Compounding Pharmacy 503A vs. 503B Explained
503A = patient-specific compounding under state pharmacy law. 503B = FDA-registered outsourcing for office-use bulk.
The Drug Quality and Security Act of 2013 created two distinct compounding categories. 503A pharmacies fill patient-specific prescriptions under state pharmacy law. 503B outsourcing facilities register with FDA and may ship bulk compounded drugs to clinics without patient-specific prescriptions.
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