Prescription Drug Advertising
Governs advertising for prescription drugs: the requirement for a true statement of information in brief summary relating to side effects, contraindications and effectiveness, fair balance between benefit and risk, and the categories of presentation FDA treats as false or misleading.
Always verify against the current published text before relying on it for a submission or inspection.
Scope & applicability
Prescription-drug advertisements, including direct-to-consumer broadcast and print. Promotional labelling — the material distributed by or on behalf of the sponsor that is not an advertisement — is reached through the labelling provisions instead, which is why promotional review has to consider both.
Key requirements
- §202.1(e) — the true statement requirement: brief summary of side effects, contraindications and effectiveness
- Fair balance in the presentation of benefit and risk information
- §202.1(e)(6) — presentations FDA considers false, lacking in fair balance, or otherwise misleading
- The adequate-provision alternative for broadcast advertisements under §202.1(e)(1)
Implementation tips
- Review promotional material against the authorised indication and the approved labelling, not against the brand strategy — a claim beyond the authorisation is an enforcement matter, not a marketing dispute
- Record what the reviewer checked against: the approved labelling version is the control, and it moves
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
21 CFR Part 202: frequently asked questions
Quick answers to common questions about 21 CFR Part 202.
What is 21 CFR Part 202?
21 CFR Part 202 — Prescription Drug Advertising — is a regulation issued by the Food and Drug Administration (United States). Governs advertising for prescription drugs: the requirement for a true statement of information in brief summary relating to side effects, contraindications and effectiveness, fair balance between benefit and risk, and the categories of presentation FDA treats as false or misleading.
Who does 21 CFR Part 202 apply to?
Prescription-drug advertisements, including direct-to-consumer broadcast and print. Promotional labelling — the material distributed by or on behalf of the sponsor that is not an advertisement — is reached through the labelling provisions instead, which is why promotional review has to consider both.
What are the key requirements of 21 CFR Part 202?
FDA 21 CFR Part 202 requires, among other things: §202.1(e) — the true statement requirement: brief summary of side effects, contraindications and effectiveness; Fair balance in the presentation of benefit and risk information; §202.1(e)(6) — presentations FDA considers false, lacking in fair balance, or otherwise misleading; The adequate-provision alternative for broadcast advertisements under §202.1(e)(1).
When was 21 CFR Part 202 last updated?
The current version of 21 CFR Part 202 dates from November 2021.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.