Policies & Procedures

December 2021 : USP 800 - Vol.18 No. 12 - Page #1
Category: USP Training Programs

Conducted in the second quarter of 2021, PP&P’s 4th annual survey of USP <800> compliance yielded a confidence interval of 5.42 (95%=/-5.42) with participation by 299 pharmacy leaders. The data points that follow demonstrate areas where pharmacy has made great strides toward compliance as well as those requirements where further effort is necessary. Our hope is that this data provides a benchmarking opportunity to both inspire your improvement efforts and celebrate your successes.


The use of ASTM 6978 gloves among all staff members (including pharmacy technicians, oncology nurses, and receiving personnel) is nearly ubiquitous. However, there is room for additional progress in the provision of HD Risk Acknowledgement forms to both male and female staff capable of reproduction who handle HDs as 21% of facilities have yet to offer these. Furthermore, just 31% of facilities require the use of a respirator for staff handling HDs outside of a PEC.


CriticalPoint is the most popular USP <800> gap analysis tool, with ASHP and homegrown tools rounding out the top three.


While just 38% of facilities have a medical surveillance plan in place for those staff working with HDs, there is strong interest in adopting these plans. An additional 39% intend to create a medical surveillance plan.


Pharmacies rely on a wide variety of equipment for nonsterile HD compounding, as dedicated counting trays, spatulas, and pill splitters are popular options. It is notable that 16% of facilities have yet to switch to dedicated equipment when compounding nonsterile HDs; these are generally smaller facilities that are still in the planning stages of addressing USP <800> requirements.

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