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
Under the FD&C Act, what is the definition of a 'dietary supplement'?
Answer: A product intended to supplement the diet that contains a vitamin, mineral, herb, amino acid, or other dietary ingredient
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.
The FD&C Act's Drug Supply Chain Security Act (DSCSA) provisions require trading partners to track and trace drugs using which identifier?
Answer: Serialized National Drug Code (sNDC) with transaction history
DSCSA requires a serialized identifier on each smallest saleable unit and electronic transaction information (TI, TH, TS) to track drugs through the supply chain.
Which FD&C Act section grants FDA authority to mandate a Risk Evaluation and Mitigation Strategy (REMS) for a drug?
Answer: Section 505-1
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.
Under the FD&C Act, a compounding outsourcing facility registered under Section 503B must:
Answer: Comply with cGMP and report adverse events to FDA
Section 503B outsourcing facilities must follow cGMP, report adverse events, and can compound without patient-specific prescriptions but must register with FDA.
A drug that was previously approved but has been withdrawn from the market for safety reasons may not be used as a reference listed drug for an ANDA because:
Answer: FDA removes withdrawn drugs from the Orange Book, blocking ANDA submissions referencing them
Drugs withdrawn for safety or effectiveness reasons are removed from the Orange Book, and FDA will not approve ANDAs referencing them.
Under the FD&C Act, which labeling element is specifically required on the immediate container of a prescription drug dispensed to a patient?
Answer: Name and address of the dispenser, prescription serial number, date, prescriber name, and patient name
Section 503(b)(2) requires the prescription container to bear the dispenser's name/address, serial number, date of dispensing, prescriber name, and patient name.
Which of the following is an example of an 'imminent hazard' that allows FDA to immediately suspend a drug's approval under the FD&C Act?
Answer: A drug linked to sudden cardiac death with no known safe dose
An imminent hazard justifying immediate suspension exists when continued marketing presents an unreasonable risk of serious injury or death to consumers.