MPJE MPJE Federal Food, Drug, and Cosmetic Act Questions and Answers 2

Question 1

Under the FD&C Act, which of the following is the correct definition of 'adulterated' as applied to a drug?

Accepted Answer

The drug contains a filthy or decomposed substance rendering it unfit for use

Answer

The drug's labeling is false or misleading

Answer

The drug is sold without a valid prescription

Answer

The drug's expiration date has passed

Question 2

Which federal agency is responsible for enforcing the Federal Food, Drug, and Cosmetic Act?

Accepted Answer

Food and Drug Administration (FDA)

Answer

Drug Enforcement Administration (DEA)

Answer

Federal Trade Commission (FTC)

Answer

Consumer Product Safety Commission (CPSC)

Question 3

A drug is considered 'misbranded' under the FD&C Act if:

Accepted Answer

It lacks adequate directions for use

Answer

It is manufactured in a state-licensed facility

Answer

It contains only GRAS (generally recognized as safe) ingredients

Answer

It was approved via the 505(b)(2) pathway

Question 4

Under the FD&C Act, the 'substantial evidence' standard for drug approval requires:

Accepted Answer

One well-controlled clinical investigation plus confirmatory evidence

Answer

Anecdotal reports from at least 10 licensed physicians

Answer

Sales data demonstrating consumer acceptance

Answer

A single published peer-reviewed study

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?

Accepted Answer

To highlight serious or life-threatening adverse reactions or restrictions

Answer

To indicate the drug is available only as a generic

Answer

To signal that the drug requires refrigerated storage

Answer

To denote that the drug is available over the counter

Question 6

Under the FD&C Act, which of the following is required on the labeling of all prescription drug products?

Accepted Answer

The statement 'Rx only' (or 'Caution: Federal law prohibits dispensing without a prescription')

Answer

A QR code linking to the manufacturer's website

Answer

The National Drug Code (NDC) in barcode format only

Answer

The retail price suggested by the manufacturer