US FDA Medical Gases cGMP

Date: December 1, 2025
Category: US Regulations
Description: On 1 December 2025 the FDA published a revised draft guidance for industry on Medical Gases cGMP, see Medical Gases — Current Good Manufacturing Practice | FDA.
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.