21 CFR § 213.80 - General requirements.
---
identifier: "/us/cfr/t21/s213.80"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 213.80 - General requirements."
title_number: 21
title_name: "Food and Drugs"
section_number: "213.80"
section_name: "General requirements."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "213"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360b, 360ddd, 360ddd-1, 371, 374."
regulatory_source: "89 FR 51770, June 18, 2024, unless otherwise noted."
cfr_part: "213"
---
# 213.80 General requirements.
(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.