FDA Issues New Guidance on CGMP for Medical Gases

2nd December 2025

FDA Issues New Guidance on CGMP for Medical Gases

Summary: The new guidance ― “Medical Gases: Current Good Manufacturing Practice (CGMP)” ― is designed to help manufacturers comply with tailored CGMP rules for medical gases, which will take effect on 18 December 2025 under a newly finalised rule.  Unlike standard pharmaceuticals, medical gases have unique production, storage, and distribution characteristics (e.g. sealed pressurised systems, reusable cylinders, and no typical ‘expiration’ concerns). The guidance covers key areas such as quality-unit responsibilities, equipment maintenance and calibration, container closure systems, filling and testing procedures, labelling, packaging, storage, distribution, and record-keeping. As well as aligning with the unique nature of medical gases, the revised regulations include certification and labelling requirements (e.g. warning statements on oxygen containers), and modified safety-reporting provisions.

Link: Medical Gases – Current Good Manufacturing Practice (CGMP)

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