503A Compounding
Traditional pharmacy compounding regulated under Section 503A of the Federal Food, Drug, and Cosmetic Act. 503A pharmacies prepare customized medications for individual patients based on valid prescriptions from licensed practitioners. They operate under state pharmacy board oversight and USP standards. 503A preparations are not FDA-approved as finished drug products and cannot be made in anticipation of prescriptions (i.e., cannot be stockpiled). Volume is limited to patient-specific orders.