Percentage of USP 797 & USP 800 Compliance



A few months ago, Pharmacy Purchasing & Products released their 2018 State of Pharmacy Compounding.  The publication summarizes survey data from hospitals of various sizes and demographics across the United States. Data showed that there is a going to be a strong growth in compounding volume over the next three years. With the amount of compounding increasing, cleanroom renovations/build-outs are also expected to increase. Moreover, the pace of cleanroom renovations are projected to increase by 69% when it comes to cleanrooms that have not been renovated in the last 5 years (PP&P).


Self-reported USP <797> Compliance

One area of the survey data highlighted USP <797> requirements for USP <797> compliance. There was a dip in compliance in 2017, but 2018 data shows facilities are back on track.

With regulation enforcement and discussion becoming more and more prevalent, many facilities are now conducting an annual gap analysis of their USP <797> compliance.

Compliance continues to be an ongoing effort, but most hospitals self-reported that they are meeting most of the










Self-reported USP <800> Compliance

Facilities are in the middle of preparing for USP <800> as the implementation date of December 2019 approaches. Over 8 out of 10 facilities surveyed prepare hazardous drugs meaning this new chapter will affect most facilities across the country. Fewer than 10% of these facilities reported that they are fully compliant with most of facilities responding they are either meeting most of USP <800> or meeting some of <800> regulation.











Aseptic Enclosures is involved with a lot of projects regarding Cleanrooms under USP <797> and USP <800> guidelines.

If you are going through a cleanroom renovation or considering new equipment for your cleanroom, give us a call 800.418.9289 and we’ll be honored to help.


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1 year ago

[…] step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A […]

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