Regulatory Focus™ > News Articles > Following Injuries and Deaths, FDA Amends Regulations on CGMP and Labeling of Medical Gases

Following Injuries and Deaths, FDA Amends Regulations on CGMP and Labeling of Medical Gases

Posted 17 November 2016 | By Zachary Brennan 

Following Injuries and Deaths, FDA Amends Regulations on CGMP and Labeling of Medical Gases

The US Food and Drug Administration (FDA) on Thursday amended its current good manufacturing practice (CGMP) and labeling regulations for medical gases.

The changes come as the agency cites “a number of incidents” where medical gas containers holding gases other than oxygen were erroneously connected to a health facility’s oxygen supply system, leading to serious injuries and deaths.

“The final rule is intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container,” FDA said in the Federal Register. “The final rule also modifies the medical gas conditional labeling exemption regulation such that it now largely reflects existing industry best practices and FDA’s current regulatory expectations regarding the labeling of medical gases.”

In terms of specifics, FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer.

The agency is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming and color requirements.

FDA is also revising an existing regulation that conditionally exempts certain medical gases, which are generally regulated as prescription drugs, from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.

The finalization of the rule comes more than a decade after FDA issued a proposed rule and follows an evaluation of about 50 comments, which the agency addresses.

“The rule is expected to provide a modest net social benefit (estimated benefits minus estimated costs) to society,” FDA said.

Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements: Final Rule


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