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.”