Not sure where to start with USP compliance? Ask these four questions

By Kenneth Maxik / Special to Healthcare Facilities Today
August 25, 2017

The deadline for USP <800> Hazardous Drugs compliance is now less than a year away (July 1, 2018) – is your healthcare facility ready? If you’re like other healthcare professionals across the country, you may not fully understand what the new chapter entails, much less be ready to implement it in your facility. With strict guidelines related to engineering controls, environmental quality, personal protective equipment and more, compliance for most facilities will mean a sharp departure from the status quo. This litany of considerations may be overwhelming, but as time is running out, it’s critical to start addressing them. To identify a manageable starting point for your facility, you may consider asking yourself these four questions. 

What does USP <800> actually say?  

This question may seem like an intuitive one, but given the tight timeline, many facilities may find themselves scrambling to incorporate the most talked about aspects of the rule without taking the time to review it in its entirety. Such an approach would be unwise, as it could easily end up costing facilities money and significantly increasing their risk of noncompliance in the long run. has a variety of great resources, which plainly outline how hazardous drugs are defined, how the chapter will be enforced, and each of the specific guidelines – big and small – facilities must consider. As soon as possible, work with your team to thoroughly review this information. You may find your facility already complies with many of these best practices, and be reassured the path to compliance will be an easy one. Alternatively, you may find your facility must undergo drastic changes, and be motivated to quickly assemble a compliance plan.     

What is the scope of USP <800>’s application to your facility? 

USP <800> applies to a wide variety of facilities; specifically, anywhere that “stores, prepares, transports, or administers hazardous drugs.” Understandably, each of these facilities – from hospitals to veterinary clinics, and everything in between – have different uses for hazardous drugs and, accordingly, different applications for USP <800> at their facilities. You must develop a unique USP <800> action plan for your facility, beginning with an accounting of the hazardous drugs (as defined by the National Institute for Occupational Safety and Health or NIOSH) it uses. Don’t rely on your assumptions of what constitutes a “hazardous drug,” as some drugs are newly considered hazardous or only become so in certain forms. Once you have this list, build it out with the potential exposure risks associated with each drug – you’ll need to cross reference your current containment strategies with USP’s recommendations to ensure adequate coverage. Finally, make a plan to update this document annually as new hazardous drugs are added to the NIOSH list, and new uses for them are adopted at your facility. 

What capital improvements must your facility make for USP <800> compliance? 

While some USP <800> guidelines, such as ensuring hazardous drugs are properly labeled as such during transport, are relatively straightforward, others may require significant changes to a facility itself. For example, USP <800>’s guidance that hazardous drugs used for nonsterile compounding not be stored in sterile compounding areas may require an adjustment to a facility’s layout (and in extreme cases, a new building, if a facility can’t be sufficiently altered for compliance). Additionally, facilities that manipulate nonsterile hazardous drugs may need to obtain a Containment Primary Engineering Control (CPEC) – a piece of equipment very few currently have for this type of compounding. Other guidelines may require significant upgrades to a facility’s HVAC system to ensure proper engineering controls. These changes are relatively expensive (quotes range from $50,000-500,000), and can be financially devastating if not adequately planned for. As soon as possible, your facility’s leadership should meet with the finance team to determine necessary capital improvements, reallocating funds, if needed, to cover them. Of course, there’s always the possibility your facility is already well laid out for USP <800> compliance, and you won’t need to make many changes at all. Either way, it’s important to know where your facility stands, so you can adequately plan. 

Who will write and implement USP <800> guidelines at your facility? 

Once you’ve identified the USP <800>-related actions your facility will need to take, you must identify someone to edit your facility’s policies and procedures, accordingly, and ensure ongoing compliance. It may be helpful to bring in an objective third party, such as a consulting firm, at the outset to conduct a comprehensive gap analysis, and help you answer the above questions – particularly as, naturally, facilities tend to overestimate their preparedness. Before this person leaves, it may be worthwhile to arrange for them to “train the trainer,” or the person who will be helping to manage the changes with employees at your facility. In some cases, this may be a full-time job, while in others, these responsibilities may be tacked on to an existing role. Once the plan is in place, employees will play the greatest role in ensuring compliance and creating the safest work environment possible. They should be trained on the new policies and procedures, and encouraged to speak up if they have questions.   

While USP <800> is undoubtedly complex, a logical approach – such as the one outlined above – can help any facility achieve compliance by next July’s deadline. No matter the extent of the changes required at your facility, it may help to remember the importance of this chapter, created in response to adverse health effects associated with hazardous drug exposure, and that timely adoption of these standards is a critical step toward not only achieving more efficient operations, but also toward fulfilling duty of care to employees.  

Kenneth Maxik, MBA, MBB, FACHE, is director of patient safety and compliance for CompleteRx.   


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