What Are the FDA Requirements for Oxygen Distributors?

Under section 201(g)(1) of the Federal Food, Drug, Device, and Cosmetic Act, oxygen and medical gases used for human consumption are considered prescription drugs. Current Good Manufacturing Practices (cGMPs) require compliance from medical gas companies that distribute gases with the "USP" or "NF" label for the holding and distribution of drugs. Title 21 CFR sections 211.142, 211.150 and 211.196, lay out medical gas companies' compliance requirements.

Registration Requirements

• A business that is buying and reselling filled oxygen cylinders or units to another business or facility must apply for licensure and register as a distributor of prescription products. The company selling filled-oxygen cylinders or units directly to the patient or end user needs only to register as a prescription products distributor (applying for a license is not mandatory). The transportation of oxygen cylinders or units may require a special license from the municipal utility commission. The distributor of prescription products registration permits the selling and handling of other medical tools or heavy-duty medical equipment.

Warehousing Procedures

• FDA requirements have specific key provisions for warehousing medical gases. The distributors must ensure that storage areas are clean, airy, dry, and free from flammable materials and safeguarded from contaminants such as rodent, bird, or insect infestation. Medical gas companies must ensure the separate storage of medical gases from industrial gases prior to distribution. Drug products stored under appropriate temperature, light, and humidity conditions guarantee that the type, quality, purity, and strength of the drug products are unaffected.

Distribution Procedures

• FDA regulations demand that companies develop and adhere to written guidelines detailing medical gas distribution. These regulations stipulate the rotation of medical gas stockpiles so that the older stock is distributed first. The FDA also expects companies to set up a system to trace the dissemination of each batch of drug product and to facilitate product recall if necessary. The FDA permits change in this regulation only if such change is temporary and fitting (e.g., distributing cylinders owned by customers).