What is 503A Pharmacy?
Compounding pharmacy that compounds pursuant to individual patient prescriptions under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA). Typically state-regulated.
503A pharmacies compound for identified individual patients based on prescriptions, and are primarily overseen by state boards of pharmacy rather than routine FDA cGMP inspection. They must still comply with USP <795>, <797>, and <800> as adopted by their state, and the FDA can inspect a 503A pharmacy — particularly after complaints or adverse events.
The practical compliance burden for a 503A is documentation: environmental monitoring records, personnel qualifications, cleaning logs, master formulation and compounding records, and beyond-use dating that can be defended during a board or FDA visit.
See how CompliRx handles this in practice:
USP <797> compliance softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.