California update: frustration

Despite negative feedback from a broad coalition of stakeholders — hospital pharmacists, compounding pharmacies, physicians, academic institutions, and healthcare organizations — the California Board of Pharmacy passed new compounding regulations yesterday that (as we pointed out in a letter to the board) are unworkable, unnecessary, detrimental to patient care, and particularly burdensome for small-business compounding pharmacies. 

The kicker: The board actually acknowledged that compounding pharmacies across the state have been shutting down, but in a stunning dismissal of logic blamed those closures on new USP standards despite the fact that no other state is seeing California’s level of compounding-only pharmacy closures. The reality, as APC’s Tenille Davis put it, is that “California’s overly stringent regulatory environment has pushed many pharmacies out of business, leaving patients with fewer options for critical medications.”

Before the new regs become effective, they have to go through some more hoops, after which the BoP will provide public notice and updated guidance. At that point, stakeholders that believe the regulation was improperly adopted can seek judicial review. That’s when something we wrote to the board concerning its process will become notably apt:

The public comment process has been inadequate. Restricting pharmacists and other experts to two-minute speaking slots — without opportunities for meaningful discussion — has stifled necessary debate and left significant misunderstandings unaddressed. Several board members have demonstrated a fundamental lack of knowledge regarding USP standards and their existing safeguards for patient safety. 

As always, we’ll be keeping a close eye on the process.