CRAP CRAP Labeling & Advertising Regulations 1 — Questions and Answers
Question 1: Under FDA regulations, what must appear on the principal display panel (PDP) of a drug product label?
- Brand name only
- Statement of identity and net quantity of contents (Correct answer)
- List of inactive ingredients
- Manufacturer contact information
Correct 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.
Question 2: Which FDA regulation governs the labeling of over-the-counter (OTC) and prescription drug products?
- 21 CFR Part 201 (Correct answer)
- 21 CFR Part 207
- 21 CFR Part 314
- 21 CFR Part 600
Correct answer: 21 CFR Part 201
21 CFR Part 201 contains the general labeling requirements applicable to both OTC and prescription drug products.
Question 3: What is the regulatory significance of a 'boxed warning' (black box warning) in FDA drug labeling?
- A warning about drug interactions listed in bold font
- The most serious FDA warning highlighting significant safety risks (Correct answer)
- A warning specific to pediatric populations only
- A warning about environmental disposal requirements
Correct 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.
Question 4: Which FDA office is responsible for regulating direct-to-consumer (DTC) prescription drug advertising?
- Federal Trade Commission (FTC)
- FDA Division of Drug Information
- FDA Office of Prescription Drug Promotion (OPDP) (Correct answer)
- NIH Office of Consumer Affairs
Correct 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.
Question 5: What does 'fair balance' require in pharmaceutical advertising?
- Equal airtime for brand and generic drugs
- Presenting risks and benefits with comparable emphasis and prominence (Correct answer)
- Balancing the number of ads for competing products
- Ensuring equal representation of patient demographics
Correct 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.
Question 6: Under 21 CFR Part 202, what is required in prescription drug advertisements?
- Full prescribing information or a brief summary of key safety information (Correct answer)
- Cost comparison with competitor drugs
- Patient testimonials approved by FDA
- Color-coded safety ratings
Correct 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.
CRAP CRAP Labeling & Advertising Regulations 1
Under FDA regulations, what must appear on the principal display panel (PDP) of a drug product label?