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Board withdraws rulemaking on pharmacy self-assessment forms, will revise drafts and post updates

2952845 ยท April 10, 2025
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Summary

The California Board of Pharmacy voted to withdraw a pending rulemaking to amend multiple self-assessment forms, directed staff to revise consolidated drafts, and approved posting updated draft forms for stakeholder review while a statutory change is pursued in the board's sunset package.

The California State Board of Pharmacy voted on April 2025 to withdraw a rulemaking package that proposed amendments to several self-assessment forms and directed staff to produce consolidated, updated drafts for later board review and public posting.

Board President Seung Oh announced that no public comments were received on one short-notice rulemaking item and proposed withdrawing the broader rulemaking on Community Pharmacy, Hospital Outpatient Pharmacy, Hospital Pharmacy and Wholesaler/3PL self-assessment forms. The board voted to withdraw the rulemaking package noticed Jan. 10, 2025, and approved a staff-led effort to rework all forms and return revised drafts to the board later in the year. Chair of the Enforcement and Compounding Committee Maria Serpa moved to withdraw the package; the motion carried.

Why it matters: board staff and members said the regulatory process has lagged behind frequent changes in pharmacy law. Moving the forms into statute as part of the board's sunset proposal and maintaining board-level approval of form text would, officials said, let the board update forms more quickly than the current regulation cycle allows.

What the board decided and next steps: the board gave staff and committee leadership authority to reexamine and consolidate the forms, incorporate committee recommendations from the March Enforcement & Compounding Committee meeting, and post updated draft versions on the board website for stakeholder review. During the discussion the board also approved a related motion to post updated draft community and hospital outpatient pharmacy self-assessment forms (staff's draft with committee edits highlighted) so the posted draft will better reflect current legal requirements while a comprehensive revision continues.

During public comment, John Gray, a registered pharmacist with Kaiser Permanente, thanked staff for incorporating hospital comments and urged that changes suggested during the 45-day comment period be carried forward into the consolidated draft. Board members and staff said they will issue subscriber alerts and website notice to reduce stakeholder confusion about which draft to rely on.

The Enforcement and Compounding Committee report, presented by Serpa, also recommended consolidating petition forms (reinstatement, modification of penalty, early termination of probation) into a single petition form; the board approved that consolidated petition form for use going forward.

Votes and formal actions taken at the meeting are summarized below. The board recorded no new regulatory adoptions for the self-assessment rule package; instead it approved withdrawal of the rulemaking and directed staff to prepare revised drafts for future board consideration.

Members stressed that any substantive changes that would conflict with statute or existing regulation require either legislative or regulatory action; staff said the draft forms largely restate statutory/regulatory language and the board would not change statutory text through the forms alone. The board will revisit the consolidated drafts and any recommended textual clarifications once staff completes the review and posts updated drafts.