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Board approves 15-day comment period to clarify pharmacy closure rules; owner to bear primary certification duty
Summary
The California State Board of Pharmacy voted to notice revised text for a 15-day public comment period to amend CCR Title 16 Section 1708.2, clarifying pharmacy discontinuance-of-business notifications and shifting certification responsibility toward owners, the board said at its meeting.
The California State Board of Pharmacy voted to notice revised regulation text for a 15-day public comment period to amend California Code of Regulations, Title 16, Section 1708.2, the board said during its meeting. The motion directs staff to incorporate the board’s discussion about patient notification methods, pharmacist-in-charge (PIC) certification, and an inpatient hospital pharmacy terminology correction, and authorizes the executive officer to complete the rulemaking if no adverse comments are received.
The motion, made by Board member Jesse and seconded by Licensee member Satinder, passed on an apparent unanimous voice vote of members present. Board staff said the board originally began a 45-day comment period on the proposal Nov. 15, 2024, which closed Dec. 30, 2024, and that the board previously approved the proposed text in April 2024.
Board member Jesse said she supported the regulation changes but raised concerns that “there’s a lot of patients who don't have access to electronic notifications. Either they don't have smartphones ... A lot of my elderly patients don't receive anything, or there's people who opt out of electronic notifications altogether.” Jesse urged flexibility so patients receive notice in the form they actually receive communications from the pharmacy.
Board staff counsel Jennifer explained that the statute requires written notice both in a physical posting visible to patients and in a “writing to the patients in a form that the pharmacy normally communicates with those patients,” and noted that electronic communications may satisfy the statute if the patient normally receives communications in that form.
After discussion, the board directed staff to: (1) modify the draft regulation to make the owner primarily responsible for certifying compliance with discontinuance requirements, with the pharmacist in charge to certify “if available;” (2) change the term “inpatient hospital pharmacy” to “general acute care hospital pharmacy” to align with statutory terminology; and (3) add a requirement that a conspicuous written notice of closure be posted at the entrance of the premises consistent with the statute’s described posting language.
John Gray, a registered pharmacist with Kaiser Permanente, told the board he supported allowing electronic notification only where the patient had elected to receive communications electronically, saying organizations “would be supportive of an approach … allowing pharmacies the flexibility to provide notification in a format in which the patient has elected to receive other communications from the business.”
With the board’s motion, staff will publish the modified text for a 15-day comment period. If no adverse comments are received, the board delegated authority to the executive officer to take the steps necessary to complete the rulemaking and to make technical or non-substantive changes required by control agencies.
The board did not set an effective date in the motion; next steps will depend on public comment and any control-agency review.
Votes at a glance: the motion to notice revised text for a 15-day comment period and, if no adverse comments, to authorize the executive officer to complete the rulemaking passed (members recorded voting “yes” included Jesse; Trevor; Renee; Jeff; KK; Jay; Satinder; Maria).
