Established name must appear with proprietary name in running text

DisputedblockerBinding lawRaised as a question — a person decides

Rule

Where an established name corresponding to the proprietary name or designation exists, on any page where the proprietary name is used in the running text but is not featured, the established name must appear at least once in that running text in association with (in direct conjunction with) the proprietary name, in the same type size as the running text. If the proprietary name is set in larger type within that running text, the established name must instead appear at least once in association with the proprietary name in type at least half as large as the type used for the most prominent presentation of the proprietary name in that running text. This requirement does not apply where no established name corresponds to the proprietary name (e.g., a multi-active-ingredient product with a proprietary name for the combination and no established name for that combination), which is instead governed by 21 CFR 202.1(c).

Check

First confirm an established name corresponding to the proprietary name or designation actually exists; if it does not (e.g., a combination product whose proprietary name has no corresponding established name, governed instead by 21 CFR 202.1(c)), this check does not apply. Where an established name does exist, for each page where the proprietary name is used in running text but is not featured, confirm the established name appears at least once in that running text in association with (in direct conjunction with) the proprietary name, in the same type size as the running text — or, if the proprietary name is set in larger type in the running text, in type at least half as large as the most prominent presentation of the proprietary name in that running text.

Escalate when

Escalate when it is unclear whether an established name corresponding to the proprietary name exists (versus the product falling under the no-established-name provision of 202.1(c)), when it is unclear whether a given use of the proprietary name counts as 'featured' versus part of the running text, when the running text contains multiple type sizes for the proprietary name and it is unclear which is the 'most prominent presentation,' or when the visual placement makes it debatable whether the established name is truly 'in association with'/'in direct conjunction with' the proprietary name rather than merely elsewhere on the page.

Where this comes from

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

…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 for the drug; but, except as provided below in this subparagraph, the established name need not be used with the proprietary name or designation in the running text of the advertisement. On any page of an advertisement 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 and in the same type size used in the running text: Provided, however, That if the proprietary name or designation is used in the running text in larger size type, the established name shall be used at least once in association with, and in type at least half as large as the type used for, the most prominent presentation of the proprietary name or designation in such running text. If any advertisement includes a column with running text containing detailed informa…

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

Mediumprint

How this rule was checked

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quoted sentence is operative regulatory text ('shall be used at least once in the running text'), not an example, definition or preamble gloss, and the rule statement tracks it closely — per-page scope, trigger of 'not featured but used in running text', the once-per-page obligation, and the same-type-size requirement with the larger-type proviso that immediately follows in the source.
- Not overstated: the obligation is mandatory ('shall'), the rule does not extend it beyond the per-page/running-text condition, and it correctly carries the 'Provided, however' half-size alternative rather than asserting strict type-size equality in all cases.
- Authority correctly 'binding': 21 CFR 202.1 is a regulation, and severity 'blocker' is defensible for a mandatory established-name disclosure failure. Locator 21 CFR 202.1(b)(1) matches the subparagraph containing the quote.
- Atomic: the type-size qualifier is a condition on the single 'use the established name once in the running text' obligation, not an independently checkable second requirement. The separate direct-conjunction/'brand of' clarity requirement and the (b)(2) prominence requirement are properly left out of this rule.
- Determinism is wrong. The gating condition 'not featured but is used in the running text' turns on whether the proprietary name is featured — a prominence/display judgment, not a literal presence test. The larger-type proviso further requires identifying the 'most prominent presentation' of the proprietary name in the running text before the half-size threshold can be applied. Both are judgment calls, so this cannot be settled by presence/absence or literal match.
- The check drops a material element of the quoted text: the established name must be used 'in association with such proprietary name or designation' (and, per the later sentence in (b)(1), 'placed in direct conjunction'). As written, the check would pass a page where the established name appears somewhere in body text unconnected to the proprietary name, which the regulation does not permit.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The quote is the operative 'shall' sentence of 21 CFR 202.1(b)(1), not an example, definition, or description of what the rule does not require; the rule statement tracks its trigger (proprietary name used in running text but not featured on that page), its obligation (established name at least once in that running text in association with the proprietary name), and its type-size condition accurately.
- The 'in direct conjunction with' gloss is supported by a later sentence of the same paragraph ('Where the established name is required to accompany or to be used in association with... the established name shall be placed in direct conjunction with the proprietary name'), which falls within the cited locator 202.1(b)(1).
- Atomic: the larger-type proviso is an alternative branch of the same single obligation (established name, in association, at a specified type size), not an independently checkable second requirement, so this is not bundling.
- determinism 'judgment' is correct: whether a use is 'featured' versus running text, which is the 'most prominent presentation,' and whether placement is 'in association with'/'in direct conjunction with' all turn on layout and impression rather than literal presence.
- authority 'binding' is correct (codified regulation); locator 21 CFR 202.1(b)(1) matches the quoted sentence; severity 'blocker' is defensible given the section 502(n) misbranding exposure from omitting the established name.
- applies_when medium 'print' is justified rather than invented, since the provision is framed in terms of pages, running text, and type size; the parallel 'column of running text' provision and the (b)(2) half-size/prominence requirement are properly left to separate rules.
- Defect: the source conditions the obligation on an established name existing -- 'the established name, if such there be, corresponding to such proprietary name or designation.' The rule and check omit this limit and would therefore fire on multi-active-ingredient products that have no corresponding established name, the situation the source routes to 202.1(c) instead.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The operative obligation is established almost verbatim by the quoted sentence of 202.1(b)(1): on any page where the proprietary name is used in running text but not featured, the established name must be used at least once in that running text in association with it and in the same running-text type size, with the larger-type proviso requiring type at least half as large as the most prominent presentation. The rule restates this accurately.
- The 'in direct conjunction with' gloss is not invented: the same paragraph states that where the established name must accompany or be used in association with the proprietary name, it 'shall be placed in direct conjunction with' it.
- The 'if such there be' / no-corresponding-established-name carve-out and the routing to 202.1(c) are grounded in the source: (b)(1) says 'the established name, if such there be,' and (c) covers multi-active-ingredient products with a proprietary name and no corresponding established name.
- determinism 'judgment' is correct: whether a use is 'featured' versus running text, whether placement is 'in association with'/'in direct conjunction with,' and which is the 'most prominent presentation' all turn on layout and impression, not literal presence.
- authority 'binding' is correct (codified federal regulation); locator 21 CFR 202.1(b)(1) matches the quoted text.
- severity 'blocker' is defensible: failure to carry the established name with the proprietary name is a section 502(n)/misbranding exposure, not a stylistic issue.
- Atomic: presence of the established name and its type size are facets of a single regulatory obligation, and the larger-type proviso is a conditional branch of that same obligation rather than an independently checkable requirement.
- Overstated on scope: section 202.1 is titled 'Prescription-drug advertisements' and (b)(1) begins 'If an advertisement for a prescription drug bears a proprietary name...', but neither the rule statement, the check, nor applies_when limits application to prescription-drug advertisements. applies_when.promotional ['promotional'] sweeps in promotional labeling (detail aids, brochures, leave-behinds), which this section does not itself govern; as written a reviewer could cite 202.1(b)(1) against a piece it does not reach.
- The medium limit to 'print' is justified rather than invented, since the provision is keyed to 'any page' of an advertisement.

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