Relationship between proprietary and established name must be made clear

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Rule

In a prescription drug advertisement, where the established name is required to accompany or be used in association with the proprietary name or designation, the relationship between the two must be made clear — by a phrase such as "brand of" preceding the established name, by brackets surrounding the established name, or by other suitable means.

Check

Where both the proprietary name and the established name are required to appear together, confirm a clarifying device is present ("brand of", brackets, or equivalent) and that it makes the relationship between the two names clear.

Escalate when

The advertisement uses a device other than the phrase "brand of" or brackets to connect the proprietary and established names, and it is unclear whether that alternative device adequately conveys the brand/established-name relationship to a reasonable reader.

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.

…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 column of running text. Where the established name is required to accompany or to be used in association with the proprietary name or designation, the established name shall be placed in direct conjunction with the proprietary name or designation, and the relationship between the proprietary name or designation and the established name shall be made clear by use of a phrase such as “brand of” preceding the established name, by brackets surrounding the established name, or by other suitable means. (2) The established name shall be printed in letters that are at least half as large as the letters comprising the proprietary name or designation with which it is joined, and the established name shall have a prominence commensurate with the prominence with which such proprietary name or designation appears, taking into account all pertinent factors, including typography, layout, contrast, and other printing featu…

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

Mediumprintbroadcastdigitalsocialin-person

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 quoted sentence is operative regulatory text in 21 CFR 202.1(b)(1) stated in mandatory terms ('shall be made clear'), not an example, definition, or preamble commentary. The rule's trigger mirrors the source's own conditional ('Where the established name is required to accompany or to be used in association with the proprietary name or designation').
- Locator correct: the quoted sentence is the final sentence of paragraph (b)(1). Note (d)(1) contains a parallel 'brand of' requirement for multi-ingredient listings, but the rule as framed (proprietary name / established name) correctly maps to (b)(1).
- Authority correctly 'binding': 21 CFR 202.1 is a codified regulation, not guidance; the verb is 'shall'.
- Severity 'blocker' is defensible: a mandatory CFR name-presentation requirement whose absence renders the advertisement misbranded-prone and is routinely cited by OPDP.
- Atomic: the rule isolates the clarifying-device obligation and does not bundle the adjacent 'direct conjunction' placement requirement or the (b)(2) half-size/prominence requirements.
- Determinism incorrect: the regulation permits the relationship to be made clear 'by other suitable means,' and the governing test is whether the relationship 'shall be made clear.' Where a piece uses something other than 'brand of' or brackets, the reviewer must assess adequacy/clarity, which is a judgment call, not a literal match.
- Overstated in scope: 21 CFR 202.1 governs prescription-drug advertisements (the section opens by defining 'prescription drug' for its own purposes). The rule statement says 'the piece' and applies_when is the unqualified 'promotional', which would extend the obligation to promotional labeling, sales aids, and non-prescription materials that this section does not reach.
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 operative mandatory text from the final sentence of 21 CFR 202.1(b)(1) ('the relationship ... shall be made clear by use of a phrase such as "brand of" ... by brackets ... or by other suitable means'), not an example, definition, or negative statement of what is not required.
- Not overstated: 'shall' is rendered as 'must'; the rule preserves the regulation's open-ended 'or by other suitable means' rather than treating 'brand of'/brackets as an exhaustive list, and it is limited to prescription drug advertisements consistent with the scope of Sec. 202.1.
- applies_when is justified: the trigger ('where the established name is required to accompany or be used in association with the proprietary name') is lifted from the regulation's own conditional clause rather than invented, and the promotional-only scope matches a provision governing advertisements.
- Atomic: the source sentence imposes two obligations (direct-conjunction placement and clarity of the relationship). The rule takes only the clarity obligation, leaving placement to a separate rule, so it states one independently checkable requirement.
- Determinism correctly set to judgment: although presence of brackets or 'brand of' would be a literal match, 'other suitable means' and 'made clear' require assessing whether an alternative device actually conveys the relationship. The escalate condition is aimed precisely at that residual judgment.
- Authority correctly binding (codified federal regulation) and the locator 21 CFR 202.1(b)(1) resolves exactly to the sentence quoted.
- Severity of blocker is defensible: the requirement implements the established-name obligation tied to section 502(n), and non-compliance renders the advertisement violative.
- Minor, non-blocking: the medium list includes broadcast and in-person while the surrounding (b)(1) text is print-framed ('on any page', 'type size', 'column of running text') and brackets are a visual device. The quoted sentence is itself medium-neutral and the rule's own trigger condition self-limits, so no covered case is made false.

Nearby rules

US-NAME-007 US-NAME-008 US-NAME-009