A compounding facility that registers with the FDA and follows federal manufacturing standards (cGMP), allowing it to make larger batches than a 503A pharmacy. 503B facilities typically supply clinics and hospitals and face tighter oversight, though their products are still not FDA-approved drugs. The stricter standards are why 503B sourcing is generally considered lower-risk than 503A for compounded medications.
Related terms: 503A pharmacy · Compounded medication