Communication must not conflict with labeled dosing, regimen, route, or strength

AI-verifiedblockerFDA guidance · non-bindingRaised as a question — a person decides

Rule

If a product communication's representations or suggestions about dosage, use regimen, route of administration, or strength conflict with what is set forth in the FDA-required labeling, the communication is not consistent with the FDA-required labeling.

Check

Compare any stated or implied dose, schedule, route, or strength in the piece against the FDA-required labeling. A violation looks like a different frequency, dose amount, administration route, or strength than labeled.

Escalate when

The piece describes a dosing scenario (e.g., a subgroup or modification) not explicitly addressed either way by the label.

Where this comes from

Q.2/A.2, Factor 1 (Dosing or Use Regimen/Administration) · page 8. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… Population – Is the patient population represented or suggested in the communication outside the approved patient population reflected in the FDA-required labeling? Limitations and Directions for Handling/Use – Do the representations/suggestions in the communication conflict with the use limitations or directions for handling, preparing, and/or using the product reflected in the FDA-required labeling? Dosing or Use Regimen/Administration – Do the representations/suggestions about the product conflict with the recommended dosage or use regimen, route of administration, or strength(s) (if applicable) set forth in the FDA-required labeling? <u>Factor 2:</u> Whether the representations/suggestions about use of the product in the product communication increase the potential for harm to health relative to the information reflected in the FDA-required labeling — When reviewing a medical product’s marketing application, FDA weighs the benefits and risks of a medical product for the conditions of use prescribed, recommended, or suggested in the product’s l…

Open the original at page 8 on fda.gov ↗Read our full copy →

Document: FDA guidance: Medical Product Communications that Are Consistent With the FDA-Required Labeling – Questions and Answers (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: 1a18b7f242bfbbf897f198df…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Basisconsistent-with-labeling

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-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Directly supported by the verbatim 'Dosing or Use Regimen/Administration' bullet of Factor 1. The rule tracks the bullet element for element (dosage or use regimen, route of administration, strength) and adds nothing.
- Atomic: one bullet, one comparison against the labeled dosing information; the enumerated elements are facets of a single conflict test rather than separate requirements.
- 'Judgment' is correct — the test covers representations and suggestions, so implied dosing (e.g. a depicted schedule) must be read. It is not settled by presence/absence of a dose string.
- 'Guidance' is correct, 'blocker' is defensible, and the locator is exact. The Escalate condition — a dosing scenario the label does not address either way — is well chosen and matches the source's acknowledgment that labeling does not exhaustively address every scenario, which is exactly when Factors 2 and 3 take over.
- Same applies_when note as the other Factor 1 rules: "promotional" is narrower than the source's 'product communication' framing, which under-includes rather than over-reaches.