Compounded Medication

A medication prepared by a licensed compounding pharmacy from individual ingredients — not the same as an FDA-approved branded drug.

A compounded medication is a customized prescription product prepared by a state-licensed compounding pharmacy from individual active pharmaceutical ingredients (APIs) and excipients. Compounded medications are NOT FDA-approved — the FDA does not review them for safety, efficacy, or quality the way it does branded drugs. Compounding is legally permitted under U.S. federal law (specifically Section 503A of the Federal Food, Drug, and Cosmetic Act for traditional pharmacy compounding, or Section 503B for outsourcing facilities). Compounded medications can be legally dispensed when prescribed by a licensed provider for an individual patient with a documented medical need. Common reasons to use a compounded medication include: drug shortages of the FDA-approved branded version, patient allergies to inactive ingredients in the branded product, or different dosing or formulation needs. Formulation, strength, inactive ingredients, and clinical effects of a compounded medication may differ from the FDA-approved branded version. Patients should discuss the trade-offs with their provider.

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This glossary is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider with questions about your individual health.