---
kind: "section"
citation: "21 C.F.R. § 226.80"
title: "21"
number: "226.80"
heading: "Packaging and labeling."
url: "https://uscodex.org/cfr/21/226.80"
---

# §226.80. Packaging and labeling.

- (a) Packaging and labeling operations shall be adequately controlled:
  - (1) To assure that only those Type A medicated article(s) that have met the specifications established in the master-formula records shall be distributed.
  - (2) **To prevent mixups during the packaging and labeling operations.**
  - (3) **To assure that correct labeling is employed for each Type A medicated article(s).**
  - (4) To identify Type A medicated article(s) with lot or control numbers that permit determination of the history of the manufacture and control of the batch of Type A medicated article(s).
- (b) Packaging and labeling operations shall provide:
  - (1) **For storage of labeling in a manner to avoid mixups.**
  - (2) For careful checking of labeling for identity and conformity to the labeling specified in the batch-production records.
  - (3) For adequate control of the quantities of labeling issued for use with the Type A medicated article(s).
- (c) Type A medicated article(s) shall be distributed in suitable containers to insure the safety, identity, strength, and quality of the finished product.

## Notes

### Authority

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

### Source

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