The short answer
Compounded bioidentical hormone therapy (cBHT) is made by a pharmacy for an individual prescription, often as creams, troches, capsules, or pellets. These preparations are not FDA-approved, so they have not been reviewed by the FDA for safety, effectiveness, or quality. FDA-approved products already contain bioidentical estradiol and progesterone. A 2020 National Academies report found insufficient evidence to support routine use of compounded hormones and recommended restricting their use, and The Menopause Society recommends FDA-approved products except in specific situations such as an allergy to an ingredient in approved products.
Why this matters for safety
Compounded hormones are not FDA-approved. They are not required to include the boxed warnings and patient information that come with FDA-approved hormone products, and potency and absorption can vary between batches.
A compounded estrogen without adequate progestogen can raise endometrial cancer risk in people with a uterus. Any bleeding after menopause should be evaluated.
Current label check
Checked 2026-10-03. There is no FDA product label for this use. Compounded preparations have no FDA label; claims rest on FDA compounding guidance, the 2020 NASEM report, and Menopause Society statements.
Established evidence
What compounded hormone therapy is
Compounding pharmacies mix hormones such as estradiol, estriol, progesterone, testosterone, and DHEA into custom doses and forms. Compounding has legitimate uses, for example when a patient is allergic to an ingredient in every approved product. It is not the same as a standardized FDA-approved medicine.
Established evidence
Bioidentical is not the same as compounded
| Hormone | FDA-approved bioidentical products |
|---|---|
| Estradiol | Patches, gels, spray, tablets, vaginal inserts, ring, cream |
| Progesterone | Prometrium and generic micronized progesterone |
| Estradiol + progesterone | Bijuva |
Established evidence
What expert reviews concluded
In 2020 the National Academies of Sciences, Engineering, and Medicine reviewed compounded bioidentical hormone therapy at FDA's request. It found insufficient evidence of clinical utility to support routine use and recommended restricting use to patients who cannot use an FDA-approved product. The Menopause Society's 2022 position statement recommends FDA-approved hormone therapy over compounded preparations for most people.
Established evidence
Hormone testing and pellets
Saliva or blood hormone levels are not recommended for dosing menopause hormone therapy, because levels fluctuate and do not track symptom relief. Hormone pellets are implanted under the skin and cannot be removed if levels run high; they are not FDA-approved for menopause.
When compounding may be considered
A clinician may consider compounding when no FDA-approved product is suitable, such as an allergy to an excipient, or when a needed dose or form is unavailable. In those cases, informed consent should cover the lack of FDA review.
Questions to ask a healthcare professional
- Is there an FDA-approved product that meets my needs?
- Why is compounding being recommended in my case?
- How will my uterine lining be protected and monitored?
Questions, answered
What people ask about Compounded bioidentical hormones
Are compounded hormones safer because they are natural?+
There is no evidence that compounded hormones are safer than FDA-approved bioidentical products, and they lack FDA review of quality and dosing.
Is estriol FDA-approved?+
No FDA-approved U.S. product contains estriol.
Does Kindr Health offer compounded hormones?+
This page is educational and does not state or imply availability through Kindr Health.
Kindr Health does not claim to offer Compounded bioidentical hormones on this page. Availability and prescribing are not implied.
A broader care pathway
Explore menopause care
Learn how Kindr Health care pathways work. An educational page is not a statement that this medication is available or appropriate for you.
SOURCES & REFERENCES
Every clinical claim on this page is sourced.
- The clinical utility of compounded bioidentical hormone therapy: a review of safety, effectiveness, and use (2020) — National Academies of Sciences, Engineering, and Medicine. nap.nationalacademies.org/catalog/25791/the-clinical-utility-of-compounded-bioidentical-hormone-therapy-a-review-of-safety-effectiveness-and-use
- Compounding and the FDA: questions and answers (2024) — U.S. Food and Drug Administration. www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
- The 2022 hormone therapy position statement of The North American Menopause Society (2022) — The Menopause Society (Menopause journal). pubmed.ncbi.nlm.nih.gov/35797481
This resource is educational and does not replace individualized medical advice. Do not start, stop, or change a prescription without guidance from a licensed healthcare professional.