Federal Food, Drug, and Cosmetic Act Flashcards
7 cards from real MPJE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Federal Food, Drug, and Cosmetic Act flashcards as text
What does the FD&C Act require for a drug to qualify for the 'Rx-to-OTC switch' pathway?
Answer: Adequate safety data showing it can be used without practitioner supervision
An Rx-to-OTC switch requires demonstrating that consumers can safely self-select and use the drug without a prescriber's supervision.
Under the FD&C Act, which section establishes the requirement for current Good Manufacturing Practice (cGMP)?
Answer: Section 501(a)(2)(B)
Section 501(a)(2)(B) deems a drug adulterated if it was not manufactured in conformance with cGMP regulations.
An 'abbreviated new drug application' (ANDA) relies on which type of existing FDA approval?
Answer: A reference listed drug (RLD) with an approved NDA
An ANDA references the safety and efficacy data of an approved RLD rather than submitting independent clinical trials.
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?
Answer: The drug must be compounded based on a valid prescription for an identified individual patient
Section 503A exemptions apply to patient-specific compounding by licensed pharmacists based on valid prescriptions.
What is the purpose of a 'drug master file' (DMF) submitted to FDA?
Answer: To provide confidential detailed information about facilities, processes, or articles used in drug manufacturing
A DMF allows manufacturers to share proprietary information with FDA without disclosing it to other parties referencing the DMF.
Under the FD&C Act, which term describes a drug whose labeling fails to bear required warnings?
Answer: Misbranded
A drug is misbranded if its labeling is false or misleading or omits required information such as warnings.
Which FD&C Act provision allows FDA to require post-market safety studies or clinical trials as a condition of approval?
Answer: Post-market requirements under Section 505(o)
Section 505(o) authorizes FDA to require post-market studies, clinical trials, or labeling changes when new safety information emerges.