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# Compounded Hormone Therapies Have Risks: National Academies
- URL: https://www.fdaweb.com/compounded-hormone-therapies-have-risks-national-academies/
- Published: 2020-07-06T12:00:00.000Z
- Updated: 2026-09-14T16:19:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147121

At the request of FDA, the National Academies of Science, Engineering, and Medicine (NASEM) has conducted an independent assessment and evaluation of the available scientific evidence on the safety and effectiveness of compounded bioidentical hormone therapy (cBHT) products. NASEM concluded that due to a lack of high-quality clinical evidence and minimal oversight of cBHT, their widespread use poses a public health concern.

The NASEM [report](https://www.nap.edu/catalog/25791/the-clinical-utility-of-compounded-bioidentical-hormone-therapy-a-review?utm%5Fcampaign=NASEM%20Assessment%20on%20the%20Safety%20and%20Effectiveness%20of%20Compounded%20Bioidentical%20Hormone%20Therapy%20%28cBHT%29&utm%5Fmedium=email&utm%5Fsource=Eloqua) (available for purchase or as a free PDF) says “there is a dearth of evidence to support many of the marketed claims for the clinical utility of cBHT as a treatment of menopausal and male hypogonadism symptoms. Based on its examination of its clinical utility, the committee recommends restricted use of cBHT, assessments of their difficulty to compound, and additional education, oversight, and research.”

The report makes these recommendations: 

- restrict the use of cBHT preparations;
- review select bioidentical hormone therapies and dosage forms as candidates for FDA’s Difficult to Compound list;
- improve education for prescribers and pharmacists who market, prescribe, compound, and dispense compounded cBHT preparations;
- implement additional federal and state oversight to better address public health and clinical concerns about the safety and effectiveness of cBHTs; collect and disclose conflicts of interest; and
- strengthen and expand the evidence base on the safety, effectiveness, and use of compounded cBHT preparations.

FDA says it is evaluating the NASEM report and recommendations to determine next steps.