Regulatory Inspections

April 2019 : State of Pharmacy Compounding - Vol.16 No. 4 - Page #16

The focus of regulatory inspections has undergone a significant evolution over the past few years. Well-prepared inspectors, who are often pharmacists themselves, now probe for <797> compliance during rigorous, multi-day inspections. No longer does the inspector simply check off that a certifier visited; rather, they are likely to request a copy of the HEPA filter documentation testing and query the results of changes made in response to the certifier’s report. Inspectors are increasingly likely to make recommendations or even cite the pharmacy for noncompliance. Areas that have caught inspectors’ attention this year include: incomplete batch records, missing line of demarcation, inconsistent cleaning techniques, lack of a light box to check for particulate matter, and improper documentation of staff competencies.

This year marks the first time that accreditation surveyors were most likely to be pharmacists. While pharmacist and physician surveyors cited facilities at equal rates, it is notable that pharmacist surveyors were three times as likely to make recommendations versus physician surveyors and five times more likely to make recommendations than non-physician surveyors.

In the past 5 years, over one-quarter of all facilities have experienced a patient incident(s) related to a compounding error. The data indicates that increases in CSP production correlate with increases in errors. Nevertheless, it is important to recognize that facilities with high risk awareness and strong reporting systems will also demonstrate higher (and more accurate) error rates.

While most surveyors have yet to focus on USP <800>, 3 out of every 10 inspections from the state board, accreditor, and CMS did include queries about this statute. While most were general questions about what plans were underway to achieve compliance, some were more specific, inquiring about storage and segregation approaches, room pressure differentials, and air exhaust setups.

While accreditor actions remain rare, there is a clear upward trend in the number of citations and recommendations being issued during surveys. Many of this year’s citations focused on cleaning deficiencies, from inconsistent practices and incorrect solutions to a lack of documentation.

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USP <797> compliance is an intrinsic component of most accreditation and state board inspections. Inspections this year are markedly thorough: well-trained inspectors come prepared to examine the complexities of <797> in detail, often utilizing their own or the NABP’s in-depth questionnaire. These multi-hour inspections typically include a comprehensive review of documentation and observation of staff practices. The surveys cover a wide array of issues with a strong focus on policies and procedures, documentation, and certification reports.

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