Bioidentical Hormones

Bioidentical Hormones

“It’s important to note that custom-compounded
bioidentical hormone therapy is NOT recommended
because it lacks regulation, rigorous safety and…”.1

Umbrella

What may the Bioidentical Hormones Umbrella include?

Depending on the Source (DotS) this Umbrella may include:

  • Bioequivalent Hormone Therapy
  • Bioidentical Hormone Medications
  • Bioidentical Hormone Replacement Therapy (BHRT)
  • Bioidentical Hormone Therapy (BHT)
  • Bioidentical Hormones
  • Bioidenticals
  • Custom-Compounded Bioidentical Hormone Therapy (C-CHT)
  • Custom-Made Bioidentical Hormones
  • Custom-Mixed Bioidentical Hormones
  • Hormone Therapy Alternatives
  • Natural Hormone Therapies
  • Pharmacy Compounded Hormones
  • ‘Compounded’ Bioidentical Hormone Replacement Therapy (cBHRT)
  • ‘Regulated’ Bioidentical Hormone Replacement Therapy (rBHRT)

Date

What can it be important to be clear about with bioidentical hormones information?

It can be important to be clear about the date of all information including the date of bioidentical hormones information, because this information may have been updated.

Symptoms or Chronic Conditions

What can it also be important to be clear about with bioidentical hormones information?

It can also be important to be clear about whether bioidentical hormones information is about the use of bioidentical hormones for the management of menopausal symptoms such as hot flushes, night sweats and vaginal dryness or for the prevention of chronic conditions such as cardiovascular disease, cancer and osteoporosis.

Bioidentical Hormones

What are bioidentical hormones?

DotS the definition of bioidentical hormones may vary. In Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? the (United States) Mayo Clinic author’s definition is:

“The term “bioidentical” means the hormones in the medicine are chemically the same as those the body makes. In fact, the hormones in bioidentical medicines may not be any different from those in traditional hormone therapy. In the United States, many hormone therapy medicines approved by the Food and Drug Administration (FDA) and prescribed by healthcare professionals have bioidentical hormones in them”.2

On page two in their BMS Consensus Statement Bioidentical HRT: Summary of Key Terminologies – Part A – Explanation of cBHRT: What Are ‘Bioidentical Hormones’? dated April 2026, the British Menopause Society’s (BMS) definition is:

“Bioidentical hormones are precise duplicates of hormones such as estradiol E2, estriol E3, estrone E1, progesterone, dehydroepiandrosterone, testosterone and levothyroxine as synthesised by the human ovary, adrenal and thyroid. However, ‘bioidentical’ is often used as a marketing term by clinics purporting the benefits of cBHRT. It has been proposed by menopause specialists that rBHRT should be referred to as ‘body identical’ to distinguish regulated hormone therapy from the compounded varieties”.3

cBHRT

What is cBHRT (Compounded Bioidentical Hormone Replacement Therapy)?

DotS the definition of cBHRT may vary. In Bioidentical HRT: Summary of Key Terminologies the BMS’s definition is:

“cBHRT: Compounded Bioidentical Hormone Replacement Therapy: Precise duplicates of human hormones which are produced by specialist pharmacies and do not follow the same MHRA regulatory pathway as conventional rBHRT”.4

rBHRT

What is rBHRT (Regulated Bioidentical Hormone Replacement Therapy)?

DotS the definition of rBHRT may vary. In Bioidentical HRT: Summary of Key Terminologies the BMS’s definition is:

“rBHRT: Regulated Bioidentical Hormone Replacement Therapy: Precise duplicates of human hormones developed in a conventional way by the pharmaceutical industry and authorised by the regulators such as the MHRA in the UK”.5

What is MHRA?

In this context MHRA can be an abbreviation for the (United Kingdom) Medicines & Healthcare Products Regulatory Agency.

Compounded Drugs

Are compounded drugs approved by individual Country Drug Regulatory bodies for example the FDA?

In Compounding and the FDA: Questions and Answers – Are Compounded Drugs Approved By FDA? the (United States) Food and Drug Administration (FDA) elaborate on:

“Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. Consumers and health care professionals rely on FDA’s drug approval process for verification of safety, effectiveness and quality”.6

Natural or Not

Are bioidentical hormones natural?

In Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? the Mayo Clinic author explains:

“The term “natural” means the hormones in the medicine come from plant sources. They’re not created in a lab right from the beginning. But many of these substances still need to be processed by a commercial lab to become bioidentical”.7

In Treatments for Menopause: Menopausal Hormone Therapy (MHT) – What Are Bioidentical Hormones? the (Australian) Jean Hailes for Women’s Health (JH) note:

Bioidentical Hormones“Some doctors prescribe “bioidentical hormones”. These are mixtures of different hormones made up in compounding pharmacies. These hormones are available as:

  • Capsules
  • Creams
  • Gels
  • Drops
  • Lozenges.

