Oxygen Regulations

The question DAN Members ask DAN's Training Department most often is "How do I get my oxygen cylinder filled. My local gas supplier won't do it for me." The answer to this question comes in two parts:

1) Why Gas Suppliers Won't Fill Cylinders
Physicians prescribe oxygen to individuals for a variety of medical conditions including chronic bronchitis and emphysema. Emergency oxygen administration can create medical complications when used with individuals suffering those or similar ailments (who under training agency standards should not be certified as recreational divers). Emergency oxygen administration outside the context of dive-related accidents requires additional training.

However, the Food and Drug Administration (FDA) has acknowledged the importance of oxygen in medical emergencies and allows for the filling of medical oxygen cylinders for appropriately trained personnel such as DAN Oxygen Providers. Below is an excerpt from one of the FDA's documents related to emergency use of oxygen. This may assist you when dealing with vendors that are requesting a prescription to fill your cylinder. The wording shows that for applications, other than emergencies, a prescription is necessary.
Human Drug CGMP Notes (December 1996, from FDA website)

1) Has FDA modified the federal caution statement requirement for medical oxygen?

Reference: Section 503(b)(4) of the Food Drug and Cosmetic Act; 21 CFR Sections 201(b)(1) and 211.130.

Yes, On September 19, 1996, FDA informed the Compressed Gas Association that a final decision had been reached on its citizen petition. The label for medical oxygen should bear the statement, "For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Caution: Federal law prohibits dispensing without prescription."

State enforcement issues are unsettled. Some, but not all, states classify medical grade oxygen as a prescriptive drug under pharmaceutical or other statutes or regulations comparable to those of the FDA. Most states having these regulations lack clear policy similar to the FDA's policy effectively exempting emergency oxygen administration from its regulatory requirements. States classifying oxygen as a prescriptive drug generally require oxygen to be administered by a physician or under the authority of a physician's prescription. Few state regulations explicitly address emergency first aid oxygen administration, or providers of all types.


2) How Do I Get Around This?
If your local gas suppliers won't fill your oxygen cylinder without a prescription, regardless of your training, you still have a couple of options. The first is to get a prescription. Some physicians will write prospective prescriptions authorizing emergency oxygen use consistent with level of training and diving industry standards This will assure technical compliance with state regulations that may partly address emergency oxygen administration.

Another option is to work with your local EMS systems, so that oxygen administration occurs under the auspices of some system explicitly authorized to administer emergency oxygen.