Compounded medications, if prescribed, are prepared by a licensed pharmacy or outsourcing facility. Compounded drugs are not FDA-approved, which means the FDA has not reviewed them for safety, effectiveness, or quality. A compounded medication may be prescribed only when a provider determines it is medically appropriate and an FDA-approved, commercially available product is not appropriate for a patient (for example, due to an allergy to an ingredient, dosage needs, or other clinical reasons). Not all patients are candidates. Individual results vary, and no specific outcome is guaranteed. Your provider will discuss the potential risks, benefits, and alternatives with you.
If clinically appropriate, your provider may prescribe either an FDA-approved medication or a compounded medication. FDA-approved medications are reviewed by the FDA for safety, effectiveness, and quality for their approved uses. Compounded medications are custom-prepared by a licensed pharmacy or outsourcing facility and are not FDA-approved, meaning the FDA has not evaluated them for safety, effectiveness, or quality. Compounded medications may be used only when a provider determines there is a specific medical need and an FDA-approved, commercially available product is not appropriate for the individual patient. Medication choice, dosing, and ongoing management are individualized based on your medical history, labs, and provider judgment. All medications can have side effects and risks; not everyone is a candidate. Individual results vary.