Stop CA Board of Pharmacy Before March 6th

I am writing to urgently request your intervention regarding the proposed amendments to Title 16 CCR Sections 1735-1738 by the California Board of Pharmacy, set for a final vote on March 6, 2025. These regulations threaten access to safe, effective, and essential treatments for Californians, particularly those with chronic conditions and firefighters exposed to toxins. The Board has falsely claimed that these amendments are needed to align with FDA and USP standards. However, the proposed rules are far more stringent than federal guidelines. The Board has not justified adopting regulations that exceed federal requirements, which could isolate California’s healthcare system from the rest of the country. This approach appears to violate the Administrative Procedure Act (APA) due to a lack of a substantiated rationale. Specifically, the Board mandates stability testing that neither FDA nor USP requires. These tests, which can cost $10,000 to $90,000 per formulation, would drastically increase costs and may eliminate access to vital compounded medications like nebulized glutathione, methylcobalamin, and NAD+. These treatments are essential for conditions such as ME/CFS, Long COVID, Lyme Disease, and for protecting firefighters from toxic exposures. Despite opposition from over 11,000 stakeholders, including patients, healthcare professionals, and firefighters, the Board has ignored this outcry and continues to push forward with these rules. This disregard for lawful regulatory processes is alarming. Given the severity of this issue and the approaching vote, I urge you to act immediately to halt these regulations. We need thorough reassessment to prevent harm to public health and patient care in California. Thank you for your prompt attention to this critical matter. I trust you will take swift action to protect the well-being of all Californians.