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FDA - US Food and Drug Administration
Center for Drug Evaluation and Research

Fresh Air "2000" - A look at FDA's Medical Gas Requirements
(excerpted summary)

Fresh Air "2000" provides FDA's interpretation of how the minimum current good manufacturing practice (CGMPs) regulations apply to the manufacturing, filling, transfilling cascading, etc. of medical gases compressed and cryogenic. Please note this presentation is not all-inclusive.

(Edit. Note:) The following paragraph on page 13 provides the exemption for emergency oxygen from prescription RX requirements . Please read the "--- or for emergency use,..." phrase. It is not easy to interpret but the FDA does confirm therein that Emergency Oxygen remains Non-Prescription.
However, if a firm sells Oxygen U.S.P. to emergency medical services, i.e.' fire departments, rescue squads, ambulance companies, etc. or for emergency use, then the label is required to contain the statement: "For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx Only."

(Edit. Note:) The following paragraph does appear on page 1 of 32, and it causes much confusion in the Emergency Oxygen industry, because you have to read page 13 to find the exemption.
Medical gases are prescription drugs that must be dispensed by prescription only. Each firm has a responsibility to determine if its consignee, not the patient is authorized to purchase the drug gas, and if required, is registered with FDA, and properly licensed with the state, where required prior to selling them medical gas.

(Edit. Note:) The following further clarifies the present policy above, in an often quoted FDA policy letter.
In a letter dated 19 September, 1996 to the Compressed Gas Association from the FDA administration regarding the use and labeling of emergency oxygen, the FDA states: "FDA recognizes that there are medical emergencies in which there is not sufficient time to seek the assistance of a physician or hospital before the administration of medical oxygen may be necessary. In such emergencies, it is desirable that properly trained personnel ... be prepared and equipped to administer oxygen to persons in immediate need of oxygen. In these situations, the FDA believes that medical oxygen should be available. This has been the agency's position for more than 40 years."


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