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Compounded medications: what the label means

Compounded medications are prepared by licensed pharmacies for individual prescriptions. They are not FDA-approved. Here is what that means in practice.

A compounded medication is prepared by a licensed pharmacy for an individual patient’s prescription. Pharmacies compound medications to combine ingredients, change a format, or prepare a medication that is not commercially available in the form a clinician prescribes.

Not FDA-approved

Compounded medications are not FDA-approved. FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed. Pharmacies that compound are licensed and overseen by state boards of pharmacy.

Questions to ask

Before starting any compounded medication, it is reasonable to ask who reviewed your health history, which licensed pharmacy prepares it, and who you can contact with questions.

This article is for general education and is not medical advice. Talk with a licensed clinician about your own health. Compounded medications are not FDA-approved.

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