{"data":{"id":"us/21-cfr-316.23","jurisdiction":"us","citation":"21 CFR 316.23","heading":"Timing of requests for orphan-drug designation; designation of already approved drugs.","body":"(a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.\n(b) A sponsor may request orphan-drug designation of an already approved drug for an unapproved use without regard to whether the prior marketing approval was for a rare disease or condition.","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":"4ddef46e1ace8cdbb05510dee65dd788dfb8a941a672669cbd7800b28cdc0e21","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-316.22","next":"us/21-cfr-316.24"},"notice":"GroundRules: Original legal text. Not legal advice."}