FDA's New Proposed Rule for Medical Gases

The Food and Drug Administration (FDA) issued a proposed rule on April 10 designed to make the contents of medical gas containers more readily identifiable, in order to prevent deaths and injuries from inadvertent use of incorrect medical gas or from use of contaminated medical gas. Between 1996 and 2006, the agency received reports of medical gas mix-ups that resulted in at least 8 deaths and 18 serious injuries.

All medical gases are prescription drugs regulated by FDA and, accordingly, must be manufactured and distributed in compliance with applicable laws and regulations, including existing FDA Current Good Manufacturing Practice (CGMP) regulations. In the Federal Register of May 6, 2003 (68 FR 24005), FDA announced the availability of a draft guidance for industry entitled "Current Good Manufacturing Practice for Medical Gases" (draft guidance). The draft guidance provides recommendations for CGMP compliance in the manufacture and distribution of medical gases which are intended to avoid medical gas mix-ups and contamination.

Go to www.GMPTrainingSystems.com/asp/resources.asp where you can download and read:

• FDA's Press Release issued April 10, 2006
• FDA's Questions and Answers on this new proposal
• cGMP for Medical Gases (draft guidance)

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