The FDA and state regulations recognize the traditional distribution of typical prescription drugs:
This distribution model works well for traditional drugs. The FDA, state Boards of Pharmacy and regulations are well structured to efficiently manage traditional pharmaceuticals. These structures are not necessarily perfectly formed for medical gas distribution.
From the drug manufacturer to the wholesale drug distributor to the pharmacy to the patient.
Typical pharmaceuticals are:
- Relatively dangerous
- Have a container that is inexpensive and disposable
- Subject to counterfeiting for economic advantage
- Subject to diversion from established distribution channels to internet and unlicensed sales
- Manufactured by relatively few, large firms with wide distribution for each drug package
Medical gases are:
- Relatively safe (most medical gases exist in the atmosphere at lesser concentrations)
- Have a container that is very expensive and reusable
- Typically, not subject to counterfeiting — e.g., there is an insignificant economic advantage to counterfeiting oxygen
- Not subject to diversion, internet or unlicensed sales — the cylinder asset is so valuable that the distribution channel is closely controlled
- Manufactured by many small firms with relatively local distribution for each drug package
Because of the fundamental uniqueness of medical gases and the variety of special medical gas applications, questions often arise about the appropriate distribution of medical gases. Here are 16 examples to clarify the rule and the exceptions:
Medical Gas Distribution Cases
A. Can I sell medical gas to another medical gas manufacturer, medical gas distributor, pharmacy or traditional pharmaceutical manufacturing company? Yes. In most situations, the company selling the medical gas and the company buying the medical gas must be licensed by the state for the sale, distribution or manufacturing of drugs. The specific licensure/permitting requirements vary by state. Usually, you must be licensed in your state and in the state of your customer.
B.Can I sell medical gas directly to a medical clinic or hospital? Yes, if the clinic or hospital is medically licensed by the state.
C. Can I sell medical gas directly to a non-medical clinic? Not usually. If the clinic is not medically licensed by the state, it is not able to buy prescription drugs for non-emergency use. See the emergency use question below (H). Examples of non-medically licensed clinics are cryosaunas. Cryosaunas may have business licenses or other non-medical licenses that do not enable them to purchase prescription drugs or medical gases. Typically, a medical doctor may purchase medical gases for a clinic under his license. In this case, ensure that the invoice and delivery is to the medical doctor and not to the clinic. Exceptions may exist, depending on state regulations.
D. Can I sell medical gas to a nurse or midwife? Maybe. Check with your state regulations. Often the medical gas sale will be allowed if the nurse or midwife is licensed and under the supervision of a licensed physician. See the emergency use question below (H).
E. 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.
F. Can I sell medical oxygen to a fire department, ambulance 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.”
The FDA would not prohibit the sale of medical oxygen with this labeling to emergency medical services without a prescription.
G. Can I sell medical nitrous oxide or other medical gases to a fire department,
ambulance or EMS without a prescription? No. Only oxygen is allowed to be sold under the “emergency use” exception. However, you can sell nitrous oxide to licensed hospitals or physicians affiliated with these establishments. Then the licensed physician/hospital can supply nitrous oxide or other drugs to the EMS. This is becoming important because new, portable pain relief devices are being marketed to EMS’s and these devices use nitrous oxide and oxygen.
H. 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:
- 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.
- 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.
- 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.
- Under no circumstances can emergency oxygen be used to fill high-pressure cylinders or be used in a mixture or blend.
Once all of these conditions are met, an individual or firm may have access to medical oxygen without a prescription.
I. 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 H are met. Rescue divers, and other specially trained divers, may buy medical oxygen under the “emergency use” exception in question H, above.
J. 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 EMS’s for patient use in Life Flights.
K. Can I sell medical gases 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.
L. Can I sell medical carbon dioxide for cannabis oil extraction? Not usually. If the firm buying the carbon dioxide does not have a medical license from the state and is not a federally registered drug manufacturer, you may not sell medical carbon dioxide to the firm. This is an evolving market and the guidance may change in the future.
M. Can I sell medical nitrogen for semen cryo-storage? No. This is not a medical application.
N. Can I sell medical nitrogen to a plumber for purging a medical gas pipeline? Yes, usually. In most states, a simple letter from the plumber about the purging requirements is all that is needed to justify selling them medical nitrogen. Some states (e.g., Florida) require special permits for plumbers to use medical nitrogen.
O. Can I sell a medical gas to a researcher? Maybe. If the gas is being used on tissues or cells that will be later used in a human or animal body, the gas should be medical grade. If the tissues or cells will be destroyed/discarded, the gas should not be medical grade.
P. What should I do if my customer insists that their application requires a different grade of gas (medical or non-medical) and we are not certain if it is appropriate? New research and new drug applications are being developed that cross the traditional definitions of medical gases. For these new, nontraditional applications, your customer likely knows more about what an appropriate gas grade is. Have the customer explain their usage in writing and consider the request. If in doubt, please contact [email protected] for guidance. Some states (e.g., Florida) will require a special permit for this exception.