{"data":{"id":"us/21-cfr-99.1","jurisdiction":"us","citation":"21 CFR 99.1","heading":"Scope.","body":"(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated:\n(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\n(2) Will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency.\n(b) This part does not apply to a manufacturer's dissemination of information that responds to a health care practitioner's unsolicited request.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 99—DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES","Subpart A—General Information"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"97cd582c31fbea3b789346df10f7c36c7064cb2b0e230c9cb9171a96321a8387","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-82.2707a","next":"us/21-cfr-99.3"},"notice":"GroundRules: Original legal text. Not legal advice."}