503B Outsourcing Facility
A compounding pharmacy registered under section 503B that can compound preparations in larger batches without a patient-specific prescription, intended for office-stock supply.
A 503B outsourcing facility is a compounding pharmacy registered under section 503B of the Federal Food, Drug, and Cosmetic Act, as added by the Drug Quality and Security Act of 2013. 503B facilities are inspected to a stricter standard than 503A pharmacies and must comply with current Good Manufacturing Practice (cGMP) requirements.
Unlike 503A pharmacies, 503B facilities can compound preparations in larger batches without a patient-specific prescription. The output is intended for administration in a healthcare setting, which means clinics can stock 503B-sourced preparations as office inventory and use them across multiple patients as appropriate.
503B preparations cannot be dispensed to patients for home use without an additional patient-specific prescription.