FDA-Approved vs Compounded HRT Providers: A 2026 Public-Claims Ledger

The ledger: what 12 online HRT services publicly claim

Below is our full review, with each company's own words linked, followed by what the labels mean, what the FDA and major medical societies actually say, and the questions worth asking before you sign up anywhere.

What we found — and what it doesn't mean

The split isn't a scoreboard, and “compounded” isn't a scarlet letter. A few things are worth sitting with.

The seven “FDA-approved” services aren't identical. Some — like Pandia and Gennev — go out of their way to say they don'tcompound. Pandia's site states flatly that it only prescribes FDA-approved medications and that compounded products aren't FDA-regulated or recommended by the Menopause Society or ACOG. Others, like Hers and MyMenopauseRx, simply present standard FDA-approved products without publishing a compounded option. That's a real distinction: “we won't compound” is a different statement than “we happen not to list a compounded option.”

The five “compounded” services aren't identical either. Midi and Evernow lead with FDA-approved products and reach for compounding in specific situations — Midi, for instance, added compounded estradiol and progesterone during the 2025–26 estrogen-patch shortage and offers compounded testosterone, both of which its own pages label as not FDA-approved. Winona sits squarely in the middle: its patches and pills are FDA-approved, its creams are compounded. Joi is compounding-forward — compounding is its primary model. Sesame is a marketplace where outcomes depend on which prescriber a patient chooses.

One more nuance: a company can offer FDA-approved hormone therapy while still compounding otherproducts. Alloy is the clearest example — its menopause HRT is FDA-approved, but it offers compounded items in other categories (skincare, sexual health). We coded the hormone-therapy pathway, not everything a company sells.

How to read the classifications

FDA-approved pathway

The company's own pages state FDA-approved hormone products or standard prescription HRT.

Compounded pathway

The pages state compounded HRT/BHRT, custom formulations, compounded estradiol/progesterone/testosterone, or provider-dependent compounded access.

Mixed

The company emphasizes FDA-approved options but also offers specific compounded formulations (Winona).

Compounded-forward

Compounding is the primary model (Joi).

Marketplace / provider-dependent

The service connects you to prescribers or fulfillment rather than operating as one clinic (Sesame, The HRT Club).

No compounded pathway found

Nothing on the pages we reviewed disclosed one. This is not proof a clinician could never prescribe a compounded product in an individual case.

FDA-approved vs compounded HRT: what's actually different

Compounding itself is legal, longstanding, and often useful — it's how a pharmacy makes a medicine tailored to one person. What compounding is not is FDA-approved. The FDA puts it plainly: it recommends FDA-approved hormone therapies because those are the ones evaluated for safety and effectiveness, and it says it has no evidence that compounded “bioidentical hormones” are safe, effective, or any better than the FDA-approved kind.

That “made with FDA-approved ingredients” line deserves its own warning label, because several providers use it. It's true and it's misleading at the same time. A pharmacy can start with an FDA-approved active ingredient and still produce a finished, custom-mixed product that the FDA never reviewed or approved as that formulation. Approved ingredient, unapproved final drug. Winona, to its credit, says this directly on its site: its creams are compounded and not FDA-approved, even though the ingredients come from regulated sources.

503A vs 503B: the two kinds of compounding

Not all compounding pharmacies operate under the same rules, and the difference matters for quality assurance.

• 503A compounding pharmacies make patient-specific preparations from a prescription. Under the FDA's framework, 503A compounding is done by a licensed pharmacist in a state-licensed pharmacy or federal facility. These pharmacies are overseen mainly by state boards, follow U.S. Pharmacopeia standards, and are exempt from federal Current Good Manufacturing Practice (CGMP) rules — so their products generally aren't batch-tested for potency and consistency the way manufactured drugs are. Winona says it owns and operates 503A pharmacies.
• 503B outsourcing facilities make larger batches, register with the FDA, and mustmeet CGMP. That's a higher manufacturing bar than 503A.

But here's the part that surprises people: even a 503B outsourcing facility's products are not FDA-approved. The FDA is explicit that drugs from compounders — including outsourcing facilities — have not gone through the premarket review for safety, effectiveness, and manufacturing quality that approved drugs undergo, and that when a patient can use an FDA-approved drug, the agency recommends the approved drug instead. Registration is not approval.

