---
kind: "section"
citation: "21 C.F.R. § 111.255"
title: "21"
number: "111.255"
heading: "What is the requirement to establish a batch production record?"
url: "https://uscodex.org/cfr/21/111.255"
---

# §111.255. What is the requirement to establish a batch production record?

- (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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

### Source

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.