USP <800> Compliance


December 2020 : USP <800> - Vol.17 No. 12 - Page #1

Pharmacy’s commitment to USP <800> remains demonstrably strong. The growth in compliance rates bodes well for pharmacies once the chapter becomes compendially applicable and is then incorporated into pharmacy inspections.


The number of hospital pharmacies reporting full compliance with USP <800> doubled this year to 24%. Likewise, the number of facilities that have yet to address these requirements fell by 50%; leaving just 9% in the category of currently planning to address USP <800>.


Overall, 73% of facilities report meeting most or all <800> requirements, with compliance rates remaining similar among all facilities with at least 100 beds. Notably, while the smallest facilities (<100 beds) have lower compliance rates, this group demonstrated solid progress this year toward meeting USP’s requirements for HD handling.


While most facilities (74%) continue to leverage USP <800> requirements to garner financial support for pharmacy efforts, the largest facilities have been the most aggressive at taking this approach.


The number of facilities that have assigned a Designated Person to manage all aspects of HD handling surged to 81% this year, a 27% jump over last year’s numbers. The commitment to this key role has been particularly strong among the largest facilities.


In three-quarters of hospital pharmacies, the Designated Person performs a review of all HD SOPs on an annual basis.


The job description for this role should list key responsibilities, required skills, attributes, and experience in addition to reporting relationships. To date, just over one-quarter of all facilities have established a job description for this position. While this is an improvement over last year’s 18%, the vast majority of facilities of all sizes need to address this issue.


For guidance on how to create a written job description, see PP&P’s February 2019 article:

Job Description for a USP <800> Designated Person

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