Established name required once in running text when proprietary name is not featured

AI-verifiedblockerFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

On any page where the proprietary name is not featured but is used only in running text, the established name must appear at least once in that running text in association with the proprietary name.

Check

For pages where the proprietary name only appears within running text (not featured), confirm the established name appears at least once within that running text.

Where this comes from

21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.D · page 7. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…) state that: If an advertisement for [or the label or labeling of] a prescription drug bears a proprietary name or designation for the drug or any ingredient thereof, the established name, if such there be, corresponding to such proprietary name or designation shall accompany such proprietary name or designation each time it is featured in the advertisement [or on the label or in the labeling] for the drug . . . . On any page of an advertisement [or any label or page of labeling] in which the proprietary name or designation is not featured but is used in the running text, the established name shall be used at least once in the running text in association with such proprietary name or designation . . . . If any advertisement [or any labeling] includes a column with running text containing detailed information as to composition, prescribing, side effects, or contraindications and the proprietary name or designation is used in such column but is not featured above or below the column, the established name shall be used at least once in such column of running text in association with such proprietary name o…

Open the original at page 7 on fda.gov ↗Read our full copy →

Document: FDA guidance: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: f6f78606542ef91596ef21f6…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Naturepromotional

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 verbatim regulatory text from Section II.D and the rule statement is a close restatement that preserves every operative element: the page scope, the not-featured condition, the running-text location, 'at least once', and 'in association with' the proprietary name.
- Not overstated. Unlike the each-time-featured requirement in the adjacent paragraph, this once-per-running-text requirement is not softened by enforcement discretion — Section II.D.1 reaffirms it ('the established name is required to accompany the proprietary name at least once in the running text') and Section II.D.3 repeats it for electronic media with a regulatory citation. The only adjacent softener is a recommendation for running text spanning multiple pages, which goes beyond this floor rather than reducing it.
- The not-featured trigger is correctly carried into the check, which limits itself to pages 'where the proprietary name only appears within running text (not featured)' — the condition that separates this rule from US-NAME-028.
- Determinism 'deterministic' is right: it resolves to whether the established name occurs at least once in that running text, a presence check.
- Atomic: one trigger, one presence test. Severity 'blocker' is defensible for a regulatory floor with no discretion attached, and authority 'guidance' under-claims rather than over-claims.
- The rule is self-limiting on medium — it speaks of pages, so it does not reach audio or radio, where running text does not exist.

Nearby rules

US-NAME-030