official form is required for a pharmacy to order Schedule II controlled substances?

  • FDA Form 3500 (MedWatch)
  • DEA Form 41 (Destruction of Controlled Substances)
  • DEA Form 106 (Theft or Loss of Controlled Substances)
  • DEA Form 222

Answer: DEA Form 222

6. The Kefauver-Harris Amendment of 1962 was enacted to require that drug manufacturers prove not only the safety of a drug but also its:

  • Affordability
  • Efficacy
  • Popularity
  • Bioequivalence

Answer: Efficacy

7. In the state of Florida, the entity responsible for the licensure, monitoring, and regulation of pharmacists and pharmacies is the:

  • Florida Pharmacy Association
  • Florida Department of Health
  • Florida Board of Pharmacy
  • Governor of Florida

Answer: Florida Board of Pharmacy

8. The Health Insurance Portability and Accountability Act (HIPAA) established federal regulations to protect the privacy and security of:

  • Financial records.
  • Patient health information.
  • Pharmacy inventory records.
  • Drug manufacturing trade secrets.

Answer: Patient health information.

9. Regulations and standards for non-sterile compounding are primarily outlined in which USP Chapter?

  • USP <797>
  • USP <800>
  • USP <795>
  • USP <1>

Answer: USP <795>

10. USP Chapter <797> provides regulations and standards specifically for:

  • Handling hazardous drugs.
  • Sterile compounding.
  • Labeling of OTC products.
  • Reporting adverse drug events.

Answer: Sterile compounding.

11. The regulations stemming from the Belmont Report govern:

  • The pricing of medications.
  • The ethical conduct of research involving human subjects.
  • The disposal of hazardous waste.
  • The advertising of prescription drugs.

Answer: The ethical conduct of research involving human subjects.

12. An Institutional Review Board (IRB) is a committee regulated to:

  • Manage a hospital’s formulary.
  • Review and approve research protocols to ensure they are ethically sound.
  • Investigate drug diversion within a pharmacy.
  • Set the salaries for university researchers.

Answer: Review and approve research protocols to ensure they are ethically sound.

13. The requirement that a pharmacist must offer to counsel Medicaid patients stems from which piece of legislation?

  • HIPAA
  • The Controlled Substances Act
  • OBRA ’90
  • The Pure Food and Drug Act of 1906

Answer: OBRA ’90

14. A drug that is decomposed or contains a filthy substance is considered to be:

  • Misbranded
  • Adulterated
  • A controlled substance
  • A generic equivalent

Answer: Adulterated

15. A drug whose labeling is false or misleading in any particular is considered to be:

  • Misbranded
  • Adulterated
  • An orphan drug
  • A REMS drug

Answer: Misbranded

16. The Poison Prevention Packaging Act (PPPA) regulates the use of:

  • Tamper-evident seals on OTC products.
  • Child-resistant packaging for most oral prescription drugs.
  • Amber vials to protect from light.
  • Auxiliary warning labels.

Answer: Child-resistant packaging for most oral prescription drugs.

17. The primary purpose of a state’s Prescription Drug Monitoring Program (PDMP) is to:

  • Allow patients to order refills online.
  • Track the prescribing and dispensing of controlled substances to prevent misuse and diversion.
  • Provide drug information to pharmacists.
  • Help patients find the lowest price for their medication.

Answer: Track the prescribing and dispensing of controlled substances to prevent misuse and diversion.

18. Regulations regarding the pharmacist-to-technician ratio are determined by the:

  • DEA
  • FDA
  • Individual state boards of pharmacy.
  • The pharmacy manager.

Answer: Individual state boards of pharmacy.

19. A Risk Evaluation and Mitigation Strategy (REMS) is a specific safety program for certain drugs that is required by the:

  • DEA
  • FDA
  • CMS
  • The Joint Commission

Answer: FDA

20. According to federal regulations, a prescription for a C-III or C-IV medication may be refilled:

  • Indefinitely.
  • Up to 5 times within 6 months of the date of issue.
  • Only once.
  • It cannot be refilled.

Answer: Up to 5 times within 6 months of the date of issue.

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

  • Their employer’s policies and procedures.
  • Federal law only.
  • State laws and regulations.
  • The pharmacist’s personal comfort level.

