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Board withdraws quality‑assurance rulemaking to reconsider after new medication‑error law
Summary
The board voted to withdraw its pending rulemaking to amend Title 16 §1711 on quality assurance programs and to refer development of new text to the enforcement and compounding committee, delegating early drafting to two board members.
The California State Board of Pharmacy voted to withdraw a pending rulemaking package amending Title 16, section 1711, the board said, to allow staff and members time to reconsider the proposed text in light of recent statutory changes and upcoming implementation of Assembly Bill 1286.
Board President Seung Oh said the board’s formal rulemaking process had not begun until August 9, 2024, despite initial board approval in February 2023, and that the one‑year deadline for the rulemaking approach required the board to act to preserve options. Staff recommended withdrawal of the current rulemaking so members could reassess whether the previously proposed language remains appropriate given the passage of AB 1286 and the bill’s medication‑error reporting provisions that take effect Sept. 1, 2025.
Licensee member Maria Serpa, chair of the enforcement and compounding committee, described the committee’s view that the board should revisit whether the earlier draft remained suitable or whether a different emphasis — on system‑level quality improvement and "just culture" principles rather than prescriptive, incident‑level requirements — would be preferable. The board agreed to delegate early drafting work to Maria Serpa and KK Jha so they could develop proposed language with staff before bringing it to the enforcement committee.
Maria Serpa moved to withdraw the existing rulemaking and to authorize members Maria Serpa and KK Jha to work with staff on revised text for committee review; the motion was seconded and the roll call showed the motion passed on a unanimous vote. Staff and committee members emphasized the withdrawal does not change existing law; it pauses the rulemaking file to allow a fresh review.
Public comment during the item urged the board both to keep the regulation high‑level and to consider formally referencing "just culture" principles in quality‑assurance language. John Gray of Kaiser Permanente told the board the existing regulatory text (17 11 d and e) already requires collective review of errors and suggested the board focus on missing elements that could help the board validate licensee practices; he advised considering adding an explicit statement about just culture.
Board counsel and staff told members the withdrawal creates flexibility for a revised approach and that Maria and KK may develop initial language even though KK is not a formal committee member; the committee can subsequently review and forward proposals to the full board. The board recorded a formal vote to withdraw the rulemaking and to delegate initial drafting to the named members.
Board staff advised that future committee meetings will consider revised language and that the board will revisit the matter before starting a new rulemaking file.
