Considerations in Qualifying Critical Suppliers.

The impending updates to United States Pharmacopeia Chapter <797> and Chapter <795> specify that compounders must obtain active pharmaceutical ingredients and should obtain excipients from FDA-registered facilities. Additionally, the U.S. Food and Drug Administration cautions compounders to know their bulk active pharmaceutical ingredients and excipients suppliers. While the U.S. Food and Drug Administration expects 503B outsourcing facilities to qualify their critical suppliers, pharmacy boards and accrediting bodies are beginning to ask 503A compounders for their list of approved suppliers and how they qualify them. As such, pharmacies should become comfortable in qualifying suppliers as part of their quality assurance program. This article discusses how pharmacies can apply the elements of supplier qualification to their practice to ensure that critical supplies and services meet company specifications for quality and compliance.