Last year, revisions were made effective to the USP 797 requirements. In addition, the USP 800 requirements were made effective. Both of these requirements shifted how pharmacies and healthcare facilities approach sterile compounding and the handling of hazardous drugs. Let’s take a look at the changes throughout the past year and what we as an industry have learned.
Understanding Revised Requirements
Revisions to USP 797 focused on sterile compounding, with more strict controls on environmental monitoring and cleanroom standards. Meanwhile, USP 800 focused on minimizing exposure to hazardous drugs through risk assessments and the use of personal protective equipment. Continuous staff training and skill checks continue to be emphasized in both standards, aiming to further standardize safety protocols.
Key Requirements Areas of Concern
- • Increased Emphasis on Risk Assessment
The 2023 USP 707 and 800 requirements push for more comprehensive risk assessments, allowing facilities to adjust safety protocols based on their specific environments. This flexibility is key to maintaining compliance and reducing risks. - • Enhanced Environmental Controls
Stricter cleanroom standards and environmental monitoring are now mandatory, ensuring higher levels of sterility. When performed regularly, this helps facilities reduce contamination risks. Utilizing resources, such as Quality Solutions, that offer Environmental Monitoring Kits (EM Kits) for on-site testing can greatly support facilities in meeting these standards. - • Personnel Training and Competence
Ongoing training continues to be critical. Regular skill assessments ensure that staff involved in compounding stay current with updated and evolving safety practices, especially when handling hazardous drugs. - • New Technologies
The requirements encourage the use of advanced technologies like closed-system transfer devices (CSTDs) to further reduce exposure to hazardous drugs. These systems have been shown to enhance safety and streamline compounding practices.
Lessons Learned from the First Year
- • Collaboration and Communication
Open communication among facility staff and all stakeholders has been vital in smoothly implementing the updated guidelines. Successful facilities bring together stakeholders from pharmacy, facilities, infection control and quality assurance. - • Continuous Improvement
The requirements serve as a foundation for continued progress, not just a checklist. Successful facilities are embracing a mindset and culture of continuous improvement, staying alert to new risks and advancements in technology.
The Future Ahead
The past year has been a transformative journey for pharmacies and healthcare facilities working to meet USP 797 and USP 800 requirements. The focus on risk management, team training, and advanced technologies promises increased safety for both patients and healthcare workers. While compliance challenges remain, the continued emphasis on safety will only keep improving standards in sterile compounding and hazardous drug handling.
Additional Resources
For support in continuing to navigate these changes, explore Quality Solutions’ full service offerings, from Environmental Monitoring Kits (EM Kits) to additional resourcing. Click here to schedule a free consultation to learn how Quality Solutions can support your facility. Additional updates to the USP requirements can be found directly through U.S. Pharmacopeia (USP).