21 CFR 99.1: Scope.

(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated:

(1) Concerns the safety, effectiveness, or benefit of a use that is not included in the approved labeling for a drug or device approved by the Food and Drug Administration for marketing or in the statement of intended use for a device cleared by the Food and Drug Administration for marketing; and

(2) Will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency.

(b) This part does not apply to a manufacturer's dissemination of information that responds to a health care practitioner's unsolicited request.