When Can I Sell Medical Oxygen?

On its face, this seems like a simple question. However, there are some interesting exceptions and conditions for selling medical oxygen. Below are the answers to seven questions about the sale of medical oxygen.

Can I sell medical oxygen to a patient with a prescription?
Yes, if a patient presents you with a valid prescription, and if you are licensed to sell medical gases, you are permitted to sell medical oxygen directly to the patient.

Can I sell medical oxygen to a fire department or Emergency Medical Service (EMS) without a prescription?
Yes. According to the 2003 Draft Medical Gas Guidance, the FDA states: If a medical gas company sells medical oxygen to emergency medical services for emergency use, the label would 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.”

FDA would not prohibit the sale of medical oxygen with this labeling to emergency medical services without a prescription.

Can I sell medical oxygen to a doctor, hospital or clinic without a prescription?
Yes, if they have a valid medical license, you may sell medical oxygen to them. Keep in mind that the licensing of medical businesses is regulated by the states and the licensing and commercial requirements vary from state to state.

Can I sell medical oxygen to a school, airport or company without a prescription?
Yes, in certain limited circumstances. The agency allows medical oxygen to be dispensed without a prescription to properly trained individuals for oxygen deficiency and resuscitation, as long as the following conditions are met:

  1. A high-pressure cylinder filled with medical oxygen and used for oxygen deficiency and resuscitation must have the “emergency use” statement present on the drug label. See above.
  2. The equipment intended for such use must deliver a minimum flow rate of 6 liters of oxygen per minute for a minimum of 15 minutes, and include a content gauge and an appropriate mask or administration device.
  3. Proper training is documentation that an individual has received training within the past 24 months, or other appropriate interval, in the use of emergency oxygen, including providing oxygen to both breathing and non-breathing patients, and safe use and handing of emergency oxygen equipment. Training may be obtained from any nationally recognized professional organization, such as the National Safety Council, the American Heart Association, the American Red Cross, etc.
  4. Under no circumstances can emergency oxygen be used to fill high-pressure cylinders or be used in a mixture or blend.
  5. Once all of these conditions are met, an individual or firm may have access to medical oxygen without a prescription.

Can I sell medical oxygen to scuba shops for routine diving use?
No, scuba diving is not a medical application. However, medical oxygen can be sold for emergency care or treatment at the scene of a diving emergency if the conditions in question 4 are met.

Can I sell medical oxygen for aircraft pilot use?
No, Aviator Breathing Oxygen is not a medical application. However, medical oxygen can be sold to EMSs for patient use in LifeFlights.

Can I sell medical oxygen for maritime use?
Yes, in certain circumstances. For United States flag vessels, the medical oxygen must be supplied via a valid prescription or to a licensed medical doctor. For foreign flag vessels, the ship must produce a certificate of proficiency of medical care.

Gases and Welding Distributors Association
Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachusetts. Members can reach him at 508-883-0927 and tom@asteriskllc.com.