Category: Compounding 101
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503A vs 503B Pharmacies: What the Difference Means for Patients
The short answer: 503A pharmacies compound medications for individual patients based on a prescription and are overseen mainly by state boards of pharmacy. 503B outsourcing facilities voluntarily register with FDA, must follow federal manufacturing-quality rules (CGMP), are inspected by FDA on a risk-based schedule, and can supply health care facilities without patient-specific prescriptions. Neither lane’s…