The latest California update

When it comes to its proposed new rules — rules we’ve had some serious concerns about — the California Board of Pharmacy has kicked the can down the road another 15 days after making some changes, including several we advocated for. 

On Thursday, the BoP passed a motion to have a 15-day comment period for the latest latest version of its proposed rules, where its members will be looking to hear from pharmacists regarding a standard of care model for enforcement in cases when a pharmacist’s judgement is involved in the compounding process. The final vote is scheduled for the board’s next meeting on March 26.

We were glad to see that the board made some of the changes we requested — e.g., removing the language related to additional testing requirements for APIs in FDA’s interim category 1 list. (The language it added in place of that removal, though, is ambiguous enough that the BoP could be subjective in how they evaluate a pharmacy’s compliance.)

One issue that still concerns us is that, while it’s currently not illegal in California (or elsewhere) to compound with methyl-B12 and glutathione, the CA BoP has repeatedly disciplined pharmacies and pharmacists for doing so. There’s no guarantee the board won't continue this practice: Cases have gone all the way to an administrative law judge, and even when the judge ruled in the pharmacy's favor, the board rejected the decision and disciplined the pharmacies anyway.

We’re also not happy with the immediate-use compounding section of the proposed regulations, which, we think, will be problematic for hospitals. Basically, if there’s an equipment failure hospitals can continue to compound under “immediate use” conditions (i.e., very short BUDs) but must fix the problem quickly and report to the board within 72 hours that immediate-use compounding was required.

Also of concern:

• The proposed rules still reference several USP chapters above 1000. 
• We still recommend that the board align its rules with national standards. 

You can read what changes the BoP is planning to make here (PDF). Trigger warning: Lots of legalese. This NBC-Los Angeles news story that aired Wednesday also does a good job summarizing concerns. We’ll keep you updated on our work in the Golden State as we move ahead.

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.