Federal Food, Drug, and Cosmetic Act Flashcards

Under the FD&C Act, which agency has primary authority to regulate prescription drug advertising?

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.

Which FD&C Act provision requires that drug labeling contain adequate directions for use?

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.

A drug product is recalled because it was found to contain glass particles. This is classified as a Class __ recall by FDA.

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.

Under the FD&C Act, what is the maximum penalty for a first-offense misdemeanor violation?

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.

Which of the following best describes a 'new animal drug' requiring FDA approval under the FD&C Act?

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.

Under the FD&C Act, FDA may seize adulterated or misbranded drugs through which legal action?

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.

The FD&C Act's adulteration provisions for drugs include which of the following conditions?

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.