Board of Pharmacy adopts revised compounding regulations after months of debate

SACRAMENTO — The California State Board of Pharmacy voted on March 26 to adopt a fourth modified text of regulations covering compounded drug preparations, hazardous drugs and radiopharmaceuticals and authorized the executive officer to complete the rulemaking process.

The action, carried by a 7–0 vote with one abstention, accepted staff responses to comments received during a 15-day public-comment period and adopted the version of the text dated Feb. 28, 2025. Licensee member Maria Serpa moved to "accept the board staff recommended responses to the comments on the fourth modified text... adopt the fourth modified text that was dated 2/28/25, and authorize the Executive Officer to take all steps necessary to complete the rulemaking process," and the board seconded the motion and voted to approve it.

Why it matters: the package affects how pharmacies compound sterile products in California and how the board oversees hazardous-drug handling and radiopharmaceuticals. Dozens of public commenters — including firefighters, physicians and patients — urged the board not to finalize language they said would limit access to patient-specific compounded medicines such as glutathione and methylcobalamin. Other commentators, and several board members, argued the revised text clarifies standards and creates a pathway aligned with federal law and national United States Pharmacopeia (USP) standards.

Board action and vote Board President Seung Oh opened the vote after members discussed the regulation revisions and public testimony. Maria Serpa made the motion; Renee Barker seconded. The roll call vote recorded the following: President Seung Oh — yes; Trevor Chandler — yes; Renee Barker — yes; Jeff Hughes — yes; Ricardo Sanchez — abstain; Satinder Sandhu — yes; Maria Serpa — yes; Nicole Tibo — yes. The board recorded the outcome as approved and delegated to the executive officer authority to complete regulatory filing and make technical, non‑substantive changes required…