Public response should convey the question involves an unapproved/uncleared use

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

Rule

The firm's public response should convey that the question pertains to an unapproved or uncleared use of the product.

Check

Check the public response for language identifying the question as pertaining to an unapproved or uncleared use of the product.

Escalate when

Whether the response adequately conveys that the question involves an unapproved or uncleared use is debatable.

Where this comes from

Section VI, Recommendation 2 · page 14. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…istributes Drug/Device X, which is not FDA-approved or cleared for Condition Y, the firm should not respond to the request because the question is not specific to Drug/Device X. 2. A firm’s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm’s contact information and should not include any off-label information. \ The firm’s public response should convey that the question pertains to an unapproved or uncleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information. \ The firm’s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication. After an individual has privately contacted a firm for…

Open the original at page 14 on fda.gov ↗Read our full copy →

Document: FDA guidance: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (see document)
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: 8ab6bfda34ad39a70987805b…

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

Applies when

Basisunsolicited-request

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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported by Section VI, Recommendation 2, first bullet, lines 396-399; the rule tracks it closely and keeps 'should'.
- Not atomic. It bundles two independently checkable content elements: (a) conveying that the question pertains to an unapproved or uncleared use, and (b) stating that individuals can contact the medical/scientific representative or medical affairs department for more information. A public response can satisfy either one without the other, and the check already reads as two separate lookups.
- Judgment is correct - whether the response 'conveys' the unapproved-use point and gives a clear referral is an evaluative reading rather than a literal match.
- Authority guidance, Section VI locator and warning severity are appropriate; the quote is a complete sentence.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete Section VI Recommendation 2 bullet with its own subject ('The firm's public response should ...'), so it does not depend on the lead-in.
- The quote contains two requirements, but the rule takes only the first (conveying that the question involves an unapproved or uncleared use), so the rule itself is atomic. The contact-statement half is left to its own rule.
- The rule keeps 'should'. Whether the response 'conveys' this is a judgment call. The locator is correct.

Nearby rules

US-SCI-009 US-SCI-010 US-SCI-039