Your health-system pharmacy has decided to partner with a new 503B sterile compounding outsourcing facility, or the time has come to audit one of your contract 503Bs. There’s just one problem: How do you know what to look for?
If you do your own patient-specific compounding under section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act, as most hospital and health-system pharmacies do, you should be familiar with the requirements of USP General Chapters <795>