Medical Gases
Air Liquide Healthcare America Corporation supplies bulk and cylinder medical gases and related services and equipment to more than 2,000 customers, hospitals and other medical institutions throughout the U.S.
Air Liquide Healthcare America promotes a policy of strict compliance with FDA standards, reassuring you that medical gases used to provide therapy and sustain life are both safe and reliable.
Medical gases are categorized as prescription drugs
A medical gas is a gaseous substance that meets medical purity standards and has application in a medical environment. Medical gas manufacturing is governed by the FDA’s current Good Manufacturing Practices (cGMP). The quality of medical gases must also meet the official standards of the United States Pharmacopoeia (USP). USP provides a listing of drugs licensed for use in the United States with the analytical standards necessary to establish purity suitable for human use applied to each of the listed drugs. Drugs sold for human consumption in the U.S. must meet or exceed the purity standards listed in the USP. Drugs meeting these requirements must include a designation on their label that demonstrates compliance with standards listed within the USP.
These standards are the legal requirements enforced by the U.S. Government under the cGMP (current Good Manufacturing Procedures) regulations. Under these standards, medical gases are categorized as prescription drugs.
Medical gases that must meet these requirements include:
- Oxygen USP
- Nitrogen NF (National Formulary)
- Helium USP
- Air USP
- Carbon Dioxide USP
- Nitrous Oxide USP
- Mixtures
