2025-21689: Medical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availability

Summary

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Medical Gases--Current Good Manufacturing Practice." This guidance is intended to assist manufacturers of medical gases in complying with regulations for current good manufacturing practice (CGMP) that become effective on December 18, 2025 (note, the conforming amendments to the CGMP requirements for combination products became effective February 2, 2026). These regulations are specific to medical gases for human and animal use and, like all CGMP requirements, contain the minimum requirements to ensure that manufacturing processes operate under a state of control to meet prespecified quality standards for identity, strength, quality, and purity, but are tailored more narrowly to how medical gases are manufactured, packaged, labeled, stored, and distributed. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance entitled "Current Good Manufacturing Practice for Medical Gases" issued in June 2017.

The agency’s own summary, as published.