FDA Finalizes Key Medical Gas Regulations Praised by CGA | Medical

The U.S. Food and Drug Administration (FDA) has finalized regulations for current good manufacturing practices (CGMP), certification, post-market safety reporting, and labeling requirements for certain medical gases.

Released earlier this month (June 2024), the final rule is the culmination of a thorough process that began in 1978 when FDA recognized the need for separate CGMPs for medical gases and resulted in the proposed rule in May 2022.

The final regulations implement an order in Section 756 of the Consolidated Appropriations Act of 2017 to amend federal drug regulations, particularly medical gases, by 15^vol July 2017.

Commending the news, the Compressed Gas Association (CGA) said the final rule represents a significant step forward in improving the regulatory framework for medical gases, ensuring safety and quality standards are upheld across the industry.

The key provisions of the final rule are as follows:

1. Labeling regulations: The rule codifies standardization requirements for the labeling of all designated medical gases and medically appropriate combinations of these gases. Additional regulations address safety warnings related to the use of oxygen near open flames and smoking
2. CGMP regulations: The new CGMP Medical Gases Regulations set out essential requirements for the production, processing, packaging and storage of medical gases. These new CGMP regulations are more appropriate than the historical CGMP regulations applicable to traditional pharmaceutical products
3. Certification provisions: The FDA has officially established a comprehensive certification process for designated medical gases, replacing guidance that has been in place since designated medical gases were approved in 2012. The process clarifies requirements for certification applications, ownership transfers, and streamlined annual reporting, closely aligning with industry best practices.
4. Post-market quality and safety reporting regulations: New and appropriate requirements for reporting adverse events related to designated human and animal medical gases ensure timely and accurate reporting of information. These regulations increase transparency and patient safety.

John Willenbrock, technical manager at CGA, described the changes as crucial to promoting efficiency and ensuring compliance with rigorous safety standards.

He continued: “This final rule represents FDA’s tailored approach to address the unique properties of medical gases, increasing transparency and consistency in labeling, manufacturing practices, certification processes, and postmarket safety reporting.