Wolters Kluwer Health today announced the launch of its new Advanced Compounding module for Simplifi 797, giving pharmacies a comprehensive solution to meet 2023 USP Chapter 797 requirements for even the most complex compounding needs—from high-risk sterile processes to advanced batch tracking and beyond-use dating—all in one closed-loop system.
Enhanced documentation and education resources support industry best practices
USP Chapter 797 outlines new compliance guidelines for Category 2 and Category 3 compounding, including more comprehensive documentation requirements, more frequent competency verification, and stricter environmental monitoring. With the Advanced Compounding module, pharmacies that are compounding medications with longer shelf life (extended beyond-use dates) and those that start with non-sterile ingredients can track newly required batch data, maintain compliance, and access detailed reports for audits and inspections.
With content and educational resources developed by Wolters Kluwer industry experts, the module provides policy and procedures, training materials, observational competencies, and the ability to record environmental monitoring results in line with strict USP guidelines—ultimately ensuring confidence with every inspection.
“Advanced compounding is one of the most challenging areas of pharmacy practice, requiring precision, specialized knowledge, and a focus on compliance and quality outcomes. Having access to tools and resources that are designed to support advanced compounding is essential for meeting regulatory standards and ensuring patient safety," said Rebecca (RJ) Johnson, MS Chem, CPhT, Corporate Quality Assurance Manager at Revelation Pharma, a national network of 503A and 503B compounding pharmacies.
Advanced Compounding supports the breadth of pharmacy needs
“The Advanced Compounding module was built to ensure pharmacies performing the highest-risk compounding have a set of robust education and compliance documentation tools to support their needs. The module content complements the compliance and safety features of our IV Workflow Management solution, which is designed to support nonsterile-to-sterile formulations and compounding at scale,” said Annie Lambert, PharmD, BCSCP, Clinical Program Manager for Compliance Solutions at Wolters Kluwer Health. “Now, our Simplifi 797 solution enables the full scope of compounders—from immediate-use to Category 3—to meet USP standards.”
Learn more about this enhanced Advanced Compounding solution.