Imagine relying on a life-saving treatment to manage your health, only to have it suddenly taken away without any clear explanation.
This is the alarming reality Californians may face if the California State Board of Pharmacy (BOP) moves forward to restrict access to essential sterile compounded treatments like glutathione, NAD+, and methylcobalamin (a bioavailable form of B12). These changes could go into effect after the BOP’s November 6-7 meeting, leaving many patients vulnerable.
These specialized compounds are not mere supplements; they are crucial medicines for patients battling cancer and chronic illnesses and even first responders like firefighters exposed to dangerous toxins. For many, these treatments are lifelines. If the new regulations are approved, California will become the only state to severely limit these treatments despite their years of safe and effective use.
The proposed changes focus on how certain medications are prepared and monitored within pharmacies, especially regarding sterile and non-sterile drug production. While the intent may be to enhance safety standards, many healthcare professionals—including major institutions like Cedars-Sinai, Walgreens, CVS, Kaiser Permanente, and the California Pharmacists Association—are deeply concerned.
They argue that the new rules will impose significant costs on pharmacies for sterility testing and environmental monitoring without providing tangible benefits to patient safety.
“In total we identify 57 specific places where the proposed regulations exceed what is required in federal law and by the compounding chapters of the U.S. Pharmacopeia,” Chief Advocacy Officer for the Alliance for Pharmacy Compounding (APC) told the board in a public comment letter addressed June 3, 2024. “In none of those instances has the board demonstrated how these excessive regulations make patients safer.”
The Human Cost of This Decision
This issue goes beyond bureaucratic red tape—directly affecting people’s lives. Firefighters, for example, face cancer as their leading cause of death, primarily due to their exposure to carcinogens on the job. Glutathione, a powerful antioxidant produced by the liver, has become a critical treatment for detoxifying their bodies and helping combat these dangerous exposures. Removing access to this treatment could be life-threatening for them.
Likewise, cancer patients and those with autoimmune conditions who rely on specialized medications like NAD+ and methylcobalamin to manage their health could see their treatment options vanish. This isn’t just an inconvenience—it’s a matter of survival for many Californians.
Crystal A. Frost, a composer and writer fighting neurological Lyme Disease, founded the advocacy effort known as Stop The BOP to protect and restore access to natural treatment options facing unprecedented restrictions in California.
“I rely on sterile compounded glutathione and NAD+ to manage late-stage disseminated neurological Lyme disease, mold and gadolinium toxicity, and resulting brain inflammation,” said Frost. “I’m a composer, but because of this life-threatening decision by the Board of Pharmacy, I put my life on hold to launch Stop The BOP, so that patients like myself stand a fighting chance against this motion to eliminate our treatments. The public should know the proposed rules change by the BOP are essentially bans disguised as regulations that will disrupt the healthcare of millions of Californians.”
Other healthcare professionals also chimed in on the importance of keeping these compounds available.
The pharmacy manager at Cedars-Sinai in Los Angeles characterized the proposed changes as a “serious patient safety risk.”
“There’s still significant issues that needs to be addressed to ensure that the regulation doesn’t negatively impact the health systems, as well as other pharmacies in California. I urge the board, again, to continue to reject this proposed language of the compounding regulations and simply adapt the evidence-based published USP chapters.”
He also requested the public comment period be extended to allow more time for the public to weigh in.
“I would ask the board if the public could provide a 45-day or a 30-day instead of a 15-day window to provide written comments. As again, 15 seems insufficient for stakeholders to review and also respond to the language that is proposed.”
A Growing Backlash
Unsurprisingly, the BOP’s move has sparked strong opposition from healthcare providers and patient advocacy groups. Over 300 pages of letters have been submitted, with significant players like Cedars-Sinai, Kaiser Permanente, the California Pharmacists Association, and many others voicing their concerns.
Despite this overwhelming pushback, board member Maria D. Serpa, a pharmacist from Elk Grove, California, is leading the charge to continue to move forward with its agenda despite the tremendous concern and outcry from key healthcare groups, pharmacists, and patients.
After years in one of the nation’s most hazardous environments, Gabe Stirnus, a paramedic fire captain in Sonoma County and member of the International Association of Firefighters and California State Firefighters Association, testified to the Board of Pharmacy in September about his and his colleagues’ constant exposure to toxic substances. ‘I developed a persistent cough from these exposures, which only nebulized glutathione could treat after other interventions failed. Now, pharmacists are too intimidated by this board to compound this essential medication. My cough has returned, and I have no alternatives. Please, don’t remove a safe, effective treatment from us on the front lines—and from community members constantly exposed to these environmental toxins.’
What’s Next?
The California Board of Pharmacy will meet on November 6 and 7 to vote on the future of these treatments. The public is urged to attend or call in and provide their comments.
Decisions made at this board meeting will likely impact the Board’s future, as it is up for its sunset review process in 2025.
For more information on the BOP and its agenda, you can see it HERE.
For more information on Crystal A. Frost and the movement to fight the proposal, visit StopTheBOP.com.
As I have been repeatedly told by the various concerned patients, “This is not just a fight for access to medicine; it’s a fight for the health and safety of all Californians.”
