21 CFR 111.255
§ 111.255 What is the requirement to establish a batch production record?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 111.255, § 111.255 What is the requirement to establish a batch production record?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84179
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Full text
(a) You must prepare a batch production record every time you manufacture a batch of a dietary supplement;
(b) Your batch production record must include complete information relating to the production and control of each batch;
(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
(d) You must make and keep batch production records in accordance with subpart P of this part.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.