Listing of established names required with prominent display of shared combination name

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Rule

In a prescription drug advertisement, when one proprietary name is used for a combination of active ingredients present in more than one preparation and there is no established name corresponding to that proprietary name, a listing of the established names of the active ingredients must be placed in direct conjunction with the most prominent display of the proprietary name.

Check

Identify the most prominent display of the proprietary name in the advertisement — weighing type size, layout, and contrast among all instances of the name — then confirm that a listing of the established names of the active ingredients is placed in direct conjunction with that specific display. A violation exists if no established-name listing appears adjacent to the display judged most prominent, even if such a listing appears elsewhere.

Escalate when

Escalate to a human reviewer when reasonable reviewers could disagree on which display of the proprietary name is 'most prominent' (e.g., competing candidates of similar size/placement, ambiguous layout, or multiple pages with varying typography) or when it is unclear whether the ingredient listing sufficiently qualifies as being in 'direct conjunction' with that display.

Where this comes from

21 CFR 202.1(d)(1). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…rominence of the proprietary name. (d)(1) If the advertisement employs one proprietary name or designation to refer to a combination of active ingredients present in more than one preparation (the individual preparations differing from each other as to quantities of active ingredients and/or the form of the finished preparation) and there is no established name corresponding to such proprietary name or designation, a listing showing the established names of the active ingredients shall be placed in direct conjunction with the most prominent display of such proprietary name or designation. The prominence of this listing of active ingredients shall bear a reasonable relationship to the prominence of the proprietary name and the relationship between such proprietary name or designation, and the listing of active ingredients shall be made clear by use of such phrase as “brand of”, preceding the listing of active ingredients. (2) The advertisement shall prominently display the name of at least one specif…

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

Document: 21 CFR 202.1
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: a542640a872b3f2702d549e8…

Applies when

Naturepromotional

Productdrug

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 — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the rule statement tracks 21 CFR 202.1(d)(1) almost verbatim, including all three triggering conditions (one proprietary name/designation for a combination of active ingredients, present in more than one preparation, and no corresponding established name). The quote is the operative mandatory clause ('shall be placed in direct conjunction'), not an example, definition, or preamble.
- Atomic: (d)(1) actually imposes three obligations — placement in direct conjunction, prominence bearing a reasonable relationship to the proprietary name, and a clarifying phrase such as 'brand of' preceding the listing. The rule correctly carves out only the placement obligation and does not bundle the other two.
- Determinism is wrong. The check requires the reviewer to first identify 'the most prominent display' of the proprietary name, which is a comparative prominence assessment (typography, layout, contrast — the same factors the section itself enumerates in (b)(2)). Presence/absence of a listing alone does not settle compliance, so this is judgment, not deterministic.
- Authority correct: 21 CFR is a regulation, properly flagged binding, and the language is mandatory ('shall').
- Locator correct: the quoted sentence is the first sentence of paragraph (d)(1) of § 202.1.
- applies_when is under-specified and thereby over-broad. § 202.1 governs prescription-drug advertisements; the rule as scoped ('promotional') would sweep in promotional labeling and non-prescription promotional material that this section does not reach. The medium/product-class limit in the source is missing.
- Severity blocker is defensible: this is an affirmative mandatory ingredient-disclosure requirement under a binding regulation, and omission would render the advertisement violative.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: 21 CFR 202.1(d)(1) is operative regulatory text using 'shall', and the rule statement reproduces both of its trigger conditions (one proprietary name used for a combination of active ingredients present in more than one preparation, and no corresponding established name) and its single obligation (listing of established names of active ingredients placed in direct conjunction with the most prominent display of the proprietary name). The quote is not from an example, definition, or preamble.
- Not overstated: 'shall be placed' is rendered as 'must be placed' with no broadening; the rule does not extend to media or audiences beyond the prescription drug advertisements that § 202.1 governs, and the rule statement expressly limits itself to prescription drug advertisements consistent with the section's scope.
- Atomic: paragraph (d)(1) contains three distinct obligations (direct-conjunction placement, prominence bearing a reasonable relationship to the proprietary name, and the 'brand of' linking phrase). The rule isolates only the placement obligation and its check tests only that; the other two are left for separate rules.
- Determinism correctly set to 'judgment': identifying the 'most prominent display' among multiple instances and deciding whether a listing is in 'direct conjunction' both turn on layout, typography, and adjacency impression rather than literal presence/absence. The escalation trigger is well matched to exactly those two judgment points.
- Authority correctly 'binding': the source is a codified FDA regulation (21 CFR 202.1), not guidance.
- Locator 21 CFR 202.1(d)(1) matches the sentence quoted; the quote appears verbatim in that paragraph.
- applies_when is defensible: promotional/drug tracks the regulation's scope over prescription-drug advertisements, and the narrower triggering conditions (multi-preparation combination, absent established name) are carried in the rule statement itself, so the rule will not fire on ordinary single-entity ads.
- Severity 'blocker' is defensible: this is a mandatory disclosure element of a prescription drug advertisement under a binding regulation, and its absence renders the advertisement non-compliant and not correctable by placement elsewhere.