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Is Enclomiphene Legal? FDA, Compounding and WADA Status

Enclomiphene's FDA status, compounding rules and anti-doping status, with a dated timeline of every change we track.

Medically reviewed by Juan Pablo Frías, MD · · DisclosureSERM (not a peptide)Updated
FDA status
Not FDA approved · compounded
PCAC vote
Not reviewed
not on the Jul 2026 PCAC agenda
WADA
Prohibited (S4.2)
In and out of competition
Not legal adviceStatus reflects public FDA and WADA records on the date shown. Rules differ by country and state.

Current status

Not FDA approved · compounded

Enclomiphene is Not FDA approved · compounded. Products sold as research chemicals are not the approved drug and are not checked by the FDA.

Enclomiphene: regulatory status by country
CountryStatusSource
United StatesNo approved product foundNo FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "enclomiphene" returned no matches on 2 Oct 2026.api.fda.govchecked 2 Oct 2026

Timeline

No FDA, advisory-committee or WADA action specific to Enclomiphene found in our records (checked 2 Oct 2026).
Every peptide on the FDA tracker

Compounding and research-use sellers

  • Category 2 is the FDA's list of bulk substances it flagged as raising significant safety concerns. Compounding pharmacies are not expected to compound from them while they are on it.
  • The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA on which substances belong on the 503A bulks list that pharmacies may compound from. Its votes are advice; the FDA decides.
  • "Research use only" products are sold outside these rules and are not checked by the FDA for identity, purity or dose.

FDA compounding record: Enclomiphene citrate is listed in FDA's 503A category 1 (bulk drug substances under evaluation). · fda.gov, checked 2 Oct 2026

Sport and drug testing

Prohibited by WADA (S4.2)

Enclomiphene is an isomer of clomifene, which is named in S4.2 (anti-estrogens/SERMs, prohibited at all times). Enclomiphene itself is not spelled out in the list text we cached, so this rests on it being a form of clomifene.

Outside the US

Rules differ by country. What each regulator's own records show, with the date we checked:

Enclomiphene: regulatory status by country
CountryStatusSource
United KingdomNo approved product foundNo approved product found in an emc (UK SmPC compendium) search for "enclomiphene" on 2 Oct 2026.medicines.org.ukchecked 2 Oct 2026
CanadaNo approved product foundNo product found in a Health Canada Drug Product Database search for ingredient "enclomiphene" on 2 Oct 2026.health-products.canada.cachecked 2 Oct 2026
AustraliaNo approved product foundNo approved product found in an ARTG search for "enclomiphene" on 2 Oct 2026.tga.gov.auchecked 2 Oct 2026
European UnionNo centrally authorised EU medicine foundEMA medicines list, searched 2 Oct 2026ema.europa.euchecked 2 Oct 2026

Common questions

Is Enclomiphene FDA approved?

Enclomiphene is Not FDA approved · compounded. Products sold as research chemicals are not the approved drug and are not checked by the FDA.

Is Enclomiphene legal to buy?

As an approved drug it requires a prescription in the US. Products sold online as research chemicals "not for human use" are not the approved drug.

Is Enclomiphene banned by WADA?

Yes. Prohibited by WADA (S4.2), in and out of competition.

More on Enclomiphene

DosageDoses used in published studies, with the source for each.Side effectsWhat labels and studies report, and what is unknown.ResultsStudy outcomes and when they were measured.PricePrice per mg and per week from dated listings. No vendor links.Half-lifeWhat is measured, by route, and what is not.StoragePowder and mixed vials: temperature and shelf life.

Sources

  1. 1World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
  2. 2United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "enclomiphene" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
  3. 3US compounding: Enclomiphene citrate is listed in FDA's 503A category 1 (bulk drug substances under evaluation).U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  4. 4United Kingdom: No approved product found in an emc (UK SmPC compendium) search for "enclomiphene" on 2 Oct 2026.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
  5. 5Canada: No product found in a Health Canada Drug Product Database search for ingredient "enclomiphene" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
  6. 6Australia: No approved product found in an ARTG search for "enclomiphene" on 2 Oct 2026.Therapeutic Goods Administration (Australia) · 2026tga.gov.auAccessed 2 Oct 2026
  7. 7EMA medicines export (centrally authorised medicines) (searched 2 Oct 2026)European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026

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