For almost a year now, the California Board of Pharmacy (BOP) has been trying to impose severe restrictions on so-called “Category 1 sterile compounds,” much to the dismay of chronically ill patients and the state’s firefighters.

Now, the deadline is getting closer, where the BOP must either pass the proposed regulations–or scrap them and start over.

The targeted substances include certain forms of glutathione, Vitamin B12, and other alternative treatments.

As Austin Murphy, a reporter for the Santa Rosa Press-Democrat newspaper, explains:

The new rules would make it more difficult for Californians to get the ‘Category 1’ meds that have shown promise clearing toxins from the bodies of firefighters — but also treatments that give patients relief from such ailments as Lyme disease, long COVID, cancer, cystic fibrosis, chronic fatigue syndrome and others.

Murphy’s article goes on to say:

The author of those regulations, Compounding and Enforcement Committee Chair Maria Serpa, has repeatedly stated that the proposed regulations do not exceed guidelines imposed by the FDA and United States Pharmacopoeia, the highly respected group which sets standards for the quality of medicines, dietary supplements, and health care products in the United States.

That’s false, say the compounders and other critics.

The proposed rules call for “stability studies” that far exceed FDA and USP standards, and which will cost compounding pharmacies $10,000 to $30,000 “per formulation,” according to Scott Brunner, CEO of the trade group Alliance for Pharmacy Compounding.

With a whopping price tag like that, it’s pretty much guaranteed that compounding pharmacies would just stop making these medications altogether.

The result: toxin-exposed firefighters and chronically ill patients will be left with no access to these life-changing treatments.

#StopTheBOP

Crystal Frost, PhD, is a Lyme patient trying to prevent that nightmare scenario. She started the #StopTheBOP movement last year, rallying patients and firefighters alike to lodge protests with the board. Immediately prior to the February 5 BOP meeting, her group presented board members with a petition with over 10,000 signatures opposing the new restrictions.

Here are blogs explaining the issues.

Californians push back against proposed restrictions on glutathione and other alternative treatments

Why compounding pharmacies matter and why you should care

What is glutathione and why must we protect patient access to it?

According to Crystal, time is running out for the Board of Pharmacy. The board has one year to pass a regulatory package, after introducing it. If it doesn’t pass during that time, it’s back to the drawing board–which is what StopThe BOP wants.

Here’s how you can take action:

Email your written comment to PharmacyRulemaking@dca.ca.gov by February 21.

• How to write it: Keep it personal or, if you are a health practitioner, provide medical data. Explain how losing access to glutathione, B12, NAD+, and other Category 1 sterile compounds would affect you. The comment can be as long or as short as you want, and you can reuse old comments if you’ve already submitted one previously.
• More info: stopthebop.com/actnow

Click here to sign the petition

Stay tuned!

TOUCHED BY LYME is written by Dorothy Kupcha Leland, President of LymeDisease.org. She is co-author of Finding Resilience: A Teen’s Journey Through Lyme Disease and of When Your Child Has Lyme Disease: A Parent’s Survival Guide. Contact her at dleland@lymedisease.org.