What are the regulations governing prescription drug labeling?

Prescription drug labeling in Washington is regulated by the Federal Code of Regulations (21 CFR) and the Washington Administrative Code (WAC). The regulations governing prescription drug labeling outline the requirements for labeling prescription drugs as well as over-the-counter (OTC) drugs. The Federal Code of Regulations (21 CFR) requires that prescription drug labels include information such as the name and address of the manufacturer, the name and strength of the drug, the active ingredients, dosage form, route of administration, and the expiration date. In addition, the labeling must also include any warnings or other important information regarding usage and potential side effects. The Washington Administrative Code (WAC) goes further by requiring that OTC drugs contain a statement of identity, including the name and description of the product. All OTC drugs also must include a statement of their intended use, dosage directions, and safety instructions. Additionally, WAC requires that all prescription and OTC drugs contain a list of active and inactive ingredients, and a short description of each. The regulations governing prescription drug labeling are designed to ensure that patients know what medications they are taking and what potential side effects may occur. By requiring manufacturers to include detailed labeling and warning information, these regulations help to ensure the safety of consumers in Washington.

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What are the regulations governing prescription drug labeling?

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