1. United States
2. Calif.
3. Letter

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 will severely limit access to life-saving treatments and put Californians at risk, particularly those with chronic illnesses and first responders exposed to toxins. The Board’s proposed rules are far stricter than federal standards, requiring costly stability tests—up to $90,000 per formulation—that will make certain safe and effective treatments unaffordable and inaccessible. These therapies are essential for severely disabling conditions that have no FDA approved treatment and for protecting firefighters and others exposed to urban-wildfire toxins. The danger is real. These medications can prevent deadly cancers and long-term health complications caused by toxic exposures. We saw this after 9/11, where first responders faced skyrocketing cancer rates from poor air quality. Today, California is facing similar risks, with wildfires burning over 56,000 acres and hazardous pollutants being released into the air for months. If these regulations pass, many will lose access to the treatments that could prevent these deadly outcomes. This is a life-or-death issue for all Californians. Over 11,000 stakeholders, including healthcare professionals and firefighters, have opposed these regulations, yet the Board is pushing forward without adequate justification, disregarding the public health threat. I urge you to intervene before the March vote. Please ensure these regulations are sent back to committee for proper review and alignment with USP standards. Californians deserve access to treatments that can save lives and prevent serious health complications. Thank you for your immediate attention to this critical matter.