CGA Releases 2025 Edition of M-2: Standard for the Manufacture of Designated Medical Gases

The Compressed Gas Association (CGA) is proud to announce the publication of the 2025 edition of CGA M-2, Standard for the Manufacture of Designated Medical Gases.

This important update provides medical gas manufacturers with the industry’s go-to resource for maintaining compliance with the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practice (CGMP) requirements for Designated Medical Gases, as outlined in the new 21 CFR Part 213. The timing of this release ensures manufacturers are well-prepared before the new FDA regulations take effect on December 18, 2025.

CGA has been a trusted leader in advancing the safety and quality of medical gases since the FDA first modernized CGMP requirements for pharmaceuticals in 1978. This new edition of M-2 marks a major milestone and provides medical gas manufacturers with a dedicated, comprehensive framework that reflects the unique processes involved in producing these life-saving products.

The 2025 edition of M-2 introduces significant revisions to align with FDA’s new medical gas CGMP rules and emphasizes the differences between the manufacture of gases and traditional pharmaceuticals.

Highlights of what’s new:

  • Updated cleaning requirements due to gases being manufactured in a sealed, closed system.
  • No time limitations on production due to medical gases not having an expiration date.
  • New gauge requirement for portable and small cryogenic containers used by patients to check product supply
  • Clear provisions for salvaging medical gases that were stored improperly, provided containers remain uncompromised

In a major enhancement, this edition also combines requirements for both bulk and cylinder operations into one unified standard. This consolidated resource makes it easier than ever for medical gas manufacturers to implement and maintain compliance with 21 CFR Part 213.

By publishing M-2 ahead of the new FDA rules, CGA continues its commitment to helping members stay ahead of regulatory changes and ensuring that medical gases are manufactured to the highest standards of safety, quality, and reliability.

For more information, be sure to register for CGA’s upcoming webinar to learn more about the FDA’s new rules and the industry’s approach to implementation and compliance.