Plain-language definitions for the terms that come up most often when working with a compounding pharmacy: regulatory categories, dosage forms, common therapies, and what pharmacies actually do.
503A Pharmacy
A traditional compounding pharmacy that prepares medications for individually identified patients based on a prescription.
503A vs 503B
The two federal regulatory pathways for compounding: 503A is for patient-specific compounded prescriptions; 503B is for FDA-registered outsourcing facilities producing batches of sterile compounds.
503B Outsourcing Facility
A federally registered outsourcing facility that can prepare batches of compounded sterile medications without a patient-specific prescription.
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