§ 99.1. Scope.
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/us/cfr/t21/s§ 99.1·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.