MPJE Federal Food, Drug, and Cosmetic Act 5

Question 1

Under the FD&C Act, what is the definition of a 'dietary supplement'?

Accepted Answer

A product intended to supplement the diet that contains a vitamin, mineral, herb, amino acid, or other dietary ingredient

Answer

Section 201(ff) of the FD&C Act defines dietary supplements as products intended to supplement the diet, taken by mouth, containing a dietary ingredient.

Question 2

The FD&C Act's Drug Supply Chain Security Act (DSCSA) provisions require trading partners to track and trace drugs using which identifier?

Accepted Answer

Serialized National Drug Code (sNDC) with transaction history

Answer

DSCSA requires a serialized identifier on each smallest saleable unit and electronic transaction information (TI, TH, TS) to track drugs through the supply chain.

Question 3

Which FD&C Act section grants FDA authority to mandate a Risk Evaluation and Mitigation Strategy (REMS) for a drug?

Accepted Answer

Section 505-1

Answer

Section 505-1 of the FD&C Act authorizes FDA to require a REMS when necessary to ensure that benefits of a drug outweigh its risks.

Question 4

Under the FD&C Act, a compounding outsourcing facility registered under Section 503B must:

Accepted Answer

Comply with cGMP and report adverse events to FDA

Answer

Section 503B outsourcing facilities must follow cGMP, report adverse events, and can compound without patient-specific prescriptions but must register with FDA.

Question 5

A drug that was previously approved but has been withdrawn from the market for safety reasons may not be used as a reference listed drug for an ANDA because:

Accepted Answer

FDA removes withdrawn drugs from the Orange Book, blocking ANDA submissions referencing them

Answer

Drugs withdrawn for safety or effectiveness reasons are removed from the Orange Book, and FDA will not approve ANDAs referencing them.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Federal Food, Drug, and Cosmetic Act 5