Truman Gin Leong

The committee held a review of multiple complaints regarding pharmacy practices. Key discussion topics included failure to report charges, human errors in prescription processing that were caught prior to patient harm, dispensing incorrect quantities of medication, and the filling of prescriptions from unlicensed practitioners. The committee also addressed cases involving the sale of expired products and instances where patient counseling was not provided for new prescriptions. Various disciplinary actions, ranging from non-disciplinary continuing education requirements and letters of concern to the dismissal of complaints against certain entities, were deliberated and moved upon.

The board conducted a two-day meeting that included various agenda items related to professional license disciplinary proceedings and compliance matters. Key discussions involved the review of consent agendas regarding multiple board cases, motions to grant state requests to deem allegations admitted, and the subsequent imposition of disciplinary actions, including revocation. A significant portion of the meeting addressed allegations against Strive Pharmacy concerning the compounding and distribution of ketamine patches, the experimental use of research-grade ingredients, and unauthorized movement of controlled substances between pharmacy facilities. The board also reviewed settlement proposals and addressed operational compliance issues, including recordkeeping inconsistencies and the involvement of high-level officials in project oversight.

The meeting focused on reviewing and discussing proposed rule amendments related to compounding practices. Key discussion points included the applicability of Title 41 regarding the adoption of the United States Pharmacopia (USP) standards, particularly concerning future potential scheduling changes by the DEA for substances like MDMA and psilocybin. Specific rule sections concerning compounding liability, adulteration, and misbranding were reviewed in relation to USP standards. Significant discussion occurred regarding language for compounding by licensed pharmacists and technicians, including jurisdictional considerations, and the future agenda item for managing compounding in cancer centers. Amendments were also discussed for rules pertaining to "essentially a copy" of FDA-approved drug products, clarifying when a prescriber can authorize such compounding based on documented medical need or drug shortage lists, and ensuring electronic prescription documentation includes individualized clinical rationale. Interpretations of requirements for active pharmaceutical ingredients versus excipients were also clarified.

The regular meeting agenda spanned two days and primarily focused on administrative actions and regulatory matters. Key discussions included the Consent Agenda items concerning complaints against various pharmacies and licensees, with recommended actions ranging from dismissal to non-disciplinary orders for continuing education or civil penalties, and scheduling hearings for unresolved violations. The Board also addressed consent agreements involving several named individuals, ratified interim consent agreements, and reviewed numerous permit, license, and registration ratifications, including approvals for testing exams (NAPLEX, MPJE, FPGEC, FPGEE, PTCB, ExCPT). Further agenda items covered review of remote dispensing, resident, non-resident, wholesaler, manufacturer, and third-party logistics permit applications, some involving change of ownership or compliance issues. The meeting also included reports from the Executive Director, Deputy Director, Chief Compliance Officer, Licensing Division Manager, and CSPMP Director, covering topics such as dismissed complaints, rule writing for prescription transfers, legislative updates on various House and Senate bills, and auditor recommendations for data submission delinquency. The agenda concluded with discussions on the election of officers and Complaint Review Committee members, and board member training.

The meeting commenced with roll call and disclosure of conflicts of interest. Discussions involved agenda item 11E (Plate Number 25-0438), which required deferral due to a respondent's scheduling conflict. Subsequent to this, the Board addressed agenda items 11F (Complaint Number 25-0469, CVS 9210) and 11G (Complaint Number 25-0438, which seems to be a reference error in the transcript, likely meaning 25-0515 based on later context), which involved similar facts regarding incorrect product dispensing despite successful scanning procedures. Compliance officers detailed the pharmacy's scanning technology, including accuracy scans and QR code utilization, noting that errors occurred after the initial scan, likely due to human error in product selection or return-to-stock handling. The board reviewed the robustness of the system's alerts, especially when processes are bypassed, and the implications of potential workload concerns cited by involved staff. Recommendations from a previous meeting indicated non-disciplinary continuing education for involved technician and pharmacist for case 11G.