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Bioidentical Hormone Therapy: FDA-approved vs. Compounded?  Tips From A Menopause Specialist To Help You Choose Which Is Best For You

Bioidentical Hormone Therapy: FDA-approved vs. Compounded? Tips From A Menopause Specialist To Help You Choose Which Is Best For You

Hormone Therapy
Perimenopause/Menopause Treatments

By Barbra Hanna, DO, FACOG, MSCP, 07/14/2023

The most effective treatment for managing menopausal symptoms according to the North American Menopause Society is hormone therapy. Understanding the differences between the types of hormone therapy available for your use will empower you to make informed decisions about your health and well-being.  Let's dive in and shed light on the difference between FDA-approved bioidentical hormone therapy and compounded bioidentical hormone therapy.

First, let’s take a moment to understand what the term bioidentical hormone therapy means. Bioidentical hormone therapy (BHRT) involves using hormones that are structurally identical to those naturally produced by your body. Hormones used for the treatment of menopause symptoms,  whether FDA-approved or compounded,  are typically derived from plant sources, such as soy or yam, and are designed to mimic the hormones your body produces.

Estradiol and progesterone are FDA-Approved bioidentical hormone products commercially available that have undergone extensive testing and approval by the U.S. Food and Drug Administration (FDA). These products come in numerous standardized doses and delivery methods (patches, gels, rings, creams, and inserts) and are prescribed by licensed healthcare providers like the certified menopause specialists at MyMenopauseRx to treat your menopause symptoms. Because standardized doses have been extensively studied for their safe use in menopause treatment, expensive hormone lab testing is not necessary when using these products.


4 Key Points about FDA-Approved Bioidentical Hormone Therapy:

  • Regulated and Tested: FDA-approved bioidentical hormone therapy undergoes rigorous testing for safety, efficacy, and quality control. These products are manufactured by pharmaceutical companies according to strict guidelines, ensuring consistency and reliability.
  • Standardized Dosages: FDA-approved products come in numerous standardized doses, allowing healthcare providers to prescribe specific doses based on individual needs. This standardized approach helps ensure accuracy and precise dosing without the need for expensive repetitive hormone testing.
  • Varied Delivery Methods: FDA-approved bioidentical hormone therapy is available in various delivery methods, including pills, patches, creams, gels, and inserts. This allows healthcare providers to tailor treatment to individual preferences and needs.
  • Covered by your health insurance. Most FDA-approved hormone formulations used to treat your menopause symptoms are covered by health insurance.  

Compounded Bioidentical Hormone Therapy refers to custom-made hormone formulations prepared by compounding pharmacies. Compounding pharmacies are specialized pharmacies that make medications prepared to formulations based on an individual’s prescriptions,  “customized” to each individual. The North American Menopause Society only recommends women use compounded hormone therapy when a patient has an allergy to an FDA-approved product. Contrary to many claims made by various healthcare providers, compounded bioidentical hormones are NOT safer than FDA-approved products.


4 Key Points about Compounded Bioidentical Hormone Therapy:

  • Customized Formulations: Compounded bioidentical hormone therapy allows for customized hormone combinations and dosages based on an individual's specific requirements. This flexibility can be beneficial for those who may require unique formulations not readily available in commercially manufactured products or if you have an allergy to an ingredient in an FDA-approved product.
  • Lack of FDA Regulation: Compounded bioidentical hormone therapy is not subject to FDA approval or regulation. The quality and safety of compounded products may vary.
  • Variable Quality Control: Compounded products may have inconsistent quality and potency, as they are not subject to the same rigorous testing and oversight as FDA-approved products. It's important to choose a reputable compounding pharmacy and consult with a knowledgeable compounding healthcare provider if you decide to use a compounded medication.
  • Not covered by your health insurance. Compounded medications are an out-of-pocket expense on most health insurance plans.

When considering bioidentical hormone therapy for menopause, it's crucial to consult with a menopause-trained healthcare provider, like a certified menopause specialist. They will assess your personal health profile, discuss treatment options, and help you make an informed decision based on the available medical evidence, your preferences, and potential risks and benefits.

The choice between FDA-approved bioidentical hormone therapy and compounded bioidentical hormone therapy is simple - safety first!  FDA-approved products have undergone rigorous testing for safety and efficacy and are covered by your health insurance. Each person’s menopause journey is unique.  Your menopause specialist, your ally in navigating menopause,  will guide you toward the most suitable treatment options tailored to support your well-being during this transformative phase of life!


The content is meant for educational purposes only. It is not intended to be a substitute for professional medical advice, diagnosis or treatment. Please seek the advice of your physician with any questions you may have regarding a medical condition.