Answer: State laws and regulations.

22. Which law created the Abbreviated New Drug Application (ANDA) process, streamlining the approval of generic drugs?

  • The Orphan Drug Act
  • The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)
  • The Prescription Drug Marketing Act
  • The Food and Drug Administration Modernization Act

Answer: The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)

23. Under federal law, which of the following is an example of a Schedule I controlled substance?

  • Cocaine
  • Morphine
  • Heroin
  • Diazepam

Answer: Heroin

24. The FDA’s “Orange Book” is a publication used to find:

  • Information on sterile compounding.
  • The latest clinical guidelines.
  • Therapeutic equivalence evaluations for generic drugs.
  • A list of all drugs currently in clinical trials.

Answer: Therapeutic equivalence evaluations for generic drugs.

25. A collaborative practice agreement is a regulatory mechanism that allows a pharmacist to:

  • Perform specific patient care functions under a protocol with a collaborating physician.
  • Supervise more technicians than the state ratio allows.
  • Waive copayments for patients.
  • Own a medical practice.

Answer: Perform specific patient care functions under a protocol with a collaborating physician.

26. The regulations governing Medication Therapy Management (MTM) programs for Medicare Part D beneficiaries are set by:

  • The DEA
  • The FDA
  • The Centers for Medicare & Medicaid Services (CMS)
  • State Boards of Pharmacy

Answer: The Centers for Medicare & Medicaid Services (CMS)

27. USP Chapter <800> provides regulatory standards for:

  • Patient counseling.
  • The safe handling of hazardous drugs in healthcare settings.
  • Pharmacy ethics.
  • Reporting medication errors.

Answer: The safe handling of hazardous drugs in healthcare settings.

28. An “informed consent” document is a key regulatory requirement in:

  • The dispensing of all OTC medications.
  • The process of compounding a non-sterile product.
  • All research studies involving human subjects.
  • Ordering C-II controlled substances.

Answer: All research studies involving human subjects.

29. The Prescription Drug Marketing Act (PDMA) was passed to regulate:

  • The prices of prescription drugs.
  • The advertising of drugs to consumers.
  • The handling and distribution of prescription drug samples and to prevent resale of discounted drugs.
  • The importation of drugs from Canada.

Answer: The handling and distribution of prescription drug samples and to prevent resale of discounted drugs.

30. Which regulatory body accredits and certifies healthcare organizations, including hospitals, and sets standards for medication safety (e.g., National Patient Safety Goals)?

  • The FDA
  • The Joint Commission
  • The DEA
  • The State Board of Pharmacy

Answer: The Joint Commission

31. Under the Controlled Substances Act, a drug’s schedule is based on its:

  • Price and availability.
  • Accepted medical use and its potential for abuse and dependence.
  • Chemical structure.
  • Manufacturer’s preference.

Answer: Accepted medical use and its potential for abuse and dependence.

32. The “beyond-use date” (BUD) on a compounded prescription is a regulatory standard that indicates:

  • The date after which the manufacturer’s product expires.
  • The date after which a compounded preparation should not be used.
  • The date the prescription was written.
  • The date the pharmacy’s permit expires.

Answer: The date after which a compounded preparation should not be used.

33. Federal regulation requires which of the following information to be on a prescription label?

  • The patient’s diagnosis.
  • The name and address of the pharmacy.
  • The cost of the medication.
  • The name of the patient’s insurance company.

Answer: The name and address of the pharmacy.

34. The main purpose of Continuous Quality Improvement (CQI) regulations for pharmacies is to:

  • Punish pharmacists for making errors.
  • Provide a systematic process for reviewing medication errors to improve patient safety.
  • Increase pharmacy profits.
  • Standardize the layout of all pharmacies.

Answer: Provide a systematic process for reviewing medication errors to improve patient safety.

35. Under federal law, what is required for a faxed prescription for a Schedule II medication to serve as the original prescription?

  • The patient is in a long-term care facility or hospice care.
  • The prescription is for any patient, as long as the pharmacy calls to verify.
  • It is never permitted.
  • The prescriber also mails a hard copy within 24 hours.

