Compressed Gas Association Welcomes FDA’s Long-Awaited Final Rule on Medical Gases

[Mclean, VA, June 26, 2024] – The Compressed Gas Association (CGA) applauds the U.S. Food and Drug Administration (FDA) for finalizing the long-anticipated rule on Current Good Manufacturing Practice (CGMP), Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases. This final rule marks a significant step forward in enhancing the regulatory framework governing medical gases, ensuring both safety and quality standards are upheld across the industry.

The FDA’s final rule, issued on June 18, 2024, culminates a thorough process that began in 1978 when FDA acknowledged the need for separate CGMPs for Medical Gases and resulted in proposed rules in May 2022. This final rule fulfills the mandate under section 756 of the Consolidated Appropriations Act, 2017, to revise federal drug regulations specific to medical gases by July 15, 2017.

“This final rule represents a tailored approach by the FDA to address the unique characteristics of medical gases, enhancing clarity and consistency in labeling, manufacturing practices, certification processes, and postmarketing safety reporting,” said John Willenbrock, Technical Manager at CGA. “These changes are pivotal in promoting efficiency and ensuring compliance with rigorous safety standards.”

Key Provisions of the Final Rule:

  1. Labeling Provisions: The rule codifies standardized labeling requirements for all designated medical gases and medically appropriate combinations of those gases.  Additional provisions address safety warnings related to oxygen use near open flames and smoking.
  2. CGMP Provisions: New CGMP regulations specific to medical gases outline essential requirements for manufacturing, processing, packaging, and holding of medical gases.  These new CGMP regulations are more appropriate than the historic CGMP regulations applicable to traditional pharmaceuticals.
  3. Certification Provisions: The FDA has officially established a comprehensive certification process for designated medical gases replacing guidance in effect since designated medical gases were deemed approved in 2012. This process clarifies requirements for certification requests, transfers of ownership, and streamlined annual reporting, aligning closely with industry best practices.
  4. Postmarketing Quality and Safety Reporting Provisions: The new and appropriate reporting requirements for adverse events associated with designated medical gases in human and animal use ensure timely and thorough submissions. These provisions bolster transparency and patient safety.

CGA issued a regulatory alert for members, RA-266, which is available on the CGA’s website. A full copy of the notice is included with RA-266.

This notice can also be found in the Federal Register.


About CGA:

CGA, founded in 1913, is an ANSI-accredited standards developing organization that is dedicated to the development and promotion of safety standards and safe practices in the industrial, medical, and food gases industry. CGA represents over 160-member companies in all facets of the industry — manufacturers, distributors, suppliers, and transporters of gases, cryogenic liquids, and related products and services. Through a committee system, CGA develops technical specifications, safety standards, and training and educational materials, and works with government agencies to formulate responsible regulations and standards and to promote compliance with these regulations and standards.

Media Contact:

Paul Pflieger
Director of Marketing, Communications, and Events
Compressed Gas Association