USP <797> Compliance

April 2021 : State of Pharmacy Compounding - Vol.18 No. 4 - Page #16
Category: USP Training Programs

With the vast majority of state boards requiring compliance with USP <797>, there is even more impetus to adopt these requirements within the pharmacy. Last year’s impressive surge in compliance continued this year as well. Seven out of every 10 hospital pharmacies now report having achieved full compliance with the currently applicable chapter. While a majority of hospital pharmacies have yet to achieve full compliance with the 2019 version, compliance rates did jump 30% this year. Furthermore, 83% of those facilities that are not yet fully compliant with the revised chapter are currently working toward this goal. These efforts are apparent on the pages that follow, as we see improvements in environmental monitoring P&Ps, a strong commitment to standardized cleanroom cleaning, and increasing technology adoptions, including BSCs, CSTDs, and IV workflow monitoring systems.

This year saw continued gains in compliance with both versions of USP <797>.

A strong majority of facilities report having achieved full compliance with the current (2008) version of USP <797>, while compliance to the revised version of the chapter has yet to reach majority status despite improved efforts by pharmacy.


In a comparison of those facilities that meet most or all of the requirements of USP <797>, there is relative parity by facility size, despite the fact that the revised 2019 version of the chapter has lower compliance rates overall versus the current 2008 version of the chapter.

The larger the facility, the more likely it is to have conducted a gap analysis over the past year.

Click here to view a larger version of this chart

2021 State Of Pharmacy Compounding Slides


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