Overview of Regulatory Updates

The Medical Gases Committee has undertaken significant work to update critical publications following the FDA’s Final Rule, which amends several sections of Title 21 of the U.S. Code of Federal Regulations (CFR). Released on June 18, 2024, this Final Rule introduces revisions affecting current good manufacturing practice (CGMP), postmarketing safety reporting (pharmacovigilance), and, most notably for companies involved with compressed gases, labeling requirements for designated medical gases.

Revised CGA Publications

To support members in achieving compliance by the effective date of December 18, 2025, the Compressed Gas Association (CGA) has released updates to the following key documents:

• M-2: Standard for the Manufacture of Medical Gases Classified as Drugs
• M-7: Standard for Qualifying Suppliers Used by Medical Gas Manufacturers, Equipment Manufacturers, and Distributors
• M-21: Guideline for Determining Pharmacovigilance Reporting Requirements in North America
• M-23: Standard for Regulatory Classification of Medical Device Gases

Industry Actions and Recommendations

Industry stakeholders—especially those managing medical oxygen and medical air—should take several important steps to ensure compliance with the new requirements. These include reviewing and revising internal procedures, updating staff training materials, and working closely with suppliers to confirm that all labeling and reporting processes are consistent with the revised standards ahead of the December 18, 2025 compliance deadline.

Emphasis on Patient Safety and Communication

The updated regulations highlight an increased focus on patient safety and clear hazard communication. This focus is especially critical as medical gases are increasingly used in home healthcare settings, where patients and caregivers may have limited formal safety training. The revisions aim to enhance safety and ensure that all stakeholders are well informed about the proper handling and reporting of medical gases.