{"data":{"id":"us/21-cfr-316.28","jurisdiction":"us","citation":"21 CFR 316.28","heading":"Publication of orphan-drug designations.","body":"Each month FDA will update a publicly available cumulative posting of all drugs designated as orphan drugs. These postings will contain the following information:\n(a) The name and address of the sponsor;\n(b) The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug;\n(c) The date of the granting of orphan-drug designation;\n(d) The designated use in the rare disease or condition; and\n(e) If the drug loses designation after August 12, 2013, the date of it no longer having designation.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 316—ORPHAN DRUGS","Subpart C—Designation of an Orphan Drug"],"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":"9bb7dbfcf9c19da0ff8a0a7ec26e312de8305a7a3909886860146a761da50e92","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-316.27","next":"us/21-cfr-316.29"},"notice":"GroundRules: Original legal text. Not legal advice."}