Submit Prescription Drug Ad Specimens at Initial Publication
AI-verifiedblockerBinding lawCheckable — presence or a literal match settles it
Rule
For a prescription drug product, the applicant must submit a specimen of any advertisement devised for promotion of the drug product to FDA no later than the time that advertisement is first published.
Check
Verify that a specimen of the advertisement was submitted to FDA on or before the date of first publication. Publication with no corresponding contemporaneous FDA submission is a violation.
Where this comes from
21 CFR 314.81(b)(3)(i). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.
…nications between FDA and the applicant, the report may, at the applicant's discretion, also contain a list of any open regulatory business with FDA concerning the drug product subject to the application (e.g., a list of the applicant's unanswered correspondence with the agency, a list of the agency's unanswered correspondence with the applicant). (3) Other reporting—(i) Advertisements and promotional labeling. The applicant shall submit specimens of mailing pieces and any other labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Mailing pieces and labeling that are designed to contain samples of a drug product are required to be complete, except the sample of the drug product may be omitted. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product's current professional labeling. For…
- Document
- 21 CFR 314.81
- Version
- 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
- Retrieved
- 2026-09-21 from www.ecfr.gov
- Fingerprint
- f78a44bfc25afe4183ff9949…