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new-fda-regulations-and-enforcement
new-fda-regulations-and-enforcement

New FDA regulations and enforcement

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Since 1938, the US Food and Drug Administration (FDA) established regulations for drug manufacturers. Medical gases are considered prescription drugs and are covered by these regulations. The regulations (21 CFR Part 211) have been revised many times.

In nearly every one of these regulation revisions, the unique aspects of medical gases have not been seriously considered. The regulations largely address traditional pharmaceuticals.

What is so unique about medical gases?

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