USP <797> categorizes CSPs into three levels based primarily on their risk of contamination. For pharmacies engaging in complex Category 3 compounding operations, this checklist provides a practical tool for assessing key requirements specific to Category 3 CSPs.
As a core element of compounding compliance, USP <797> distinguishes three categories of Compounded Sterile Preparations (CSPs): Category 1, Category 2, and Category 3, based on complexity and risk factors, including environmental control and microbial growth. The higher the category, the greater the risk of contamination, leading to increased danger of patient harm.
For pharmacies engaging in Advanced Compounding operations within the framework of USP <797>, our checklist serves as a practical, printable companion tool to highlight requirements specific to Category 3 CSPs.
The checklist is built by clinical experts to help pharmacies assess, decide, and ensure key considerations around complex Category 3 CSPs, including:
- Facilities and equipment
- Environmental monitoring
- Personnel management
- Formulation and documentation
- Testing requirements
