---
kind: "section"
citation: "21 C.F.R. § 226.102"
title: "21"
number: "226.102"
heading: "Master-formula and batch-production records."
url: "https://uscodex.org/cfr/21/226.102"
---

# §226.102. Master-formula and batch-production records.

- (a) For each Type A medicated article(s) master-formula records shall be prepared, endorsed, and dated by a competent and responsible individual and shall be independently checked, reconciled, endorsed, and dated by a second competent and responsible individual. The record shall include:
  - (1) **The name of the Type A medicated article(s) and a specimen copy of its label.**
  - (2) The weight or measure of each ingredient, adequately identified, to be used in manufacturing a stated weight of the Type A medicated article(s).
  - (3) A complete formula for each batch size, or of appropriate size in the case of continuous systems to be produced from the master-formula record, including a complete list of ingredients designated by names or codes sufficiently specific to indicate any special quality characteristics; an accurate statement of the weight or measure of each ingredient, except that reasonable variations may be permitted in the amount of ingredients necessary in the preparation of the Type A medicated article(s), provided that the variations are stated in the master formula; an appropriate statement concerning any calculated excess of an ingredient; and a statement of the theoretical yield.
  - (4) Manufacturing instructions for each type of Type A medicated article(s) produced on a batch or continuous operation basis, including mixing steps and mixing times that have been determined to yield an adequately mixed Type A medicated article(s); and in the case of Type A medicated article(s) produced by continuous production run, any additional manufacturing directions including, when indicated, the settings of equipment that have been determined to yield an adequately mixed Type A medicated article(s) of the specified formula.
  - (5) **Control instructions, procedures, specifications, special notations, and precautions to be followed.**
- (b) A separate batch-production and control record shall be prepared for each batch or run of Type A medicated article(s) produced and shall be retained for at least 2 years after distribution by the manufacturer has been completed. The batch-production and control record shall include:
  - (1) **Product identification, date of production, and endorsement by a competent and responsible individual.**
  - (2) Records of each step in the manufacturing, packaging, labeling, and controlling of the batch, including dates, specific identification of drug components used, weights or measures of all components, laboratory-control results, mixing times, and the endorsements of the individual actively performing or the individual actively supervising or checking each step in the operation.
  - (3) A batch number that permits determination of all laboratory-control procedures and results on the batch and all lot or control numbers appearing on the labels of the Type A medicated article(s).

## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 360b, 371, 374.

### Source

Source: 40 FR 14031, Mar. 27, 1975, unless otherwise noted.