Last year saw a dip in the number of recommendations and citations issued by accreditors, given the changes to USP chapters. That respite is clearly behind us as the number of citations and recommendations issued this year hit an all time high following the November 2023 enforcement date of USP<797> and <800>. While FDA inspections remain rare, the likelihood of receiving a 483 observation has sharply increased.

Compounding errors are reaching patients. In fact, the frequency of patient incidents involving compounding errors has remained notably consistent over the past 17 years. This year 29% of facilities report having had a patient incident(s) involving a compounding error over the past 5 years; this number has not changed over the lifetime of this survey.

As expected, both citations and recommendations from accreditors increased this year. Common areas of focus include cleaning training and documentation; remediation practices for out of specification events; and hand hygiene, particularly when moving and in and out of the ISO 5 hood.

FDA inspections remain rare. Nevertheless, 5% of all hospital pharmacies have been inspected by the FDA in the past 2 years, up from just 2% in 2022. The likelihood of receiving a 483 observation during such an inspection skyrocketed: Last year, just 6% of FDA inspections resulted in 483 observations, while 32% of this year’s inspections included 483 observations.

Pharmacy can expect continuing emphasis on USP <797> during inspections; notably, both accreditors and CMS expanded their USP focus this year.

Accreditors now expect full compliance with <797>. This is reflected in the number of facilities receiving recommendations and citations form their accreditors, which hit an all time high this year.

Both accreditors and CMS are increasingly likely to include USP <800> queries as part of their surveys.

Although more accreditation surveys are conducted by physicians, it is important to note that pharmacy is more likely to receive a recommendation or citation when the surveyor is a pharmacist.