Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements (PDF)

The Food and Drug Administration (FDA) is proposing to amend its current good manufacturing practice (CGMP) regulations to include new requirements for the label, color, dedication, and design of medical gas containers and closures. These requirements are intended to do the following: Make the contents of medical gas containers more readily identifiable, reduce the likelihood that containers of industrial or other gases would be inappropriately connected to medical oxygen supply systems, and reduce the risk of contamination of medical gases. FDA is also proposing to include medical air, oxygen, and nitrogen among, and exclude cyclopropane and ethylene from, those gases intended for drug use that are exempt from certain labeling requirements.

Read the full text of “Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements” (PDF)