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Committee approves minutes and FAQ updates; begins rulemaking on accessible prescription labels
Summary
The Enforcement and Compounding Committee approved draft minutes and two FAQ updates and voted to initiate rulemaking for accessible prescription drug labels; members will continue discussion on labeling implementation and staff will refine regulatory text before full‑board consideration.
Several procedural and rulemaking items were decided by the Enforcement and Compounding Committee on June 11.
- The committee voted to approve the draft minutes of the March 27, 2025 meeting. Motion made by Song; a roll call recorded members voting in the affirmative and the motion passed.
- The committee approved updated “Ask an Inspector” FAQs (Attachment 2). Members asked staff to refine two FAQ answers (about remote verification and recordkeeping for pharmacist verification) in consultation with legal counsel and to consider further clarifying examples on preferred names on badges. Motion to approve the updated FAQs carried on a roll call vote.
- The committee approved updates to FAQs related to implementation of Assembly Bill 1286 (community pharmacy changes and error reporting to ISMP/CAMER). Staff noted additions about the Institute for Safe Medication Practices (ISMP) as the designated recipient of community‑pharmacy medication error reports and included registration and fee information for CAMER. Motion carried.
- The committee voted to initiate rulemaking to add a new California Code of Regulations section 17.07.51 on accessible prescription drug labels, consistent with AB 1902 and committee direction. The proposed text directs pharmacies to adopt policies and procedures that: (1) describe how staff will determine a patient’s accessibility needs; (2) provide a list of accessibility options available to patients at the pharmacy; (3) describe any deviations from ordinary labeling required to achieve accessibility and how those deviations are documented; and (4) document training provided to pharmacy personnel to implement the policy. Committee members debated whether staff signatures on a policy acknowledgment should be required; staff said the proposed regulation would remain intentionally flexible to allow pharmacies to choose technologies and processes as long as they ensure timely, appropriate access for patients. The committee directed staff to refine language and authorized the executive officer to make non‑substantive edits before submitting the rulemaking file to the full board.
All motions passed by roll call. Members who recorded votes on the roll calls included Renee Barker, Seung Oh and Nicole Thiebaud; the motions carried and will move to the full board agenda where additional comment and votes may occur.
Ending: Staff will refine the FAQ language and the proposed regulation text as requested and prepare the materials for full‑board review.
