Bioidentical and Compounded Hormones in Integrative Practice: Claims, Testing and Regulation

Safety first

Hormone treatment is medical treatment. Sudden face drooping, arm weakness or trouble speaking are stroke signs: MedlinePlus says to call 911 or the local emergency number right away. [1] Do not start, change or stop a hormone or any prescribed medicine without talking to your prescriber. This page is information, not advice for your situation.

What the words mean

"Bioidentical" describes hormones chemically and structurally identical to those the human body produces. [2] It is a description of molecules, not a quality or safety guarantee. These hormones come either as FDA-approved products or as non-FDA-approved compounded preparations. [2] A 2021 review in the journal of the International Menopause Society notes that the structures of many hormones in "bioidentical" therapy are the same as those in conventional hormone therapy. [3] So the useful question is not "bioidentical or not" but "approved product or custom-compounded?"

Compounding means a pharmacy or other compounder prepares a custom version of a medicine. The FDA states that compounded drugs are not FDA-approved, so FDA does not verify their safety, effectiveness or quality before they are marketed. [4] State boards of pharmacy generally have primary responsibility for day-to-day oversight of state-licensed pharmacies. [4] (FDA page content current as of 16 September 2025.) For a general explanation, see compounded medicines and compounded vs approved products.

Where this shows up in integrative practice

Compounded hormones are used for menopause symptoms and, according to the National Academies, for male hypogonadism. [2] Whether a particular naturopathic or integrative practitioner can prescribe hormones depends on the jurisdiction and license; see scope of practice. NCCIH notes that scope for licensed naturopathic doctors varies by state. [5] We do not describe individual practitioners or pharmacies.

What the National Academies found (2020)

The FDA asked the National Academies of Sciences, Engineering, and Medicine to review compounded bioidentical hormone therapy; the study was sponsored by the FDA. [2][6] Its findings:

The report's authors recommended restricting compounded use to a small number of patients who cannot use an approved product. [2]

A 2011 evidence review for primary care found that randomized trial data were enough to support only estropipate, estradiol and progesterone for menopausal symptoms, and that 17β-estradiol is FDA approved for those symptoms. [7] In other words, some FDA-approved products are themselves bioidentical. The same review concluded that compounded bioidenticals and salivary hormone testing are unnecessary and not standardized. [7] It covered literature from 1999 to 2009, so newer work is not included. [7]

Hormone testing

• Saliva testing. Compounding pharmacies frequently use saliva testing to customize formulations. [3] A 2021 review calls it a misconception that salivary hormone levels are equivalent to free hormone in blood. [3] See saliva hormone tests.
• Blood tests for menopause. NICE (UK) recommends identifying perimenopause and menopause without laboratory tests in otherwise healthy women aged 45 or over with symptoms. [8] It advises against estradiol, anti-Müllerian hormone, inhibin and imaging tests for that purpose at 45 or over. [8] It suggests considering an FSH blood test only in specific age groups: 40 to 45 with symptoms, or under 40 if menopause is suspected. [8]
• Unregulated preparations. NICE tells clinicians to explain that the efficacy and safety of unregulated hormone preparations are unknown. [8]

Tests have legitimate medical uses, such as evaluating suspected early menopause under a clinician's care. [8] For broader "hormone panels," see hormone and nutrient testing in aging and hormone balancing claims checked.

Approved hormone therapy: benefits and risks in brief

The NHS (England) says HRT is effective at relieving most perimenopause and menopause symptoms. [9] It also says HRT can slightly increase breast cancer risk, with around 5 extra cases per 1,000 women taking combined HRT for 5 years; people who have had breast cancer are usually advised not to take it. [9] Tablets can raise blood clot risk (still low) while patches, sprays and gels do not. [9] That NHS page was last reviewed 8 February 2023, and guidance can differ in other countries. These figures describe approved HRT; the National Academies found no comparable body of evidence for compounded products. [2]

Who should talk to a clinician first

Anyone with a history of breast or other hormone-sensitive cancer, blood clots, stroke, liver disease, or unexplained vaginal bleeding; people who are pregnant; people taking several medicines; and anyone considering pellets or multi-hormone creams. Ask a doctor or pharmacist about your own case. See perimenopause and menopause and menopausal hormone therapy: what the trials show.

Questions worth asking

• Is this an FDA-approved product or a compounded one, and why?
• Which test is it based on, and does a guideline recommend that test?
• What does it cost, and who profits from selling it?
• Who will monitor me, and how do I report a side effect?