Ingredient info block must be unbroken when 502(n) data is shown

AI-verifiedblockerBinding lawCheckable — presence or a literal match settles it

Rule

This rule applies only to advertisements for prescription drugs as defined in the opening sentence of 21 CFR 202.1 (drugs under FD&C Act section 503(b)(1) or 21 CFR 201.105), not to promotional materials generally. It is triggered only where the advertisement is required to present, or does present, the ingredient information called for by FD&C Act section 502(n); if no such ingredient information appears, the rule does not apply. Where triggered, all of that required ingredient information — including established-name listings and quantitative ingredient amounts — must appear together as a single unbroken block, with no written, printed, or graphic matter interposed anywhere within it, except that proprietary names of ingredients may be inserted alongside the listing of established names.

Check

First confirm the piece is a prescription-drug advertisement and that it is required to, or does, present section 502(n) ingredient information (ingredient names and/or quantities); if not, this rule does not apply. If it does apply, locate the entire ingredient information block (established names plus quantitative data) and scan it end-to-end for any inserted text, headlines, graphics, images, logos, or unrelated content anywhere within the block. The only permitted insertion is a proprietary ingredient name placed with its corresponding established name in the listing. Any other interposed matter, anywhere in the block (not just between ingredient names), is a violation.

Where this comes from

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

… § 202.1 Prescription-drug advertisements. Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter, applicable to drugs intended for use by humans and to veterinary drugs, respectively. (a)(1) The ingredient information required by section 502(n) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names. (2) The order of listing of ingredients in the advertisement shall be the same as the order of listing of ingredients on the label of the product, and the information presented in the advertisement concerning the quantity of each such ingredient shall be the same as the corresponding information on the label of the product. (3) The advertisement shall not employ a fanciful proprietary name for the drug or any ingr…

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

Audiencehcpconsumer

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 'shall' text of 21 CFR 202.1(a)(1), not a definition, example, or preamble; the rule statement tracks it sentence-for-sentence including the proprietary-name exception.
- Not overstated: 'shall appear together, without any intervening written, printed, or graphic matter' maps directly to 'must be grouped together with no intervening text or graphics,' and the exception is preserved rather than dropped.
- Atomic: a single co-location obligation with its own built-in exception; the exception is not a separately checkable requirement.
- Determinism correct: presence or absence of intervening matter within the ingredient statement is observable, unlike the 'reasonable relationship to the prominence' tests in 202.1(c) and (d)(1), which would require a judgment flag.
- Authority and locator correct: codified regulation, and the quoted sentence is exactly 21 CFR 202.1(a)(1).
- Severity defensible: noncompliance with a binding presentation requirement in a prescription-drug advertisement warrants blocker.
- Scope gap: the source opens by limiting 202.1 to prescription-drug advertisements, and (a)(1) applies only where section 502(n) ingredient information is presented. The rule's applies_when is a bare 'promotional', which would extend it to promotional labeling and to materials carrying no 502(n) ingredient statement.
- Check is narrower than the rule: it looks only at gaps 'between listed ingredients', whereas the regulation protects the ingredient information as a whole (including quantitative information) from intervening matter.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The quote is the operative text of 21 CFR 202.1(a)(1) — a mandatory 'shall appear together, without any intervening written, printed, or graphic matter' command — and the rule statement restates it without adding obligations. The only permitted exception (proprietary names with the listing of established names) is carried over accurately.
- Scope is correctly limited: the rule expressly confines itself to prescription-drug advertisements per the opening definitional sentence of § 202.1 ('drug defined in section 503(b)(1) ... or § 201.105'), and does not extend to promotional materials generally. The applies_when audience values (hcp, consumer) are appropriate because § 202.1 draws no audience distinction for paragraph (a)(1).
- The trigger condition ('required to present, or does present, section 502(n) ingredient information') tracks the conditional phrasing of the source — the requirement attaches to 'the ingredient information required by section 502(n),' so it is inert where no such information is at issue. This is a justified limit, not an invented one.
- Reading 502(n) ingredient information to include quantitative amounts as well as established-name listings is supported in context by the surrounding paragraphs of the same section, which refer to 'the quantity of each such ingredient' (a)(2) and to 'the quantitative ingredient information required in the advertisement by section 502(n)' (c) and (d)(2).
- Atomic: a single testable requirement — contiguity of one information block — with the exception stated as a carve-out rather than a second obligation.
- Determinism defensible as deterministic: the test is the presence or absence of interposed written, printed, or graphic matter within the ingredient block, an observable layout fact. It does not turn on prominence, adequacy, balance, or overall impression (unlike (b)(2), (c), and (d)(1) in the same section, which do).
- Authority correctly 'binding' (codified federal regulation) and the locator 21 CFR 202.1(a)(1) matches the quoted sentence exactly.
- Severity 'blocker' is defensible: non-compliance is a direct violation of a mandatory regulatory layout requirement for prescription-drug advertising, not a stylistic issue.
- Minor, non-blocking note: the phrase 'or does present' in the trigger could in principle sweep in voluntarily presented ingredient information that section 502(n) does not require; this is a reasonable practical framing and does not rise to overstatement of the underlying obligation.