In this article
"Bioidentical" is one of the most searched words in menopause care, and one of the most confusing. You may have heard that bioidentical hormones are natural, safer, or custom-made just for you. Some of that is marketing, and some of it is true of products you might not expect. This guide sorts out what the word means, how approved and compounded hormones differ, and what the major medical groups say. In the interest of being upfront: WarriorBabe Health's own hormone products are compounded, which we come back to at the end.
What "bioidentical" means
A bioidentical hormone has the same chemical structure as a hormone your body makes. The Menopause Society says the term can be misleading, because there are both government-approved and compounded bioidentical hormone therapies [1]. Its patient guidance adds that "bioidentical hormone therapy" began as a marketing term for custom-compounded hormones [2].
So "bioidentical" tells you about the molecule. It does not tell you whether a product was tested, how it was made, or whether it is FDA-approved. Two products can contain the same bioidentical estradiol and be regulated in completely different ways.
FDA-approved bioidentical hormones
Many women are surprised to learn that bioidentical hormones are available as FDA-approved prescriptions. The Menopause Society lists estradiol, estrone, and micronized progesterone as FDA-approved bioidentical hormones, which are regulated and monitored for purity and efficacy [1]. They come with package inserts containing extensive product information based on randomized trials, and may carry boxed warnings for side effects [1]. The FDA says it has approved drugs containing hormones identical to the ones the body makes naturally [3].
Micronized progesterone is a good example. The FDA label for Prometrium, an approved progesterone capsule, describes its progesterone as chemically identical to progesterone of human ovarian origin [6]. It is approved to prevent overgrowth of the uterine lining in postmenopausal women who still have a uterus and take conjugated estrogens tablets [6]. One of its listed doses is 200 mg at bedtime for 12 days of each 28-day cycle [6].
A 2021 review in the Journal of the American Pharmacists Association counted only 13 FDA-approved bioidentical hormone therapy dosage forms, including 5 for progesterone [5]. That limited range is part of why compounding exists.
What compounded hormones are
Compounded hormones are prepared by a compounding pharmacist from a provider's prescription [1]. The Menopause Society notes they may combine several hormones, such as estradiol, estrone, estriol, DHEA, testosterone, and progesterone, and may use untested combinations or delivery methods such as implants, pellets, or troches [1].
The key regulatory fact is simple. Compounded drugs are not FDA-approved, which means the FDA does not review their safety, effectiveness, or quality before they are marketed [4]. The FDA also notes that compounded drugs can serve an important medical need for patients [4]. And it points out that many products marketed as "bioidentical hormones" are compounded drugs, and that marketed drugs containing estriol are compounded, not FDA-approved [3].
Compounded hormones are widely used. The National Academies of Sciences, Engineering, and Medicine estimated that between 1 and 2.5 million US women aged 40 and older use them, with 26 to 33 million prescriptions filled each year, according to the 2021 review [5].
| FDA-approved | Compounded | |
|---|---|---|
| FDA review before sale | Yes | No [4] |
| Prescribing information | Package insert based on trials, with warnings [1] | No standard label outlining risks [1] |
| Dose consistency testing | Regulated and monitored for purity and efficacy [1] | Risk of overdosing or underdosing [1] |
| Clinical trial evidence | Randomized trials behind the label [1] | Lack of well-controlled trials [5] |
What The Menopause Society, ACOG and the FDA say
The Menopause Society
The Menopause Society's 2022 position statement finds little high-quality data on the safety and effectiveness of compounded bioidentical hormones, and insufficient evidence to support their overall use for menopause symptoms [1]. It lists safety concerns: minimal government regulation and monitoring, overdosing and underdosing, impurities and lack of sterility, lack of efficacy and safety data, and no label outlining risks [1].
Its patient guidance is blunter. It says custom-compounded hormones are not safer or more effective than approved bioidentical hormones, are not tested to show the active ingredients are absorbed properly or give predictable blood levels, and may not contain the prescribed amount of hormone [2].
The statement does not rule compounding out. It says prescribers should consider compounded hormone therapy only when a woman cannot use an approved product, for reasons such as an allergy to an ingredient in an approved formulation, or a dose or formulation that approved products do not offer [1]. It says patient preference should be discussed, but preference alone should not justify compounded hormones, particularly when approved bioidentical options are available [1]. It also asks prescribers to document the medical reason for choosing a compounded product [1].
The FDA
The FDA recommends that women use FDA-approved hormone therapies, which are evaluated for safety and effectiveness [3]. It says it does not have evidence that compounded "bioidentical hormones" are safe and effective [3].
