Submit advertisements and promotional labeling to FDA per 314.81(b)(3)(i)

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

Rule

Advertisements and promotional labeling for the licensed biologic must be submitted to FDA (CBER or CDER, as applicable) in accordance with the submission requirements of 21 CFR 314.81(b)(3)(i).

Check

Confirm the piece has been or will be submitted to FDA (typically via Form FDA 2253) at the time required by 314.81(b)(3)(i); a violation looks like distribution or use of the piece with no record of the required FDA submission.

Where this comes from

21 CFR 601.12(f)(4). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… Changes to the most recent revision date of the labeling as specified in § 201.57(a)(15) of this chapter. (E) A change made pursuant to an exception or alternative granted under § 201.26 or § 610.68 of this chapter. (ii) The applicant may distribute a product with a package insert, package label, or container label bearing such change at the time the change is made. (4) Advertisements and promotional labeling. Advertisements and promotional labeling shall be submitted to the Center for Biologics Evaluation and Research or Center for Drug Evaluation and Research in accordance with the requirements set forth in § 314.81(b)(3)(i) of this chapter. (5) The submission and grant of a written request for an exception or alternative under § 201.26 or § 610.68 of this chapter satisfies the requirements in paragraphs (f)(1) through (f)(2) of this section. (6) For purposes of paragraph (f)(2) of this section, information will be considered newly acquired if it consists of data, analyses, or other information not previously submitted to the agency, which may include…

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

Document: 21 CFR 601.12
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: bac9eabe8f8844b1b69e5fa2…

Applies when

Naturepromotional

Productbiologic

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-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the entire text of 21 CFR 601.12(f)(4) and the locator matches. The provision is mandatory ('shall be submitted'), so stating it as an obligation is faithful and not an overstatement.
- The rule correctly carries the cross-reference rather than paraphrasing away the operative standard: the submission must be made 'in accordance with the requirements set forth in § 314.81(b)(3)(i)'. It does not invent timing or content requirements of its own beyond that pointer.
- applies_when with product-type 'biologic' is justified: § 601.12 governs changes to an approved biologics license application, so the limit is drawn from the source rather than invented.
- Atomic: a single obligation to submit advertisements and promotional labeling to the relevant Center.
- 'Deterministic' is acceptable here: the check turns on whether a required submission exists for the piece, which presence/absence settles; it does not turn on impression, adequacy, prominence or balance.
- Authority 'binding' is correct (codified regulation) and 'blocker' is defensible for a mandatory submission obligation.
- Noted but not disqualifying: the check's reference to 'Form FDA 2253' does not appear in this source text — it comes from the cross-referenced § 314.81(b)(3)(i) — but it is hedged as 'typically' and does not change the requirement being checked.