USP <800> Compliance


July 2020 : Hazardous Drug Handling - Vol. 17 No. 7 - Page #4

Pharmacy’s commitment to USP <800> compliance is impressive. The number of facilities at full compliance more than doubled this year and most facilities maintained their efforts despite the enforcement delays. A majority continues to leverage the USP requirements to garner budgetary support for pharmacy efforts. The resulting dividends are increases in the number of facilities conducting risk assessments, assigning a Designated Person for HD handling, and completing HD SOPs.


Two thirds of all facilities are continuing with their HD compliance efforts despite the delay in enforcement resulting from the appeals process.


Facilities of all sizes are making strong progress toward full compliance with USP <800>. To date, just 24% of facilities report being fully compliant, but an additional 49% have met most requirements with efforts underway to achieve full compliance in the near term.


The vast majority of facilities (95%) are developing HD handling SOPs and this year saw significant progress in their development. Nevertheless, additional efforts are needed for P&Ps that address CSTDs in administration, nonsterile compounding, surface sampling, and medical surveillance programs.

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A clear majority have chosen to perform risk assessments, rather than manage all NIOSH HDs under USP <800>.


While most facilities have appointed a designated person, the effort has been more consistent at larger facilities. 75% of those serving in this role conduct an annual review of all HD SOPs.

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