Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

Integrative Medical Center of New Mexico, PC, a medical practice, is urging patients to support the continued availability of IV Alpha Lipoic Acid and Glutathione. They argue that these compounded substances provide significant patient benefits and that the FDA's evaluation of bulk drug substances could negatively impact patient access.

An individual is advocating for the inclusion of Alpha Lipoic Acid (ALA) and Glutathione in the list of bulk drug substances allowed for compounding. They argue that these substances are highly effective at chelating heavy metals and have provided significant health improvements for their relative with Wilson's Disease and for military veterans with heavy metal overload.

A patient with multiple sclerosis argues that the proposed action would be devastating because it could make IV ALA unavailable. They claim that IV ALA has significantly improved their quality of life and ability to work, and they believe the FDA should not prevent its use.

An individual patient with cirrhosis reports significant health improvements from IV Alpha Lipoic Acid therapy. They request that the agency consider keeping this supplement on the market for use in compounding drug products.

Dennis and Louise Galli are parents of a child with a chronic liver disease who benefits from Alpha Lipoic Acid (ALA) infusions. They support the continued availability of these infusions, noting the significant physical and psychological improvements they provide to their son and other patients.

An individual patient who uses ALA IV treatments for kidney issues expresses their preference for this treatment over synthetic drugs. They argue that making these treatments unavailable would not be in the public interest and oppose efforts to restrict access to them.

An individual patient who has experienced personal health benefits from IV ALA therapy argues that patients should maintain access to this treatment. They contend that it is a beneficial alternative for those who have exhausted traditional medical options and request that the agency keep it available.

Bobbie Suggs, a private individual, expresses strong support for the inclusion of ALA in the list of bulk drug substances for compounding. The commenter argues that ALA has been life-saving for loved ones with cancer and should remain available to patients.