MPJE Federal Food, Drug, and Cosmetic Act 2 — Questions and Answers
Question 1: Under the FD&C Act, which agency has primary authority to regulate prescription drug advertising?
- FDA Office of Prescription Drug Promotion (OPDP) (Correct answer)
- Federal Trade Commission (FTC)
- Drug Enforcement Administration (DEA)
- Centers for Medicare & Medicaid Services (CMS)
Correct answer: FDA Office of Prescription Drug Promotion (OPDP)
FDA's OPDP regulates prescription drug advertising under the FD&C Act, while FTC oversees OTC drug advertising.
Question 2: Which FD&C Act provision requires that drug labeling contain adequate directions for use?
- Section 502(f) (Correct answer)
- Section 503(b)
- Section 505(a)
- Section 510(k)
Correct answer: Section 502(f)
Section 502(f) of the FD&C Act deems a drug misbranded if labeling does not bear adequate directions for use.
Question 3: A drug product is recalled because it was found to contain glass particles. This is classified as a Class __ recall by FDA.
- Class I (Correct answer)
- Class II
- Class III
- Class IV
Correct answer: Class I
Class I recall involves a situation where use of or exposure to the product will cause serious adverse health consequences or death.
Question 4: Under the FD&C Act, what is the maximum penalty for a first-offense misdemeanor violation?
- 1 year imprisonment and/or $1,000 fine (Correct answer)
- 3 years imprisonment and/or $10,000 fine
- 5 years imprisonment and/or $50,000 fine
- 10 years imprisonment and/or $100,000 fine
Correct answer: 1 year imprisonment and/or $1,000 fine
A first-offense misdemeanor under the FD&C Act carries up to 1 year imprisonment and/or a $1,000 fine.
Question 5: Which of the following best describes a 'new animal drug' requiring FDA approval under the FD&C Act?
- Any drug intended for use in animals not generally recognized as safe and effective (Correct answer)
- Any drug derived from natural sources used in animals
- Any OTC veterinary product not previously marketed
- Any antibiotic used in livestock feed operations
Correct answer: Any drug intended for use in animals not generally recognized as safe and effective
A new animal drug is one not generally recognized as safe and effective (GRASE) for its intended animal use and requires an approved NADA.
Question 6: Under the FD&C Act, FDA may seize adulterated or misbranded drugs through which legal action?
- Libel in rem action (Correct answer)
- Criminal prosecution only
- Injunctive relief only
- Administrative detention only
Correct answer: Libel in rem action
FDA initiates a libel in rem (seizure) action against the article itself in federal district court to remove adulterated or misbranded products.
Question 7: The FD&C Act's adulteration provisions for drugs include which of the following conditions?
- Drug was prepared under insanitary conditions where it may have been contaminated (Correct answer)
- Drug label omits the manufacturer's phone number
- Drug is sold at a price higher than the AWP
- Drug container is not child-resistant
Correct answer: Drug was prepared under insanitary conditions where it may have been contaminated
Preparation under insanitary conditions where contamination may occur is explicitly an adulteration basis under FD&C Act Section 501.
MPJE Federal Food, Drug, and Cosmetic Act 2
Under the FD&C Act, which agency has primary authority to regulate prescription drug advertising?