Clinical Utility of Treating Patients with Compounded "Bioidentical Hormone Replacement Therapy"
An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (National Academies) will conduct a study to assess the clinical utility of treating patients with compounded BHRT drug products. The committee will:
• Review the current and historic use of compounded BHRT drug products to treat patients, including information about the medical condition(s) that these compounded drug products have been used to treat;
• Describe the physical and chemical characteristics of compounded BHRT drug products (e.g., active ingredient, inactive ingredient(s), dosage forms, routes of administration, strengths);
• Review and assess the available evidence (or lack of evidence) regarding the safety and effectiveness of compounded BHRT drug products;
• Based on the available evidence, summarize findings and make recommendations with respect to
- the clinical utility of compounded BHRT drug products;
- whether the available evidence of safety and effectiveness supports use of compounded BHRT drug products to treat patients; and
- the patient populations that might need a compounded BHRT drug product in lieu of an FDA-approved drug product.
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