The California State Board of Pharmacy has proposed regulatory language that would block patient access to vitamin B12 (methylcobalamin) injections, IV glutathione, intranasal glutathione, alpha lipoic acid, as well as numerous other medications. This serious threat to crucial medicines must be opposed immediately to prevent significant harm to patients suffering from debilitating illnesses. We are also concerned that California’s actions regarding compounding provide a dangerous precedent as the FDA also considers a ban on methylcobalamin, glutathione, and other compounded supplements.
Wrire to the State Board of Pharmacy and the state legislature, urging them to protect access to crucial natural medicines.
Please protect important natural medicines
Dear [Decision Maker],
The California State Board of Pharmacy has proposed regulatory language that would block patient access to vitamin B12 (methylcobalamin) injections, IV glutathione, intranasal glutathione, alpha lipoic acid, as well as numerous other medications. I am deeply concerned that these actions will harm patients by removing their access to medicines they rely upon.The State Board of Pharmacy has proposed to ban the sterile compounding of ingredients that only have USP dietary supplement monographs. This resulted from an incident in January 2019 where medicines distributed by Letco Medical were contaminated with endotoxins. As a result, seven patients who received the injectable drug experienced adverse events. The State Board of Pharmacy can and would accept a USP drug monograph, but is proposing to ban substances that have a supplement monograph. This is an arbitrary decision and represents a direct attack on vitamin B12 shots, glutathione, and more. It is arbitrary because drug and supplement monographs are essentially the same. According to USP:"A monograph is a written standard that establishes public specifications for an article's quality. A USP monograph--whether for a drug product/ingredient or a dietary supplement--provides the name of that article; its definition; package, storage and labeling requirements; and a list of tests with related analytical procedures and acceptance criteria (usually expressed in percentage ranges or limits) needed to ensure identity, strength, purity and the absence of or control for contaminants."Further, compounding pharmacies are required to follow the guidelines set forth in USP , which delineates standards for compounding sterile preparations in all pharmacy settings. These guidelines were specifically designed to avoid patient harm through exposure to, among other things, excessive bacterial endotoxins. These standards should be sufficient to prevent contaminants in glutathione, and those pharmacies that do not adhere to these standards should be held accountable.. This was one bad batch, and the problem should have been caught and solved very simply by testing for endotoxins. But once again, government health authorities are using an isolated incident to restrict patient access to important medicines.That vitamin B12 and other dietary supplement ingredients are being singled out in California is of great concern. Methylcobalamin is helpful for a variety of conditions. It promotes brain function, can help with pain, vision, and sleep, mitigates the risk of birth defects, and there is research suggesting B12 can help with depression, Alzheimer's, and autism.Further, most commercially available B12 comes in two forms (although there are in fact a total of five forms of B12). Cyanocobalamin is the most popular because it is cheap to produce and has a longer shelf life. Once taken, cyanocobalamin needs to be converted into an active form of the vitamin, methylcobalamin or adenosylcobalamin. The problem is that some patients cannot properly perform this conversion, so they must take methylcobalamin, which is why many integrative doctors prefer methylcobalamin supplementation.For these reasons, blocking access to this important medicine will have an adverse effect on patient health. Here is a list of other substances that could be banned in California: Glutathione, the body's most important antioxidant; Alpha lipoic acid (another important antioxidant); Glucosamine (helpful for osteoarthritis) MSM (helpful for joints, detoxification, and potential for protection against cancer); Curcumin (tremendously anti-inflammatory with so many health benefits it would take a book to list them all); CoQ10 (an antioxidant that the body produces naturally and that cells use for growth and maintenance); Acetyl-l-carnitine (functions as an antioxidant, and promotes the production of glutathione in cells); Citrulline (an amino acid compounded for pediatric patients with metabolic disorders).Removing access to this medically necessary treatment when there is often no commercially available alternative is irresponsible and will cause harm to many patients. The State Board of Pharmacy's actions are confusing given that the problem could be solved very simply by requiring additional testing for the presence of endotoxins.Please take immediate action to protect access to these important medicines.
Sincerely,[Your Name] [Your Address] [City, State ZIP][Your Email]