The latest USP <797> chapter revisions, released in November 2023, require hospital-based compounding pharmacies to implement more stringent workflows and commit resources to comply with new standards, including:
- More rigorous personnel training requirements
- Enhanced cleaning and garbing protocols
- Increased frequency of microbiological air and surface sampling
- New beyond-use date (BUD) assignments for compounded sterile preparations (CSPs)
While many health systems have taken steps to address these new standards, developing a proactive strategy can be challenging. Leveraging IV compounding automation to streamline cleanroom processes can help improve operational efficiency and enhance patient safety, while maintaining compliance with USP <797> Beyond-Use Dates.
The latest BUD guidance outlined in USP <797> introduced a new categorization system (Categories 1, 2, and 3), replacing the previous low, medium, and high-risk classifications. This new system, along with factors like the compounding method and sterility testing, determines the BUD for each CSP. Selecting the appropriate category for your IV room operations is critical to successful compliance.
Once the appropriate CSP category is determined, setting optimal BUDs becomes a key strategic decision. For example, in Category 2, BUDs can range from:
- Room temperature: 4 to 45 days
- Refrigerated: 10 to 60 days
- Frozen: 45 to 90 days
These ranges depend on factors such as the sterility of materials, environmental conditions during preparation, and sterilization techniques used. The goal is to maximize shelf life while minimizing waste and operational costs.
There are several strategies to consider in finding the best BUD balance for your sterile compounding operation. These include:
- Analyzing utilization data and adjusting your production schedule accordingly to minimize waste
- Experimenting with both USP <71> sterility testing and rapid microbial methods to see which is best suited for your needs
- Leveraging multiple storage conditions to maximize dating
Successfully complying with USP <797> is not a one-time effort—it requires ongoing assessment and adaptation. The industry is still learning what works best in this evolving regulatory environment. Some strategies may need to be adjusted as data and outcomes are evaluated.
Omnicell’s expert team leverages data-driven insights and best practices from across its customer base to help optimize production workflows, batch sizes, protocol mixes, and more. This collaborative approach supports continuous improvement and ensures that your sterile compounding program is not only compliant—but also efficient and patient-centered.
These expert services are offered as part of Omnicell’s IV Compounding Service (IVCS) which also includes IV robotics and intelligent software workflows through a subscription-based model. IVCS also offers novel data services and application support including access to USP compliant stability studies to support extended beyond-use dating. This unique model is designed to help health systems reduce outsourcing costs, minimize OR waste, and gain supply chain control.
Balancing clinical, financial, and operational goals to select the best compounding category is key to USP compliance. Explore these key considerations for operationalizing USP <797> standards to help build your strategy.
