Study on Compounded Bioidentical Hormones

FDA has announced that the National Academies of Science, Engineering, and Medicine (NASEM) is conducting a study to examine the clinical utility of treating patients with compounded “bioidentical hormone therapy” products, such as progesterone and testosterone. NASEM is expected to provide a report evaluating the available scientific evidence relating to the safety and effectiveness of these products and discussing whether the available evidence supports use of such compounded products to treat patients.

FDA notes that compounded bioidentical hormone therapy products are sometimes marketed as having advantages over FDA-approved products, such as that they are derived from natural sources and are safer than FDA-approved drugs that are synthetic or chemically modified, or that they do not have the same risks or potential side-effects associated with FDA-approved hormone therapies. To learn more, please visit the NASEM Web page for this study.