Are bioidentical hormones the same as compounded hormones?

This is the single biggest misconception in the whole category, and compounding pharmacies have leaned on it for years. ACOG says so outright: many pharmacies use “bioidentical” as a marketing term to imply their products are more natural, safer, and more effective than FDA-approved options — and the evidence for those claims is lacking.

If you want a bioidentical hormone, the FDA-approved shelf is already stocked. We assembled the common FDA-approved options in one place:

The estriol catch

Here's a specific, verifiable fact that cuts through a lot of marketing: there are no FDA-approved drugs that contain estriol. The FDA states that every marketed product containing estriol is a compounded drug, not FDA-approved, and that it has no evidence estriol is a “safer form of estrogen.” That matters because estriol is a headline ingredient in the popular compounded “Biest” (estriol + estradiol) and “Triest” (estriol + estradiol + estrone) creams. If a formula contains estriol, it is compounded by definition — there's no FDA-approved version to fall back on.

Is compounded HRT FDA-approved or safe? What the FDA and medical societies say

The consensus here is unusually tight for a health topic. We put the four positions side by side:

One caution runs through the guidance: the saliva and blood tests some clinics use to “customize” a compounded dose don't do what they promise. ACOG notes that individualized hormone testing isn't recommended for dosing estrogen and progesterone, and Mayo Clinic points out that saliva hormone levels don't correspond to blood levels or to symptoms. A personalized-looking number isn't the same as a meaningful one.

Compounded HRT statistics: how many women use compounded hormones?

Key figure: An estimated 1.0–2.5 million U.S. women aged 40+ use compounded bioidentical hormone therapy — roughly 26–33 million prescriptions and about $1–2 billion a year.

Those are 2020 figures based on limited, largely survey-based data — not a live count — and they're the newest rigorous national estimate we could find. The scale is the point: this isn't a fringe practice, it's a multi-million-patient market built substantially on the idea that “compounded bioidentical” is safer — an idea the evidence doesn't support.

When is compounded HRT actually appropriate?

The 2020 National Academies review didn't say “never.” It said “narrowly.” It recommended restricting compounded bioidentical hormone therapy to two circumstances: an allergy to an ingredient in an FDA-approved product, and the need for a dose or form that isn't commercially available.

ACOG gives a clean, real-world example of the first case. There's an FDA-approved oral progesterone (Prometrium) that's suspended in peanut oil. For a patient with a peanut allergy, a pharmacy can compound progesterone without the peanut oil so she can take it safely. That's compounding doing exactly what it's for — solving a specific problem an approved product can't. It's a very different thing from blending custom “bioidentical” creams and marketing them as superior.

Testosterone: the FDA-approval gap for women

Testosterone is where the FDA-approved shelf runs out. ACOG and the Endocrine Society both note there's no FDA-approved testosterone formulation for the management of menopausal symptoms, and the Endocrine Society suggests that, when testosterone is used, titrating an FDA-approved male product is preferable to a compounded one.

Among the services we reviewed, the approaches diverge. Pandia says plainly it doesn't prescribe testosterone, noting there's no FDA-approved formulation for women. Midi, by contrast, offers testosterone for women and states directly that there's no FDA-approved testosterone specifically indicated for women in the U.S. and that its compounded testosterone is not FDA-approved. Joi also offers testosterone to women, which — again — is off-label or compounded by definition. Both the “we do” and “we don't” camps can be honest here; they've just made different calls about the same gap.

Why this matters now: the 2025–26 FDA labeling change

For two decades, a black-box warning cast a long shadow over hormone therapy. The FDA initiated removal of the boxed warnings — for cardiovascular disease, breast cancer, and probable dementia — in November 2025, after a scientific review, an expert panel, and a public comment period. On February 12, 2026, the FDA approved the first batch of six relabeled products. At the FDA's request, 29 drug companies submitted proposed labeling changes; this first batch covered six products. The agency kept the endometrial-cancer boxed warning for systemic estrogen-alone products.

