CRAP Labeling & Advertising Regulations Flashcards
6 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CRAP Labeling & Advertising Regulations flashcards as text
Under FDA regulations, what must appear on the principal display panel (PDP) of a drug product label?
Answer: Statement of identity and net quantity of contents
The PDP must include the statement of identity and net quantity of contents per FDA labeling requirements under 21 CFR Part 201.
Which FDA regulation governs the labeling of over-the-counter (OTC) and prescription drug products?
Answer: 21 CFR Part 201
21 CFR Part 201 contains the general labeling requirements applicable to both OTC and prescription drug products.
What is the regulatory significance of a 'boxed warning' (black box warning) in FDA drug labeling?
Answer: The most serious FDA warning highlighting significant safety risks
A boxed warning is the FDA's most serious warning, placed in a black-bordered box to prominently highlight significant safety risks to prescribers.
Which FDA office is responsible for regulating direct-to-consumer (DTC) prescription drug advertising?
Answer: FDA Office of Prescription Drug Promotion (OPDP)
The FDA's Office of Prescription Drug Promotion (OPDP) regulates DTC prescription drug advertising to ensure it is truthful and not misleading.
What does 'fair balance' require in pharmaceutical advertising?
Answer: Presenting risks and benefits with comparable emphasis and prominence
Fair balance requires that risk information be presented with similar prominence and emphasis as benefit information in drug promotional materials.
Under 21 CFR Part 202, what is required in prescription drug advertisements?
Answer: Full prescribing information or a brief summary of key safety information
21 CFR Part 202 requires that prescription drug ads include either the full prescribing information or a brief summary disclosing contraindications, warnings, and adverse effects.