Current Good Manufacturing Practice for Medical Gases
The CGMP regulation written for medical gases, in force since 18 December 2025. It contains "the minimum current good manufacturing practice for preparation of medical gases for administration to humans or animals" (213.1), and Part 211 now excludes medical gases from its scope (211.1(a)). Part 230, published in the same rule, sets certification and postmarketing reporting for designated medical gases.
Always verify against the current published text before relying on it for a submission or inspection.
Scope & applicability
Manufacturers, fillers, transfillers, packers and holders of medical gases for human or animal use, including designated medical gases such as oxygen and nitrogen as defined in section 575(1) of the FD&C Act.
Key requirements
- §213.22 — a quality unit with authority to approve or reject components, containers and closures, labelling and medical gases, and to review production records
- §213.82 — on receipt of an incoming designated medical gas, full compendial testing or a signed certificate of analysis with the required content, plus an identity test
- §213.94 — containers and closures that do not alter the gas, with gas-specific use outlet connections on portable cryogenic containers
- §213.165 — laboratory determination of conformance to final specifications, including identity and strength, before release of each batch
- §213.67 and §213.68 — written cleaning and maintenance procedures, calibration of automatic equipment and validation of computerised systems
Implementation tips
- Rebase procedures written to Part 211 on Part 213 section by section; the numbering follows Part 211 closely, but several provisions are adapted to sealed gas systems and some do not carry over
- Treat the certificate of analysis as evidence only if your supplier-reliability programme under §213.82(a)(2) shows it can be trusted
Revision notes
New part, published 18 June 2024 (89 FR 51738) and in force 18 December 2025; Part 211 was amended at the same time to exclude medical gases. eCFR shows no amendment to Part 213 since.
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21 CFR Part 213: frequently asked questions
Quick answers to common questions about 21 CFR Part 213.
What is 21 CFR Part 213?
21 CFR Part 213 — Current Good Manufacturing Practice for Medical Gases — is a regulation issued by the Food and Drug Administration (United States). The CGMP regulation written for medical gases, in force since 18 December 2025. It contains "the minimum current good manufacturing practice for preparation of medical gases for administration to humans or animals" (213.1), and Part 211 now excludes medical gases from its scope (211.1(a)). Part 230, published in the same rule, sets certification and postmarketing reporting for designated medical gases.
Who does 21 CFR Part 213 apply to?
Manufacturers, fillers, transfillers, packers and holders of medical gases for human or animal use, including designated medical gases such as oxygen and nitrogen as defined in section 575(1) of the FD&C Act.
What are the key requirements of 21 CFR Part 213?
FDA 21 CFR Part 213 requires, among other things: §213.22 — a quality unit with authority to approve or reject components, containers and closures, labelling and medical gases, and to review production records; §213.82 — on receipt of an incoming designated medical gas, full compendial testing or a signed certificate of analysis with the required content, plus an identity test; §213.94 — containers and closures that do not alter the gas, with gas-specific use outlet connections on portable cryogenic containers; §213.165 — laboratory determination of conformance to final specifications, including identity and strength, before release of each batch.
When was 21 CFR Part 213 last updated?
The current version of 21 CFR Part 213 dates from December 2025. New part, published 18 June 2024 (89 FR 51738) and in force 18 December 2025; Part 211 was amended at the same time to exclude medical gases. eCFR shows no amendment to Part 213 since.
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