After a concerted effort by APC and many of its members — as well as a coalition of California...
In which we comment (again) on California’s costly contemplated compounding changes
APC continues to press the California Board of Pharmacy regarding its proposed standards for compounding with active pharmaceutical ingredients included in FDA’s Interim Category 1. Although the board has made some tweaks to its proposals, the latest proposed testing and documentation requirements still go beyond the standards set by USP and FDA guidance. This puts a greater and unnecessary burden on compounders without resulting in safer products, just greater expense. And that is sure to mean reduced access for patients.
On Monday we submitted new comments to the board addressing those latest proposed compounding standards. (We also plan to testify at the board’s Feb. 6 meeting.) You can read those comments in full at the link above, but the gist is that adding testing and documentation requirements beyond those outlined in USP standards to those Interim Category 1 drugs will, we argue, “create significant barriers that make compounding for all necessary dosage forms and strengths impractical.”
A few examples:
- California is considering requiring full stability studies in all cases involving sterile compounding under Category 1 or 2, which can cost tens of thousands of dollars per formulation, while USP (more logically, we believe) aligns required tests with the compound’s beyond-use date.
- California would create requirements based on USP chapters above 1000, although USP is clear that those are intended for informational purposes only. If enacted, California would be the only state to have those requirements.
- California would require additional tests for APIs that could — and should — be performed by the manufacturer, repackager, or wholesaler and listed on certificates of analysis.
In short, we hope to see the board of pharmacy align its regulations with the national standards set by USP, rather than trying to second-guess them. We believe that creates a perfect balance between patient safety and medication availability.