New module supports updated USP Chapter 797 standards, empowering pharmacies with integrated advanced compounding education, workflows, and documentation
WALTHAM, Mass.–(BUSINESS WIRE)–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 & 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 the enhanced Advanced Compounding solutions.
About Wolters Kluwer
Wolters Kluwer (EURONEXT: WKL) is a global leader in information, software solutions and services for professionals in healthcare; tax and accounting; financial and corporate compliance; legal and regulatory; corporate performance and ESG. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with technology and services.
Wolters Kluwer reported 2024 annual revenues of €5.9 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 21,600 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.
For more information, visit www.wolterskluwer.com, follow us on LinkedIn, Facebook, YouTube and Instagram.
Contacts
Media Contact
André Rebelo
Director, External Communications
Wolters Kluwer Health
+1 (781) 392-2411
[email protected]
