503B Outsourcing Facility
A federally registered outsourcing facility that can prepare batches of compounded sterile medications without a patient-specific prescription.
A 503B outsourcing facility is governed by section 503B of the Federal Food, Drug, and Cosmetic Act. 503B facilities are registered with the FDA and can prepare compounded sterile medications in larger batches, typically for clinics and hospitals rather than individual patients.
503B facilities are subject to FDA inspection and Current Good Manufacturing Practice (cGMP) requirements. They are typically used by clinics, hospitals, and surgical centers that need compounded sterile medications in office-use quantities rather than on a per-prescription basis.
503B is a different regulatory pathway than 503A, not a higher tier of the same pathway. A 503A pharmacy is the right setting for patient-specific compounded prescriptions; a 503B outsourcing facility is the right setting for office-use sterile compounded batches.
Most patient-facing compounded prescriptions are dispensed by 503A pharmacies. 503B facilities most often serve healthcare facility purchasers rather than individual patients.