Regulatory Inspections


April 2021 : State of Pharmacy Compounding - Vol.18 No. 4 - Page #18

As expected, there was a drop in the number of regulatory inspections from accreditors, state boards, and CMS over the past year due to COVID-19.There was a similar dip in the number of regulatory actions taken by accreditors. While accreditation surveys were generally conducted by physicians, a third of accreditation surveyors were pharmacists, who were also more likely to issue citations or recommendations. Notably, there were very few FDA inspections.


Looking ahead, an equal number of facilities plan to be inspected under the 2008 and 2018 versions of chapter <797> during their next accreditation survey.


Over the past 5 years, 22% of facilities have reported experiencing a patient incident involving a compounding error. There is a notable correlation between compounding volume and error reporting, which is likely impacted by a culture that supports incident reporting.


The small dip in accreditors’ citations and recommendations reflects the dip in the number of inspections.


Most regulators include USP <797> compliance queries as part of their inspections. This year saw a strong focus on documentation, specifically cleaning logs, documentation of training and competency testing, and pharmacy’s understanding of and response to accreditation reports. In addition, many inspectors reviewed cleaning procedures before and after drug preparation, sterile product storage, as well as room pressure and humidity monitoring.

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Inspectors’ queries about USP <800> were somewhat less rigorous and primarily focused on plans for achieving compliance, room design, air exhaust, current HD storage practices, and CSTD use.


2021 State Of Pharmacy Compounding Slides

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