Estrogen PatchTracker

Why the FDA and ASHP disagree

Ask whether there is an estrogen patch shortage in the US and you get two answers. ASHP says yes, and has since January. The FDA says no. Both are telling the truth about different things.

Updated

FDA

Not listed as a shortage

The FDA says patches "remain available" even though brands vary by pharmacy, that supply has nearly doubled in a year, and that it is working with all six makers. FDA, September 3, 2026.

ASHP

In shortage since January

ASHP lists 17 packs from five makers as affected, on back order or allocation, in its last update. ASHP, August 12, 2026.

What the FDA says

The FDA's page on patch supply, posted on September 3, 2026, never uses the word shortage. It says the agency knows people are having trouble getting their usual patches "due to increased demand", that it is working with all six makers, and that "estradiol transdermal patches remain available" even if particular brands vary by pharmacy. It adds that supply of approved patches has nearly doubled over the past year, and puts the jump in demand down to its November 2025 move to drop the old boxed warnings (FDA).

Asked again in late September, an FDA spokesperson told Reuters the patches "are not in shortage" and that the agency would post it if they fell into shortage nationally (Reuters). In May, FDA Commissioner Marty Makary said they had "not risen to the criteria" for the list (NBC News). We checked the FDA's shortage database on October 18, 2026: no estradiol entry.

What ASHP says

ASHP, the society of pharmacists who work in hospitals and health systems, keeps a separate shortage list with the University of Utah's drug information service. It opened an estradiol patch bulletin on January 30, 2026 and last updated it on August 12, listing 17 packs from five makers: Sandoz, Amneal, Viatris, Noven and Zydus (ASHP). Its list is "100% reported" by practitioners, pharmacists, patients and caregivers, ASHP's Michael Ganio told NBC News, which is why it picks up a problem at the counter before national figures do.

So a product can be short in ASHP's sense, hard to get for a lot of people, while the FDA's national numbers say enough is being made overall. The FDA judges from demand data that lawmakers say may lag behind how fast patch prescriptions have grown (CBS News).

What an FDA listing would change

The biggest practical difference is compounding. Under FDA guidance, a drug in "currently in shortage" status in the FDA's database is not treated as commercially available, so a pharmacy may compound a copy of it, and an outsourcing facility may make identical or nearly identical copies (503A guidance, 503B guidance). An ASHP listing doesn't trigger this. Today, with no FDA listing, the usual limits on compounding copies apply.

Whether compounders could make patches at all is another matter. The generic makers' trade group says the technical skill a transdermal patch needs puts it beyond most compounders, though they can make other forms of estradiol for the skin (Chain Drug Review). That is an industry view. A listing can also help trigger other steps, such as finding other suppliers (NBC News).

More on compounded estradiol, and what ACOG and the FDA say about it

Who is pushing for a listing

Representative Debbie Dingell and seven colleagues wrote to the FDA about patch supply in July. The House Democratic Women's Caucus followed at the end of September, asking for a timeline and for the agency to consider listing the patches (Reuters). On October 14 Jackie Speier, the former congresswoman and now a San Mateo County supervisor, urged members of Congress to press the FDA to "declare an official shortage, or similar status" (San Mateo County).

Questions

Has the FDA declared an estrogen patch shortage?

No. As of October 18, 2026 estradiol patches are not in the FDA's drug shortage database. The FDA told Reuters on September 29 that "estradiol patches are not in shortage" and that it would post it on its website if they fell into shortage nationally.

Why does ASHP list a shortage when the FDA doesn't?

They measure different things. ASHP's list is built from reports by pharmacists, doctors, nurses and patients, so it picks up products that are hard to get at the pharmacy. The FDA looks at national supply across all makers, and says patch supply has nearly doubled in a year.

What would change if the FDA listed the patches?

Under FDA guidance, a drug in "currently in shortage" status in its database is not treated as commercially available, so pharmacies and outsourcing facilities could compound copies of it. A listing can also prompt steps such as finding other suppliers. Compounding a patch is technically hard, and the generic makers' trade group says compounders are unlikely to meet the demand.

Sources

  1. FDA Update on Estradiol Transdermal Patch Availability, FDA, September 3, 2026.
  2. FDA Drug Shortages database, FDA, October 18, 2026.
  3. Democratic women lawmakers press FDA on estrogen patch supply (Reuters), Reuters, via WSAU, September 29, 2026.
  4. FDA says estrogen patches aren't in shortage, NBC News, May 11, 2026.
  5. Drug Shortage Detail: Estradiol Transdermal System, ASHP, August 12, 2026.
  6. Estrogen patch shortage: calls for an FDA declaration, CBS News, September 3, 2026.
  7. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A, FDA guidance, January 1, 2018.
  8. Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B, FDA guidance, January 1, 2018.
  9. Generic medicines manufacturers ramp up patch supply to meet demand, Chain Drug Review, October 14, 2026.
  10. Supervisor Speier urges members of Congress to demand FDA declare official estrogen patch shortage, San Mateo County, October 14, 2026.