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Compounded Bioidentical Hormones: Myths and Realities. The spectacular success of compounded bioidentical hormone therapy is a product of the unanticipated negative-to-neutral findings of the Women's Health Initiative hormone trial and the peculiarities of their regulatory status. By not having to provide scientific evidence of safety and efficacy, a requirement for all Food and Drug Administration (FDA)-approved hormone therapy products, the industry's relatively unfettered marketing now accounts for about one third of menopausal hormone therapy prescriptions. Clinicians are often caught in the middle between patient beliefs and a desire to practice evidence-based medicine. Strategies are needed to redirect patients towards truly safe and effective treatment for their menopausal symptoms.