Final Rule Modifies Requirements for Medical Gas Containers

Oxygen and nitrogen were added to the list of medical gases subject to conditional label exemptions, while cyclopropane and ethylene were removed, according to a final rule from the FDA.

The rule also requires that portable cryogenic medical gas containers lacking permanent gas use outlet connections to have gas-specific connections that cannot be readily removed or replaced, except by the manufacturer.

It also modifies the proposed rule to add a warning statement for oxygen labeling, and expands the proposed rule’s scope to include medically appropriate mixtures of medical gases. The rule also requires that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming and color requirements.