FDA Issues Draft Guidance on CGMPs for Medical Gases

The Food and Drug Administration issued an updated draft guidance document on current good manufacturing practices for medical gases, it said (here). The updated guidance provides additional information “regarding the application of certain regulations to medical gases,” FDA said in the draft (here). “This guidance is expected to reduce the regulatory compliance burden for the medical gas industry by providing clear, up-to-date, detailed recommendations regarding CGMP issues that have been the subject of industry questions,” it said. The document supersedes draft guidance on CGMPs for medical gases issued by FDA in 2003. Comments are due Aug. 28.