USP 800 standards progress: What the numbers reveal
According to the July 2024 Pharmacy Purchasing & Product's report, 89% of compounding facilities report meeting most or all of the USP <800> requirements. The number of hospitals reporting full compliance increased to 46%. However, this group still has not passed the 50% mark. Additionally, the number of facilities that are currently planning to address USP <800> requirements is reported at 3%.
Other specific indicators of USP <800> standards progress include:
- Almost 40% of organizations have created a designated person job description, bringing the number of organizations having a designated person role assignment to 90%
- Almost 50% of facilities report performing an assessment of risk per USP <800>
- More than 85% of facilities review their hazardous drug Standard Operating Procedures (SOPs) annually
- More than 90% of facilities have committed to segregating the storage of hazardous drugs
- Less than 5% of facilities still unpack hazardous drugs in positive pressure areas
How to align with USP 800 standards and the updated NIOSH list
With the publication of the finally updated NIOSH List in December of 2024, pharmacies may feel overwhelmed navigating the steps they should be taking to update their hazardous drug program. Our advice, therefore, is to keep it simple by first paying attention to USP <800> standards that have not changed before moving on to the items that have.
- Conduct Hazardous Drug rounds to assess compliance with policies and procedures. Whether safe-handling practices have been in place for a few months or a few years, it is important to look for compliance with personal protective equipment (PPE), use of engineering controls, and to solicit feedback from stakeholders. This may inform your annual review of policies or confirm your risk assessment, containment strategies, and work practices.
- Conduct a review of your facility's NIOSH hazardous drug list and adapt this list based on the 2024 NIOSH two-table structure. This review should also include an assessment of drugs approved since 2016 for inclusion in your facility list. Regulatory bodies will be looking for criteria that extend beyond the NIOSH list.
- Ensure hazardous drug SOPs, training, and competencies are up to date. Inspectors will be looking for SOPs, documentation of training, and acknowledgment of hazardous drug risk that is consistent with the updated NIOSH list, USP <800>, and your policies, especially for staff involved in receiving and preparing hazardous drugs.
Establishing a designated person role to drive USP 800 compliance
Finally, according to the Pharmacy, Purchasing & Products report mentioned above, 90% of facilities have assigned a designated person (DP) to manage hazardous drug handling. Too often, however, facilities fail to fully define the role beyond responsibility for annually reviewing and updating SOPs. Just over a quarter of facilities also list key responsibilities, required skills, attributes, experience, and reporting relationships for the DP.
Yet if the DP is accountable and responsible for the operation and performance of the compounding facility and personnel, he or she must have clear authority to oversee quality assurance and control programs that establish a system of adherence to procedures, address quality problems, evaluate complaints and adverse events, and implement appropriate investigations and corrective actions. Moreover, with those responsibilities, the DP must be fully qualified to play such a role. Senior leadership backing is also critical for the DP to be able to drive the implementation of all compounding requirements and hold teams accountable.
In short, establishing a clearly defined DP role, with the clear support of senior leadership, sends an essential message about your organization’s commitment to a culture of quality and patient safety. The benefits are many and include saved lives, reduced morbidity, prevention of adverse events, financial savings, and strong regulatory compliance.
On the last point, it’s worth noting that as of this writing, state adoption and enforcement of USP standards into pharmacy regulations is still inconsistent, as rule-making and revisions can take several years. Moreover, The Joint Commission is cross-walking the USP standards to The Joint Commission accreditation standards, meaning it will inspect organizations who are compounding hazardous drugs are following USP General Chapter <800> and its policies for such items as staff training, garbing and use of PPE, facility and engineering controls (including microbial sampling), and beyond-use dating.
Because progress in the past couple of years across all of these areas is so encouraging, now is an opportune time to finish the process. It’s the right thing to do for patient and employee safety – and your entire facility will reap the benefits.
