California Board of Pharmacy faces scrutiny over compounding rules and proposed ‘standard of care’ model

The California State Board of Pharmacy defended a proposed shift to a “standard of care” practice model and defended its ongoing compounding regulation rewrite during a joint sunset review hearing held by the Assembly Business and Professions Committee and the Senate committee on business, professions and economic development.

Seung Oh, president of the California State Board of Pharmacy, told the joint committee the board is “a consumer protection agency charged with regulating the businesses, people, and products throughout the drug supply chain in our state until the product is dispensed to the patient by a pharmacist.” He said the board’s proposals seek to remove “administrative burdens” that restrict pharmacist-provided preventive medicines and other services. “The proposed transition to a standard of care practice model will remove these and other persistent barriers and allow for the natural transition of practice to occur without the administrative burdens currently placed on the Board and its licensees,” Oh said.

Why it matters: the board’s proposals could change how pharmacists deliver care statewide and how compounding is regulated — affecting patient access, provider practice, and pharmacy business models. The hearing drew broad participation from trade groups, medical societies, compounding pharmacists, hospital representatives and patients, many of whom expressed concern that the changes would either exceed federal or national standards or expand pharmacists’ authority without adequate guardrails.

Most of the hearing focused on compounding rules and stakeholder engagement. The board described a multi-year, public process that began in 2019 and resumed in 2023, with the formal rulemaking process and multiple comment periods. The board said it has issued multiple revisions and is currently on a fourth modified text, which it has released for comment. Anne Sodagrin, the board’s executive officer, described the board’s broader consumer-protection approach as including licensing, education and enforcement, and said enforcement efforts are prioritized around imminent public-harm risks.

Stakeholder concerns were wide-ranging. Physician groups warned that broad “standard of care” language could be read as expanding pharmacists’ scope beyond existing training and could create liability or operational conflicts when pharmacists lack access to full patient medical records. The California Medical Association told the committee it worries proposed language could be read to impose pharmacist-centric requirements on physicians in office settings.

Industry and workforce groups pushed back on some board proposals while supporting others. The California Pharmacists Association and other pharmacy groups urged adoption of a standard-of-care model to allow pharmacists to use clinical judgment and maintain patient access when federal guidance changes; pharmacy employers and chains urged changes in workforce rules such as the pharmacy technician ratio and asked the board to pursue permanent remote-processing allowances for certain administrative functions.

Board enforcement, transparency and process also drew scrutiny. Multiple compounding pharmacists and patient advocates argued the board’s enforcement actions over the past several years have reduced the number of community compounding pharmacies in California, raising access issues. Witnesses described litigation and enforcement disputes over the compounding of substances such as glutathione and methylcobalamin; several speakers asked the legislature to increase oversight of board enforcement practices and to appoint practicing community sterile compounding pharmacists to the board.

The board acknowledged those concerns and said it has made changes to proposed text in response to comments; it also said it is bound by federal law, Food and Drug Administration guidance and United States Pharmacopeia (USP) standards when evaluating compounding and the safety of bulk drug substances.

No final actions were taken at the hearing. Committee chairs and members repeatedly emphasized the hearing was for oversight and discussion; statutory change, if any, would require future legislation. The board and stakeholders signaled willingness to continue negotiations through the formal rulemaking and legislative processes.

Looking ahead: the board’s fourth modified text on compounding is out for comment and the legislature has multiple related policy choices to weigh, including whether to authorize fee waivers for pharmacies in underserved areas, to change technician ratio statutes, or to codify any part of a standard-of-care enforcement approach.

Ending note: committee chairs closed the board portion of the hearing and said the panels will continue oversight and follow-up as the rulemaking and any legislative proposals are developed.