On September 12, the California State Board of Pharmacy is expected to vote to eliminate access to safe and critical Category 1 substances like methylcobalamin (a form of vitamin B12) and glutathione infusions. These are relied upon by some of California’s most vulnerable populations, including chronic illness sufferers, cancer patients and firefighters.

A grassroots organization called #STOPTHEBOP seeks to protect access to these irreplaceable treatments. Click here to sign their Change.org petition.

The following press release from #STOPTHEBOP gives background on this important issue:

On July 31, the California Board of Pharmacy (BOP) was met with overwhelming opposition to their proposed regulations that would severely restrict the production and administration of essential treatments such as glutathione, NAD, and methylcobalamin, the active form of vitamin B12.

Over 100 members of the public, including firefighters, doctors, pharmacists, and patients with chronic illnesses, joined the meeting to voice their unanimous disapproval.

Major medical institutions including Cedars-Sinai, California Pharmacists Association, and California Hospital Association have also requested changes to the proposed regulations. According to the Alliance for Pharmacy Compounding (APC), the proposed regulations exceed federal standards in 57 instances.

“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 APC Tenille Davis told the board at a June 18 public hearing. “In none of those instances has the board demonstrated how these excessive regulations make patients safer.”

A threat to patient access

The proposed regulations, which allow for very limited exceptions, threaten to end patient access to all 47 Category 1 Sterile Compounds despite the fact that they are federally allowed under the FDA’s interim policy. These regulations, if passed, would make California the only state to restrict these treatments.

Firefighters face unique risks, many of whom depend on glutathione therapies to recover from toxic exposure after battling massive fires. Losing access to these medications would also be catastrophic for many patients with chronic illnesses such as ME/CFS, cancer, Lyme disease, anemia, multiple sclerosis, Crohn’s disease, and CIRS who have come to depend on these substances for quality of life and disease management.

#STOPTHEBOP

The Stop The BOP movement, led by Crystal Frost and Jacqui Jorgeson, launched a petition in mid-July that has garnered significant support, reaching more than 2200 signatures on August 15.

The petition highlights the critical need to preserve access to these life-saving treatments and has gained traction quickly, reflecting widespread public concern. Frost depends on glutathione and NAD to combat her neurological Lyme disease.

Jorgeson, founder of the Volunteer Fire Foundation, helped pioneer a detoxification pilot study for firefighters involving glutathione which has yielded phenomenal results.

On August 2, Frost spoke with reporter Marla Tellez on Fox 11 Los Angeles. “Our sterile compounding pharmacies are already under very strict regulations,” she told Fox 11. “Ten years ago, we estimate that there were 100 sterile compounding pharmacies in California, and now we only have 18 left because they had to close down because they can’t abide by these…regulations that aren’t the same in the other states.”

Due to pushback from the public and some uncertainty amongst board members, the board decided to hold off on further action until their September 12 board meeting.

Stop The BOP continues to mobilize support and raise awareness about the negative impact of the proposed regulations in hopes that Chairwoman of the Enforcement and Compounding Committee Maria Serpa will change course to protect patient access.

For more information, visit stopthebop.com.

See more from the Santa Rosa Press-Democrat: Firefighters say this medicine could save their lives. Why does California want to restrict it?

Click here to sign the Change.org petition.