What 21 CFR Part 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices (FDA Off-Label Information Regime) requires
21 CFR Part 99 governs the dissemination by a manufacturer of written information on a use of an approved or cleared drug, biologic, or device that is not included in the FDA-approved labeling or the cleared statement of intended use (off-label or new-use information), where the information will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency. Section 99.1 sets the scope (it does not apply to a manufacturer's response to an unsolicited request from a health care practitioner). Section 99.3 defines clinical investigation as an investigation in humans that tests a specific clinical hypothesis, and defines health care practitioner, group health plan, health insurance issuer, and pharmacy benefit manager. Section 99.101 permits dissemination of an unabridged reprint of a peer-reviewed article from a scientific or medical journal about a clinical investigation considered scientifically sound by experts qualified by scientific training or experience, or an unabridged reference publication including information about a clinical investigation, provided the drug or device has been approved, licensed, or cleared by FDA, the dissemination does not pose a significant risk to public health, and is not false or misleading. Section 99.103 requires mandatory statements including a prominently displayed disclosure on the front of each reprint reading 'This information concerns a use that has not been approved by the Food and Drug Administration' (for drugs) or 'This information concerns a use that has not been approved or cleared by the Food and Drug Administration' (for devices), disclosure of manufacturer financial sponsorship, and identification of authors with significant financial ties to the manufacturer during the study and one year post-publication. Section 99.105 limits recipients to health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, or Federal or State Government agencies. Section 99.201 requires the manufacturer to submit to FDA, sixty days before disseminating any written information, an identical copy of the information, the bibliography, and any required statements. Section 99.203 lets a manufacturer request to extend the time for completing planned studies. Section 99.205 permits an application for exemption from the requirement to file a supplemental application where it would be economically prohibitive or unethical to conduct the studies necessary. Section 99.301 sets FDA agency action on a submission within 60 days, including determining non-compliance, requiring additional information for objectivity and balance, requiring an FDA-prepared objective statement, or requiring records identifying individual recipients. Section 99.401 provides FDA corrective actions and cessation of dissemination, including an order to cease dissemination after notice and opportunity for a meeting when noncompliance is more than minor or when post-dissemination data show ineffectiveness or significant risk.
Pillar: Medical & Healthcare · Authority: United States Food and Drug Administration, Department of Health and Human Services, implementing section 401 of the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115) and the Federal Food, Drug, and Cosmetic Act under 21 USC 321-393; codified in the Code of Federal Regulations Title 21 Part 99 and maintained on a current basis by the Office of the Federal Register · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99
SHA-256 integrity: 7a8a222c785b751e3a12e7b895e73c109e9d5cfeb23f65b93c2dabb9bdf01f1b
Primary Citations — 12 traced to source
- 21 CFR 99.1 - Scope - Part 99 applies to dissemination of information on human drugs (including biologics) and devices where the information concerns the safety, effectiveness, or benefit of a use not in the approved labeling for an approved drug or device or in the statement of intended use for a cleared device, and will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency; Part 99 does not apply to a manufacturer's dissemination responding to a health care practitioner's unsolicited request
- 21 CFR 99.3 - Definitions - including clinical investigation as an investigation in humans that tests a specific clinical hypothesis, group health plan, health care practitioner, health insurance issuer, manufacturer, and pharmacy benefit manager
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