Compounded vs FDA-Approved Hormones: How to Tell What You're Getting

FDA approval happens before the sale. A company submits evidence, FDA reviews it, and the product ships with a label the agency cleared: indications, warnings, strengths, all of it public.

Compounding is different work. A licensed pharmacist or physician mixes, combines or alters ingredients to make a medicine for one person. It is legal and long-standing. What it is not is reviewed: FDA’s compounding page says drugs made this way “are not FDA-approved,” and that the agency “does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.”

They are not generics either, which is the substitution most buyers assume. FDA’s answer to that question is “No”: a generic is approved under section 505(j) and must establish therapeutic equivalence to a brand-name drug, “while a compounded drug is not approved by FDA.”

Two sections of the same law describe who may compound:

• A 503A pharmacy compounds for one named patient: FDA’s conditions say compounding “must be based on the receipt of a valid prescription for an identified individual patient,” and state boards of pharmacy hold “primary responsibility for the day-to-day oversight” of these state-licensed pharmacies.
• A 503B outsourcing facility is “a category of compounders established in 2013 by the Drug Quality and Security Act.” It registers with FDA, is inspected “according to a risk-based schedule,” and meets current good manufacturing practice (CGMP) requirements.

Neither category makes an approved drug. The label tells you who inspects the facility and which quality rules apply, nothing more. Our 503A vs 503B explainer covers both.

The term describes molecular structure: a hormone built to match the one your ovaries made. Winona’s pharmacy page calls these “natural, plant-derived hormones” that are “molecularly identical to the hormones the body produces.” As chemistry, that is fair.

What it does not tell you is who reviewed the product. It is not an FDA category, and it appears on both sides of the line. FDA’s menopause page says many marketed products called “bioidentical hormones” are compounded drugs, and adds: “FDA does not have evidence that compounded ‘bioidentical hormones’ are safe and effective.”

What the National Academies concluded

In 2020 the National Academies reviewed compounded bioidentical hormone therapy (cBHT). Its conclusion: “there is insufficient evidence to support the overall clinical utility of cBHT as treatment for menopause and male hypogonadism symptoms.” On claims of superiority, the committee wrote that “the data do not support the claims of superior safety or efficacy of cBHT preparations compared to FDA-approved BHT products.”

It also found “a lack of standardization of best practices for compounding and dispensing cBHT preparations,” producing “significant state-by-state and even pharmacy-by-pharmacy variability,” and cautioned that “the lack of data should never be interpreted as a marker of safety and/or effectiveness.”

The marketing usually leaves out that approved products can be bioidentical too. Prometrium’s label describes “an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin.” The word “bioidentical” never appears there, but that is what the term means, and the product went through FDA review. So the word is not evidence either way. Our menopause hormone therapy basics guide covers the approved forms.

Pellets are implanted under the skin and release hormone over months. FDA has not approved one for menopausal hormone therapy, so pellets sold in the US are compounded preparations, with nothing about them reviewed before marketing.

FDA’s statement of September 9, 2019 describes a 2018 inspection of a company compounding hormone pellets, where inspectors found “4,202 adverse events that had never been reported to the agency.” FDA said those reports involved pellets “possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion.”

FDA was careful about what that proves: it “was able to attribute only a small percentage of the adverse events (61 reports), such as pellet extrusion and cellulitis,” to the pellets.

FDA used the same statement to flag marketing claims, noting that “some compounders market BHRT products as superior to FDA-approved drugs by making assertions that they are more natural, safer or better.” If a program offers pellets, ask who implants them, what removal involves, and what you have paid for once the pellet is in.

Ask through the patient portal or by email, so the answer is in writing. First read three pages: the treatment page, the pharmacy page, and the help-center article on FDA status.

1. Which product, by name, strength and form? Patch, tablet, capsule, cream or pellet. Status attaches to a product, not a company; one prescription can hold both kinds.
2. For each item, is it an approved product, or is it compounded for me? A company-level answer is not an answer.
3. Which pharmacy fills it, and is it a 503A pharmacy or a 503B outsourcing facility? Get the legal name, city and state; you need them to check the license.
4. If it is compounded, what is the clinical reason in my case, and is it in my chart? A good answer names something about you.
5. Can I fill this at a pharmacy of my own choosing, and does that change the price? Winona’s help center states that “a $50 monthly platform fee applies if patients use outside pharmacies instead of Winona’s compounding services.” Midi’s help center describes both routes, including where “you requested your prescription to be sent to your local pharmacy.”