Why include this on a page about compounding? Because it sharpens the contrast. The products that just got a fresh, evidence-based safety review are the FDA-approved ones. Compounded “bioidentical” formulations weren't studied, weren't relabeled, and remain outside that process. As renewed interest pulls more people toward hormone therapy — the FDA has noted that of roughly 41 million U.S. women aged 45–64 in 2020, only about 2 million were on a hormone-therapy prescription — the question of which kindyou're being prescribed only gets more consequential.

How we built this

For each service we looked for four signals: whether the page stated an FDA-approved hormone pathway; whether it stated a compounded, custom-Rx, or compounding-pharmacy pathway; which hormone forms were named; and how the page used words like “bioidentical,” “natural,” “compounded,” and “FDA-approved.”

We coded a service as FDA-approved pathway only when its own pages said so or listed standard prescription hormone products. We coded a compounded pathwayonly when the pages disclosed compounded HRT/BHRT, custom formulations, or provider-dependent compounded access. “No compounded pathway found” is a statement about the pages we read on the verification date — nothing more. Any commercial relationships The HRT Index may have are disclosed separately and did not affect which providers were included, how they were classified, or how this page is worded. Where a company changes its own language after our verification date, this snapshot will lag until we re-check it.

Limitations: what this ledger does and doesn't show

• It's a snapshot. Provider pages, formularies, prices, and state availability change. We date every review for that reason.
• It's about public claims, not prescriptions.What an individual clinician prescribes depends on your symptoms, history, contraindications, state rules, pharmacy availability, insurance, and shortages. The table can't and doesn't predict that.
• “No compounded pathway found” is not “never compounds.” It means we didn't see it disclosed.
• It is not a quality, safety, or outcomes ranking.Compounded isn't automatically unsafe, and an FDA-approved product still carries real risks and contraindications.
• Some entries aren't single clinics. Sesame and The HRT Club are marketplaces or fulfillment models; we labeled them as such.
• It is educational, not medical advice.For what's right for your body, talk to a licensed clinician and consult the primary sources linked throughout.

Questions worth asking any online HRT provider

1. Is the exact medication you're prescribing FDA-approved as a finished product?
2. If it's compounded, why compounded instead of an FDA-approved option?
3. Is anything being prescribed off-label?
4. What pharmacy fills it — and is it a 503A pharmacy or a 503B outsourcing facility?
5. Does my insurance cover it? (FDA-approved products are far more likely to be covered; compounded ones often aren't.)
6. What's the monitoring plan, and how are doses adjusted?
7. What happens during a shortage?
8. Given my personal and family history, what are the risks and contraindications?

How to cite this page

If you reference this comparison, you can attribute it as:

The HRT Index Editorial Team. “FDA-Approved vs Compounded HRT Providers: A 2026 Public-Claims Ledger.” The HRT Index, Research. Last verified July 1, 2026. https://thehrtindex.com/research/fda-approved-vs-compounded-hrt-providers/

The underlying regulatory facts should be attributed to their original sources — the FDA, the National Academies (NASEM), ACOG, and the Endocrine Society — which are linked throughout.

Frequently asked questions

Sources

• U.S. Food and Drug Administration — Menopause (Office of Women’s Health)
• U.S. Food and Drug Administration — Compounding and the FDA: Questions and Answers
• U.S. Food and Drug Administration — Questions and Answers: Outsourcing Facility Registration
• U.S. Food and Drug Administration — FD&C Act Provisions That Apply to Human Drug Compounding
• U.S. Food and Drug Administration — FDA Approves Labeling Changes to Menopausal Hormone Therapy Products (Feb 12, 2026)
• U.S. Department of Health and Human Services / FDA — Removal of boxed warnings from HRT (Nov 2025)
• National Academies of Sciences, Engineering, and Medicine — The Clinical Utility of Compounded Bioidentical Hormone Therapy (2020): news release
• National Academies — NASEM 2020 report (use and prevalence)
• American College of Obstetricians and Gynecologists — Clinical Consensus No. 6: Compounded Bioidentical Menopausal Hormone Therapy (2023)
• Endocrine Society — Compounded Bioidentical Hormone Therapy (position statement)
• Mayo Clinic — Bioidentical hormones: Are they safer?
• Provider public pages (self-disclosures), each linked in the ledger and the row-by-row sources section above.