21 CFR § 111.255 - What is the requirement to establish a batch production record?

---
identifier: "/us/cfr/t21/s111.255"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 111.255 - What is the requirement to establish a batch production record?"
title_number: 21
title_name: "Food and Drugs"
section_number: "111.255"
section_name: "What is the requirement to establish a batch production record?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "111"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264."
regulatory_source: "72 FR 34942, June 25, 2007, unless otherwise noted."
cfr_part: "111"
---


# 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.