Pharmacy 503B Outsourcing refers to a specific type of pharmaceutical outsourcing facility regulated under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). It involves the outsourcing of compounded medications by a pharmacy facility that is registered with the U.S. Food and Drug Administration (FDA). These pharmacies are authorized to produce large quantities of compounded drugs for hospitals, clinics, and other healthcare providers, primarily for office use and without requiring individual prescriptions for each patient.
