Reminder ads are not permitted for drugs with a boxed warning

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

Rule

Reminder ads (other than price-only reminder ads meeting § 200.200) may not be used for a drug whose labeling carries a boxed warning about a serious hazard.

Check

If the piece is a reminder ad and the product's labeling has a boxed warning, confirm it qualifies as a price-only reminder under § 200.200; otherwise flag as prohibited.

Where this comes from

21 CFR 202.1(e)(2)(i). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…or distributor or other written, printed, or graphic matter containing no representation or suggestion relating to the advertised drug product. If the Commissioner finds that there is evidence of significant incidence of fatalities or serious injury associated with the use of a particular prescription drug, he may withdraw this exemption by so notifying the manufacturer, packer, or distributor of the drug by letter. Reminder advertisements, other than those solely intended to convey price information including, but not limited to, those subject to the requirements of § 200.200 of this chapter, are not permitted for a prescription drug product whose labeling contains a boxed warning relating to a serious hazard associated with the use of the drug product. Reminder advertisements which are intended to provide consumers with information concerning the price charged for a prescription for a drug product are exempt from the requirements of this section if they meet all of the conditions contained in § 200.200 of this chapter. Reminder advertisements, other than those subject to the requirements of § 200.200 of this chapter, are not permitted for a drug for which an annou…

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-opus-5 · 2026-09-21
Reviewer's reasons
- The quote is the operative prohibitory sentence of 21 CFR 202.1(e)(2)(i) ('are not permitted'), not an example, definition, or description of what the rule does not require. The rule statement tracks it one-for-one.
- Not overstated: the regulation is flatly prohibitory, and the drafter preserved the price-only/§ 200.200 carve-out in both the rule statement and the check rather than dropping it, which would have been the obvious failure mode here.
- Atomic: a single prohibition with its own built-in statutory exception; the exception defines the scope of the same requirement rather than adding a second independently checkable obligation.
- Determinism 'deterministic' is defensible: the triggers are (a) whether the piece meets the paragraph's own presence/absence definition of a reminder ad (name only, no indications or dosage recommendations) and (b) whether labeling contains a boxed warning. Neither turns on impression, prominence, balance, or adequacy.
- Authority 'binding' is correct: 21 CFR 202.1 is codified regulation, not guidance.
- Locator 21 CFR 202.1(e)(2)(i) is accurate; the quoted sentence appears in the 'Reminder advertisements' subparagraph of the exempt-advertisements provision.
- Severity 'blocker' is defensible: the piece is outright prohibited with no remediation short of withdrawal or conversion to a compliant price-only reminder.
- applies_when ('promotional') is justified and not invented: 202.1 governs prescription drug advertisements, and reminder ads are by nature promotional; the check itself supplies the reminder-ad and boxed-warning limits.
- Minor and non-blocking: the source says 'prescription drug product' where the rule says 'drug' (immaterial, since boxed warnings attach to prescription labeling), and the paragraph's separate NAS/NRC 'possibly effective' prohibition is correctly excluded as a distinct requirement.

Nearby rules

US-RISK-012