MCQ Quiz: Food, Drug, and Cosmetic Act

MCQ Quiz: Food, Drug, and Cosmetic Act

The Federal Food, Drug, and Cosmetic Act (FDCA) is a critical piece of legislation that forms the backbone of drug regulation in the United States, directly impacting pharmacy practice and the responsibilities of pharmacists. Understanding the FDCA and its numerous amendments is essential for PharmD students to ensure they can navigate the complex legal landscape surrounding medications, devices, and cosmetics. This Act governs everything from drug approval and manufacturing to labeling, marketing, and dispensing. This quiz will test your knowledge on the historical context, key provisions, definitions, and significant amendments related to the Food, Drug, and Cosmetic Act.

1. The Pure Food and Drug Act of 1906 was primarily enacted to:

• a) Ensure all drugs were proven effective.
• b) Prevent the manufacture, sale, or transportation of adulterated or misbranded foods and drugs.
• c) Establish the Food and Drug Administration (FDA).
• d) Create two classes of drugs: prescription and over-the-counter.

Answer: b) Prevent the manufacture, sale, or transportation of adulterated or misbranded foods and drugs.

2. The Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 was passed largely in response to which public health tragedy?

• a) The thalidomide disaster.
• b) The sulfanilamide elixir tragedy.
• c) The smallpox epidemic.
• d) Contamination of polio vaccines.

Answer: b) The sulfanilamide elixir tragedy.

3. A key requirement introduced by the FDCA of 1938 was that new drugs had to be proven:

• a) Effective for their intended use.
• b) Safe for use under the conditions prescribed, recommended, or suggested in the labeling.
• c) Affordable.
• d) Non-addictive.

Answer: b) Safe for use under the conditions prescribed, recommended, or suggested in the labeling.

4. Under the FDCA, an “adulterated” drug refers to one that:

• a) Makes false or misleading claims on its label.
• b) Is manufactured under conditions that do not conform to Current Good Manufacturing Practices (CGMP).
• c) Is not listed in the United States Pharmacopeia (USP).
• d) Is sold without a prescription.

Answer: b) Is manufactured under conditions that do not conform to Current Good Manufacturing Practices (CGMP).

5. A “misbranded” drug under the FDCA is one whose:

• a) Strength differs from, or its quality or purity falls below the standard set forth in an official compendium.
• b) Labeling is false or misleading in any particular.
• c) Container is composed of a poisonous substance.
• d) Manufacturing facility is not registered with the FDA.

Answer: b) Labeling is false or misleading in any particular.

6. The Durham-Humphrey Amendment of 1951 to the FDCA is most notable for:

• a) Requiring drugs to be proven effective.
• b) Establishing two classes of drugs: prescription (legend) and over-the-counter (OTC).
• c) Mandating child-resistant packaging.
• d) Regulating dietary supplements.

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

7. The Kefauver-Harris Amendment of 1962 required that new drugs be proven:

• a) Only safe.
• b) Both safe and effective for their intended use.
• c) Only effective.
• d) Less expensive than existing therapies.

Answer: b) Both safe and effective for their intended use.

8. Which of the following is a requirement for the label of a prescription drug dispensed to a patient?

• a) The chemical structure of the drug.
• b) The name and address of the dispenser.
• c) The manufacturer’s batch number.
• d) The wholesale acquisition cost.

Answer: b) The name and address of the dispenser.

9. The term “labeling” under the FDCA is broader than just the physical label on the immediate container and includes:

• a) Only advertisements in medical journals.
• b) All labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.
• c) Verbal statements made by a pharmacist.
• d) The color and shape of the dosage form.

Answer: b) All labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.

10. The FDA Modernization Act of 1997 (FDAMA) included provisions for:

• a) Banning all direct-to-consumer advertising.
• b) Streamlining the drug approval process and codifying the FDA’s mission.
• c) Removing the requirement for proving drug efficacy.
• d) Establishing the Drug Enforcement Administration (DEA).

Answer: b) Streamlining the drug approval process and codifying the FDA’s mission.

11. The FDA Amendments Act of 2007 (FDAAA) granted the FDA authority to:

• a) Control drug prices.
• b) Require Risk Evaluation and Mitigation Strategies (REMS) for certain drugs.
• c) Eliminate post-marketing surveillance.
• d) Approve generic drugs without bioavailability studies.