ACOG and the National Academies
The 2021 review summarizes the American College of Obstetricians and Gynecologists' 2012 position: evidence is lacking to support claims that compounded bioidentical hormones are superior [5]. The same review describes a 2020 report from the National Academies, requested by the FDA, which concluded there is insufficient evidence to support the overall clinical usefulness of compounded bioidentical hormone therapy [5]. That report recommended limiting compounded hormones to patients with allergies to specific components of approved products, or who need a dosage form not available as an approved product [5].
The report also raised specific concerns. Compounded progesterone capsules have not been tested for bioequivalence with approved products [5]. Pellets can work their way out of the skin in up to 10% of cases, and the committee recommended the FDA consider pellets for its list of drugs that are difficult to compound [5].
When compounding may make sense
Here is one real-world example of why compounding exists. The approved Prometrium capsule contains peanut oil and should not be used by people allergic to peanuts [6]. An ingredient allergy like that is exactly the kind of situation The Menopause Society describes as a reason to consider a compounded product [1].
Other situations it names include a dose or formulation not available in approved products [1]. In every case, the Society asks for the medical reason to be documented [1].
Saliva and urine hormone testing
Some compounded hormone programs set doses using saliva or urine tests. The Menopause Society says those tests are unreliable and not recommended for dosing, because hormone levels vary through the day, between people, and in how they are absorbed [1]. It says blood hormone testing is rarely needed [1]. Instead, the Society recommends tailoring dose and route to your symptom relief, side effects, and preferences [1].
Bioidentical does not mean risk-free
Whether approved or compounded, a bioidentical estradiol is still estrogen, and it carries the risks of estrogen. If you have a uterus, systemic estrogen needs an adequate progestogen to protect the lining [1]. The FDA label for approved micronized progesterone lists warnings drawn from the Women's Health Initiative, including blood clots, stroke, heart attack, and breast cancer [6]. For the full picture, read is HRT safe?
Where WarriorBabe Health fits
We want to be clear about our own products. WarriorBabe Health's hormone treatments, including oral estradiol, the estradiol patch, estradiol cream, estradiol vaginal cream, and the progesterone capsule, are compounded by a licensed pharmacy. They are not FDA-approved, and the FDA does not verify the safety, effectiveness, or quality of compounded drugs [4].
FDA-approved bioidentical estradiol and micronized progesterone also exist. Ask your clinician to talk through both options and why one may suit you better. You can learn more about our approach on our hormone treatments page, or take the 2-minute quiz.
Frequently asked questions
Are bioidentical hormones safer than regular HRT?
Not as a rule. The Menopause Society says custom-compounded hormones are not safer or more effective than approved bioidentical hormones [2]. The FDA says it has no evidence that compounded bioidentical hormones are safe and effective [3]. Bioidentical estradiol and progesterone carry the same kinds of risks as other hormone therapy [1, 6].
Are there FDA-approved bioidentical hormones?
Yes. The Menopause Society lists estradiol, estrone, and micronized progesterone as FDA-approved bioidentical hormones [1]. Prometrium, for example, is an approved micronized progesterone capsule described as chemically identical to the progesterone the ovaries make [6].
Why would someone use compounded hormones?
The Menopause Society says compounding may be considered when an approved product does not fit, such as an allergy to one of its ingredients, or a dose or formulation not available in approved products [1]. For instance, the approved Prometrium capsule contains peanut oil [6].
Do I need a saliva test to dose bioidentical hormones?
No. The Menopause Society says saliva and urine hormone tests are unreliable for setting doses and are not recommended, and blood testing is rarely needed [1]. The Society recommends adjusting based on symptom relief, side effects, and your preferences [1].
Are WarriorBabe Health's hormones FDA-approved?
No. Our hormone products are compounded by a licensed pharmacy, and compounded drugs are not FDA-approved [4]. FDA-approved versions of estradiol and progesterone also exist. Your clinician can explain the difference and help you decide.
References
- The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022;29(7):767-794. menopause.org/wp-content/uploads/professional/nams-2022-hormone-therapy-position-statement.pdf
- The Menopause Society. Hormone therapy. Menopause Topics, patient education. menopause.org/patient-education/menopause-topics/hormone-therapy
- US Food and Drug Administration. Menopause. Women's Health Topics. 2023. www.fda.gov/consumers/womens-health-topics/menopause
- US Food and Drug Administration. Understanding the risks of compounded drugs. www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs
- MacArthur RB, Mattison D, Parker RM. Compounded bioidentical hormone products, a path forward. J Am Pharm Assoc. 2022;62(1):42-48. pmc.ncbi.nlm.nih.gov/articles/PMC11404534/
- Prometrium (progesterone, USP) capsules prescribing information. DailyMed, US National Library of Medicine. Updated 2026. dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1cf237ff-c4f8-4faa-a7aa-77599c856889
This article is for general information. It is not medical advice and does not replace a visit with a licensed clinician who knows your history. Do not start, stop or change a medication without talking to your clinician. If you think you are having a medical emergency, call 911.
