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Board initiates several rulemaking actions including off‑site records, outsourcing closure notices and APDS location rules
Summary
The board voted June 24 to initiate formal rulemaking on amendments clarifying waivers for off‑site record storage, a proposed requirement for outsourcing facilities to give advance notice of closure, and to add a regulation clarifying locations where Automated Patient Dispensing Systems may be used; motions passed and staff were directed to submit regulatory packages for pre‑notice review.
The California State Board of Pharmacy authorized staff on June 24 to begin formal rulemaking on several licensing and facilities topics aimed at clarifying regulatory authority and improving continuity of care.
Licensing committee members reviewed a proposed amendment to Title 16, section 1707, to clarify the board's authority to grant waivers allowing off‑site storage of records by licensed entities. Public comment raised concerns about access control for off‑site records; a commenter urged that pharmacists‑in‑charge explicitly maintain logs of off‑site locations and access lists to avoid loss or inappropriate access. The board voted to initiate rulemaking and to direct staff to submit the proposed text to the Department of Consumer Affairs for review.
The board also authorized staff to initiate rulemaking on a new Section 1708.2 to require outsourcing facilities to give advanced notice before business closure or cessation of operations in California, a measure intended to help health‑care providers and patients find alternate sources of necessary products. Public commenters urged expanding any notice requirement to include planned discontinuation of specific products, noting the long lead time for another supplier to ramp up production of certain compounded or specialty products.
Finally, the board approved initiating rulemaking to add Section 1713.1 to clarify where Automated Patient Dispensing Systems (APDS) may be located, specifying 'medical offices or other locations where patients are regularly seen for diagnosis or treatment' and confirming that APDS located within medical offices may serve established patients regardless of telehealth or in‑person modality. The motions to initiate each rulemaking were seconded and passed in roll‑call votes.
Staff were directed to prepare rulemaking packages, undertake pre‑notice review, and return with hearing schedules and final documents as required by the Administrative Procedure Act.
