Board of Pharmacy advances new compounding regulations after marathon public comments; 15-day posting approved

Sacramento — The California State Board of Pharmacy voted March 6 to publish a fourth modified text of proposed changes to Title 16 of the California Code of Regulations covering sterile and nonsterile compounding, hazardous drugs and radiopharmaceuticals and to open a 15-day public comment period on that text.

The board’s Enforcement Committee members presented a summary of comments received and staff recommendations before the vote. Board member Maria Serpa, chair of the Enforcement Committee, told colleagues, “As the record shows, we received far fewer comments during this 15 day public comment period.” The package before the board included proposed deletions and additions to several section numbers and a third-modified text that staff recommended further revise.

Why it matters: The rule package aims to clarify local regulatory expectations where federal guidance and United States Pharmacopeia (USP) standards intersect, while also spelling out requirements for immediate-use situations, the handling of certain bulk drug substances, and standard operating procedures (SOPs) for compounding facilities. Stakeholders and patients said the outcome will affect access to often niche compounded therapies, while compounding and hospital pharmacy groups cautioned against duplicative or overly prescriptive state standards that go beyond USP and federal guidance.

What the board approved: The motion — offered by board member Maria Serpa and…