MPJE Federal Food, Drug, and Cosmetic Act 2

Question 1

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

Accepted Answer

FDA Office of Prescription Drug Promotion (OPDP)

Answer

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?

Accepted Answer

Section 502(f)

Answer

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.

Accepted Answer

Class I

Answer

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?

Accepted Answer

1 year imprisonment and/or $1,000 fine

Answer

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?

Accepted Answer

Any drug intended for use in animals not generally recognized as safe and effective

Answer

A new animal drug is one not generally recognized as safe and effective (GRASE) for its intended animal use and requires an approved NADA.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test