USP <797> and USP <800> Auditing Assessment

IndustryClinic Pharmacy
ProblemAn oncology clinic’s pharmacy was operating as a physician dispensing site for the preparation of their compounded chemotherapeutic medications. Because physician dispensing sites are not subject to the same requirements as state-licensed pharmacies, the organization’s management was concerned that the pharmacy’s operational practices and physical components, such as compounding hood(s), were not fully compliant with USP <797> and USP <800>.
PHSI SolutionPHSL held preliminary discussions with management, created an audit plan, and reviewed the organization’s existing policies and procedures to better understand current operations before completing an onsite assessment. The onsite audit compared the pharmacy’s current physical layout and operations to USP 797 and USP 800 guidance. PHSL was also able to perform a gap analysis between the P&Ps and actual pharmacy practices. PHSL provided the clinic with a comprehensive report highlighting areas of concern and recommendations to remediate.
ResultsThe audit findings report and subsequent action plan highlighted the pharmacy issues for clinic management, allowing them to focus efforts on improving the pharmacy work environment for employees and potentially avoiding audit or patient safety risks in the future.