California Board of Pharmacy opens 15‑day comment period on revised compounding rules after months of debate

The California State Board of Pharmacy on March 6 approved sending a fourth modified draft of proposed regulations on sterile and nonsterile compounding, hazardous drugs and radiopharmaceuticals out for a 15‑day public comment period and delegated to staff and two board members authority to review any additional comments.

The decision, made after more than two hours of discussion and more than three hours of public testimony, passed on a recorded vote of 7‑2. The motion approved staff responses to comments on the third modified text; approved the board's fourth modified text dated Feb. 28, 2025, for a 15‑day comment period; and delegated authority to the executive officer and to board members Maria Serpa and Renee Barker to review non‑substantive changes and any comments received during that period and return recommendations to the full board.

The vote followed a staff presentation and a lengthy review by Enforcement Committee chair Maria Serpa and member Renee Barker of changes the board is proposing to Title 16 of the California Code of Regulations. The proposed changes aim to clarify when ‘‘immediate use’’ compounding is allowed, to update procedures for compounding with category 1 bulk drug substances that appear on the FDA interim list, and to revise standard operating procedure (SOP) requirements for evaluating active pharmaceutical ingredients and components used in sterile compounding.

"In reviewing each of these comments, consideration and reflection of the board's consumer protection mandate was at the forefront of the assessment and the recommendation," Maria Serpa said while walking members through the fourth modified text. Serpa emphasized that the board began the rulemaking in 2019, resumed work in 2023 after USP finalized compounding chapters, and sought to align certain requirements with USP while clarifying state expectations.

Why it matters: The changes affect how pharmacies across California may compound medications for home and clinic use, including preparations for inhalation and other sterile products. The board’s decision to proceed with a fourth modified text and to open a new 15‑day comment period keeps the rulemaking active and…