The U.S. Food and Drug Administration (FDA) has approved dozens of hormone therapy products for men and women, including estrogen, progesterone, testosterone, and related compounds. These products have been reviewed for safety and efficacy and are indicated for treatment of symptoms resulting from hormonal changes associated with menopause or other endocrine-based disorders. In recent decades, an increasing number of health care providers and patients have turned to custom-formulated, or compounded, drug preparations as an alternative to FDA-approved drug products for hormone-related health concerns. These compounded hormone preparations are often marketed as "bioidentical" or "natural" and are commonly referred to as compounded bioidentical hormone therapy (cBHT). In light of the fast-growing popularity of cBHT preparations, the clinical utility of these compounded preparations is a substantial public health concern for various stakeholders, including medical practitioners, patients, health advocacy organizations, and federal and state public health agencies. This report examines the clinical utility and uses of cBHT drug preparations and reviews the available evidence that would support marketing claims of the safety and effectiveness of cBHT preparations. It also assesses whether the available evidence suggests that these preparations have clinical utility and safety profiles warranting their clinical use and identifies patient populations that might benefit from cBHT preparations in lieu of FDA-approved BHT. Table of ContentsFront MatterSummary1 Introduction2 An Overview of Compounding3 Regulatory Framework for Compounded Preparations4 Reproductive Steroid Hormones: Synthesis, Structure, and Biochemistry5 Compounded Bioidentical Hormone Preparations6 Bioavailability of Compounded Bioidentical Hormone Therapy Preparations7 The Safety and Effectiveness of Compounded Bioidentical Hormone Therapy8 The Use of Compounded Bioidentical Hormone Therapy9 Clinical Utility and RecommendationsAppendix A: Study ApproachAppendix B: Study MethodsAppendix C: GlossaryAppendix D: BiosketchesAppendix E: 503A and 503B Distribution SupplementAppendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active IngredientAppendix G: Compounded Bioidentical Hormone Therapy Formulations with Two or More Active IngredientsAppendix H: Boxed Warnings on U.S. Food and Drug AdministrationApproved Estrogen and Testosterone Products
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