FDA Closes DESI 7661: Unapproved Estrogen-Androgen Fixed-Combination Products Unlawful to Ship Interstate
Last updated 2026-10-31 · Source: Federal Register (FDA), 91 FR 31462, FR Doc. 2026-10479, May 27, 2026
FDA's May 27, 2026 notice closed DESI 7661: shipping an estrogen-androgen fixed-combination product without an approved NDA or ANDA across state lines is unlawful.
What this means for your practice
Telehealth platforms, medspas, and hormone health practices that prescribe or dispense compounded or unapproved estrogen-androgen combination products — including conjugated estrogens with methyltestosterone or esterified estrogen formulations — must immediately verify whether those products carry an FDA-approved NDA or ANDA. As of June 26, 2026, interstate shipment of any DESI 7661-covered product lacking that approval is unlawful under the FD&C Act. Practices offering hormone replacement therapy (HRT), menopause management, or testosterone-estrogen combination protocols via telehealth are most directly exposed. Compounding pharmacies supplying these practices should also be consulted to confirm compliance status. Now is the time to audit your formulary and supply chain.
On May 27, 2026, the Food and Drug Administration (FDA) published a Federal Register notice (91 FR 31462, Docket No. FDA-1998-P-0083, DESI 7661) closing the Drug Efficacy Study Implementation (DESI) proceeding on estrogen-androgen fixed-combination drug products. Its last phase began with a 2003 notice of opportunity for hearing. Every outstanding hearing request has been withdrawn, so FDA finalized its finding that these products have not been shown to be effective for use under the conditions in their labeling.
What the notice decides
Shipment in interstate commerce of any product identified in DESI 7661, or any identical, related or similar (IRS) product, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful.
The notice gives two dates. Its summary says that shipment is unlawful "as of the date of this notice," May 27, 2026. Its dates section says the notice is effective June 26, 2026, and its conclusions tie the prohibition and FDA's enforcement to that effective date. Both dates have now passed. FDA says that after the applicable date it intends to take enforcement action, without further notice, against any firm that manufactures or ships an unapproved product covered by the notice in interstate commerce.
How the proceeding got here
- 1962: the Drug Amendments required new drugs to be shown effective as well as safe, and required FDA to review the effectiveness of drugs approved for safety only between 1938 and 1962. FDA's implementation of that review is DESI.
- September 8, 1972 (37 FR 18225): FDA found five estrogen-androgen combination products effective for postpartum breast engorgement and for the menopausal syndrome in patients not improved by estrogen alone.
- September 29, 1976 (41 FR 43112): FDA narrowed the menopausal indication to moderate to severe vasomotor symptoms associated with the menopause in patients not improved by estrogen alone.
- 1981: at the sponsors' request, FDA applied that finding to conjugated estrogens and methyltestosterone, and to esterified estrogens and methyltestosterone.
- December 17, 1998 (63 FR 69631): FDA withdrew approval of estrogen-containing products for postpartum breast engorgement because estrogens were not shown to be safe for that use.
- April 14, 2003 (68 FR 17953): FDA reclassified the products as lacking substantial evidence of effectiveness for menopausal vasomotor symptoms and offered a hearing. Syntho Pharmaceutical (Syntest D.S. and Syntest H.S.) and Solvay Pharmaceuticals (Estratest and Estratest HS) asked for one.
- 2011 and 2025: Abbott, which had acquired Solvay, withdrew its request in 2011. Syntho withdrew its request in August 2025.
- May 27, 2026: with no hearing requests left, FDA closed DESI 7661.
Which products are covered
The notice names Syntest D.S. (1.25 mg esterified estrogens/2.5 mg methyltestosterone) and Syntest H.S. (0.625 mg esterified estrogens/1.25 mg methyltestosterone) tablets, and the proceeding covers any IRS product as well. FDA asks anyone who wants to know whether the notice covers a specific product to write to the contact named in the notice at FDA's Center for Drug Evaluation and Research.
The notice does not discuss compounded drugs. Whether it reaches a compounded estrogen-androgen preparation is a separate legal question that the notice does not answer, so treat it as unsettled and ask regulatory counsel and your pharmacy partner rather than assuming either way.
What this means for hormone and menopause programs
- Check the approval status of every estrogen-androgen combination you prescribe. If a manufactured fixed-combination product has no approved NDA or ANDA, the notice makes its interstate shipment unlawful.
- Ask, don't assume, about compounded combinations. Get a written answer from your pharmacy partner and counsel on how they read the notice for any compounded estrogen-androgen preparation you use.
- Write down what you checked. Record the products reviewed, their status and any protocol change, with the date.
Key facts
| Detail | Value |
|---|---|
| Document | FDA notice, FR Doc. 2026-10479, 91 FR 31462 |
| Published | May 27, 2026 |
| Dates in the notice | Summary: unlawful as of the notice date (May 27, 2026). Dates section: effective June 26, 2026 |
| Docket | FDA-1998-P-0083 (formerly 76N-0377); DESI 7661 |
| Products named | Syntest D.S. and Syntest H.S. tablets (esterified estrogens/methyltestosterone) |
| Scope | Any DESI 7661 or IRS product without an approved NDA or ANDA |
| Finding | Not shown to be effective under the labeled conditions of use |
Frequently asked questions
Is it unlawful now?
Yes. Whichever date in the notice applies, May 27 or June 26, 2026, both have passed.
Does it cover compounded estrogen-testosterone preparations?
The notice does not say. That is a separate legal question; get advice from counsel and your pharmacy partner.
How do I find out whether a specific product is covered?
The notice asks firms to write to its named FDA contact at the Center for Drug Evaluation and Research.