21 CFR §99.1

1. (a)This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated:
   1. (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. (2)Will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency.
2. (b)This part does not apply to a manufacturer's dissemination of information that responds to a health care practitioner's unsolicited request.