Other dosage forms need quantitative info equal in prominence to name listing

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Rule

This rule applies only where, per 21 CFR 202.1(d)(1), a prescription-drug advertisement uses one proprietary name or designation for a combination of active ingredients present in more than one preparation (the preparations differing as to quantities of active ingredients and/or dosage form) and there is no established name corresponding to that proprietary name or designation. In such an advertisement, where dosage forms other than the one specific dosage form prominently displayed under 21 CFR 202.1(d)(2) are listed, the quantitative ingredient information for those other dosage forms must appear in direct conjunction with, and in equal prominence to, the most prominent listing of the names of those dosage forms.

Check

Applies only to prescription-drug advertisements employing one proprietary name/designation for a combination of active ingredients present in more than one preparation (preparations differing in active-ingredient quantities and/or dosage form) with no corresponding established name (21 CFR 202.1(d)(1)). For each other dosage form listed beyond the one specific dosage form prominently displayed under 202.1(d)(2): (a) confirm its quantitative ingredient information appears in direct conjunction with the most prominent listing of that dosage form's name; (b) confirm that information is in equal prominence (type size, contrast, layout) to that listing. A violation is quantitative information that is separated from the dosage-form name listing or displayed less prominently than it.

Escalate when

Escalate when it is unclear whether the (d)(1) predicate is met (i.e., whether the ad uses a single proprietary name/designation for a combination present in multiple differing preparations with no established name), or when prominence of the quantitative information appears close to, but not clearly equal to, the dosage-form name listing.

Where this comes from

21 CFR 202.1(d)(2), read with 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.

…ship 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 specific dosage form and shall have the quantitative ingredient information required by section 502(n) of the act in direct conjunction with such display. If other dosage forms are listed in the advertisement, the quantitative ingredient information for such dosage forms shall appear in direct conjunction and in equal prominence with the most prominent listing of the names of such dosage forms. (e) True statement of information in brief summary relating to side effects, contraindications, and effectiveness: (1) When required. All advertisements for any prescription drug, except advertisements described in paragraph (e)(2) of this section, must present a true statement of information in brief summary relating to side effects, contraindications (when used in this section, “side effects, contraindications…

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

Drug classificationprescription

Labeling scenariosingle-proprietary-name-multiple-preparations-no-established-name

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 in substance: the quote is operative mandatory text ('shall appear in direct conjunction and in equal prominence') from 21 CFR 202.1(d)(2), not a definition, example, or exemption, and the rule statement and check follow directly from it.
- Overstated as to medium/product scope: Section 202.1 governs 'Prescription-drug advertisements' and its opening sentence defines prescription drug by reference to FDCA 503(b)(1) / 201.105. The applies_when of bare 'promotional' would fire on OTC promotion, device promotion, and non-advertising promotional pieces that the source does not reach.
- Overstated as to the paragraph (d) predicate: (d)(2) sits within paragraph (d), whose triggering condition is stated in (d)(1) - an advertisement employing one proprietary name or designation for a combination of active ingredients present in more than one preparation (differing as to quantities of active ingredients and/or form of the finished preparation) where there is no corresponding established name. The rule presents the 'other dosage forms' sentence as a universal requirement for any ad listing an additional dosage form, which the cited text does not establish.
- Determinism correctly set to judgment: 'direct conjunction' and 'equal prominence' turn on layout and visual impression, not on presence/absence or a literal match. The escalate condition ('prominence appears close but not clearly equal') is consistent with this.
- Authority correctly binding: 21 CFR is regulation.
- Locator 21 CFR 202.1(d)(2) is accurate - the quoted sentence is the second sentence of that subparagraph.
- Atomic: adjacency and equal prominence are a single composite obligation about how one item (the quantitative ingredient information) is presented relative to one anchor (the most prominent listing of the dosage form names), imposed in one sentence and evaluated on the same element.
- Severity 'warning' is defensible for a placement/prominence requirement; not a blocking issue.
- Minor: the rule drops the first sentence of (d)(2) (affirmative duty to prominently display at least one specific dosage form with its quantitative ingredient information in direct conjunction). That is acceptable as a separate rule, but the 'additional dosage forms' framing presupposes that anchor and should not read as free-standing.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The quoted sentence is operative mandatory text ('shall appear') in 21 CFR 202.1(d)(2), not an example, definition, or description of what is not required; the rule statement is a close paraphrase using the regulation's own terms 'direct conjunction' and 'equal prominence'.
- The applies_when limitation to the (d)(1) scenario (single proprietary name/designation for a combination of active ingredients present in more than one preparation, preparations differing in quantities and/or dosage form, no corresponding established name) is justified: (d)(2) has no independent predicate and opens 'The advertisement shall…', taking its antecedent from (d)(1). The limit is neither invented nor missing.
- No overstatement: the rule does not import the weaker 'reasonable relationship to the prominence' standard of (c)/(d)(1) nor inflate it; it applies the 'equal prominence' standard only where the text does, i.e., to dosage forms other than the one prominently displayed under the first sentence of (d)(2).
- determinism 'judgment' is correct — 'equal prominence' depends on typography, contrast, and layout impression and cannot be resolved by presence/absence or literal match; the escalation clause for near-equal prominence is consistent with this.
- authority 'binding' is correct: 21 CFR is a codified regulation, and the cited source is labeled binding.
- Atomic: the two check sub-steps (direct conjunction; equal prominence) are components of one presentation requirement imposed by a single sentence on a single item of information, not independently imposed obligations that should be separate rules.
- Severity 'warning' is defensible for a placement/prominence defect in a narrow, conditional formatting provision. Locator '21 CFR 202.1(d)(2), read with 21 CFR 202.1(d)(1)' precisely identifies both the operative sentence and the source of the predicate.
- Non-blocking observation: Part 202.1 governs prescription-drug advertisements rather than promotional labeling generally; the applies_when taxonomy only carries 'promotional', but both the rule statement and the check expressly say 'advertisement', so the medium limit is preserved in the text a reviewer reads.