{"data":{"id":"us/21-cfr-4.3","jurisdiction":"us","citation":"21 CFR 4.3","heading":"What current good manufacturing practice requirements apply to my combination product?","body":"If you manufacture a combination product, the requirements listed in this section apply as follows:\n(a) The current good manufacturing practice requirements in parts 210 and 211 of this chapter apply to a combination product that includes a drug constituent part other than a medical gas;\n(b) The current good manufacturing practice requirements in part 820 of this chapter apply to a combination product that includes a device constituent part;\n(c) The current good manufacturing practice requirements among the requirements (including standards) for biological products in parts 600 through 680 of this chapter apply to a combination product that includes a biological product constituent part to which those requirements would apply if that constituent part were not part of a combination product;\n(d) The current good tissue practice requirements including donor eligibility requirements for HCT/Ps in part 1271 of this chapter apply to a combination product that includes an HCT/P; and\n(e) The current good manufacturing practice requirements in part 213 of this chapter apply to a combination product that includes a drug constituent part that is a medical gas.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 4—REGULATION OF COMBINATION PRODUCTS","Subpart A—Current Good Manufacturing Practice Requirements for Combination Products"],"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":"f3c96eb681463b7b86e0efc90d255745cb69edab318ee76b712bb0b4e7d79ac4","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-4.2","next":"us/21-cfr-4.4"},"notice":"GroundRules: Original legal text. Not legal advice."}