Wolters Kluwer Health has announced the launch of its Advanced Compounding module for Simplifi 797 to help pharmacies meet 2023 USP Chapter 797 requirements for complex compounding operations.
The new module provides pharmacies with a comprehensive system designed to address high-risk sterile processes, advanced batch tracking, and beyond-use dating within a closed-loop workflow. It supports updated USP Chapter 797 standards, which include expanded requirements for Category 2 and Category 3 compounding, such as more detailed documentation, more frequent competency verification, and stricter environmental monitoring.
The Advanced Compounding module enables pharmacies compounding medications with extended beyond-use dates and those initiating compounding from non-sterile ingredients to track newly required batch data, maintain compliance, and generate detailed reports for audits and inspections. It includes policies and procedures, training materials, observational competencies, and tools for recording environmental monitoring results, all aligned with USP guidelines.
The update reflects industry perspectives that advanced compounding involves significant complexity and requires a focus on precision, specialized knowledge, regulatory standards, and patient safety considerations. The module is described as offering robust education and compliance documentation tools for pharmacies performing high-risk compounding and complements existing IV Workflow Management solution that support nonsterile-to-sterile formulations and large-scale compounding. The combined features of Simplifi 797 are outlined as enabling pharmacies performing immediate-use through Category 3 compounding to meet USP standards.
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