Current Good Manufacturing Practice for Medical Gases

• By: Staff Editor
• Date: February 13, 2017

Current Good Manufacturing Practice for Medical Gases

The FDA recently amended its CGMP (current good manufacturing practice) and labeling regulations for medical gases. The agency requires that portable cryogenic medical gas containers that are not manufactured with a permanent gas use outlet connection must have gas-specific use outlet connections that cannot be removed nor replaced, except by the manufacturer.

FDA also requires that portable cryogenic medical gas containers as well as high pressure medical gas cylinders adhere to stipulated naming, labelling, and color requirements.

The Purpose of the Rule

The chief requirements of the rule seek to:

• Ensure that the contents of the medical gas containers are accurately identified
• Reduce instances or incidents where the wrong gas is connected to a gas supply system or container

The Proposed Rule and the Final Rule

On April 10, 2006, the FDA first issued a proposed rule to modify the regulations on CGMP to embrace new requirements for labeling, design, and color of medical gas containers and closures. While the final rule retains most provisions of the 2006 proposed rule, there are nevertheless some modifications. This includes key amendments like removing cyclopropane and ethylene from the list of medical gases in § 201.161(a), and adding oxygen and nitrogen to the list.

The rule is effective since January 17, 2017. This guidance will explore the purpose of the final rule, provide a summary of the major provisions of the rule, highlight the legal authority of the rule, and also offers an analysis of the environmental impact of the rule.