American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2025
Considerations for developing a health-system 503B outsourcing strategy.
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Pamphile Gilnou, Yaniv Angela, Burton Samantha, Boreen Christopher, Eggers Garrett
Аннотация
PURPOSE: To provide guidance for health systems on how to develop a strategy for utilizing 503B outsourcing facilities for sterile product preparation.
SUMMARY: Health-system pharmacies face an increasingly complex set of challenges related to providing sterile products to patients. New United States Pharmacopeia <797> regulations, increasing drug shortages, and an ongoing pharmacy technician workforce shortage have made sterile compounding more difficult than ever for health-system pharmacies. Outsourcing of production to 503B outsourcing facilities is one strategy pharmacy leaders can use to help navigate these challenges. However, there are many factors to consider when deciding whether to outsource a product and which 503B vendors are safe and reliable. The Cleveland Clinic Health System (CCHS) has developed a robust internal structure to appropriately vet 503B outsourcing facilities for safety and reliability, as well as standardized criteria used to determine which products will be outsourced. This article describes the tools CCHS has used to evaluate 503B outsourcing vendors and to evaluate individual products to determine the pros and cons of outsourcing vs insourcing. Additionally, general considerations regarding outsourcing are described.
CONCLUSION: Outsourcing to 503B facilities can be an effective strategy for navigating sterile compounding challenges but is not without some risk. Pharmacy leaders must develop a standardized approach to thoroughly evaluate 503B vendors and products to ensure their outsourcing strategy is both safe and cost-effective.
SUMMARY: Health-system pharmacies face an increasingly complex set of challenges related to providing sterile products to patients. New United States Pharmacopeia <797> regulations, increasing drug shortages, and an ongoing pharmacy technician workforce shortage have made sterile compounding more difficult than ever for health-system pharmacies. Outsourcing of production to 503B outsourcing facilities is one strategy pharmacy leaders can use to help navigate these challenges. However, there are many factors to consider when deciding whether to outsource a product and which 503B vendors are safe and reliable. The Cleveland Clinic Health System (CCHS) has developed a robust internal structure to appropriately vet 503B outsourcing facilities for safety and reliability, as well as standardized criteria used to determine which products will be outsourced. This article describes the tools CCHS has used to evaluate 503B outsourcing vendors and to evaluate individual products to determine the pros and cons of outsourcing vs insourcing. Additionally, general considerations regarding outsourcing are described.
CONCLUSION: Outsourcing to 503B facilities can be an effective strategy for navigating sterile compounding challenges but is not without some risk. Pharmacy leaders must develop a standardized approach to thoroughly evaluate 503B vendors and products to ensure their outsourcing strategy is both safe and cost-effective.