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U.S. women are receiving testosterone prescriptions at a much higher rate than a few years ago — and many are hitting unexpected denials, delays, and workarounds at the pharmacy counter. That tension landed around an FDA public workshop on testosterone use in menopausal women held September 17, 2026.
The numbers: scripts up ~146% since early 2023
An analysis for Reuters by healthcare analytics firm Truveta found that the rate of women receiving a testosterone prescription jumped 146% from January 2023 through July 2026. Truveta says overall prescribing has risen across ages and sexes; its findings are preliminary and not peer-reviewed.
No FDA-approved testosterone product for women
There is still no U.S.-approved testosterone product labeled for women. Off-label prescribing is legal, but those uses have not been evaluated by FDA for safety, efficacy, or dosing for women.
- The primary evidence-backed, guideline-supported use discussed for menopausal women is hypoactive sexual desire disorder (HSDD).
- The Menopause Society and other groups do not endorse testosterone for muscle mass, bone density, mood, or general well-being based on current evidence.
- Interest and prescribing are not the same as FDA approval.
Why pharmacies deny or delay fills
Because products are packaged for male dosing, women are often told to split or customize gels and other formulations. Reuters reported denials or problems at Amazon Pharmacy, CVS, and Walgreens.
- Amazon Pharmacy said it does not dispense some prescriptions requiring customized doses, citing safe and compliant dispensing, and refers customers to compounding pharmacies for specialized doses.
- Clinicians reported compounded testosterone may cost more than a commercial supply; these figures are not independently verified.
- Most insurance plans do not cover testosterone for women, according to interviewed clinicians and patients.
- Pharmacists flagged controlled-substance record-keeping, dosing accuracy, and stability concerns.
Educational takeaway: access barriers are often logistics and policy. Compounded medications are not FDA-approved.
What the FDA examined on Sept. 17, 2026
The FDA Office of Women’s Health and CDER held a hybrid public workshop, “Testosterone Use in Menopausal Women.” It examined evidence and knowledge gaps for future research and possible drug development.
| Detail | Information |
|---|---|
| When | Thursday, Sept. 17, 2026 · 9:00 a.m.–4:30 p.m. ET |
| Where | FDA White Oak Campus and virtual |
| Public comments | Docket FDA-2026-N-5479, due Oct. 19, 2026 at 11:59 p.m. ET |
Meeting materials highlighted evidence gaps involving sexual function, cognition, mood, musculoskeletal health, measurement of levels, and limited long-term safety data, including cardiovascular and breast cancer risk. The workshop informed research; it was not approval of a women’s testosterone drug.
Quick definitions
- FDA-approved indication: labeled use FDA reviewed for safety and effectiveness.
- Off-label use: legal clinician use for a different condition, dose, or population, but not FDA-endorsed for that use.
- HSDD: persistently low desire causing distress.
- Compounded: pharmacy-prepared for an individual; not FDA-approved as a finished product.
- Public workshop: science meeting on evidence gaps, not a product approval hearing.
What this means for readers — and what it does not
- Demand and prescribing are rising fast.
- Access can be messy: dosing workarounds, pharmacy policies, cost, and coverage.
- Regulators examined the evidence gap; they did not approve a new product.
- Evidence is strongest around HSDD in appropriately assessed menopausal women; broader wellness claims remain poorly supported.
This feature does not recommend changing therapy, interpret labs, compare clinics for treatment decisions, or rank pharmacies. We will continue educational follow-ups as public comments close Oct. 19, 2026.
Limitations
This summarizes public reporting and agency notices as of September 23, 2026 (ET). It is not medical advice, a coverage guarantee, or ranked endorsement. Details can evolve. Do not start, stop, or switch medications based on this article.
Sources
- Reuters, “Testosterone scripts for women rise, along with denials and delays,” Sept. 15, 2026.
- Truveta Research, “Testosterone use is rising,” Sept. 15, 2026 (preliminary).
- FDA / Federal Register, Docket FDA-2026-N-5479.
- FDA Office of Women’s Health event page, Sept. 17, 2026.
Hormone Health Desk · Last reviewed September 23, 2026 (ET) · Educational publisher