21 CFR 213.80
§ 213.80 General requirements.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 213.80, § 213.80 General requirements, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86046
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Full text
(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components, incoming designated medical gases, and medical gas containers and closures; such written procedures shall be followed.
(b) Components, incoming designated medical gases, and medical gas containers and closures shall at all times be handled and stored in a manner to prevent contamination and mix-ups.
(c) Lots of incoming designated medical gases or components, whether used directly as supply or commingled with an existing supply, shall be assigned a unique identification number.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.