California’s legislature is no stranger to big debates about public health, regulation, and the well-being of our communities. However, a decision by the California State Board of Pharmacy (BOP) might be slipping under the radar, and it could have severe consequences for many Californians. At stake is access to critical medications that help people fight cancer, manage chronic illnesses, and detoxify from harmful exposures—like the ones faced by California’s firefighters.
On November 6-7, the Board of Pharmacy will decide on regulations limiting the availability of some essential medications—glutathione, NAD+, and methylcobalamin (a form of B12), among others. If the board moves forward, California will become the only state in the country to enforce strict limits on these compounds, which have been used safely and effectively for years.
So why should you care? This isn’t just a niche healthcare topic; it concerns the health and lives of people in our state. Understanding what the Board of Pharmacy is doing—and why it matters—could mean the difference between people getting the treatment they need and facing life-threatening consequences.
The Big Picture: What’s Changing?
The BOP’s proposed rules are focused on how certain medications, specifically sterile and non-sterile compounds, are prepared and tested in pharmacies. If you’ve ever picked up a prescription, you’ve benefited from the system that ensures these medicines are made safely. However, many healthcare professionals, including pharmacists and doctors from large healthcare providers like Cedars-Sinai and Kaiser Permanente, are raising alarms that these new regulations could go too far, making it harder for pharmacies to deliver treatments without any clear benefit to safety.
What’s the issue? One primary concern is the increased burden on pharmacies to meet new, costly requirements, such as environmental testing, additional sterility testing, and detailed tracking of all the equipment used. These changes will take time and resources, increasing the cost of medications and making it harder for people—especially those needing specialized treatments—to fill their prescriptions.
Who Will Be Affected?
Let’s put a face on this issue. California’s firefighters, for example, are one group that could be directly impacted. Firefighters are exposed to harmful chemicals and carcinogens as part of their job, which is why cancer is now their leading cause of death. One treatment they rely on is glutathione, an antioxidant that helps the body detoxify from dangerous toxins. If access to this treatment is restricted, many firefighters may lose a critical tool in their fight against cancer.
But firefighters aren’t the only ones affected. Cancer patients, Lyme Disease patients, people with autoimmune and neurological conditions, and others dealing with long-term health issues depend on these treatments to manage their conditions. Restricting access isn’t just an inconvenience—it’s a matter of life and death for some.
Why the Outrage?
Healthcare providers, pharmacists, and patient advocates are sounding the alarm because they’ve seen firsthand the benefits these treatments provide. More than 300 pages of opposition letters have been submitted to the BOP, with major organizations like Cedars-Sinai, Kaiser Permanente, CVS Health, and UCSF Medical Center weighing in. These experts agree: the proposed rules will cause much more harm than good, driving up costs and ending access to life-saving treatments without offering a scientific or safety-based explanation. In fact, the BOP was met with unanimous opposition at both previous board meetings and the June public hearing on this matter, with not one person standing up in support of the regulations.
Yet despite this overwhelming opposition, the BOP is pushing forward with the proposal. What’s especially troubling is that an unelected body is making this decision without sufficient transparency or clear justification for why these changes are necessary. Many authorities have even asserted that The Board of Pharmacy has been wrongfully enforcing these regulations despite the fact that they haven’t been enacted yet. “The Board has used taxpayer dollars in attempt to enforce non-existent regulation and to enact punitive action against some sterile compounding pharmacies for offenses that have no bearing on patient safety,” stated Tenille Davis, Chief Advocacy Officer for the Alliance for Pharmacy Compounding, in her public comment letter to the Board of Pharmacy on June 3, 2024.
What Can Be Done?
This is where California’s legislature—and the public—need to get involved. Patient advocates are encouraging the public to sign the petition and speak up at the November 6-7 board meeting where the BOP will discuss and vote on this matter once again. Every individual has the right to give a public comment at the board meeting via Webex or in-person in San Diego If the issue continues to fly under the radar, countless people could lose access to the medications they depend on.
Patients, healthcare providers, and the public all have a stake in this decision, and their voices need to be heard. For more information on how to make a difference and stop the BOP’s proposal from becoming a reality, visit StopTheBOP.com.
The health and safety of Californians hang in the balance. Let’s not let bureaucracy get in the way of people getting necessary treatments to stay alive and healthy.
You can find the reference comments and letters here https://www.pharmacy.ca.gov/meetings/agendas/2024/24_jul_bd_mat_iv_comments.pdf.