{"data":{"id":"us/21-cfr-111.255","jurisdiction":"us","citation":"21 CFR 111.255","heading":"What is the requirement to establish a batch production record?","body":"(a) You must prepare a batch production record every time you manufacture a batch of a dietary supplement;\n(b) Your batch production record must include complete information relating to the production and control of each batch;\n(c) Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and\n(d) You must make and keep batch production records in accordance with subpart P of this part.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION","PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS","Subpart I—Production and Process Control System: Requirements for the Batch Production Record"],"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":"c4d37aa35cfbcb586d133bf90e573a3ee5806c6767eb6c11550ed0ebac9ec983","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-111.210","next":"us/21-cfr-111.260"},"notice":"GroundRules: Original legal text. Not legal advice."}