Three words, three different things
| What it means | FDA-approved? | What the evidence says | |
|---|---|---|---|
| Bioidentical | A hormone with the same chemical structure as one the body makes, such as estradiol or progesterone | Many are: estradiol patches, gels, a spray, tablets and vaginal forms, and micronized progesterone capsules [1] [2] | ACOG says compounding pharmacies use “bioidentical” as a marketing term [3] |
| Compounded | Mixed by a pharmacy for one patient’s prescription, often as a cream, a blend such as Bi-Est, or a custom strength | No [4] | The National Academies found insufficient evidence for the overall clinical use of compounded bioidentical hormones [5] |
| Pellets | Compounded hormone pellets placed under the skin, which release hormone for months | No [6] | ACOG advises other forms for testosterone because of missing safety data and because a pellet cannot be removed [3] |
“Bioidentical” is about structure, not safety
Estradiol and progesterone have the same chemical structure as the hormones the ovaries make, so they are bioidentical whether a factory or a compounding pharmacy makes them. The word says nothing about who made a product or whether it was tested. The FDA says many products marketed as “bioidentical hormones” are compounded drugs that are not FDA-approved, and that it has no evidence they are safer or more effective than FDA-approved hormone therapy [4].
The Endocrine Society says little or no scientific evidence supports the claims made for compounded bioidentical hormones, and that their preparation is not subject to FDA oversight [7]. ACOG says compounded hormone therapy should not be prescribed routinely when FDA-approved formulations exist [3].
Compounded hormones: when and why
A compounding pharmacy prepares a medicine for one patient. That has a real use: an allergy to an ingredient in an approved product, such as the peanut oil in micronized progesterone capsules [2], or a form no approved product comes in. The National Academies, in a 2020 report the FDA commissioned, recommended limiting compounded bioidentical hormones to those two situations and said patient preference alone should not decide it [5] [8]. The Menopause Society says the same about preference [9].
- Estriol, the E3 in Bi-Est and Tri-Est blends, is in no FDA-approved drug [4].
- Saliva and urine tests to set a hormone dose are unreliable and not recommended, and blood hormone tests are rarely needed [9]. ACOG says these extra hormone tests are not recommended for dosing [3].
- The lack of data is not proof of safety. The National Academies wrote that the lack of data should never be read as a marker of safety, and that widespread use is a public health concern [5] [8].
Pellets
Hormone pellets are compounded estradiol or testosterone placed under the skin, where they release hormone for months. ACOG points to the missing safety data and to the fact that a pellet cannot be removed once it is in [3]. In 2019 the FDA reported that a 2018 inspection of one company uncovered 4,202 adverse events that had never been reported to the agency, suggesting compounded hormone pellets were possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks and deep vein thrombosis [6]. The National Academies recommended that all compounded hormone pellets be considered for the FDA’s list of drugs that are difficult to compound [5]. VevaMD does not offer pellets.
Where VevaMD stands
Plainly: the estradiol skin cream and capsules and the testosterone cream that VevaMD’s pharmacies fill are compounded and not FDA-approved. FDA-approved estradiol exists as patches, gels, a spray, tablets and vaginal products, and FDA-approved micronized progesterone capsules exist too; ask your physician which product you receive and about FDA-approved options. Each medicine’s status is on its own page: estradiol, progesterone, testosterone for women and vaginal estrogen.
Compounded or not, the same medical rules apply: the same reasons not to take estrogen, the same need for a progestogen if you have a uterus, and the same check-ins. The FDA’s 2026 label change applies only to FDA-approved products: see the FDA label change tracker.