<797> Compliance

April 2020 : State of Pharmacy Compounding - Vol.17 No. 4 - Page #14
Category: USP Training Programs

Full compliance to <797> has been elusive for many facilities, despite this regulation having been on the books since 2008. There is no small irony in the fact that the proposed update to the regulation appears to have inspired a renewed effort at compliance, resulting in the first time that a majority (57%) report being in full compliance with the currently applicable chapter. And yet, a full 43% of facilities have yet to achieve that same milestone. While the 2008 version of <797> remains the guiding document for the time being, it is clear that required compliance to a revised version is in the offing. With just under one-quarter of facilities (24%) confident in their compliance to the 2019 revised chapter, pharmacy still has much work to do.


After 5 years of stagnant progress, this year saw a stunning surge in the number of facilities that have achieved full compliance with the 2008 version of USP <797>. For the first time, a majority of facilities (57%) report that they now meet or exceed all of the requirements in the current (unrevised) chapter.


While a majority of facilities report having achieved full compliance with the current (2008) version of USP <797>, less than one quarter of facilities are confident that they have achieved full compliance with the revised version of the chapter, which is currently on hold.


Compliance rates for the currently applicable version of <797>, as well as the revised chapter, do not differ significantly by facility size. On average, 93% of facilities meet most or all of the current requirements, while 74% meet most or all of the requirements in the revised chapter.


This year saw an increasingly strong commitment on pharmacy’s part to conduct a gap analysis. Just over three-quarters (76%) of facilities completed one this year; however, smaller facilities continue to lag behind their larger counterparts in this endeavor.

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