{"data":{"id":"us/21-cfr-207.3","jurisdiction":"us","citation":"21 CFR 207.3","heading":"Bulk drug substance.","body":"Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in § 207.3(a)(4), means the same as “active pharmaceutical ingredient” as defined in § 207.1.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER C—DRUGS: GENERAL","PART 207—REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE","Subpart A—General"],"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":"a4733a297427d1852c9e25ab3a218702a4cf59e45826cc22545a1915984321c3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-207.1","next":"us/21-cfr-207.5"},"notice":"GroundRules: Original legal text. Not legal advice."}