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Sutter Coast Hospital Pharmacy tells Board of Pharmacy it has corrected sterile compounding deficiencies
Summary
At a Sept. 11 hearing, Sutter Coast Hospital Pharmacy presented evidence that it remodeled its sterile compounding area, implemented training and a compliance system, and passed multiple inspections while on probation, and petitioned the Board of Pharmacy for early termination of a three‑year probation.
Sutter Coast Hospital Pharmacy told the California State Board of Pharmacy at a Sept. 11 petitioner hearing that it has met the conditions of a 2023 stipulated settlement addressing sterile compounding failures and asked the board to end its probation early.
At the hearing, Administrative Law Judge Sean Gavin presided while Deputy Attorney General Christina Jarvis summarized causes for discipline that led to the stipulated settlement effective July 26, 2023, including insufficient training and competencies, lack of a sink in the sterile area, poor documentation of compounding, inadequate cleaning and protective garments, and recurring insanitary citations dating to 2016–2019. Jarvis told the board the pharmacy has completed more than two years of probation, paid $18,000 in investigative and prosecution costs, and has had no orders of correction in at least four inspections during probation.
Lucy Dunn, director of pharmacy and the current PIC at Sutter Coast, testified that the facility now has a segregated compounding area with a compliant sink, a new hood, and a clear sterile/nonsterile line of demarcation. She said training records are maintained in the Pharmacy Stars compliance system and that staff complete regular competencies. Consultant Melanie Horn, appointed by Sutter Health and also acting as the board-appointed consultant, described repeated in-person inspections and said she found Sutter Coast’s physical renovations, staff training and documentation exceed the board’s requirements. Horn said Sutter Health implemented an enterprise compliance software (Pharmacy Stars), standardized training modules and system-level oversight across 40 compounding sites.
Board members questioned Dunn and Horn about staffing levels, the number and frequency of self-assessments, the facility’s outsourcing of some compounded products to premixed commercial supplies, and how support would continue if probation ended. Dunn and Horn said system supports and on-call consultation would remain available after probation, and Horn said she would continue periodic inspections and that Sutter Health maintains enterprise-level oversight.
No board decision was reached at the hearing; the matter was submitted and the record closed. The board moved into closed session to deliberate and will notify petitioner of its decision in writing.
