Submit Promotional Labeling Specimens at Initial Dissemination

AI-verifiedblockerBinding lawCheckable — presence or a literal match settles it

Rule

For a prescription drug product, the applicant must submit specimens of any labeling (including mailing pieces) devised for promotion of the drug product to FDA no later than the time that labeling is first disseminated.

Check

Verify that a submission package (specimen of the promotional labeling) was sent to FDA on or before the date the piece was first distributed. A gap between first dissemination and FDA submission, or no submission at all, 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…

Open the original at these words on ecfr.gov ↗Read our full copy →

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…

Applies when

Naturepromotional

Launch stagepost-approval

Rx statusprescription

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quoted sentence of 21 CFR 314.81(b)(3)(i) is an operative obligation ('The applicant shall submit specimens of mailing pieces and any other labeling ... at the time of initial dissemination of the labeling'), not an example, definition or preamble, so it establishes the requirement the rule states.
- The rule splits the source sentence along the line the source itself draws: labeling is tied to 'initial dissemination', advertising to 'initial publication'. Confining this rule to labeling (including mailing pieces) at first dissemination tracks the text rather than broadening it.
- Not overstated: 'shall submit' is mandatory, and 'no later than the time that labeling is first disseminated' is if anything slightly permissive relative to 'at the time of' (it allows earlier submission), so the rule is not stronger than the source.
- Atomic: one obligation (submit a specimen) with one timing condition; the Form FDA-2253 and professional-labeling requirements from the same paragraph are correctly carved out into separate rules.
- Determinism 'deterministic' is right: the check compares the existence of a submission and its date against the first-dissemination date — presence/absence plus a date comparison, with no judgment about impression, adequacy or balance.
- Authority 'binding' is correct — this is a codified regulation (21 CFR), not guidance.
- applies_when is justified: 'prescription' comes from the sentence's own limiting phrase 'for a prescription drug product'; 'post-approval' follows from § 314.81(a), which applies the section to each approved application and abbreviated application; 'promotional' follows from 'devised for promotion of the drug product'.
- Severity 'blocker' is defensible: § 314.81(d) provides that failure to make reports required under this section can lead FDA to withdraw approval and prohibit continued marketing.
- Locator 21 CFR 314.81(b)(3)(i) matches where the quoted sentence sits in the source text.

Nearby rules

US-ADM-003 US-ADM-004 US-ADM-005 US-ADM-006