Bioidentical hormones are often promoted as “natural” or “tailored”, but these are advertising terms”.8

Safe or Not

Are bioidentical hormones safe?

In International Menopause Society (IMS) Recommendations and Key Messages on Women’s Midlife Health and Menopause: 25. Compounded ‘Bioidentical’ or ‘Natural’ Hormones, dated 23 December 2025, the authors note:

  • “Prescribing of compounded bioidentical hormone therapy (cBHT) is not recommended due to safety and efficacy concerns, including lack of quality control and rigorous regulatory oversight, and absence of scientific evidence of safety, purity and efficacy. ⨁⨁⨁◯ A”.9

The authors also include:

  • “Women should be informed that cBHT is not standardized and does not undergo the same strict regulatory processes as is the case for MHT. ⨁⨁⨁◯ A
  • Women should be informed that, unlike cBHT, MHT is strictly regulated and distributed with relevant package inserts and safety warnings. ⨁⨁⨁⨁ A
  • Women requesting cBHT should be informed about safety issues, and encouraged to use or switch to MHT which is stringently tested for strength, purity and quality. ⨁⨁⨁◯ A”.10


Recommended or Not

Hormone TherapyDo menopause societies and other organizations, recommend the use of bioidentical hormones?

On page four in the International Menopause Society’s Leaflet for Women for World Menopause Day on 18 October 2024 Menopause and Menopause Hormone Therapy: 2. What Is MHT? the International Menopause Society note:

“It’s important to note that custom-compounded bioidentical hormone therapy is NOT recommended because it lacks regulation, rigorous safety and efficacy testing, batch standardization, and purity measures”.11

On page three in their BMS Consensus Statement Bioidentical HRT: Summary of Key Terminologies – Part A – Explanation of cBHRT: Prescribing cBHRT, dated April 2026, the BMS note:

“In line with national and international guidance, the BMS does not recommend the prescribing of cBHRT. The potential benefits of bioidentical hormone therapy can be achieved using conventionally licensed products, without needing to use compounded varieties from specialist pharmacies”.12

Government Approved

Are government approved bioidentical hormones available?

In Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? the author notes:

“Some FDA-approved products come from plants. Examples include Estrace, Alora and other products that contain estrogens, and Prometrium, a natural progesterone”.13

Health Care Provider

What if I choose to use bioidentical hormones?

The BMS remind us:

“The management of women with menopause related problems should be underpinned by national and international guidance and wherever possible, regulated products should be prescribed”.14

Health Topics A-Z

Where may I find Health Topics A-Z related to Bioidentical Hormones?

In Health Topics A-Z you may find:

Health Topics A-Z

Links

Where may I find Links related to Bioidentical Hormones?

Your Country may have Links similar to:

Links

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New or Updated

  1. Are Bioidentical Hormones Superior To Hormone Medications?
  2. BMS TV: Bioidentical Hormones
  3. BMS TV: Testosterone Explained
  4. Bioidentical HRT
  5. Bioidentical Hormone Therapy
  6. Bioidentical Hormones
  7. Bioidentical Hormones: Are They Safer? Are bioidentical or natural hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms?
  8. Complementary & Alternative Therapies: Non-Hormonal Treatments for Menopause Symptoms
  9. Complementary Medicines and Therapies for Hot Flushes
  10. Complementary Medicines and Therapies: Options for Menopausal Symptoms
  11. Compounding and the FDA: Questions and Answers
  12. Consumer Video and Podcast Series: 2023 Consumer Videos and Podcasts – New FDA-Approved Nonhormone Option for the Treatment of Hot Flashes
  13. Consumer Video and Podcast Series: 2024 Consumer Videos and Podcasts – Preparing for Your Menopause Health Care Visit
  14. Deciding About Hormone Therapy Use
  15. FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
  16. FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
  17. Find A Menopause Practitioner [United States and Other]
  18. Find A Practitioner [Australasian Menopause Society i.e. Australia and New Zealand]
  19. Find Your Nearest BMS Menopause Specialist [British Menopause Society]
  20. Follicle-Stimulating Hormone (FSH) Levels Test
  21. HRT Questions Answered
  22. Handling Hot Flushes and Night Sweats| Dr Louise Newson
  23. Herbal Remedies and Complementary Medicines for Menopause Symptoms: Bioidentical Hormones or “Natural” Hormones
  24. Hot Flashes
  25. Hot Flashes
  26. International Menopause Society (IMS) Recommendations and Key Messages on Women’s Midlife Health and Menopause
  27. Is It Really ‘FDA Approved?’ FDA Doesn’t Approve Compounded Drugs
  28. Luteinizing Hormone (LH) Levels Test
  29. Menopause
  30. Menopause
  31. Menopause Map: Downloadable Resources – My Personal Path Print Tools: Questions for Your Health Care Provider
    Bioidentical Hormones
  32. Menopause Symptoms and Relief
  33. Menopause Symptoms: Mayo Clinic Expert Outlines Hormone and Nonhormonal Therapies
  34. Menopause: Diagnosis & Treatment
  35. Menopause: Identification and Management [NICE Guideline]
  36. Menopause: Identification and Management [NICE Guideline]Phytoestrogens
  37. National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients With Compounded “Bioidentical” Hormone Therapy
  38. National Center for Complementary and Integrative Health: How Safe Is This Product or Practice?
  39. National Center for Complementary and Integrative Health: Natural Doesn’t Necessarily Mean Safer, or Better
  40. Natural Remedies To Help Manage Perimenopause Symptoms
  41. Nonhormone Treatments for Hot Flashes and Night Sweats
  42. Online Events [International Menopause Society]: IMS Partnership Symposia Series – What’s Hot? Options for Treatment of Hot Flushes 2025
  43. Online Events [International Menopause Society]: Past Webinars – 2024: Non-Pharmacological Interventions For VMS
  44. Online Events [International Menopause Society]: Past Webinars – 2026: New IMS Recommendations – Midlife Body Changes [21 April 2026]
  45. Safety and Efficacy of Compounded Bioidentical Hormone Therapy (cBHT) In Perimenopausal and Postmenopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
  46. Treatments for Menopause
  47. Videos & Podcasts: Videos – Menopause and Hormone Therapy: Current Perspectives and Controversies
  48. World Menopause Day 2024: Leaflet for Women – Menopause and Menopause Hormone Therapy [Multiply Languages]

Sources

Where may I find the Sources quoted?

You may find the Sources quoted at:

Sources

  1. Menopause and Menopause Hormone Therapy: 2. What Is MHT? 2024:4. International Menopause Society https://www.imsociety.org/wp-content/uploads/2024/10/2024-WMD-Leaflet_English.pdf Accessed: 26 May 2026
  2. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 26 May 2026
  3. Bioidentical HRT: Summary of Key Terminologies – Part A – Explanation of cBHRT: What Are ‘Bioidentical Hormones’?Reviewed: April 2026. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 26 May 2026
  4. Bioidentical HRT: Summary of Key Terminologies. Reviewed: April 2026. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 26 May 2026
  5. Bioidentical HRT: Summary of Key Terminologies. Reviewed: April 2026. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 26 May 2026
  6. Compounding and the FDA: Questions and Answers – What Is Compounding? Content Current As of: 16 September 2025. Food and Drug Administration https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm339764.htm Accessed: 26 May 2026
  7. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 26 May 2026
  8. Treatments for Menopause: Menopausal Hormone Therapy (MHT) – What Are Bioidentical Hormones? Jean Hailes for Women’s Health https://www.jeanhailes.org.au/health-topics/menopause/treatments-for-menopause/#section-menopausal-symptom-treatments Accessed: 26 May 2026
  9. International Menopause Society (IMS) Recommendations and Key Messages on Women’s Midlife Health and Menopause: 25. Compounded ‘Bioidentical’ or ‘Natural’ Hormones. 23 December 2025 https://www.tandfonline.com/doi/full/10.1080/13697137.2025.2585487#abstract Accessed: 26 May 2026
  10. Menopause and Menopause Hormone Therapy: 2. What Is MHT? 2024:4. International Menopause Society https://www.imsociety.org/wp-content/uploads/2024/10/2024-WMD-Leaflet_English.pdf Accessed: 26 May 2026
  11. Bioidentical HRT: Summary of Key Terminologies – Part A – Explanation of cBHRT: Prescribing cBHRT. Reviewed: April 2026. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 26 May 2026
  12. Bioidentical HRT: Summary of Key Terminologies – Part A – Explanation of cBHRT: Prescribing cBHRT. Reviewed: April 2026. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 26 May 2026
  13. Burnett, T. Bioidentical Hormones: Are They Safer? 03 October 2024. https://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460 Accessed: 26 May 2026
  14. Bioidentical HRT: Summary of Key Terminologies – Part B – Explanation of rBHRT: Key Messages. Reviewed: April 2026. British Menopause Society https://thebms.org.uk/publications/consensus-statements/bioidentical-hrt/ Accessed: 26 May 2026
Topic Last Updated: 26 May 2026 – Topic Last Reviewed: 26 May 2026

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