Industrial Customers Requesting Medical Gases

How to meet both demand and the law

By J. Robert Yeoman

It is not uncommon for industrial customers to request medical grade gases in the belief that they will receive gases of a higher purity than the industrial counterpart. Other times, industrial customers want medical grade gases because they intend to use the gas as part of a breathable mixture. There are strict requirements regarding who is authorized to purchase medical gases, and making a mistake could put a distributor in violation of federal law.

Medical gases such as Oxygen USP, Nitrogen NF, Carbon Dioxide USP, Helium USP, Nitrous Oxide USP, Air USP and mixtures of these gases are prescription drugs as defined by the Federal Food, Drug, and Cosmetic Act. Under 21 U.S.C. 321(g)(1), these gases can only be provided to authorized health care facilities, licensed practitioners and individuals possessing a doctor's prescription. There is one exception for Oxygen USP that allows this drug to be sold to legitimate emergency response entities without a prescription.

Recently, a number of GAWDA members received requests from dive shops and underwater contractors requesting medical gas mixtures higher than a 21% oxygen concentration mixture. The customers specifically request that medical grade gases be provided, but do not have either a doctor's prescription or a licensed practitioner on staff. Since these customers will be breathing the gas mixtures, they believe they can ensure the quality attributes of the gas mixture by selecting a medical grade. Providing a dive shop with a prescription pharmaceutical is against federal law, so how can a GAWDA member company legally serve these types of customer requests?

Meet CGA Specifications
Provide gases that meet the CGA commodity specifications for that particular gas. For oxygen, this is CGA G 4.3 Commodity Specification for Oxygen, and the grade designation is “C” for industrial. You should odor test the gas as if it were medical grade, and assign the gas or gas mixture a lot number for traceability. In other words, the gas is labeled as industrial grade, but has been manufactured, tested and certified to medical specifications. You should provide a certificate of analysis for each lot, and in the case of breathable mixtures, make sure that each cylinder is tested for oxygen concentration.

This recommendation also applies to customers requesting oxygen or breathable mixtures for oxygen bars, oxygen cosmetic spas and non-hospital hyperbaric chambers.

By using this process, your customer will receive the gases that have the quality attributes and assurances they need, and your company will not potentially run afoul of FDA regulations.

Nitrogen Requests
For surgical air tools used in hospitals, dental offices and other health care facilities including veterinary clinics, both GAWDA and CGA recommend that only medical grade nitrogen (Nitrogen NF) should be provided. If a health care facility is requesting nitrogen to purge or pressure test any piping in its facility, medical grade nitrogen should also be supplied for this application. Health care facilities that purchase liquid nitrogen for cryo-surgery, such as wart removal, should also have medical grade for this application; however, liquid nitrogen used for tissue sample or sperm sample freezing does not need to be medical grade.

If your company supplies nitrogen to a pharmaceutical and biotech manufacturing company, it is acceptable to supply medical grade nitrogen if the company requests it for use in its manufacturing operations, as these firms would be considered legitimate health care facilities.

The CGA Safety Alert SA-6, which is available on GAWDA's Web site, recommends that only medical grade gases should be supplied “for any other applications or customers in the health field where the end use application for the gas is unknown.” A similar approach is recommended by the FDA in the 2003 draft of the Medical Gas Guidelines.