We work with licensed compounding pharmacies — both 503A pharmacies (which prepare patient-specific prescriptions under USP standards) and 503B outsourcing facilities (which operate under FDA current Good Manufacturing Practice standards, the same standards applied to commercial pharmaceutical manufacturing).
Depending on the product and preparation type, testing may include:
Sterility testing — verifies the product is free of microbial contamination
Bacterial Endotoxin Testing (BET) — verifies the product is free of bacterial toxins
Potency testing — verifies the active ingredient is present at the intended concentration
Ingredient verification — confirms the identity of ingredients used in the preparation
Stability studies — confirms the product remains within specification over its labeled shelf life
Testing is performed by the compounding pharmacies and, in many cases, by independent third-party laboratories. Certificates of Analysis are available upon request.