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503a Compounding Pharmacy

Meaning

A 503a compounding pharmacy is a facility that prepares patient-specific medications pursuant to a prescription, operating under the direct oversight of state boards of pharmacy. This designation, outlined in Section 503A of the Federal Food, Drug, and Cosmetic Act, mandates the creation of customized formulations, dosages, and delivery systems that are not commercially available. These pharmacies focus on traditional compounding practices, maintaining a direct relationship with the prescribing clinician and the individual patient. They are essential partners in personalized hormonal therapy, addressing unique patient needs like allergies or required non-standard doses.