Grouped side-effect terms allowed only if previously approved for that use

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

A general/group term may replace listing of specific side effects/contraindications only if that substitution has itself been approved or permitted in the drug's labeling.

Check

If a grouped term (e.g., 'blood dyscrasias') is used, confirm labeling itself permits that grouping rather than requiring the individual terms.

Escalate when

Approval status of the grouped term in labeling is unclear.

Where this comes from

21 CFR 202.1(e)(3)(iii). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…tted labeling for the advertised drug dosage form(s): Provided, however, (a) The side effects and contraindications disclosed may be limited to those pertinent to the indications for which the drug is recommended or suggested in the advertisement to the extent that such limited disclosure has previously been approved or permitted in drug labeling conforming to the provisions of §§ 201.100 or 201.105; and (b) The use of a single term for a group of side effects and contraindications (for example, “blood dyscrasias” for disclosure of “leukopenia,” “agranulocytosis,” and “neutropenia”) is permitted only to the extent that the use of such a single term in place of disclosure of each specific side effect and contraindication has been previously approved or permitted in drug labeling conforming to the provisions of §§ 201.100 or 201.105. (4) Substance of information to be included in brief summary. (i)(a) An advertisement for a prescription drug covered by a new-drug application approved pursuant to section 505 of the act after October 10, 1962, or a prescription drug covered by a new animal drug application approved pursuant to section 512 of the act after August 1, 1969, or any approved s…

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

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: the quoted proviso at (e)(3)(iii)(b) permits a single term standing in for a group of side effects and contraindications 'only to the extent that the use of such a single term in place of disclosure of each specific side effect and contraindication has been previously approved or permitted in drug labeling'. The rule states exactly that conditional permission, with the source's own 'blood dyscrasias' example carried into the check.
- Not overstated: the rule preserves the 'only to the extent' limitation and does not turn a permission into a prohibition, nor a prohibition into an absolute ban on grouped terms. It correctly locates the condition in the labeling approval, not in the reviewer's opinion of whether the grouping is reasonable.
- Atomic: one condition on one practice (substituting a group term for specific terms).
- Determinism 'judgment' is correct: the reviewer must determine whether the labeling previously approved or permitted that substitution, which is not settled by a literal match against the ad, and the rule's escalate-when covers the unclear case.
- Authority 'binding' is correct (regulation).
- Severity 'warning' is defensible: it is a qualified-permission provision, and an unpermitted grouped term typically surfaces as an incomplete specific-disclosure finding under US-RISK-014, which carries the blocker.
- applies_when (promotional) is justified; no further limit appears in the source.
- Minor, not grounds to withhold a pass: the locator is given as (e)(3)(iii) when the quoted proviso is specifically (e)(3)(iii)(b), and the rule statement omits the source's tail clause 'conforming to the provisions of §§ 201.100 or 201.105'. Both would be improvements in precision; neither changes what a reviewer checks.

Nearby rules

US-RISK-014