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NOVEMBER 22, 2022

Part 1 of a 2-part series

Health System–Based 503Bs Not for the Faint of Heart

By Gina Shaw

When the Drug Quality and Security Act was signed into law in late 2013, creating two designations for sterile drug compounders—503A compounding facilities and 503B outsourcing facilities—Fairview Health Services hospital pharmacy director Craig Else, PharmD, proposed that Fairview should pursue the 503B option.

“I thought, ‘This’ll be easy; here’s a new revenue opportunity for pharmacy, let’s go compound drugs for ourselves and