Regulatory Inspections

April 2020 : State of Pharmacy Compounding - Vol.17 No. 4 - Page #16

Regulatory inspections of the cleanroom remain exacting and rigorous experiences regardless of the inspecting body. Inspectors are well-prepared and thorough in their evaluations. Pharmacy can expect a comprehensive review of all documentation, from certification reports to staff competencies, as well as observation of staff practices. Areas of special focus this year include air sampling volumes, drug storage practices, and sealed ceiling tiles.

While USP <800> is not yet compendially applicable, many state boards are querying facilities about their compliance plans. Areas that received particular attention from state board inspectors include receiving storage, garbing practices, pressure monitoring, room exhaust, CSTD use, and hazardous waste handling.


This year saw a significant increase in the number of accreditation surveys conducted by physicians rather than pharmacists. This is significant as facilities are more likely to receive citations and/or recommendations when the surveyor is a pharmacist.


Over the past 5 years, 23% of facilities have experienced a patient incident involving a compounding error. While the data correlates CSP production volume with error rates, it is important to note that facilities with strong tracking systems and a culture that supports incident reporting will likely demonstrate higher (and more accurate) error rates.


Despite the fact that USP <800> is currently informational and not compendially applicable, just over one-third of recent accreditation and state board inspections have included queries as to the institution’s compliance with this chapter.


Accreditation actions remain quite rare; nevertheless, there is a clearly increasing trend in the number of citations given and recommendations made. This year saw recommendations focus on SOPs and competencies that were not updated, poor hand hygiene practices, and ensuring mixing occurs in first air. Citations were issued for a broad range of issues including timing of handwashing, lack of documentation of training and follow up, not swabbing prior to the start of a batch, and using the same alcohol swab on two vials.


Accreditation and state board inspections increasingly focus on <797> compliance. Pharmacy can expect experienced inspectors to scrutinize compounding practices at a very detailed level. Most inspections include thorough documentation reviews with a strong interest in cleaning practices, BUDs, smoke tests, and certification reports. Notably, many pharmacy directors found their state board inspections to be particularly exacting.

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