Two phrases dominate menopause hormone marketing and mean very different things: "FDA-approved" and "compounded" — the latter usually sold as bioidentical, natural, or custom. The distinction affects your safety, your cost, and in one specific case your cancer risk. Because Menova sells no hormones, here is the plain version.

Where we stand: Menova is an independent publication. We sell no hormones, we have no compounding pharmacy to refer you to, and we are not your doctor. This is general education, not medical advice. A few links below are Amazon affiliate links — Menova may earn a small commission at no extra cost to you.

Bioidentical does not mean compounded

The single biggest source of confusion, and the one the marketing depends on.

Bioidentical means the hormone is chemically identical to what your body makes. Compounded means a pharmacy custom-mixes it for an individual prescription. These are unrelated facts about a product.

Many FDA-approved products are bioidentical: estradiol as patches, gels, sprays, and tablets, and micronized progesterone capsules. So you can have bioidentical hormones that are also tested, standardized, and often inexpensive as generics.

Any marketing implying you must visit a special clinic to get "natural" or "bioidentical" hormones is trading on a confusion it created. See bioidentical hormones explained.

What each term actually guarantees

FDA-approved means the product was tested in clinical trials for safety and effectiveness, is manufactured to consistent quality and dosing standards, carries labelling the FDA has reviewed, and — for menopause products — has met endometrial safety requirements.

Compounded means a pharmacy prepared it to a prescription. It is not FDA-approved and does not go through that testing. Dose can vary between batches, absorption is not verified, and there is no per-product FDA oversight of quality.

That is the whole distinction: one comes with verification, the other comes with a promise.

What the evidence bodies concluded

This is not a fringe position:

  • A 2020 report from the National Academies of Sciences, Engineering, and Medicine found insufficient evidence that compounded hormones are safe or effective and discouraged their routine use
  • The Menopause Society has stated the same in position papers
  • ACOG recommends FDA-approved hormone therapy over compounded products where an approved option exists, and advises against routine prescribing of compounded versions

There is no evidence that compounded hormones are safer or more effective. There is documented risk of inconsistent dosing and contamination.

The safety point with real consequences

If you take estrogen and still have a uterus, you need adequate progestogen to prevent the lining thickening — untreated, that raises the risk of endometrial hyperplasia and endometrial cancer.

Compounded progesterone creams are not considered adequate for endometrial protection. Absorption through skin is too variable to rely on for this purpose. If you are on estrogen plus a progesterone cream and have a uterus, that specific combination is worth raising with a different clinician — see progesterone in menopause.

Pellets: a category of their own

Implanted pellets are heavily marketed within compounded practice and carry a structural problem: once implanted, the dose cannot be adjusted or removed.

Levels frequently run above the physiologic range, and side effects concentrate there — unwanted hair growth, acne, and, with sustained testosterone excess, voice deepening and clitoral enlargement, which may not fully reverse. A clinic leading with pellets is a reason for a second opinion; see testosterone for women.

The testing that justifies the custom blend

Custom dosing is usually justified by saliva or blood hormone testing. Two problems:

  • Saliva testing is not considered a reliable basis for dosing. Levels fluctuate constantly at this stage of life
  • Blood testing is generally not recommended for diagnosing the transition over 45, for the same reason — so "optimizing" you toward a number is chasing a moving target

If a programme includes recurring paid testing to adjust a custom preparation, notice what that structure is for. See when testing is actually appropriate.

When compounding is legitimate

It is not always wrong. Genuine reasons:

  • A documented allergy to an ingredient in every approved formulation — peanut oil in micronized progesterone capsules being a real example
  • A dose or form not commercially available
  • A manufacturer supply shortage

The distinction is exception versus default. Compounding decided with a clinician for a stated reason is medicine. Compounding sold as automatically more natural is marketing.

Why this is worth your attention right now

A large share of cash-pay menopause marketing runs on "natural," "personalized," and "bioidentical," partly because margins are higher and oversight is lighter.

And one easy confusion to avoid: the FDA's 2025 boxed-warning change applies to FDA-approved products. It does not make compounded preparations approved or proven, and it should not be cited to you as though it does. See what the 2025 FDA change actually meant.

The cost angle nobody mentions

Compounded programmes are typically cash-pay, often bundled into a membership with recurring testing. FDA-approved generic estradiol and micronized progesterone are long off-patent and frequently inexpensive — with insurance or without it.

So the compounded route is often more expensive and less verified. If cost was your reason for considering it, that is worth checking before committing; see what HRT costs in 2026.

Four questions that settle it

  • "Is there an FDA-approved option, including a bioidentical one, that would work for me?"
  • "If you're recommending compounded, why specifically — beyond that it's customized?"
  • "How is my uterine lining being protected?"
  • "What will this cost over twelve months, including any testing, and is any of it covered?"

Evasiveness on the first question tells you what you need to know. Our guides to finding a clinician who knows menopause and getting HRT online cover how to spot a good programme from a bad one.

What most women end up on

For a large proportion of women, the mainstream answer is also the bioidentical one: an FDA-approved transdermal estradiol patch or gel — which has not been shown to carry the clot risk associated with oral estrogen — plus micronized progesterone if you have a uterus. See HRT types and forms, HRT and blood clot risk, and is HRT safe.

Before that conversation, the free 2-minute Menova self-check turns your symptoms into a printable summary, and the free visit prep sheet has space for the questions above. No account, not a diagnosis, and your answers never leave your device.

Further reading

Independent books we rate on editorial merit (Amazon affiliate links — Menova may earn a small commission at no extra cost to you; we sell no hormones and have no stake in what you conclude):

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.

Sources: National Academies of Sciences, Engineering, and Medicine (2020), ACOG Clinical Consensus — Compounded Bioidentical Menopausal Hormone Therapy, FDA — Human Drug Compounding, and The Menopause Society.