Clinical Utility of Treating Individuals with Compounded “Bioidentical Hormone Replacement Therapy”

What are the benefits of treating people with compounded “Bioidentical Hormone Replacement Therapy (BHRT)”?

A diverse committee from the National Academies of Sciences, Engineering and Medicine, in partnership with the FDA, will carry out a report to measure the clinical power of treating individuals with compounded "bioidentical hormone replacement therapy (BHRT)” medications.

The committee will:

  • Review the existing patient history of compounded BHRT medications, and other compounded products, and to document the care of patients, including the conditions compounded medications have showcased in their history.
  • Describe the physical and chemical substance characteristics of compounded BHRT medications (example: active components, inactive components).
  • Review and measure the available proof, or insufficient evidence, concerning the safety and performance of compounded BHRT medications.
  • Review findings and make recommendations based on the obtainable evidence regarding the medical utility of compounded BHRT medications.
  • And finally, find the available evidence for:
    • Clinical utility of BHRT medications;
    • Whether safety and efficiency helps BHRT practice on patients; and
    • Supporting the replacement of BHRT medications with FDA-approved products.

The FDA plans to distribute all updates about this study with the public as information becomes available.


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