California Board of Pharmacy adopts revised compounding regulations after months of debate; public commenters warn of access loss

The California State Board of Pharmacy on March 26 adopted a revised package of regulations governing compounded sterile and nonsterile drug preparations, hazardous drugs and radiopharmaceuticals, voting to accept staff responses to public comments, adopt the fourth modified text and authorize the executive officer to complete the rulemaking process.

The action came after months of meetings, multiple text revisions and a 15-day public-comment period that closed March 21. President Seung Oh, speaking before the vote, said he had “personally voiced my very strong desire to ensure category 1 bulk drug substances remain accessible.”

Why it matters: The regulations are intended to clarify how pharmacies and health-care facilities may compound sterile products and handle hazardous drugs while referencing federal law, federal guidance and the United States Pharmacopeia (USP) standards. Supporters on the board said the fourth modified text streamlines prior drafts and creates a clearer pathway for compliance. Opponents and many public commenters said the changes — and prior enforcement actions — have already reduced access to certain compounded medicines, particularly glutathione and other Category 1 bulk substances used by some patients and first responders.

Board action and procedure

Dr. Maria Serpa moved to: accept staff responses to comments on the fourth modified text, adopt the fourth modified text (identified in the meeting as a February 28, 2025 draft), authorize the executive officer to take all steps necessary to complete the rulemaking, and delegate to the executive officer authority to make technical or non‑substantive changes required by control agencies. Renee Barker seconded the motion. The board recorded seven yes votes, zero nos and one abstention (Ricardo Sanchez), and the motion carried. The board’s president said staff will undertake post‑implementation review and that the text may be revisited in future rulemaking.

Public comment and stakeholder concerns

Dozens of members of the public — including pharmacists, physicians, patients and firefighters who said they have used or rely on compounded products — addressed the board during a lengthy public‑comment period. Speakers described clinical use of compounds such as glutathione, methylcobalamin (a B12 form) and NAD for toxin reduction, chronic illness and post‑fire recovery, and warned that enforcement actions and uncertainty about state rules have already limited…