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Category: Supplying Medical Oxygen

What is cGMP and why is it important?

September 05, 2013 by Kristen Cifranic

The Food, Drug and Cosmetic Act states that a drug, such as medical oxygen is adulterated and subject to legal action if it is not manufactured in accordance with the current good manufacturing practices (CGMPs), or does not comply with appropriate official standards such as strength and quality as cited in the United States Pharmacopoeia/National Formulary (U.S.P./NF). So what does that mean to Oxygen Providers? Heres an example. Terry, who owns a struggling home health care business in a ruralarea, decides to save money by supplying his patients with industrial oxygen rather than the more costly medical oxygen. He has a local welding distributor deliver industrial oxygen cylinders to his garage where he removes the cylinder labels, places the unlabeled cylinders in the bed of his pickup truck, and delivers them to patients. One of Terrys patients is severely injured from breathing oxygen contaminated with acetylene gas. The FDA is notified and with the aid of U. S. Marshals seizes

Posted in CGMP, Supplying Medical Oxygen

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