The California State Board of Pharmacy (BOP) is poised to deny access to a long list of natural compounded medications that are vital to the health of tens of thousands of Californians, including firefighters and first responders, through their proposed updates to Title 16 CCR Sections 1735–1738.
At their March 6, 2025, meeting the BOP intends to revise its current drug compounding regulations, ostensibly to improve patient safety and ensure compliance with U.S. Pharmacopoeia (USP) standards. However, these new regulations far exceed federal standards and would instead block patients’ access to a long list of Category 1 Sterile Compounds such as glutathione, methyl B12, and NAD+. Cancer patients undergoing chemo and people suffering from Parkinson’s, Alzheimer’s, Long COVID, cystic fibrosis, Lyme Disease, and diabetes depend on these compounded drugs.
Firefighters, who suffer the highest cancer rates of any profession because of the toxins they’re exposed to, routinely use glutathione to reverse the toxicity. Case in point: pop-up clinics administered nebulized glutathione on a daily basis to hundreds of firefighters who were on the frontlines of the Los Angeles fires to help rid their bodies of dangerous toxins.
A yes vote by the BOP would severely affect the people who depend on these compounded drugs. Many could even die.
The patient-led advocacy group Stop The BOP is a driving force in the broad coalition opposing the BOP’s proposal, launching the first major petition which is supported by health practitioners, firefighters, and patients statewide. Many major organizations have publicly opposed the Board’s proposal and are major players in the opposition efforts, including the Alliance for Pharmacy Compounding, Volunteer Fire Foundation, LymeDisease.org, California Naturopathic Doctors Association, and more. StopTheBOP’s petition has garnered more than 11,000 signatures—a clear indication that the Board’s proposed regulations are severely misguided.
Additionally, the Alliance for Pharmacy Compounding (APC) has calculated that stability testing would cost between $10,000 and $30,000 per API under these new rules. This would make it financially impossible for most compounding pharmacies to continue to offer critical formulations of Category 1 Sterile Compounds. In rare cases when it would be accessible, costs would increase exponentially for patients.
It’s time for state lawmakers to get involved. There are a slew of actions legislators can take to need to take a hard look at the BOP’s motives behind these ill-considered regulations:
Intervene to Block the Proposal – Take all necessary legislative and regulatory actions to prevent the Board’s proposed rule from advancing and becoming law. (The final vote is scheduled for their March 6 Board Meeting.)
Investigate the Board’s Underground Enforcement Actions – Launch a full investigation into the Board of Pharmacy’s unauthorized enforcement activities, which have already made these vital prescriptions inaccessible in California since 2023—despite the fact that this proposal was not publicly introduced until April 2024.
Strengthen Oversight of the Board of Pharmacy – Implement increased legislative oversight to prevent regulatory overreach and ensure that all pharmacy regulations are based on sound scientific evidence, patient needs, and stakeholder input.
Protect Patient Access to Critical Treatments – Enact legislation that explicitly prevents the Board from restricting access to widely used, physician-prescribed compounded medications—particularly those that align with FDA policy and remain available in 49 other states.
Ensure Proper Representation on the Board – Work with the Governor’s Office to secure the appointment of at least one additional sterile compounding pharmacist to the Board of Pharmacy to ensure expert representation in regulatory decision-making.
The BOP will be taking a final vote on March 6, 2025. If the vote fails to pass, it will be a victory for compounding pharmacies, firefighters, and patients with chronic illnesses. The BOP would be forced to develop regulations that actually meet the needs of the people who rely on these sterile compounded therapies.
