---
kind: "section"
citation: "21 C.F.R. § 213.89"
title: "21"
number: "213.89"
heading: "Rejected components, incoming designated medical gases, and medical gas containers and closures."
url: "https://uscodex.org/cfr/21/213.89"
---

# §213.89. Rejected components, incoming designated medical gases, and medical gas containers and closures.


Rejected components, incoming designated medical gases, and medical gas containers and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable and shall be documented and assessed.


## Notes

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360b, 360ddd, 360ddd-1, 371, 374.

### Source

Source: 89 FR 51770, June 18, 2024, unless otherwise noted.