California’s approves new pharma regs

California’s Office of Administrative Law has approved the state board of pharmacy’s updated compounding regulations. 

Throughout the long process, the California board made edits to the proposed regulations — often at our urging — but we can’t say we’re thrilled at the outcome. “The final result is still problematic,” as APC Chief Advocacy Officer Tenille Davis put it. “They go above and beyond what is required in USP without showing why or how the increased requirements improve patient safety.”

While the board did remove sections that prohibited compounding with APIs in FDA’s interim category 1 (after hundreds of public comments in opposition), the board has said it could continue to take action against pharmacies compounding with these APIs in the field. And there continue to be issues raised with other sections of the regulations, e.g., provisions for immediate-use compounding and compounding copies of drugs in shortage. 

The new regulations take effect October 1, 2025, and at this point we only have the full, legalese version (see the 45-page PDF here). The board, however, has said it will release a statement explaining its expectations during the transition period, which we’ll share as soon as we see it.