Despite increases in both survey frequency as well as inspectors’ focus on <797> this year, the number of facilities receiving recommendations and citations related to compounding practices declined from 14% to 9% and from 9% to 7%, respectively.

Across the country, 27% of facilities have reported experiencing a patient incident involving a compounding error over the past 5 years. The frequency of these serious compounding errors rises along with compounding volume.

FDA inspections, while rare, are not nonexistent in hospital pharmacies. Over the past 2 years, 4% of hospital pharmacies have been inspected by the FDA and 6% of those inspections have resulted in 483 observations.

A strong focus on USP <797> compliance can be expected during accreditation and state board inspections. CMS has also increased their attention to <797>-compliant practices.

There was a significant drop off in the number of recommendations made and citations issued by accreditors this year; however, that is likely to change once the regulations become official in November.

While a minority of inspections expected USP <800> compliance this year, that will change with the November deadline.

While physicians continue to conduct most accreditation surveys, the number of nurses and pharmacists serving as accreditors is increasing. It is important to note that pharmacist surveyors are most likely to cite or make recommendations during a pharmacy inspection.