Place quantitative ingredient info with prominent proprietary name for unnamed drug mixtures

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

Where an advertisement for a prescription drug containing two or more active ingredients bears a proprietary name or designation for the mixture and there is no corresponding established name, the quantitative ingredient information required by section 502(n) must be placed in direct conjunction with the most prominent display of that proprietary name or designation.

Check

(1) Confirm the product contains two or more active ingredients and the piece bears a proprietary name or designation for the mixture with no corresponding established name; if not, the rule does not apply. (2) Identify the most prominent display of the proprietary name or designation. (3) Confirm the required quantitative ingredient information appears in direct conjunction with that display.

Escalate when

Escalate when it is unclear which display of the proprietary name is the 'most prominent' (e.g., competing displays of similar size/placement across a page or spread), or when the spatial/visual relationship between the ingredient information and that display is ambiguous as to whether it satisfies 'direct conjunction' (e.g., separated by intervening graphics, columns, or page breaks).

Where this comes from

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

…e with which such proprietary name or designation appears, taking into account all pertinent factors, including typography, layout, contrast, and other printing features. (c) In the case of a prescription drug containing two or more active ingredients, if the advertisement bears a proprietary name or designation for such mixture and there is no established name corresponding to such proprietary name or designation, the quantitative ingredient information required in the advertisement by section 502(n) of the act shall be placed in direct conjunction with the most prominent display of the proprietary name or designation. The prominence of the quantitative ingredient information shall bear a reasonable relationship to the prominence 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 finish…

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

Mediumprintdigital

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 quote is the operative first sentence of 21 CFR 202.1(c), a mandatory codified requirement ('shall be placed in direct conjunction with the most prominent display of the proprietary name or designation'), not an example, definition, or preamble commentary. The rule statement reproduces both the trigger and the obligation.
- Authority correctly marked binding (codified regulation) and locator 21 CFR 202.1(c) is accurate — the quoted sentence appears verbatim in paragraph (c).
- Atomic: the drafter correctly excluded the second sentence of (c) ('The prominence of the quantitative ingredient information shall bear a reasonable relationship to the prominence of the proprietary name'), which is a separate and distinct requirement. Only one obligation is checked.
- Determinism is incorrect. Applying the rule first requires identifying 'the most prominent display' of the proprietary name, which is a prominence determination — the same section (202.1(b)(2)) treats prominence as depending on 'typography, layout, contrast, and other printing features.' 'Direct conjunction' adjacency in a laid-out promotional piece is also a spatial/layout judgment, not a presence/absence or literal match. Should be 'judgment'.
- Scope imprecision: the rule says 'multi-ingredient mixture' while the source says 'containing two or more active ingredients.' Given that 202.1(a)(4) separately addresses inert or inactive ingredients, the rule's wording could be read to cover products that are multi-ingredient only by virtue of inactive ingredients.
- The check does not verify the triggering conditions before testing the obligation. As written it would flag single-active-ingredient products or products that do have a corresponding established name, neither of which 202.1(c) reaches. applies_when carries only 'promotional' and does not capture the source's own limits.
- Severity 'blocker' is defensible: this is a mandatory placement requirement tied to section 502(n) ingredient disclosure in prescription drug advertising, and non-compliance is a regulatory violation rather than a stylistic issue.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quote is the operative first sentence of 21 CFR 202.1(c), a mandatory 'shall' requirement, not an example, definition, or preamble. The rule statement reproduces the source's full conditional structure (prescription drug with two or more active ingredients + advertisement bears a proprietary name/designation for the mixture + no corresponding established name) and its consequence (quantitative ingredient information required by 502(n) placed in direct conjunction with the most prominent display of that name).
- Not overstated: 'shall be placed' is rendered as 'must be placed' with no broadening. The rule does not extend the obligation beyond the two-or-more-active-ingredient / no-established-name case, and it does not reach the separate second sentence of (c).
- Atomic: paragraph (c) contains two independently checkable obligations — the placement requirement (first sentence) and the 'prominence ... reasonable relationship' requirement (second sentence). The rule correctly takes only the placement requirement; the check's three steps are sequential elements of that single obligation, not bundled requirements.
- Determinism 'judgment' is correct: whether a given display is the 'most prominent' and whether the ingredient information is in 'direct conjunction' with it both turn on layout, visual relationship, and prominence — not on presence/absence or literal match. The escalation trigger is well matched to exactly these two judgment points.
- Authority 'binding' is correct: the source is a codified regulation (21 CFR 202.1(c)), not guidance.
- Locator '21 CFR 202.1(c)' is exact; the quoted language appears verbatim in paragraph (c).
- applies_when is defensible: 'promotional' is right (the provision governs advertisements), and restricting to print/digital is a narrowing rather than an overreach, justified by the spatial nature of 'placed in direct conjunction with the most prominent display.' Note this leaves broadcast visual displays outside scope, but under-inclusion here does not create a false obligation.
- Severity 'blocker' is defensible: a mandatory regulatory placement requirement whose violation makes the advertisement non-compliant under section 502(n)/202.1.

Nearby rules

US-NAME-014