Attach Completed Form FDA-2253 to Ad/Labeling Submissions
AI-verifiedblockerBinding lawCheckable — presence or a literal match settles it
Rule
Every submission of an advertisement or promotional labeling specimen to FDA under this section must be accompanied by a completed transmittal Form FDA-2253.
Check
Confirm that each submitted specimen package includes a completed Form FDA-2253. A submission lacking this form, or with the form incomplete, 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.
…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. Form FDA-2253 is available on the Internet at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html. (ii) Special reports. Upon written request the agency may require that the applicant submit the reports under this section at different times than those stated. (iii) Notification of a permanent discontinuance or an interrupti…
- 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…