Board approves another 15‑day comment period on compounding regulations after heated public remarks on access to glutathione

The California State Board of Pharmacy voted 7–2 on Feb. 5 to publish a third modified text of proposed regulations on sterile and nonsterile compounding, hazardous drugs and radiopharmaceuticals for another 15‑day public comment period.

The motion directs staff to post the recommended third modified text, to accept the staff responses to comments from the prior 15‑day period and to delegate to members Maria Serpa and Renee Barker the authority to review comments received during the new 15‑day period and return recommendations to the board. The board also delegated to the executive officer authority to make non‑substantive, technical edits.

Why it matters: The measure moves a long‑running rulemaking effort forward after years of updates to U.S. Pharmacopeia (USP) chapters and multiple public hearings. Board staff and members said the additional comment period will allow them to refine language about where state regulations restate or clarify federal law, USP standards and inspection expectations — and to respond to repeated public concerns that the proposed rules could reduce patient access to certain compounded products.

Board staff presented the package as an effort to clarify California requirements around compounding rather than to create new federal standards. “The board's proposed regulation provides a pathway that navigates federal law and federal guidance related to the use of bulk substances and ... USP requirements,” said Maria Jacobs, a board staff member who led the presentation.

Board members and staff spent several hours reviewing…