|
return to safety tip archive index
May, 2002 - Restrictions on Medical Gas Sales Compressed gas users occasionally request "medical grade" gas in an attempt to resolve problems in which commercial grade gas is suspect. Medical grade gas is also commonly requested for gases that will be breathed, such as compressed air or Aviator s Breathing Oxygen. Medical gases identified by the term, "USP" (United States Pharmacopeia) or "NF" (National Formulary), are strictly regulated as drugs or medical device gases by the U.S. Food and Drug Administration and State boards of pharmacy. Medical drug gases are called "legend drugs" because of the labeling legend, "CAUTION: Federal Law Prohibits Dispensing Without Prescription," which has recently been changed to simply, "Rx Only." In other words, the Federal Food, Drug, and Cosmetic Act prohibits your supplier from distributing medical grade (drug) gases labeled as such to anyone not authorized by law to purchase them. The mere fact that a gas will be breathed does not necessarily qualify it as a drug gas, justifying the legend and "USP" or "NF" on its label. A drug gas must be intended for a drug purpose (i.e., used for treatment of disease, injury, or illness, etc). If you have had problems with commercial grade gases or suspect gas impurities, switching to medical grade is not the answer. Ask your distributor to recommend a specialty gas grade suited to your application. "Specialty gas" is a broad term referring to gases that have specific purity levels or limits of impurities, extremely rare or special-purpose gases, gases that have undergone specific analytical or packaging procedures, etc. Frequently, gas problems do not relate to purity directly; rather, a specific impurity may be causing the problem. For gases to be breathed in non-medical applications, cylinder labels should clearly indicate they are intended for breathing and the gas should "meet or exceed" USP specification without actually being labeling as "USP" or "NF."
Copyright
© 2000 Prest-O-Sales & Service, Inc.
|
