The Food and Drug Administration (FDA) has published draft guidance entitled “Medical Gases—Current Good Manufacturing Practice” to help manufacturers of medical gases comply with tailored current Good Manufacturing Practices (cGMP) requirements (codified in 21 CFR part 213), that become effective on December 18, 2025.
The conforming amendments to the cGMP requirements for combination products will take effect on February 2, 2026.
This new draft guidance amends and replaces the draft guideline entitled “Current Good Manufacturing Practices for Medical Gases” published in June 2017, and has been drafted to reflect new and revised regulations in various areas, with the aim of reducing, as appropriate, the regulatory burden for the medical gas industry.
Unlike standard pharmaceuticals, medical gases have unique production, storage, and distribution characteristics (e.g. sealed pressurised systems, reusable cylinders, and no typical ‘expiration’ concerns).
These regulations contain the minimum requirements to ensure that manufacturing processes operate according to acceptable quality standards, but are more specifically tailored to the methods of manufacturing, packaging, labeling, storage, and distribution of medical gases.
In addition to aligning with the unique nature of medical gases, the updated regulations include certification and labeling requirements (e.g., warnings statements on oxygen containers) and modified safety reporting provisions.
Comments on the draft guidance may be submitted in electronic or paper format by January 30, 2026.
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