While 503A compounding pharmacies fulfill a vital need for patient-specific compounded products, 503B outsourcing facilities fulfill another need to the medical community. 503B outsourcing facilities can provide custom solutions with confidence in quality for those products needed for in-office use. According to a scholarly article published by the FDA Group*, it’s important to know significant differences between 503A and 503B Compounding Pharmacy requirements. Here’s a summary of the differences.
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*Ritchie, Gary E. The Importance of cGMP to the Safety of Compounded Drugs How Current Good Manufacturing Practices (CGMP) Offer a Reliable Remedy to Poorly Compounded Drugs. TheFDAGroup.com. Web.