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 minimum period for which a brand-name drug manufacturer must provide patent and exclusivity information listed in the 'Orange Book'?
Answer: The duration of the patent or exclusivity period as applicable
Orange Book listing reflects the actual remaining patent life and any applicable exclusivity period granted at NDA approval.
A pharmacy receives a drug product with labeling that lacks the required National Drug Code (NDC) number. Under the FD&C Act, this drug is considered:
Answer: Misbranded
Absence of required labeling information such as the NDC number renders the drug misbranded under the FD&C Act.
Which of the following triggers the 30-month stay on FDA approval of a generic drug's ANDA?
Answer: The brand manufacturer files a patent infringement lawsuit within 45 days of receiving the Paragraph IV certification
A 30-month stay automatically results when the NDA holder sues for patent infringement within 45 days of receiving a Paragraph IV certification notice.
Under the FD&C Act, 'homeopathic' drug products are regulated as:
Answer: Drugs subject to the same adulteration and misbranding provisions as other drugs
Homeopathic products are regulated as drugs under the FD&C Act and must comply with adulteration and misbranding requirements.
Which FD&C Act pathway provides 5 years of new chemical entity (NCE) exclusivity for a newly approved drug?
Answer: Hatch-Waxman new chemical entity exclusivity under Section 505(j)
The Hatch-Waxman Act (which amended the FD&C Act) grants 5 years of NCE exclusivity to drugs containing an active moiety never previously approved by FDA.
A pharmacist dispenses a drug product that was imported from a foreign country without FDA approval. Under the FD&C Act, this product is classified as:
Answer: Unapproved drug subject to seizure and enforcement action
Dispensing a non-FDA-approved imported drug violates the FD&C Act, and the product is subject to FDA seizure and enforcement regardless of foreign approval.
Under the FD&C Act, which entity is primarily responsible for reporting serious and unexpected adverse drug reactions from clinical trials to FDA?
Answer: The IND sponsor
The IND sponsor bears primary responsibility for submitting IND safety reports (including 15-day alert reports) to FDA for serious unexpected adverse reactions.