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FDA Compounding 503a

Meaning

FDA Compounding 503a refers to a specific section of the Federal Food, Drug, and Cosmetic Act that outlines the conditions under which traditional compounding pharmacies are permitted to compound medications. These pharmacies, often state-licensed, are generally required to compound based on a valid patient-specific prescription and are exempt from the FDA’s new drug approval process, labeling requirements, and current Good Manufacturing Practice (cGMP) regulations. The provision is designed to ensure patients have access to customized medications when commercially available products are unsuitable, such as for specific hormonal dosing or allergen exclusion. Strict adherence to these rules is mandatory to maintain the legal status of the compounded preparation.