Why Aren't Compounded Bioidentical Hormones FDA approved?

The FDA doesn't approve any compounded products, for any condition, because those products aren't standardized. That doesn't mean that compounding is bad. Compounding can be useful for patients who are allergic to an additive in an FDA-approved product, says Kathleen Uhl, MD, the FDA's assistant commissioner for women's health. But "the purpose of compounding is to do it on a patient-by-patient basis, so there's nothing that's submitted to FDA to evaluate, so they're not FDA approved," Uhl explains. And because compounded products don't go through the FDA approval process, they don't bear the same warnings as other hormone therapy. A woman who gets a prescription for an FDA-approved hormone therapy for menopausal symptoms is "going to get a lot of warning information," but if she gets a compounded product instead, "you don't get any of those warnings," Uhl says. "There's no requirement for them to provide that because those products are not FDA approved.  more

The FDA doesn't approve any compounded products, for any condition, because those products aren't standardized. That doesn't mean that compounding is bad. Compounding can be useful for patients who are allergic to an additive in an FDA-approved product, says Kathleen Uhl, MD, the FDA's assistant commissioner for women's health. But "the purpose of compounding is to do it on a patient-by-patient basis, so there's nothing that's submitted to FDA to evaluate, so they're not FDA approved," Uhl explains. And because compounded products don't go through the FDA approval process, they don't bear the same warnings as other hormone therapy. A woman who gets a prescription for an FDA-approved hormone therapy for menopausal symptoms is "going to get a lot of warning information," but if she gets a compounded product instead, "you don't get any of those warnings," Uhl says. "There's no requirement for them to provide that because those products are not FDA approved." L.D. King, executive ...