December 12, 2024
“Simply not a rational approach to regulating an industry”
We’re talking about California, of course.
It’s old news that the California Board of Pharmacy has proposed significant – and we would say unjustified – changes to their compounding regulations. Despite extraordinary negative public feedback on the proposed changes, CA BOP has made only minor revisions to the proposal. Now, the Board is moving in on finalizing those changes. This week APC offered its final (and pointed) suggestions to the Board.
If passed, it would make California the only state prohibiting compounding with Category 1 bulk drug substances.
Unfortunately, as we emphasized in a letter to the board this week, the CA BOP has not always been presented accurate info from its staff about the proposals. For example (we pointed out), during its latest meeting, a presentation was chock full of misleading information clearly intended to sway the board rather than inform it. These weren’t small errors that could be attributed to a misunderstanding. One slide referenced a case in Kentucky where (the speaker claimed) the state acted against a compounder for using an API in FDA’s interim Category 1. In fact, that case involved compounding with a biologic agent, not a drug, and with an API listed on FDA’s interim Category 2, not Category 1.
A neverending story
In that most recent letter, we wrote:
We continue to have significant concern with proposed regulations that exceed USP guidelines, and we are frustrated that the Board seems to be unwilling to produce any evidence that the proposals that exceed the USP standards keep patients safer.
And also this:
The Board seems to be arguing that violation of existing regulation by some demands not simply robust enforcement, but more stringent regulation of all compounding pharmacies — as if more regulation will lead to more compliance. It’s simply not a rational approach to regulating an industry.
APC has been pushing back on the California BoP for six months now on these proposed regulations:
- In June, our comments on the first iteration of the proposed changes identified 57 specific places where the proposed regulations exceed what is required in federal law and by USP.
- On July 31, after a concerted effort by APC and many of its members — as well as a coalition of California firefighters, hospitals, and others — the BOP pushed pause on its proposal. It then released a modified version of the proposed changes at the end of August.
- In November, after five hours of public comment (and a very biased presentation), the California BOP decided to move the modified proposed changes forward to a 30-day comment period.
- APC submitted our comments on the modified proposed regulations earlier this week.
So here we are. What’s next after all that, you may ask? The California BOP will discuss all the received written comments during their next full meeting on Jan. 8, 2025. Based on that discussion, they may decide to continue to consider comments or pass the proposed regulations and send them to the California Department of Consumer Affairs for review.
Regardless, we will continue to engage as the proposal moves through the rulemaking process.
