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  1. Human Drug Compounding

National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy

NASEM study leads: Andrew Pope, PhD, Director, Board on Health Sciences Policy, Health and Medicine Division; Leigh Miles Jackson, PhD, Senior Program Officer, Board on Health Sciences Policy

Project Start: September 2018

Compounded “bioidentical hormone therapy” (BHT) products, such as progesterone and testosterone, are used by some providers and patients instead of FDA-approved drug products for hormone therapy. Compounded BHT products are sometimes marketed as having certain 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.

Compounded BHT products are not FDA-approved, which means these products have not undergone an FDA assessment of safety, effectiveness and quality.

NASEM will examine the clinical utility of treating patients with compounded BHT products. NASEM will 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 compounded BHT products to treat patients.

Please see the NASEM web page for this study.