Tell FDA: Preserve Access to IV Glutathione

The California State Board of Pharmacy has proposed regulatory language that would block patient access to IV glutathione, as well as numerous other medications. This serious threat to a crucial medication must be opposed immediately. We are also concerned that California’s actions regarding compounding could give the FDA similar ideas as the agency develops its own policies regarding compounded supplements.

Write to Congress and the FDA, urging them to preserve patient access to compounded glutathione IVs!

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Preserve Access to IV Glutathione

Dear [Decision Maker],

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I understand that the FDA is currently deciding whether or not to pursue a ban on compounded IV glutathione treatments. I'm writing to express deep concern over a ban on this treatment.

Glutathione is a potent antioxidant that helps the liver to rid the body of pollutants. It helps regulate many cellular processes such as DNA synthesis, gene expression, and immune system responses. IV glutathione is one of the body's most important defenses against disease. Dozens and dozens of peer-reviewed research point to glutathione's ability to help with a variety of diseases, including cancer, Parkinson's, Alzheimer's, pulmonary disease, tuberculosis, HIV, mercury and acetaminophen toxicity, diabetes, cystic fibrosis, and more. Because of these many benefits, glutathione is used widely in integrative medicine practices.

Removing access to this medically necessary treatment when there is no commercially available alternative is irresponsible and will cause harm to many patients.

There also seems to be concern that glutathione does not have a USP drug monograph. While USP-NF monographs may not be elaborated to the extent of USP drug ingredient monographs, high standards of purity are nevertheless required. USP-NF monographs include lists of tests with related analytical procedures and acceptance criteria 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 standards should be sufficient to prevent contaminants in glutathione, and those pharmacies that do not adhere to these standards should be held accountable.

Please preserve access to these important medicines that patients rely on and cannot get anywhere else.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
[Your Email]