Navigating the Revised USP 797: Key Changes and Compliance Strategies for Pharmacies
Aug 30, 2025
Introduction
The United States Pharmacopeia (USP) General Chapter <797> sets standards for compounding sterile preparations (CSPs) to ensure patient safety by minimizing risks such as microbial contamination, chemical instability, and dosing errors. The chapter underwent significant revisions, effective November 1, 2023, introducing changes to improve clarity, enhance safety, and align with modern compounding practices. These revisions shift from risk-based levels to categories based on environmental controls and testing, impacting pharmacies' operational protocols. This article explores the key changes in the revised USP <797> and provides practical compliance strategies for pharmacies to adapt effectively.
Overview of USP <797> Revisions
The 2023 revision of USP <797> replaces the previous low-, medium-, and high-risk categories with Categories 1, 2, and 3, focusing on compounding conditions, environmental monitoring, and microbial growth potential rather than preparation complexity. This shift aims to standardize practices across diverse settings, from hospital pharmacies to compounding facilities. Key updates include stricter environmental monitoring, enhanced garbing requirements, extended beyond-use date (BUD) options for tested CSPs, and the elimination of PDF access to the chapter (now online-only). These changes reflect advancements in contamination control and aim to balance safety with patient access to compounded medications.
Key Changes in the Revised USP <797>
New Categorization System:
Category 1: CSPs prepared in an ISO Class 5 primary engineering control (PEC) within an unclassified segregated compounding area (SCA); suitable for short-term use (e.g., ≤12 hours at controlled room temperature).
Category 2: CSPs compounded in a cleanroom suite (ISO Class 5 PEC in an ISO Class 7 buffer room); allows longer BUDs with enhanced controls.
Category 3: Also in a cleanroom suite, but with advanced requirements like sporicidal disinfectants, frequent monitoring, and batch sterility/endotoxin testing; supports extended BUDs (e.g., up to 180 days for terminally sterilized CSPs).
Immediate-use CSPs remain a special provision for emergencies (≤4 hours, ≤3 sterile components).
Environmental Monitoring Enhancements:
Category 3 requires more frequent viable air sampling (monthly) and surface sampling (weekly), compared to Category 2 (semiannual air, monthly surface). Sporicidal disinfectants are mandatory for Category 3 to address resistant contaminants like bacterial spores.
Facilities must establish baseline microbial levels and action plans for excursions.
Extended BUDs with Testing:
Category 3 allows longer BUDs (e.g., 90 days at CRT for aseptically processed CSPs with testing, 180 days frozen for terminally sterilized CSPs) if sterility, endotoxin (where applicable), and stability tests are passed.
Single-dose vial puncture time extended from 6 to 12 hours in ISO Class 5 or cleaner air.
Garbing and Personnel Requirements:
Stricter garbing protocols, including sterile gloves and gowns for Category 2 and 3, with competency assessments every 6 months for Category 3 (12 months for Category 2).
Training emphasizes aseptic technique and contamination prevention.
Facility and Equipment Standards:
Cleanroom suites for Categories 2 and 3 must maintain ISO classifications with certified PECs and buffer rooms. SCAs for Category 1 need not be classified but must have ISO Class 5 PECs.
Regular certification (every 6 months) and maintenance of equipment like laminar airflow workbenches are required.
Documentation and Access:
The revised chapter is accessible online only, requiring USP accounts for updates. Facilities must maintain detailed standard operating procedures (SOPs) and documentation for compounding, monitoring, and testing.
Compliance Strategies for Pharmacies
To align with the revised USP <797>, pharmacies should adopt the following strategies:
Assess Facility Readiness:
Evaluate current compounding areas against category requirements. Upgrade to cleanroom suites for Category 2 or 3 if extended BUDs are needed, or maintain SCAs for Category 1.
Ensure PECs (e.g., laminar airflow hoods) are certified and maintained per ISO standards.
Enhance Environmental Monitoring:
Implement a robust monitoring program with regular air and surface sampling. Use sporicidal agents for Category 3 and train staff on proper cleaning protocols.
Document baseline microbial levels and establish action thresholds for contamination excursions.
Train and Certify Personnel:
Conduct regular training on aseptic technique, garbing, and hand hygiene. Schedule competency assessments (every 6 or 12 months, depending on category).
Use simulation-based training to mimic real-world compounding scenarios.
Optimize BUD Assignment:
Leverage Category 3 for extended BUDs by investing in sterility and stability testing, especially for high-volume CSPs.
Maintain accurate stability data and consult USP <71> for sterility testing protocols.
Update SOPs and Documentation:
Revise SOPs to reflect new categories, monitoring frequencies, and garbing requirements. Ensure all staff are trained on updated procedures.
Use digital tools like IV workflow systems to streamline documentation and track compliance.
Stay Informed on Regulatory Changes:
Regularly access the USP website for updates, as the chapter is no longer available in PDF format.
Engage with professional organizations (e.g., ASHP, IACP) for guidance and training resources.
Challenges and Considerations
Transitioning to the revised USP <797> may present challenges, particularly for smaller pharmacies with limited resources. Upgrading facilities to cleanroom suites or implementing frequent monitoring can be costly. Staff training and competency assessments require time and investment. To address these, pharmacies can:
Prioritize Category 1 for low-volume, short-term CSPs to avoid cleanroom costs.
Partner with third-party testing labs for sterility and endotoxin testing to support Category 3 compounding.
Seek grants or shared resources through pharmacy networks to offset compliance costs.
Conclusion
The revised USP <797>, effective November 1, 2023, introduces significant changes to enhance the safety of compounded sterile preparations through new categories, stricter monitoring, and extended BUD options. Pharmacies must adapt by upgrading facilities, training staff, and updating SOPs to ensure compliance. By implementing strategic measures and leveraging resources, pharmacies can navigate these changes effectively, maintaining patient safety and operational efficiency. Consult the official USP chapter and facility-specific SOPs for detailed guidance.
References
United States Pharmacopeia. General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. Effective November 1, 2023.
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