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:
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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.
