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:
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.