What a straight answer looks like

Midi draws the line on the page itself. Its hormone-therapy page says, “Midi prescribes FDA-approved bioidentical hormones, which have been tested for safety,” and sets that against “compounded preparations, which are not regulated by the FDA.” That is the shape of answer you want: a category, stated on the product page. Note that Midi’s Custom Rx store pages, including the DHEA/Estradiol Cream at $90 per 30-day supply, give ingredients and strengths without stating a category, so ask per item.

When a company’s own pages do not match

Winona describes its products differently depending on which page you open. All four were read on September 18, 2026:

• The hormone-therapy page: “Winona’s estrogen patches, estrogen tablets, and progesterone capsules are FDA approved.”
• The 503A pharmacy page: “As 503A compounding pharmacies, Winona pharmacies are not directly regulated by the FDA and therefore are not subject to FDA-approval.”
• The help-center article “Are Winona’s treatments FDA approved?”: its treatments “are not FDA approved, though they use FDA-approved ingredients.”
• The treatments page tags Body Cream, Vaginal Cream and Pills as “Compounded,” while the Patch carries only a “Plant-derived” label.

Those say different things, and we are not choosing one for you: ask about the exact item on your prescription, and keep the reply. Our Midi Health review and Winona review record each company’s own wording and terms.

Compounding exists because approved products do not fit everyone. FDA’s own examples: a patient “who cannot be treated with an FDA-approved medication,” someone who “has an allergy to a certain dye and needs a medication to be made without it,” and a patient who “cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.”

• An ingredient you cannot take. Prometrium’s label says the capsules “contain peanut oil and is contraindicated in patients allergic to peanuts,” a real gap a made-to-order preparation can close.
• A strength or form nobody sells. Testosterone is the clearest case in women’s hormone care. FDA’s testosterone page says these “products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition,” and a September 17, 2026 FDA meeting addressed “critical knowledge gaps related to testosterone use in menopausal women.” So testosterone for a woman is either off-label use of a male-indicated product or a compounded preparation. Midi’s store lists a Testosterone Cream “starting at $100” for 90 days; Winona says, “Currently, we do not prescribe testosterone.”
• A documented reason that is about you. FDA’s 503A conditions require a compounder that “does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product.” Convenience is not a clinical reason; ask for yours in the chart.

The honest limit is the one the National Academies described: practice varies pharmacy by pharmacy, and the data are thin rather than reassuring. That does not make a made-to-order preparation wrong for you; it makes it a choice worth making deliberately, for a reason you could repeat to another clinician. Terms like 503A and off-label are defined in our telehealth terms glossary.

All public, all free, none of them needing the company’s cooperation.

1. FDA BeSafeRx offers “resources and tools so you can make safer, more informed decisions when purchasing prescription medicine from an online pharmacy,” including one to “Locate a State-Licensed Online Pharmacy.” fda.gov: BeSafeRx
2. NABP Safe.Pharmacy says that “in 1999, we began helping the public identify safe pharmacy websites with an accreditation program for online pharmacies,” and since 2014 has issued the .pharmacy domain to verified sites. safe.pharmacy
3. Your state board of pharmacy is where a license is confirmed. NABP partners “with our members, the state boards of pharmacy, to protect public health,” and its directory reaches your own board. nabp.pharmacy: Boards of Pharmacy
4. FSMB DocInfo checks the prescriber. FSMB calls DocInfo.org “the nation’s most up-to-date, publicly available repository of core information about physicians,” free to the public, covering “Disciplinary actions, License history, Medical school” and board specialty. fsmb.org: Information for Consumers
5. Drugs@FDA checks the drug. FDA’s database of approved products lists “most of the drug products approved since 1939”. Search the exact ingredient, strength and form on your prescription; if it is not there, raise that with the prescriber. fda.gov: About Drugs@FDA

A sensible order: read the treatment and pharmacy pages, send the five questions, then check the pharmacy with your state board and the product in Drugs@FDA. Compare what each program charges on the menopause clinic hub.