Accompany unsolicited-request response with FDA-required labeling, if any

DisputedwarningFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

Information distributed in response to an unsolicited request should be accompanied by a copy of the FDA-required labeling, if any, for the product (e.g., the FDA-approved package insert, or patient labeling/client information sheet as applicable).

Check

Confirm a copy of the FDA-required labeling, if any, for the product is included with or attached to the response. Do not flag the absence of FDA-required labeling for products that have no such labeling.

Where this comes from

Section V, Recommendation 6 (A copy of the FDA-required labeling bullet) · page 12. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: Information distributed in response to an unsolicited request should be accompanied by the following:

…rly documenting responses. By contrast, because sales and marketing personnel are focused by training and experience on promoting a firm’s products, FDA recommends that sales and marketing personnel have no input on the content of responses to unsolicited questions or requests for off-label information. 6. Information distributed in response to an unsolicited request should be accompanied by the following: \ A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet) \ A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided \ A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product \ A prominent statement providing all important safety information including, if applicable, any boxed warning for the product \ A complet…

Open the original at page 12 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

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported by Section V, Recommendation 6, which lists a copy of the FDA-required labeling among the items that should accompany a response.
- The quote is a bare bullet fragment - a noun phrase with no subject or modality. Detached from the lead-in at lines 300-301 it does not state a requirement at all, so as quoted it does not establish the rule.
- The source says 'the FDA-required labeling, if any'; the rule and check drop the qualifier and demand the labeling unconditionally. Because the rule is scoped to drugs and devices alike, and the guidance expressly covers devices marketed without individual approval or clearance, dropping 'if any' broadens the requirement beyond the source.
- The title and check say 'current' FDA-required labeling. 'Current' appears in the Section VI public-response recommendation (line 431), not in this Section V bullet, so it is imported from a different recommendation.
- Deterministic is correct - whether a labeling copy is enclosed is a presence question. Authority guidance and warning severity are fine.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported by the first bullet of Section V, Recommendation 6: 'A copy of the FDA-required labeling, if any, for the product (...)'. The rule keeps 'should' and 'if any'.
- The quote is only the list's lead-in, with the stray list number '6.', and does not contain the labeling requirement at all.
- The deterministic flag is correct, because whether the labeling copy is present settles it. The rule is atomic.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The rule text faithfully restates the first bullet of Section V Recommendation 6 with 'should', and the check correctly exempts products with no FDA-required labeling.
- The quote is a bare list item ('A copy of the FDA-required labeling, if any...') with no lead_in; the recommendation itself lives only in the non-adjacent lead-in sentence.
- The title 'Accompany unsolicited-request response with FDA-required labeling, if any' is a bare command for a guidance 'should'.
- Section V applies to private responses to non-public unsolicited off-label requests; the rule text does not carry that limit.
- Deterministic is correct: presence of the labeling copy settles it.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Quote plus lead_in from Section V, Recommendation 6 establishes that the response should be accompanied by a copy of the FDA-required labeling, if any; the rule body and check follow faithfully, including the 'if any' carve-out and consumer/animal-drug examples.
- Deterministic is correct: presence or absence of the labeling copy settles it.
- The title 'Accompany unsolicited-request response with FDA-required labeling, if any' is a bare imperative, turning a non-binding 'should' recommendation into a command.