As of Sept. 14, 2022, nine years after the Drug Supply Chain Security Act created two designations for sterile drug compounders—503A compounding facilities and 503B outsourcing facilities—only six of the 78 503B compounders registered with the FDA were directly affiliated with and operated by healthcare systems. There’s a reason for that: It’s not easy.
“Systems tend to underestimate how difficult it is to build and run their own 503B, to be under the