Dioxyfin is carbon dioxide mist that has been manufactured in accordance with FDA mandated GMP requirements as specified in Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211 in FDA registered medical gas facilities.

Why is this important? The transdermal application of pure carbon dioxide diffuses through the skin or into openings caused by wounds in concentrations much greater than would occur in normal physiological activity. The elevated concentration of carbon dioxide directly affects the physiology and biology of the tissue and causes responses that would not occur without the presence of elevated concentrations of carbon dioxide.

Because of the effects of carbon dioxide on the physiology and biology of the tissue, it is considered a supraphysiological, or pharmacological, concentration and, as such, a drug. Consequently, to be used safely it must be manufactured in compliance with FDA standards and treated like any other drug. This includes the requirement that the device used to administer the drug must be designed in a way that prohibits the use of gas that has not been manufactured according to these regulations.

The FDA classifies any drug, including carbon dioxide, that is not manufactured in accordance with its regulations as an adulterated drug.  

How is pharmaceutical carbon dioxide different than other carbon dioxide? Compliance with FDA manufacturing requirements insures that contaminants are removed. Possible contaminants of the gase include: nitrogen, oxygen, alkanolamine, nitrogen oxides (also named NOx), sulphurous compounds, and volatile organics. It also insures the removal of contaminants from the capsule or vessel. This includes contaminants such as water, heavy metals, and lubricants that are frequently used in the manufacture of these metal vessels.

What are the risks of using non-pharmaceutical carbon dioxide? The use of adulterated carbon dioxide is less safe and risks the health of the patient by possibly exposing it to contaminants. It also heightens the risk that the carbon dioxide being used may not fully effective because the concentration of carbon dioxide may be less, even substantially less, than optimum for the treatment.

Dioxyfin, as well as the sleees used with the it, may be purchased only by licensed veterinarians.