State advocacy update: California (again)

We wouldn’t be lying if we said this was starting to get old. In yet another letter to the California Board of Pharmacy we had to express our serious concerns about the proposed compounding regulations the board seems about to pass.

As we’ve pointed out — this will be the fourth time — not only do these new regs include restrictions and requirements significantly out of the norm (e.g., exceeding USP standards or adding what’s effectively duplicate testing), but the board seems to be playing fast and loose with the concept of public comment.

“A broad coalition of hospital pharmacists, compounding pharmacies, physicians, academic medical centers, and healthcare institutions have consistently raised concerns about the unintended consequences of these rules,” we wrote, “Yet the board appears poised to move forward without addressing these concerns meaningfully.”

Our request: that the board hold off on new rules and instead enforce existing USP standards “while taking the necessary time to become better informed on the realities of compounding practice.”

For more on the situation in California, and an update on the ongoing advocacy efforts of APC's California Coalition with the California Board of Pharmacy, don’t miss the related lunch briefing at the Owner Summit: Join Peter Koshland for focusing on the impact of proposed regulatory changes on compounding pharmacies. This session will provide insights into the key issues being addressed, including recent developments in compounding regulations, and how advocacy is shaping the future for compounders in California.