Answer: b) Require Risk Evaluation and Mitigation Strategies (REMS) for certain drugs.

12. The Orphan Drug Act of 1983 was designed to:

• a) Provide tax incentives and exclusive marketing rights to manufacturers developing drugs for rare diseases or conditions.
• b) Regulate drugs that have been abandoned by their original manufacturer.
• c) Ensure all children have access to necessary medications.
• d) Control the distribution of opioids.

Answer: a) Provide tax incentives and exclusive marketing rights to manufacturers developing drugs for rare diseases or conditions.

13. The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) aimed to:

• a) Increase the patent life for all new drugs.
• b) Make it easier for generic drugs to get FDA approval by creating the Abbreviated New Drug Application (ANDA) process.
• c) Eliminate competition from generic drug manufacturers.
• d) Set a national price cap for prescription medications.

Answer: b) Make it easier for generic drugs to get FDA approval by creating the Abbreviated New Drug Application (ANDA) process.

14. The Prescription Drug Marketing Act of 1987 (PDMA) was enacted to:

• a) Encourage direct-to-consumer advertising of prescription drugs.
• b) Prevent the sale of counterfeit, adulterated, misbranded, subpotent, or expired prescription drugs by regulating drug samples and resale.
• c) Allow pharmacies to import drugs from any country.
• d) Eliminate the need for prescriptions for certain medications.

Answer: b) Prevent the sale of counterfeit, adulterated, misbranded, subpotent, or expired prescription drugs by regulating drug samples and resale.

15. The Prescription Drug User Fee Act (PDUFA) allows the FDA to:

• a) Collect fees from drug manufacturers to fund the new drug approval process.
• b) Set the price of prescription drugs.
• c) Market prescription drugs directly to consumers.
• d) Waive efficacy requirements for certain drugs.

Answer: a) Collect fees from drug manufacturers to fund the new drug approval process.

16. Under the FDCA, a “drug” is defined, in part, as an article intended for use in the:

• a) Diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.
• b) Normal functioning of the body, not related to disease.
• c) Enhancement of athletic performance only.
• d) Cosmetic alteration of appearance.

Answer: a) Diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

17. A “dietary supplement” is regulated by the FDA primarily under which act?

• a) The Kefauver-Harris Amendment.
• b) The Dietary Supplement Health and Education Act of 1994 (DSHEA).
• c) The Poison Prevention Packaging Act.
• d) The Controlled Substances Act.

Answer: b) The Dietary Supplement Health and Education Act of 1994 (DSHEA).

18. What is a key difference in how drugs and dietary supplements are regulated regarding pre-market approval?

• a) Dietary supplements require more rigorous pre-market approval for safety and efficacy than drugs.
• b) Drugs require pre-market approval by the FDA for safety and efficacy; dietary supplements generally do not.
• c) Neither drugs nor dietary supplements require pre-market approval.
• d) Only generic drugs require pre-market approval.

Answer: b) Drugs require pre-market approval by the FDA for safety and efficacy; dietary supplements generally do not.

19. A “device” under the FDCA is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article intended to affect the structure or any function of the body, which does NOT achieve its primary intended purposes through:

• a) Mechanical action.
• b) Chemical action within or on the body or by being metabolized.
• c) Physical force.
• d) Electrical energy.

Answer: b) Chemical action within or on the body or by being metabolized.

20. A “cosmetic” under the FDCA is defined as an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for:

• a) Treating a skin disease.
• b) Cleansing, beautifying, promoting attractiveness, or altering the appearance.
• c) Preventing pregnancy.
• d) Affecting the structure or function of the body.

Answer: b) Cleansing, beautifying, promoting attractiveness, or altering the appearance.

21. If a drug’s strength is lower than what is stated on its label, it would be considered:

• a) Only misbranded.
• b) Only adulterated.
• c) Both adulterated and misbranded.
• d) Neither adulterated nor misbranded if the patient is informed.

Answer: c) Both adulterated and misbranded.

22. The statement “Rx only” on a drug label indicates that the drug:

• a) Is an over-the-counter medication.
• b) Is a prescription drug.
• c) Is a controlled substance.
• d) Has a black box warning.

Answer: b) Is a prescription drug.

23. A Black Box Warning in a drug’s labeling is used to call attention to:

• a) Common, mild side effects.
• b) Serious or life-threatening adverse reactions.
• c) The drug’s mechanism of action.
• d) The expiration date.

