Complying with USP <800> ensures safety and reduces healthcare facility risk
By Mike Zorich
Over the past couple of years, I’ve been writing and presenting about the new United States Pharmacopeial General Chapter 800 “Hazardous Drugs – Handling in Healthcare Settings,” generally known as USP <800>. The standard is intended to protect healthcare workers and patients from harm associated with exposure to hazardous drugs, and many healthcare facilities have taken steps to meet compliance; IMEG has provided engineering consulting on more than 200 such projects.
The number of facilities yet to begin the compliance process is substantial, however. Perhaps this is because, like USP <797>, USP <800> is a set of rules and standards written in a context that could be enforced, but neither chapter has authority until it is adopted by an authority having jurisdiction, such as a state’s board of pharmacists.
Still, both USP <797> and USP <800> are identified as the standard of care for the industry, and many healthcare organizations voluntarily follow the chapters to ensure patient and staff safety. Overall, the new guideline is a significant step in the healthcare industry’s growing regulatory focus on compounding practices, which, when subpar, can result in preventable patient and staff incidents, penalties, and other risks for an organization.
The most recent USP <795> and <797> chapters were published on Nov. 1, 2022, and there is a one-year implementation period before it becomes official. Therefore, the industry is tracking Nov. 1, 2023, as the enforcement date, which also includes USP <800>. But regardless of the deadline, healthcare facilities now working toward compliance and those who will do so in the future need to have a comprehensive grasp of USP <800>. It’s also important to understand a facility’s sterile and nonsterile compounding processes, set a realistic construction budget, and achieve early engagement of a certifier.
Together, these steps will lay the foundation for success in completing a USP <800> compliance project.
Watch a recording of Mike Zorich’s webinar on USP <800> compliance.