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What is a 503A compounding pharmacy?
A 503A pharmacy prepares patient-specific medications from an individual prescription — for example, a custom dose or a combination not sold commercially. It is a category of pharmacy practice, not an FDA approval, and compounded preparations are not FDA-approved.
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No. Compounded medications are not FDA-approved. The FDA does not review them for safety, effectiveness, or quality. They are prepared by a licensed pharmacy for a specific patient based on a prescription, and they can be appropriate when a clinician determines so.
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