Answer: b) Serious or life-threatening adverse reactions.

24. Pregnancy warnings in drug labeling (e.g., the previous A, B, C, D, X categories, now the Pregnancy and Lactation Labeling Rule) are intended to:

• a) Help prescribers assess the risk versus benefit of using a drug during pregnancy and lactation.
• b) Guarantee the safety of the drug for pregnant women.
• c) Indicate that the drug is also approved for pediatric use.
• d) Restrict the sale of the drug to women of childbearing age.

Answer: a) Help prescribers assess the risk versus benefit of using a drug during pregnancy and lactation.

25. A drug recall initiated by a manufacturer or the FDA because a product poses a serious health hazard or risk of death is classified as a:

• a) Class I recall.
• b) Class II recall.
• c) Class III recall.
• d) Market withdrawal.

Answer: a) Class I recall.

26. Current Good Manufacturing Practices (CGMPs) are regulations established by the FDA to ensure:

• a) Drugs are sold at the lowest possible price.
• b) The identity, strength, quality, and purity of drug products.
• c) Pharmacists counsel all patients.
• d) All drugs are covered by insurance.

Answer: b) The identity, strength, quality, and purity of drug products.

27. If a pharmacy dispenses a medication after its expiration date, this could be considered dispensing an:

• a) Investigational drug.
• b) Adulterated drug.
• c) OTC drug without consultation.
• d) Off-label use.

Answer: b) Adulterated drug.

28. Which agency is primarily responsible for enforcing the FDCA?

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

Answer: c) The Food and Drug Administration (FDA).

29. The Poison Prevention Packaging Act (PPPA) requires child-resistant packaging for most:

• a) Cosmetics.
• b) Prescription drugs and certain OTC products.
• c) Medical devices.
• d) Dietary supplements.

Answer: b) Prescription drugs and certain OTC products.

30. A pharmacist can dispense a prescription medication in non-child-resistant packaging if:

• a) The drug is an over-the-counter product.
• b) The patient or prescriber requests it.
• c) The pharmacy is out of child-resistant containers.
• d) The drug is a liquid.

Answer: b) The patient or prescriber requests it.

31. “Off-label use” of a medication refers to:

• a) Using a drug for an indication not approved by the FDA.
• b) Dispensing a drug without a valid prescription.
• c) Selling a drug that has been recalled.
• d) Using a counterfeit drug.

Answer: a) Using a drug for an indication not approved by the FDA.

32. While prescribers may prescribe drugs for off-label uses, manufacturers are generally prohibited by the FDCA from:

• a) Studying drugs for new indications.
• b) Marketing or promoting their drugs for unapproved (off-label) uses.
• c) Providing any information about off-label uses to prescribers.
• d) Manufacturing drugs that have known off-label uses.

Answer: b) Marketing or promoting their drugs for unapproved (off-label) uses.

33. The term “New Drug Application” (NDA) refers to the process by which a manufacturer:

• a) Applies for a patent for a new drug.
• b) Seeks FDA approval to market a new drug.
• c) Registers a new pharmacy.
• d) Reports an adverse drug event.

Answer: b) Seeks FDA approval to market a new drug.

34. An “Abbreviated New Drug Application” (ANDA) is typically submitted for approval of a:

• a) New chemical entity.
• b) Generic drug product.
• c) Medical device.
• d) Dietary supplement.

Answer: b) Generic drug product.

35. To gain approval for an ANDA, a generic drug manufacturer must primarily demonstrate:

• a) That the generic drug is safer than the brand-name drug.
• b) Bioequivalence to the brand-name (innovator) drug.
• c) That the generic drug has a novel mechanism of action.
• d) Superior efficacy compared to the brand-name drug.

Answer: b) Bioequivalence to the brand-name (innovator) drug.

36. The main purpose of post-marketing surveillance by the FDA is to:

• a) Set the price of newly approved drugs.
• b) Monitor the ongoing safety and effectiveness of drugs once they are on the market.
• c) Control the advertising of drugs.
• d) Approve new indications for existing drugs.

Answer: b) Monitor the ongoing safety and effectiveness of drugs once they are on the market.

37. If a food product’s label fails to declare a major allergen as required by law, it would be considered:

• a) Adulterated.
• b) Misbranded.
• c) A device.
• d) An orphan product.

