August 6, 2024

California BOP pauses new compounding regs

After a concerted effort by APC and many of its members — as well as a coalition of California firefighters, hospitals, and others — the California Board of Pharmacy has postponed its proposed new restrictions on compounded medication after a long and detailed meeting on July 31.

APC, along with a long list of other organizations, had written to the board in opposition to those proposed restrictions, saying the board would not only be exceeding its authority (FDA regulates drug substances, not states), it had failed to show that the restrictions were rooted in science or make patients safer. In fact, as this piece about the benefits of glutathione for California firefighters illustrates, the proposals would end up hurting real patients.

Perhaps most notably among the proposals were regulations that would have blocked the use of items in FDA’s interim bulks list 1 in compounded sterile preparations, notably glutathione and methylcobalamin. An amended version, which was under discussion Thursday, would have allowed for use of those APIs, but with additional compounding, testing, and documentation requirements — requirements that would have increased the cost to compound significantly.

During that long meeting (it ended near 8:00 PM) it became obvious that there was no consensus on how to move forward, and whether many of the proposed regulations were even necessary. APC’s Tenille Davis spoke there, thanking them for some of the edits they had made to the proposals but saying there was still a long way to go.

Thus, instead of moving the proposed restrictions forward to a 15-day comment period, the board opted to have two members incorporate additional changes discussed during the meeting and bring the proposals back to the full board in September.

The good: The draft proposal isn’t moving forward, as the restrictions it included would have not only been legally and scientifically questionable, but would have directly hurt patients.

The less good: The proposals weren’t thrown out entirely. APC will, of course, be watching and when necessary commenting on whatever new version of these regulations emerges in September.