California Board reviews pharmacy compounding regulations amid public concerns

The California State Board of Pharmacy convened on March 26, 2025, to discuss significant regulatory changes concerning compounded drug preparations, hazardous drugs, and radiopharmaceuticals. The meeting, led by President Seung Oh, welcomed back Ricardo Sanchez to the board while noting the departure of Indira Cameron Banks, who has taken a position on another commission.

The primary focus of the meeting was the proposed adoption of new regulations following a 15-day comment period on the fourth modified text concerning sterile and non-sterile compounding. The board reviewed feedback received during this period and discussed the implications of the proposed regulations. Members expressed their appreciation for the thorough consideration of public comments and the collaborative efforts that shaped the proposed changes.

During the meeting, board members acknowledged the complexity of the regulatory landscape and the importance of ensuring that regulations are both effective and clear. Member Maria Serpa made a motion to accept the staff's recommendations regarding the comments received and to adopt the proposed regulations as presented. This motion was seconded by member Renee Barker, who emphasized the thoughtful nature of the discussions leading to this point.

Public comments were invited, with several stakeholders expressing their views on the proposed regulations. One pharmacy owner raised concerns about the clarity and scientific justification of the regulations, warning that they could inadvertently limit access to compounded medications for patients in need. The speaker urged the board to reconsider the adoption of the proposed regulations without further revisions.

The board's discussions highlighted the ongoing commitment to consumer protection while balancing the needs of pharmacy practice. As the meeting concluded, the board members prepared to finalize their decisions on the proposed regulations, underscoring the importance of their role in safeguarding public health in California.