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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices |
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Subpart A - General Information |
§ 99.1 - Scope.
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§ 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.