MPJE Federal Food, Drug, and Cosmetic Act 3

Question 1

What does the FD&C Act require for a drug to qualify for the 'Rx-to-OTC switch' pathway?

Accepted Answer

Adequate safety data showing it can be used without practitioner supervision

Answer

An Rx-to-OTC switch requires demonstrating that consumers can safely self-select and use the drug without a prescriber's supervision.

Question 2

Under the FD&C Act, which section establishes the requirement for current Good Manufacturing Practice (cGMP)?

Accepted Answer

Section 501(a)(2)(B)

Answer

Section 501(a)(2)(B) deems a drug adulterated if it was not manufactured in conformance with cGMP regulations.

Question 3

An 'abbreviated new drug application' (ANDA) relies on which type of existing FDA approval?

Accepted Answer

A reference listed drug (RLD) with an approved NDA

Answer

An ANDA references the safety and efficacy data of an approved RLD rather than submitting independent clinical trials.

Question 4

Under FD&C Act Section 503A, which of the following is a requirement for a compounded drug to be exempt from NDA and labeling requirements?

Accepted Answer

The drug must be compounded based on a valid prescription for an identified individual patient

Answer

Section 503A exemptions apply to patient-specific compounding by licensed pharmacists based on valid prescriptions.

Question 5

What is the purpose of a 'drug master file' (DMF) submitted to FDA?

Accepted Answer

To provide confidential detailed information about facilities, processes, or articles used in drug manufacturing

Answer

A DMF allows manufacturers to share proprietary information with FDA without disclosing it to other parties referencing the DMF.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test