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Rules/submission/US-ADM-004

Submit Sample-Carrying Mailers Complete, Minus the Physical Sample

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Rule

If a mailing piece or item of labeling is designed to hold a drug product sample, the FDA submission of that piece must be complete (all printed content, inserts, and labeling included); only the physical drug sample itself may be omitted from the submission.

Check

For any sample-carrier mailer or labeling submitted to FDA, confirm all printed/labeling content is present and unabridged in the submitted specimen, with only the physical sample missing. A submission missing any printed component (beyond the physical sample) 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.

… 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. 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 re…
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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
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