Estrogen PatchTracker

Compounded estradiol and the shortage

Compounding pharmacies mix medicines to order. Some readers ask whether one could make their patch. Today the rules say mostly not, and the reason is the FDA's shortage list.

Updated

Why the FDA's list matters

A compounding pharmacy may not regularly make what the FDA calls "essentially copies" of a medicine you can buy. The exception is a medicine on the FDA's shortage list: one in "currently in shortage" status in the FDA's database is not treated as commercially available, so copies of it may be compounded (FDA 503A guidance). The same goes for the larger outsourcing facilities (FDA 503B guidance, FDA).

Estradiol patches are not on that list. ASHP's shortage listing doesn't count for this. So for now the usual limits on compounding copies of approved estradiol products apply. Why the FDA and ASHP disagree.

Could anyone compound a patch?

We haven't found a source saying compounded estradiol patches are made in the US. The generic makers' trade group says the technical skill a transdermal system needs puts it beyond most compounders, though they "can and do provide other topical formulations of estrogen" such as creams (Chain Drug Review). That is an industry view.

What doctors' groups and the FDA say

  • ACOG: compounded bioidentical hormone therapy "should not be prescribed routinely when FDA-approved formulations exist" (ACOG Clinical Consensus 6). ACOG repeated in November 2025 that it recommends against compounded estrogen products (ACOG).
  • The FDA: it "does not have evidence that compounded 'bioidentical hormones' are safe and effective" (FDA).
  • NAMS, now The Menopause Society, in 2022: prescribers should only consider compounded hormones for reasons such as an allergy to an ingredient or a dose not available in approved products, and "patient preference alone" is not a reason (NAMS).

Several approved forms of estradiol are not short: gels, a spray, a systemic ring and tablets. See the alternatives page.

A compounded product is a prescription decision with different safeguards from an approved one. Ask your prescriber what they recommend.

Sources

  1. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A, FDA guidance, January 1, 2018.
  2. Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B, FDA guidance, January 1, 2018.
  3. Compounding when drugs are on FDA's drug shortages list, FDA, August 8, 2025.
  4. Generic medicines manufacturers ramp up patch supply to meet demand, Chain Drug Review, October 14, 2026.
  5. Compounded bioidentical menopausal hormone therapy (Clinical Consensus 6), ACOG, November 1, 2023.
  6. ACOG president says label change on estrogen will increase access to hormone therapy, ACOG, November 10, 2025.
  7. Menopause, FDA Office of Women's Health, December 14, 2023.
  8. The 2022 hormone therapy position statement, The North American Menopause Society, July 1, 2022.