Board hears medical presenters on infusion, home‑health and long‑term care pharmacies; members consider exemptions not new licenses

Seung Oh, chair of the California State Board of Pharmacy Licensing Committee, opened a Jan. 8 meeting that included education on three pharmacy business models and a discussion of whether the board should create distinct license types or allow targeted exemptions.

Sam Martinez, infusion center pharmacy manager at UC San Diego Health, told the committee infusion centers prepare and administer parenteral therapies on‑site "under direct clinical supervision" and do not dispense medications for self‑administration. "The most important distinction is that the medications are not dispensed for self administration at home," Martinez said, arguing that many retail‑oriented requirements — counters, retail signage, retail style labeling and staffing rules — do not align with infusion practice and create operational burden without improving safety.

Martinez urged a regulatory approach that preserves oversight while aligning rules with clinical practice: "This is not a request for exemption from oversight, it's a request for alignment." He pointed to sterile compounding, hazardous drug handling, order verification, quality assurance and adverse event reporting as the areas that should receive priority attention.

Janice Dang, the board's chief of enforcement, presented on pharmacies that provide home‑health services and on skilled nursing/long‑term care pharmacies. Dang outlined the different operational workflows — intake coordination, nursing partnerships, cycle fills and automated drug dispensing systems — and noted legal and practical constraints, including multiple methods for obtaining controlled‑substance prescriptions, partial‑fill rules for terminally ill patients, and different technician ratio rules for community versus licensed home‑health settings.

Dang described how some skilled‑nursing facilities historically destroy unused medications on site and said that, while in‑house destruction remains common, the board can authorize and encourage installation of secure drug take‑back receptacles: "The drug take back receptacles are under our jurisdiction," she said.

Committee members probed practical consequences of different approaches. Several members, including Satinder Sandu and KK Jha, warned that creating new license categories could have unintended consequences (for example, forcing take‑home ancillary prescriptions to be filled at a separate retail site) and recommended pursuing exemptions within the existing PHY (community/outpatient pharmacy) license. Members discussed the possibility of requiring annual business‑model reporting or a PIC (pharmacist‑in‑charge) self‑assessment to capture dominant activities for enforcement and data collection.

In public comment, John Gray, a registered pharmacist with Kaiser Permanente, said his organization "largely agree[d] with the issues that Doctor Martinez flagged" and supported seeking exemptions for infusion sites rather than creating new licensure classes.

What happens next: The committee asked presenters to provide specific citations to the Business and Professions Code and CCR provisions that apply to the operational issues raised. Members framed next steps as drafting definitions and considering whether regulatory or statutory changes would be needed for any exemptions, then returning to the committee and, if appropriate, to the full board for formal proposals.

The committee did not take a formal regulatory action at the meeting.