When you start researching hormone therapy for menopause, you quickly run into two phrases that sound similar but mean very different things: "FDA-approved" and "compounded" — the latter often marketed as "bioidentical," "natural," or "custom." The difference matters, and the people selling each have very different incentives. Because Menova sells no hormones, here is the honest, plain-English version.

Bioidentical does not mean compounded

First, let's clear up the biggest source of confusion: "bioidentical" does not mean "compounded." Bioidentical simply means the hormone is chemically identical to the ones your body makes. Many FDA-approved products are bioidentical, including estradiol (available as patches, gels, sprays, and pills) and micronized progesterone. In other words, you can get bioidentical hormones that are also FDA-approved. Marketing that implies you must visit a special compounding pharmacy to get "natural" or "bioidentical" hormones is misleading.

What FDA-approved and compounded actually mean

What "FDA-approved" means is that the product was tested in clinical trials for safety and effectiveness, is manufactured to consistent quality and dosing standards, and carries labeling the FDA has reviewed. To be approved, a menopause therapy generally has to show in a controlled trial that it reduces symptoms and meets endometrial-safety checks.

What "compounded" means is that a compounding pharmacy custom-mixes a preparation for an individual prescription. Compounded bioidentical hormone therapy is not FDA-approved and does not go through that testing. Dosing can vary from batch to batch, and there is no FDA oversight of each product's quality.

What the evidence says about compounded hormones

This is not a fringe opinion. A 2020 report from the National Academies of Sciences, Engineering, and Medicine and a 2022 statement from The Menopause Society (formerly NAMS) both concluded that there is a lack of safety data and no good trials showing compounded hormones are safe or effective. The American College of Obstetricians and Gynecologists recommends FDA-approved hormone therapy over compounded products when an approved option exists, and advises that compounded versions should not be prescribed routinely. There is no scientific evidence that compounded hormones are safer or more effective than FDA-approved ones, and they can carry added risks such as inconsistent dosing and contamination. Claims that saliva or blood "hormone level" testing is required to customize your dose are also not well supported.

When compounded hormones make sense

None of this means compounded hormones are never appropriate. They can make sense in specific situations, such as a documented allergy to an ingredient in an approved product, or a dose or form that simply is not available commercially. The point is that compounding should be a deliberate exception decided with a clinician, not the default, and not something marketed to you as automatically better or more natural.

Here is why this matters right now. A great deal of cash-pay menopause marketing leans on words like "natural," "personalized," and "bioidentical" to sell compounded products, partly because the margins can be higher and the oversight is lighter. And note an easy point of confusion: the FDA's 2025 decision to update the boxed warning applies to FDA-approved hormone therapy products. It does not make compounded products approved or proven. If a provider pushes compounded hormones as obviously superior, that is a reason to ask more questions, not fewer.

Questions to ask your clinician

A few questions worth bringing to your clinician:

  • Is there an FDA-approved option, including a bioidentical one, that would work for me?
  • If you are recommending a compounded product, why specifically, beyond "it's customized"?
  • What evidence supports it for my situation, and what are the risks?
  • How is the dose kept consistent, and what will it cost, including whether any of it is covered?

You deserve to know exactly what you are being offered and why. For most women, the major medical bodies point to FDA-approved hormone therapy first, and that does include bioidentical options. Compounded therapy has a place, but as a considered exception, not a default sold on marketing.

This article is general education, not medical advice. The right choice for you is one you make with a licensed clinician who knows your history.

If you want to go deeper, a few widely respected, independent books on menopause are worth reading. (These are Amazon affiliate links — Menova may earn a small commission if you buy, at no extra cost to you. We sell no hormones and recommend these on editorial merit, not for commission.)

Sources: FDA / National Academies (NASEM) review of compounded bioidentical hormones and ACOG Clinical Consensus on compounded bioidentical menopausal hormone therapy.