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Pharmacies prepare for revisions to USP 797

For pharmacists, pharmacy technicians, and other staff, a clock is counting down to November 1, 2023, and revisions to USP 797. That’s the date by which the United States Pharmacopeia Convention, or USP, has set for implementing changes to USP Chapter 797. USP 797 outlines requirements and procedures for compounding sterile drugs – among the riskiest duties undertaken by pharmacists on behalf of their patients.

The convention first put in place USP 797 on January 1, 2004. The chapter sets forth a standard of practice for pharmacists. And the authors originally wrote this section to “prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.”

Industry pundits say there are mixed feelings among pharmacy professionals for the latest revisions. Opinion pieces in trade journals say that professionals like the idea of reclassifying sterile compounds into numbered categories tied to where the compounding happens. That change, they say, makes more sense than assigning a general level of risk for compounds. On the other hand, industry watchers also say some pharmacists and pharmacy technicians will balk at the more frequent cleaning the new USP 797 requires for areas where sterile compounding happens.

But pharmacists know compounding–especially sterile compounding–can spell danger when mismanaged. In 2018, the Associated Press reported that five people were convicted following an investigation into a meningitis outbreak linked to the Framingham, Mass.-based New England Compounding Center. Journalists reported the outbreak sickened almost 800 people due to contaminated injections of medical steroids made at the now-closed facility. Prosecutors said the New England Compounding Center made drugs in unsanitary conditions. Specifically, investigators noted that fungal matter from unopened vials was the source of the contamination, which underscores how overlooked locations can harbor microbes.

The situation at the New England Compounding Center was extreme. Regardless, it is always beneficial to improve the processes and rigor by which pharmacies undertake compounding. Doing so improves patient care. But new training and processes are only a first step. To meet the Nov. 1 deadline, many pharmacists are already working to ensure they are documenting their preparations. Pharmacies will also want to show state boards of pharmacy and departments of health records for successfully training staff and implementing their new procedures.

Documenting and organizing the work to comply with the USP 797 revisions will require many pharmacies to make use of numerous spreadsheets, lists, calendar alerts, and, possibly, project management software. To accomplish the job, pharmacy staff will compile and sort through to-do lists, create checklists to remember tasks, input data, and file and refile documents all while keeping tabs on other licenses and records apart from USP 797.

With a conscientious team to keep this on track and corral their coworkers, most pharmacies will meet the deadline and comply with the revisions. But at what cost? Manually tracking the training component of USP 797 would be a heavy lift. Add to that job accounting for written and practical exams, best practices, and competency levels for a variety of employees, and the work grows exponentially. There’s also the need to document changes in policies and procedures. And most pharmacies are overworked and understaffed.

To help pharmacies shoulder the work of preparing for the USP 797 revisions, managers should opt for a compliance management system. Simply put, compliance management software tracks licenses, activities, certifications, and the work a team needs to tackle to demonstrate compliance. These systems store everything in a central repository. Managers can easily tap into the software for updates. And if boards of pharmacy and departments of health want to examine a pharmacy’s records, the system quickly serves up what managers want to share.

To be compliant with USP 797, managers don’t need a confederation of paper-based reminders, data entry, and spreadsheets. A compliance management system (including license tracking software) takes all the tools and tactics mentioned above and automates them. That helps pharmacists, pharmacy technicians, and staff focus on safely compounding.