Wolters Kluwer Launches Advanced Compounding Module to Support 2023 USP 797 Compliance

The module is designed for operations involving high-risk processes, extended beyond-use dating, and advanced batch tracking, integrating education, workflows, and documentation into a single system.

Wolters Kluwer Health has introduced a new Advanced Compounding module for its Simplifi 797 platform, offering pharmacies a closed-loop solution to meet the updated 2023 USP Chapter 797 requirements for complex sterile compounding. The module is designed for operations involving high-risk processes, extended beyond-use dating, and advanced batch tracking, integrating education, workflows, and documentation into a single system.

The launch comes as pharmacies work to comply with expanded USP 797 standards, which set stricter expectations for Category 2 and Category 3 compounding. These include increased documentation, more frequent competency assessments, and enhanced environmental monitoring. The Advanced Compounding module enables pharmacies to capture newly required batch data, document processes, and maintain detailed reports that can be used during inspections and audits.

The module incorporates content developed by Wolters Kluwer industry experts, offering policy and procedures, training materials, observational competency tools, and support for recording environmental monitoring results. This allows compounding teams to align daily operations with the regulatory updates and maintain consistent compliance across workflows.

“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.

According to Wolters Kluwer, the new module expands the range of compounding support available within Simplifi 797. “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.

With this launch, Simplifi 797 now covers the full spectrum of compounding—from immediate-use to the most complex Category 3 preparations—offering pharmacies a structured pathway to meet USP standards across varying levels of risk and workflow complexity.

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