Compounded medications are legal customized medications made by state licensed pharmacies to meet the unique medical needs of individual patients. They can be prescribed by a licensed provider when the provider deems the compounded medication is necessary to meet the specific medical need of an individual patient that cannot be addressed by a commercially available FDA-approved product (i.e. a patient allergy or a change in dosage form) or when an FDA approved product is not commercially available (i.e. shortage).

Compounded medications are not evaluated or approved by the FDA for safety, efficacy or quality. However, patient-specific compounding is permitted under federal law (Section 503A of the Federal Food, Drug, and Cosmetic Act) when performed by a state licensed pharmacy based on a valid prescription for a specific, individual patient. Compounded medications should only be used under the guidance of a qualified healthcare provider.