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What are the Registration Requirements for Oxygen and/or Medical Gases?

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What are the Registration Requirements for Oxygen and/or Medical Gases?

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Oxygen and/or medical gases for medical purposes are considered prescription drugs under registration and licensure requirements. If a facility is manufacturing or transfilling oxygen or other medical gases, they must register as a Manufacturer of prescription products and apply for licensure. A facility that is purchasing and reselling filled oxygen units/cylinders to another facility or business must register as a Distributor of prescription products and apply for licensure. A facility selling filled oxygen units/cylinders directly to the ultimate user/patient only needs to register as a Distributor of prescription products (application for licensure is not required). Note: Registration as a Distributor of prescription products permits the handling and selling of other medical devices or durable medical equipment.

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