503B Outsourcing Facility
A compounding pharmacy registered directly with the FDA 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 directly with the FDA 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. Pricing per unit is typically lower at volume than 503A pricing because the facility can run larger batches.