Master the most complex areas of sterile compounding under USP 797

Extended Category 2 and Category 3 compounding represent the most demanding work your pharmacy performs, and the smallest gap carries real risk to patients and staff. For compounding pharmacies and IDN central service centers batching commonly used CSPs, starting with nonsterile ingredients, or assigning extended beyond-use dates (BUDs), the 2023 USP 797 standards raise the bar on education, environmental monitoring, and competency.

The Simplifi 797 Advanced Compounding module gives you a single, expert-driven solution built for this level of complexity. It combines specialized continuing education, end-to-end batch surface sample tracking, and enhanced competency scheduling, so your team can extend BUDs, maximize batch productivity, and reduce waste while staying inspection ready.

Based on USP 797 standards, and maintained by in-house, board-certified pharmacists, means you can trust the guidance behind every workflow. You get the depth required for Category 3 CSPs without building it yourself, saving your team hundreds of hours of development time.

When demand surges or drug shortages peak, advanced compounding processes help you meet patient needs at scale. The Advanced Compounding module helps you do it with confidence, consistency, and a complete audit trail across your entire system.

Everything you need for advanced compounding, in one platform 

The Advanced Compounding module extends your existing Simplifi 797 program with the education, monitoring, and competency tools required for the highest-complexity CSPs. Each component reduces manual effort and keeps your team audit-ready. 
  • Competency Management

  • Batch Surface Sampling

  • SoleSource Academy Continuing Education

  • Category 3 frequencies, automated

    Simplifi 797 adjusts recurring frequencies to meet Category 3 requirements. Aseptic manipulation and ongoing hand hygiene and gloved fingertip competencies move to every three months instead of every six.

  • Aligned monitoring cadences

    Surface sampling shifts to weekly and air sampling to monthly, with schedules and reminders managed for you so nothing slips through the cracks.

  • Policies to build on

    The module includes SOP template as the foundation for your complete, connected advanced compounding program.

  • Purpose-built for Category 3

    Document surface sampling within the primary engineering control (PEC) used to prepare Category 3 CSPs, at the end of each batch in line with USP 797 requirements.

  • Complete sampling records

    Track key batch information, media sample details, colony-forming unit (CFU) counts, and approval or rejection decisions, with built-in remediation suggestions when results fall out of limit.

  • Controlled approvals and data export

    Apply a dedicated batch sample approval permission to maintain accountability, then export your batch surface sampling data to Excel for reporting and trending.

  • Analytics dashboard

    Monitor sampling performance across your sites from a centralized analytics dashboard, giving you real-time visibility into your environmental monitoring program.

  • Category 2 with Extended BUDs

    Build foundational knowledge for extending beyond-use dates safely. This overview course covers the conditions and requirements that allow for longer dating while protecting sterility.

  • Category 3 CSPs and nonsterile-to-sterile workflows

    Go deep on Category 3 preparation, including starting with nonsterile ingredients in a sterile CSP. Courses cover Category 3 CSPs overview and nonsterile-to-sterile workflows and requirements.

  • Stability, sterility, and sterilization

    Equip your team with the operational knowledge behind extended dating and validation, including stability and sterility testing, sterilization by filtration, and dry heat and steam terminal sterilization.

  • Assign and track with ease

    Assign and monitor every Advanced Compounding course through your Simplifi 797 and Analytics continuing education dashboards, the same way you manage all other USP course catalogs.

See how Simplifi 797’s Advanced Compounding module supports your most complex compounding

 Talk with our team about extending your USP 797 program to Extended Category 2 and Category 3 operations. We'll walk you through education, batch surface sampling, and competency tools built for your pharmacy.
Screenshot Category 3
Category 3 CSP advanced compounding checklist for USP 797
Simplify USP 797 compliance with our Category 3 sterile compounding checklist. Built by clinical experts, it helps pharmacies ensure safety and quality for complex workflows. 

Everything you need for advanced compounding success

See the Advanced Compounding Pharmacy software at work

Request a personalized demo and discover how Simplifi 797 helps your central-fill pharmacy manage Extended Category 2 and Category 3 compounding with expert education, batch surface sampling, and accelerated competencies.

What you'll learn:

  • How to assign and track the Advanced Compounding continuing education catalog
  • How end-to-end batch surface sample tracking aligns with USP 797
  • How enhanced competency scheduling meets Category 3 frequency requirements
  • How centralized analytics keep your environmental monitoring program inspection-ready
  • How the module builds on the Simplifi 797 foundation

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