FDA Oxygen Regulations

The U.S. Food and Drug Administration (FDA) regulates compressed medical gases including liquid and gaseous oxygen. These compressed gases are drug products that are included in the Federal Food, Drug and Cosmetic Act. A compliance policy guidance manual stipulates the issuance of warning letters when firms are in violation of the provisions of the Act.

Labeling

• The FDA requires that prescription drugs, including oxygen, must provide sufficient usage instructions. The label must indicate if the oxygen was produced using the air-liquefaction process that the United States Pharmacopeia (USP) requires. Labeling must also provide the product name, measurement of contents, name and address of the distributor or manufacturer, ingredients and lot number.

Standards

• Laboratory apparatus, instruments and gauges must be calibrated at proper intervals to be ensure accuracy and precision is within established limits.

Testing

• Scientifically reliable testing and specifications procedures must be established in order to assure conformity with required standards of strength and identity. Each drug product batch must be tested to make sure it conforms with the final specifications before it is released. The FDA requires the manufacturer to document the specificity, sensitivity, reproducibility and precision of the methods used for testing.

Filling

• The FDA notes concerns regarding the filling of high pressure cylinders with regard to testing of the final product. In particular, the transfer of oxygen from larger cylinders to smaller cylinders may not be handled appropriately. Prior to filling them, the cylinders should be vacuum evacuated and double purged. In the case of home respiratory care, home units may not be filled on the patient's premises. The Center for Drug Evaluation and Research (CDER) provides guidelines to help firms with compliance of the regulations for manufacturing. The CDER is part of the FDA and is responsible for ensuring that drugs are safe and effective in the U.S. by regulating all prescription and over-the-counter drugs.

Inspection

• If it is warranted during inspection, the FDA will issue warning letters to firms that do not have specifications or test procedures in writing, fail to calibrate testing instruments daily as directed by the manufacturer or fail to evaluate a minimum of one small cylinder when filling from a larger cylinder. In addition, if the incoming liquid oxygen is not tested according to the regulations, is not properly labeled or if the firm is using unofficial test procedures, a warning will be issued. If a firm fails to comply following the issuance of a warning letter, the FDA may submit a recommendation of seizure to the CDER.