California Pharmacy Board reviews new compounding regulations amid public concerns

The California State Board of Pharmacy convened on March 6, 2025, to address critical updates to regulations governing compounded drug preparations, hazardous drugs, and radiopharmaceuticals. President Seung Oh emphasized the board's commitment to consumer protection, stating that public safety remains the top priority as they navigate complex regulatory changes.

A significant focus of the meeting was the review of comments received during a recent 15-day public comment period regarding proposed modifications to existing regulations. Chair Maria Serpa highlighted that while fewer comments were submitted this time, they reflected a spectrum of opinions—some stakeholders felt the regulations were too stringent, while others believed they did not go far enough to ensure safety.

The board discussed specific recommended changes to the proposed regulations, including clarifications on immediate use provisions and the use of bulk drug substances. Serpa noted that the proposed modifications aim to align with national standards while ensuring that compounding practices remain safe and effective for consumers.

Public comments during the meeting revealed concerns about the potential impact of these regulations on the availability of compounding pharmacies in California. Commenter Marie Cottman warned that the new rules could lead to fewer compounding options for patients, ultimately increasing costs and limiting access to necessary medications. Another speaker, Jackie Jorgensen, echoed these concerns, citing a dramatic decline in the number of compounding pharmacies over the years.

As the board prepares to move forward with the proposed fourth modified text, they plan to open another public comment period to gather further input. The board's next steps will be crucial in determining how these regulations will shape the future of pharmacy practice in California, balancing the need for consumer safety with the operational realities faced by compounding pharmacies.