As you may be aware, the California Board of Pharmacy has proposed compounding regulations that include both stability studies and bulk drug testing requirements on Category 1 substances — requirements that would exceed both USP <797> and FDA requirements.
APC has been pressing the board on the issue, and we were able to comment during the board’s latest meeting. We expressed our deep concerns about the latest draft of California’s compounding regulations (the third iteration, if you’ve been counting).
Perhaps most notably, we pointed out that board staff and members seem to have a fundamental misunderstanding of their proposed testing requirements, which carry significant costs — up to $40,000 per formulation — that could make compliance nearly impossible for many compounding pharmacies. That would severely limit patient access to specialized therapies like glutathione for inhalation.
We urged the board to reject the current proposal and instead align with USP <795>, <797>, and <800> to protect patient safety without unnecessary barriers to care.
The big question here is: How would these regs make patients safer? That’s the very question the Santa Rosa Press Democrat asked, looking specifically at the role compounded glutathione played in saving the lives of firefighters. Reporter Austin Murphy did an excellent job — with help from APC — explaining how the actions of a well-meaning but overzealous board of pharmacy could deprive these first responders of a therapy that seems to be helping them amidst the wildfires.