Simplifi 797 Advanced Module Addresses Critical Compliance Gap in Complex Pharmacy Compounding

Pharmacies performing advanced compounding operations now have a dedicated compliance platform. Wolters Kluwer Health has launched an Advanced Compounding module for Simplifi 797, specifically engineered to address the heightened regulatory demands introduced by the 2023 USP Chapter 797 updates.

The Compliance Challenge Behind Complex Compounding

The updated USP Chapter 797 standards impose substantially stricter requirements for Category 2 and Category 3 compounding operations. Facilities that prepare medications with extended shelf lives or begin with non-sterile raw materials face three major compliance hurdles: more rigorous documentation protocols, enhanced competency verification cycles, and rigorous environmental monitoring. For pharmacy operations managing high-risk sterile processes and advanced batch tracking, maintaining compliance while ensuring patient safety has become operationally complex.

Rebecca Johnson, Corporate Quality Assurance Manager at Revelation Pharma, a national network of 503A and 503B compounding pharmacies, underscores the challenge: “Advanced compounding is one of the most demanding pharmacy practice areas, demanding precision, specialized knowledge, and unwavering focus on compliance and quality outcomes. Access to purpose-built tools is essential for meeting regulatory standards and protecting patient safety.”

How Simplifi 797 Closes the Compliance Gap

The Advanced Compounding module within Simplifi 797 consolidates the tools pharmacies need into a single closed-loop system. The platform enables facilities to:

• Track complex batch data in real time, capturing all parameters required by Category 2 and Category 3 guidelines
• Manage beyond-use dating with precision, including extended shelf-life formulations that begin with non-sterile ingredients
• Document environmental monitoring results automatically, streamlining audit preparation
• Access comprehensive training materials developed by Wolters Kluwer clinical experts, covering policies, procedures, and observational competencies

The module’s content—built in collaboration with industry pharmacists and compliance specialists—ensures that every documentation requirement, every training component, and every audit trail aligns with USP standards. This approach transforms compliance from a reactive burden into an integrated operational practice.

Scope and Scale: From Immediate-Use to Category 3

Wolters Kluwer designed Simplifi 797 to serve the full spectrum of compounding operations. Annie Lambert, PharmD, BCSCP, Clinical Program Manager for Compliance Solutions at Wolters Kluwer Health, explains: “The Advanced Compounding module was built to ensure pharmacies performing the highest-risk compounding have robust education and compliance documentation tools. The module complements our IV Workflow Management solution, which supports nonsterile-to-sterile formulations and compounding at scale.”

This integration means that whether a pharmacy handles immediate-use preparations or complex Category 3 compounding, Simplifi 797 provides the appropriate level of automation, tracking, and documentation support—eliminating the need for multiple disconnected systems.

Industry Impact and Future Readiness

By consolidating advanced compounding compliance into a single platform, Simplifi 797 reduces operational friction while strengthening regulatory positioning. Pharmacies gain visibility into their compounding workflows, accelerate audit readiness, and reduce the risk of non-compliance findings. More significantly, the solution allows pharmacy leadership to redirect resources from manual compliance documentation toward clinical oversight and quality assurance.

For pharmacy networks and independent compounding operations alike, having a platform purpose-built for complex compounding represents a strategic advantage in an increasingly regulated environment.

About Wolters Kluwer Health

Wolters Kluwer (EURONEXT: WKL) is a global information and software solutions provider serving professionals in healthcare, tax, accounting, legal, regulatory, and corporate performance sectors. The company reported 2024 revenues of €5.9 billion and serves customers across more than 180 countries with operations in over 40 countries and approximately 21,600 employees worldwide. Headquartered in Alphen aan den Rijn, the Netherlands, Wolters Kluwer provides mission-critical solutions that enable professionals to make informed decisions daily.