ASHP Resources Help Pharmacists Achieve Compliance with USP’s Revised Standards

Dear Colleagues,

We have seen significant changes in pharmacy practice over the last few years as the healthcare landscape continues to evolve. At the end of 2022, the U.S. Pharmacopeia (USP) published the highly anticipated final versions of General Chapters <795> and <797>. These revisions, to be implemented by Nov. 1, 2023, represent a significant change from the 2008 standards.

Although the USP revisions will impact the entire healthcare community, applying the new standards and understanding the risks associated with compounding is critical to our role as medication therapy and safety experts. 

We recently surveyed ASHP members to assess their needs and readiness for complying with the USP revisions by the deadline. According to preliminary results, in general, larger facilities (those with 299 beds or more) indicated a higher level of confidence for implementing the Chapter <797> revisions. The respondents indicated that the areas they were most concerned about complying with were cleaning and disinfecting, facilities, and engineering controls.

We also asked respondents about the types of resources that would be most helpful to their organization as they work to implement the new chapter revisions. Based on this feedback, and input from our staff and content experts, ASHP has developed timely and accurate information to help members implement and comply with the new standards.

Resources to Support Compliance
We encourage you to visit ASHP’s new Compounding Resource Center, an information hub containing useful news, resources, products, and services to help pharmacy professionals navigate the upcoming revisions. Our experts have compiled a series of documents exclusively for ASHP members that outline the fundamental changes in the revised USP Chapters <795> and <797>. There is also a list of standard operating procedures for each chapter, which can be used during implementation to ensure compliance.

Additional resources include the new IV Workflow Management Systems Implementation Checklist, the USP <800> Risk Assessment Toolkit, and updated compounding publications, including The Chapter <795> Answer Book and The Chapter <797> Answer Book.

We invite you to listen to ASHP’s podcasts and webinars on the latest topics in compounding practice, including innovative approaches to compounding challenges. Webinars often include continuing education as well.

We also created a new ASHP Connect Community on compounding, which provides a discussion forum for those interested in sterile and nonsterile compounding, and hazardous drug safety. With nearly 28,000 professionals in the compounding community, it is an excellent opportunity for you to share information and engage with peers as you work toward compliance with the new standards.

Professional Development
ASHP offers valuable educational resources to support pharmacists and pharmacy technicians in compounding pharmacy practice. The Compounded Sterile Preparations Certificate for Pharmacists covers the knowledge and skills required to comply with the updated USP <797> standards. The Practical Training in Compounding Sterile Preparations Certificate covers sterile preparation practice standards and regulations for pharmacy technicians and pharmacists, including the updated USP <797> standards. ASHP’s recertification courses, the Intensive Studies for Recertification: Compounded Sterile Preparations Pharmacy and the Compounded Sterile Preparations Specialty Selected Readings, have also been updated to include compliance with the new standards. The Compounding Sterile Preparations Competency Library is also undergoing a significant revision to align with the revised standards and will launch in July as the new Compounding Competency Assessment Center to provide comprehensive competency training for staff. 

Compounding Sessions at the ASHP Summer Meetings
As we look ahead to our 2023 Summer Meetings & Exhibition in Baltimore, June 10-14, Sterile Product Compounding is highlighted as an area of focused programming. Compounding experts will lead sessions on engaging topics, including what leaders need to know about complying with the revised USP standards, outlining the requirements and recommendations within USP <797> on actionable environmental monitoring limits of a cleanroom, and identifying viable environmental and surface sampling requirements of the USP Chapter <797>. With a theme of “Be Bold, Be More,” we look forward to seeing you at this exceptional learning and networking event. Registration for the 2023 Summer Meetings is now open. 

Thank you for being a member of ASHP and for all you do for your patients and our profession.



Posted on April 18, 2023