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The Labeling of Medical Air

The U.S. Food and Drug Administration (FDA) regulates the labeling of compressed medical gases, including medical air (a mixture of oxygen and nitrogen). A Compliance Policy Guide specifies the procedure for issuing warnings for labeling violations and follow up for noncompliance.

  1. Basic Requirements

    • Medical gas labels are required to include the manufacturer or distributor's name and address, the name of the product, the measurement of the contents (such as liters), the lot number and the ingredients. These details provide the manufacturing history for adequate control of the product.

    Product

    • The label must also indicate if the air was produced using the air-liquefaction process that is a requirement of the United States Pharmacopeia (USP).

    Directions

    • Labels must provide clear directions for its use.

    Violations

    • The FDA issues a warning letter in the event of a violation of the regulations. If the violation continues, a recommendation for seizure may be sent to the Center for Drug Evaluation and Research, which provides compliance guidance to the industry.

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