The U.S. Food and Drug Administration has published the revised draft guidance for industry, Medical Gases — Current Good Manufacturing Practice.

On June 18, 2024, FDA issued a final rule that established requirements more specifically tailored to medical gases to better address the unique characteristics of these drugs. The final rule, which becomes effective on December 18, 2025, is intended to reduce the regulatory burden for the medical gas industry. This deregulatory effort addressed several areas in which either new regulations were needed, or existing regulations required revision because they were not well-suited for medical gases.  One area where new regulations were established was current good manufacturing practice (CGMP).

This guidance is intended to assist manufacturers of medical gases in complying with the new CGMP regulations, once effective. These new CGMP regulations  are specific to medical gases for human and animal use. Like all CGMP regulations, they serve to ensure products meet quality standards for identity, strength, quality, and purity. However, they are specifically tailored to reflect the unique ways in which medical gases are manufactured, packaged, labeled, stored, and distributed.   [FDA]