Don't be misled by assertions that the API compounders use isn't tested or that there's no batch testing of sterile compounded preparations before dispensing ...
What about testing of API and of compounded preparations, you ask? Here's a primer: Manufacturers are required under federal law to provide wholesalers and pharmacies a certificate of analysis of the active pharmaceutical ingredient it sells it. In addition, most wholesalers will conduct third-party testing of the manufacturer’s API and will share the testing results with pharmacies that purchase the API. Alliance for Pharmacy Compounding further recommends that its member pharmacies have their own third-party testing done when they are using API from a new and unfamiliar manufacturer. And all of that is before any compounding of the API is done. ? Under the standards of the US Pharmacopeia, a compound pharmacy making a GLP-1 injectable?that will have a beyond-use date longer than 4 days – as most will –?must have a sample of every batch of sterile injectables it prepares analyzed by a third-party lab before?distributing any of?dispensing?any of that batch to a patient. Learn more by downloading our 'Best Practices for Compounding Shortage Drugs': #compounding #pharmacycompounding