<797> Compliance


April 2019 : State of Pharmacy Compounding - Vol. 16 No. 4 - Page #12
Continuing the trend of upward, albeit markedly slow, progression, 85% of pharmacy directors are confident that their facilities meet most or all of the current USP <797> requirements. However, it is important to note that there has been no measureable increase in the number of facilities reporting having achieved complete compliance in the past 5 years. We will monitor pharmacy’s continuing progress toward compliance with the revised <797> which becomes effective December 1, 2019.

Progress toward complete compliance with the current version of USP <797> remains stalled at 37% of all facilities for the past few years. Nonetheless, it is important to note that enforcement impacts compliance efforts: facilities located in states that require <797> compliance are almost twice as likely to have achieved full compliance versus those facilities located in states that do not require full compliance.


Overall, 67% of hospital pharmacies have conducted a gap analysis over the past year and the frequency improves with increases in facility size and compounding volume.

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With the exception of the smallest facilities, 90% of pharmacy directors report having met most or all of the requirements in the current version of USP <797>.


The revised USP <797> (like USP <800>) will be effective on December 1, 2019. It is quite telling that only 2% of facilities are confident that they are currently in full compliance with the revised chapter. While most facilities expect to be compliant by the end of the year, such a timeline may be challenging.


Overall, 85% of facilities report that they meet most or all of the requirements under the current version of USP <797>. Larger facilities have been faster to achieve compliance; however, it is important to note that 100% compliance continues to elude 63% of all facilities.

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