In compounding, active pharmaceutical ingredients (APIs) are the building blocks of customized medications. FDA recently published a "green list" of approved foreign manufacturers of GLP-1 API. These are manufacturers that the FDA has evaluated or inspected and have been deemed compliant with the rigorous standards set by the agency. Manufacturers on the "green list" can sell to U.S. based wholesalers for use in both commercial and compounded drug products.

Manufacturers must adhere to strict standards, known as Current Good Manufacturing Practices (CGMP), when producing API for both drugmakers and compounding pharmacies.

Here’s why it matters: if the ingredient isn’t exactly what it claims to be – the precise potency and purity – then the medicine made from it can’t do its job, and that means your health is on the line. That’s why pharmacists take API quality so seriously.

Compounding pharmacies don’t typically source API directly from the manufacturer. Instead, they get it from FDA-registered wholesalers. Those wholesalers purchase API from FDA-registered manufacturers, who are required under federal law to provide a certificate of analysis of the API. In addition, most wholesalers will conduct independent third-party testing of the manufacturer’s API to validate potency and purity, and will share the testing results with pharmacies to whom they sell the API.

APC further recommends that pharmacies conduct their own third-party testing when they are using API from a new and unfamiliar manufacturer. And all of that is before any compounding of the drug is done. All active ingredients come from FDA-registered manufacturers, just like commercial medications. Every batch of API includes a certificate of analysis to verify quality.