---
kind: "section"
citation: "21 C.F.R. § 212.80"
title: "21"
number: "212.80"
heading: "What are the requirements associated with labeling and packaging PET drug products?"
url: "https://uscodex.org/cfr/21/212.80"
---

# §212.80. What are the requirements associated with labeling and packaging PET drug products?

- (a) A PET drug product must be suitably labeled and packaged to protect the product from alteration, contamination, and damage during the established conditions of shipping, distribution, handling, and use.
- (b) Labels must be legible and applied so as to remain legible and affixed during the established conditions of processing, storage, handling, distribution, and use.
- (c) All information stated on each label must also be contained in each batch production record.
- (d) Labeling and packaging operations must be controlled to prevent labeling and product mix-ups.

## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 352, 355, 371, 374; Sec. 121, Pub. L. 105-115, 111 Stat. 2296.

### Source

Source: 74 FR 65431, Dec. 10, 2009, unless otherwise noted.