MPJE MPJE Federal Food, Drug, and Cosmetic Act Questions and Answers 2 — Questions and Answers
Question 1: Under the FD&C Act, which of the following is the correct definition of 'adulterated' as applied to a drug?
- The drug's labeling is false or misleading
- The drug contains a filthy or decomposed substance rendering it unfit for use (Correct answer)
- The drug is sold without a valid prescription
- The drug's expiration date has passed
Correct answer: The drug contains a filthy or decomposed substance rendering it unfit for use
Under the FD&C Act, a drug is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it has been prepared under unsanitary conditions.
Question 2: Which federal agency is responsible for enforcing the Federal Food, Drug, and Cosmetic Act?
- Drug Enforcement Administration (DEA)
- Federal Trade Commission (FTC)
- Food and Drug Administration (FDA) (Correct answer)
- Consumer Product Safety Commission (CPSC)
Correct answer: Food and Drug Administration (FDA)
The FDA is the federal agency charged with enforcing the FD&C Act, overseeing the safety and effectiveness of drugs, biologics, medical devices, and food.
Question 3: A drug is considered 'misbranded' under the FD&C Act if:
- It lacks adequate directions for use (Correct answer)
- It is manufactured in a state-licensed facility
- It contains only GRAS (generally recognized as safe) ingredients
- It was approved via the 505(b)(2) pathway
Correct answer: It lacks adequate directions for use
A drug is misbranded if its labeling is false or misleading, or if it lacks adequate directions for use, among other labeling deficiencies listed in the FD&C Act.
Question 4: Under the FD&C Act, the 'substantial evidence' standard for drug approval requires:
- One well-controlled clinical investigation plus confirmatory evidence (Correct answer)
- Anecdotal reports from at least 10 licensed physicians
- Sales data demonstrating consumer acceptance
- A single published peer-reviewed study
Correct answer: One well-controlled clinical investigation plus confirmatory evidence
The FD&C Act requires substantial evidence of effectiveness, typically consisting of adequate and well-controlled investigations, which the FDA generally interprets as at least two pivotal trials.
Question 5: What is the purpose of a 'black box warning' (boxed warning) on a drug's labeling under FDA regulations implementing the FD&C Act?
- To indicate the drug is available only as a generic
- To highlight serious or life-threatening adverse reactions or restrictions (Correct answer)
- To signal that the drug requires refrigerated storage
- To denote that the drug is available over the counter
Correct answer: To highlight serious or life-threatening adverse reactions or restrictions
A boxed warning is the FDA's strongest warning label, used when a drug carries a significant risk of serious or life-threatening adverse effects that must be prominently communicated.
Question 6: Under the FD&C Act, which of the following is required on the labeling of all prescription drug products?
- A QR code linking to the manufacturer's website
- The statement 'Rx only' (or 'Caution: Federal law prohibits dispensing without a prescription') (Correct answer)
- The National Drug Code (NDC) in barcode format only
- The retail price suggested by the manufacturer
Correct answer: The statement 'Rx only' (or 'Caution: Federal law prohibits dispensing without a prescription')
Federal law requires prescription drug labeling to bear the statement 'Rx only,' indicating that the drug may only be dispensed pursuant to a valid prescription.
MPJE MPJE Federal Food, Drug, and Cosmetic Act Questions and Answers 2
Under the FD&C Act, which of the following is the correct definition of 'adulterated' as applied to a drug?