Answer: b) Misbranded.

38. The FDCA gives the FDA authority to regulate the labeling of:

• a) Foods, drugs, and cosmetics.
• b) Only prescription drugs.
• c) Only imported goods.
• d) Alcoholic beverages.

Answer: a) Foods, drugs, and cosmetics.

39. If a drug is packed under insanitary conditions whereby it may have been contaminated with filth, it is considered:

• a) Misbranded
• b) Adulterated
• c) A counterfeit drug
• d) An investigational drug

Answer: b) Adulterated

40. A drug that is sold under the name of another drug would be considered:

• a) Adulterated
• b) Misbranded
• c) Both adulterated and misbranded
• d) A generic equivalent

Answer: c) Both adulterated and misbranded

41. The FDCA requires that the labeling of OTC drugs contains:

• a) The pharmacist’s contact information.
• b) “Adequate directions for use” for the layperson.
• c) The patent number.
• d) A statement that it is not FDA approved.

Answer: b) “Adequate directions for use” for the layperson.

42. Which of the following is NOT a prohibited act under the FDCA?

• a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.
• b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.
• c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
• d) Prescribing an FDA-approved drug for an unapproved (off-label) use in accordance with professional judgment.

Answer: d) Prescribing an FDA-approved drug for an unapproved (off-label) use in accordance with professional judgment.

43. The development of a Risk Evaluation and Mitigation Strategy (REMS) program for a drug might be required if the FDA determines that:

• a) The drug is not effective.
• b) The drug has serious safety concerns that necessitate measures beyond routine labeling to ensure benefits outweigh risks.
• c) The drug is too expensive.
• d) A generic version is about to be launched.

Answer: b) The drug has serious safety concerns that necessitate measures beyond routine labeling to ensure benefits outweigh risks.

44. Who has the primary responsibility for determining if a drug is safe and effective before it can be marketed in the U.S.?

• a) The drug manufacturer.
• b) The Food and Drug Administration (FDA).
• c) The United States Pharmacopeia (USP).
• d) The National Institutes of Health (NIH).

Answer: b) The Food and Drug Administration (FDA).

45. If a pharmacy repackages OTC products for sale, the repackaged product must comply with:

• a) Only state labeling laws.
• b) FDCA labeling requirements for OTC drugs.
• c) Prescription drug labeling requirements.
• d) No specific labeling requirements if it’s an OTC product.

Answer: b) FDCA labeling requirements for OTC drugs.

46. The “Beyond Use Date” (BUD) on a compounded prescription is determined based on:

• a) The manufacturer’s original expiration date only.
• b) Stability and sterility considerations for the specific compounded preparation, often guided by USP standards.
• c) The date the patient picks up the prescription.
• d) The pharmacy’s software default.

Answer: b) Stability and sterility considerations for the specific compounded preparation, often guided by USP standards.

47. The FDCA prohibits the introduction into interstate commerce of any new drug unless:

• a) It has been on the market in another country for at least 5 years.
• b) An approval of an application filed pursuant to the act is effective with respect to such drug.
• c) It is a natural product.
• d) The manufacturer has conducted at least one clinical trial.

Answer: b) An approval of an application filed pursuant to the act is effective with respect to such drug.

48. A drug manufactured in a facility not registered with the FDA and not inspected as required would likely be considered:

• a) Misbranded
• b) Adulterated
• c) An orphan drug
• d) A dietary supplement

Answer: b) Adulterated

49. What is the significance of the United States Pharmacopeia (USP) and National Formulary (NF) in relation to the FDCA?

• a) They are government agencies that approve drugs.
• b) They are official compendia recognized by the FDCA, and drugs recognized in them must meet their standards for strength, quality, and purity unless plainly stated otherwise.
• c) They primarily publish information for consumers.
• d) Their standards are voluntary and not enforced by the FDA.

Answer: b) They are official compendia recognized by the FDCA, and drugs recognized in them must meet their standards for strength, quality, and purity unless plainly stated otherwise.

50. The overall intent of the Food, Drug, and Cosmetic Act and its amendments is to:

• a) Promote the pharmaceutical industry.
• b) Protect and promote public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
• c) Ensure all Americans have health insurance.
• d) Control the cost of medications.

Answer: b) Protect and promote public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.