WASHINGTON, Dec. 1 -- Food and Drug Administration has issued a notice called: Medical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Dec. 1 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Medical Gases-Current Good Manufacturing Practice."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 CG...