Strategies for USP <797> Compliance in Compounding

This article presents strategies for achieving compliance with the revised USP <797> standards, which were officially updated in November 2023. It outlines the new stringent requirements for personnel training, cleaning, garb, microbiological sampling, and beyond-use date (BUD) assignments for compounded sterile preparations (CSPs). The document categorizes CSPs into three groups based on environmental control needs and microbial growth potential. It emphasizes the importance of selecting the appropriate compounding category and balancing clinical, financial, and operational goals. The article details optimal BUD assignments and suggests strategies for minimizing waste and adapting to the evolving regulatory landscape. Additionally, it highlights the role of automation and expert guidance in navigating the complexities of USP <797> compliance. The content is designed to assist hospital-based compounding pharmacies in improving operational efficiency and patient safety while adhering to the new regulations.