Answer: The patient is in a long-term care facility or hospice care.

36. A key regulation established by the Nuremberg Code for human research is:

  • The requirement for an Institutional Review Board (IRB).
  • The absolute requirement for voluntary consent of the subject.
  • The need for government funding.
  • The mandate to publish all results.

Answer: The absolute requirement for voluntary consent of the subject.

37. Which agency would regulate a new monoclonal antibody drug product?

  • The DEA
  • The FDA
  • CMS
  • The FTC

Answer: The FDA

38. The FDA’s MedWatch program is a system for:

  • Reporting adverse drug events and medication errors.
  • Tracking the inventory of controlled substances.
  • Approving new drug applications.
  • Monitoring the financial status of drug companies.

Answer: Reporting adverse drug events and medication errors.

39. Regulations related to pharmacy permits and licensure are primarily handled at the:

  • Federal level by the FDA.
  • State level by the Board of Pharmacy.
  • County level by the local health department.
  • National level by professional organizations.

Answer: State level by the Board of Pharmacy.

40. A “legend” drug is another term for a(n):

  • Over-the-counter medication.
  • Prescription medication.
  • Orphan drug.
  • Controlled substance.

Answer: Prescription medication.

41. The FDA’s regulation of dietary supplements is:

  • The same as its regulation of prescription drugs, requiring proof of efficacy before marketing.
  • More stringent than its regulation of prescription drugs.
  • Less stringent than for prescription drugs; manufacturers are responsible for ensuring safety, but do not have to prove efficacy before marketing.
  • Handled by the Department of Agriculture.

Answer: Less stringent than for prescription drugs; manufacturers are responsible for ensuring safety, but do not have to prove efficacy before marketing.

42. Which piece of information is required on a prescription for a controlled substance that is not always required for a non-controlled substance?

  • The patient’s address.
  • The prescriber’s DEA number.
  • The pharmacy’s address.
  • The date the prescription was filled.

Answer: The prescriber’s DEA number.

43. The primary goal of most pharmacy regulations is to:

  • Increase the administrative burden on pharmacists.
  • Protect the public health.
  • Generate revenue for the state.
  • Limit patient access to medications.

Answer: Protect the public health.

44. A pharmacist’s failure to adhere to state or federal regulations can result in:

  • Disciplinary action from the Board of Pharmacy, including fines or license suspension.
  • A promotion at work.
  • An award from a professional organization.
  • No consequences.

Answer: Disciplinary action from the Board of Pharmacy, including fines or license suspension.

45. What does the term “drug labeling” encompass, according to FDA regulations?

  • Only the sticker placed on the prescription vial.
  • The label on the container, the package insert, and any Medication Guides.
  • Only the information printed on the manufacturer’s stock bottle.
  • The advertising materials for the drug.

Answer: The label on the container, the package insert, and any Medication Guides.

46. The regulation of pharmacist-administered immunizations, including which vaccines can be given, is typically determined by:

  • The vaccine manufacturer.
  • The CDC’s recommendations.
  • State law and Board of Pharmacy rules.
  • The patient’s insurance company.

Answer: State law and Board of Pharmacy rules.

47. A “black box warning” is the most serious warning required by which regulatory agency?

  • DEA
  • FDA
  • CMS
  • USP

Answer: FDA

48. An example of a quality metric that is regulated and publicly reported for Medicare Part D plans is:

  • The pharmacy’s hours of operation.
  • The number of pharmacists on staff.
  • Patient medication adherence rates for certain chronic conditions.
  • The brand of computer system used by the pharmacy.

Answer: Patient medication adherence rates for certain chronic conditions.

49. The Orphan Drug Act of 1983 provides regulatory incentives for the development of drugs for:

  • Common conditions like hypertension.
  • Pediatric patients.
  • Geriatric patients.
  • Rare diseases.

Answer: Rare diseases.

50. Staying up-to-date on changes in pharmacy law and regulation is:

  • Optional for licensed pharmacists.
  • A core component of maintaining professional competence and ensuring compliant practice.
  • Only necessary for pharmacy managers.
  • The sole responsibility of the state board of pharmacy.

Answer: A core component of maintaining professional competence and ensuring compliant practice.

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