Safety First Blog

Roundup: USP <800> Info You Need to Know

Posted by Laura Paxton on Dec 12, 2022 9:46:05 AM
Laura Paxton
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How are you handling the news that USP <797> and, therefore, USP <800> will be enforceable in less than a year? 

The Rpharmy team has been meeting with pharmacy directors over the last few months, and more than 70% say it will still take them at least a year to be fully compliant with USP <800> hazardous drugs safe handling and disposal requirements. Because USP <800> compliance covers so many aspects of your healthcare system’s operations, from the equipment and PPE used and in which part of the facility to the assessment and introduction of new drugs and the communication of safe medication administration and disposal, and much more. 

We’re here to help you in this important and yet arduous process. We’ve gathered several articles from Rpharmy’s Safety First Blog covering key (and tedious) parts of USP<800>. 

Let’s start off with the basics. What is USP <797>, and how is this regulation related to USP <800>?

According to the CDC, more than 8 million healthcare workers are exposed to hazardous materials each year. In our recent conversations, 82% of those we spoke with grossly underestimated this shocking statistic. Clearly, there is a need to protect healthcare workers in a more regulated way from the deadly effects of hazardous drug exposure. The most recent updates to USP <797> and USP <800> drastically increase healthcare systems' required steps to protect their employees. Start off with a basic primer on these two regulations that are, no doubt, taking over your life at the moment in USP <797>: Are You Ready?

There is no ‘one-size fits all’ USP <800> requirement foriStock-1331256506 PPE usage and disposal. When communicating the PPE needed to prevent exposure to hazardous drugs, you can feel like you’re back in junior high, making your way through a “Choose Your Own Adventure” book. For instance, “Use an N95 respirator … unless working with gases or vapors and then you need to use a full-facepiece, chemical type-respirator or elastomeric half-mask respirator with multi-has cartridges and P100 filters. But you do not need a respirator if you’re compounding in a BSC with the sash down and CACI.” Read 8 Questions Answered About PPE & USP <800> Requirements for clarity on the top questions we’ve heard around PPE usage and disposal. 


USP <800> offers a lot of guidance with flexibility since it is intended for many types of facilities that interact with hazardous drugs. But it also can be challenging when working to accurately comply with this important regulation. The same goes for the Communications Plan required in USP <800>. USP <800> outlines the pieces of the plan, but how and where that plan is communicated is up to the healthcare system. We’re kind of pros in this area, so we’ve outlined “How” Safety Information Should be Communicated and “What” Safety Information Should be Communicated

While USP <800> will be enforceable beginning November 2023, State Boards of Pharmacy and other accrediting agencies have been assessing for USP <800> compliance in the last year or so. Among the top policies or processes, they check for involve hazardous drug safety. These policies need to be documented and communicated AND followed through on. Learn more about the required policies and find out which ones are the most reviewed by the State Boards of Pharmacy, Centers for Medicare and Medicaid Services and other accrediting agencies in USP <800> Wrap-Up: Policies and Procedures for Healthcare Worker Safety.

This is only a short list of the resources we have available to help inform you of all aspects of USP <800>. Check out the rest of the Safety First Blogs or sign up to be notified when a new blog is available. 

Topics: Rhazdrugs, Policy, USP <800>, Formweb

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