503A Pharmacy
A traditional compounding pharmacy that prepares medications for individually identified patients based on a prescription.
A 503A pharmacy is a traditional compounding pharmacy governed by section 503A of the Federal Food, Drug, and Cosmetic Act. 503A pharmacies prepare medications for individually identified patients based on a valid prescription, under state board of pharmacy oversight.
503A pharmacies make per-prescription compounded medications and operate at a patient-by-patient scale. They are regulated primarily by state boards of pharmacy and follow USP standards for sterile and non-sterile compounding.
503A pharmacies are distinct from 503B outsourcing facilities, which are federally registered with the FDA and can produce compounded medications in larger batches without a patient-specific prescription. Most directory listings on this site are 503A pharmacies.
Patients interact with 503A pharmacies the same way as a traditional pharmacy: the prescriber sends or calls in the prescription, and the pharmacy prepares and dispenses the compounded medication for that patient.