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DECEMBER 5, 2019

A Primer on 503A and 503B Compounding

To (503)B or not to B

By Gina Shaw

Understanding the complex regulatory issues surrounding sterile compounding can be a daunting task. But experts agree that one helpful place to start is to explore the key differences between the 503A and 503B categories that govern the practice. Armed with that knowledge, facilities then can make educated decisions about which type of compounding is the best fit, based on staffing, investment capacity, product volume and other key considerations.

Under the Drug Quality