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Is Sermorelin Legal? FDA, Compounding and WADA Status

Sermorelin'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 · · DisclosureGHRH analogUpdated
FDA status
Compounded by prescription
PCAC vote
Not reviewed
not on the Jul 2026 PCAC agenda
WADA
Prohibited (S2.2.4)
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

Compounded by prescription

No. Sermorelin is not FDA approved for any use.

Sermorelin: regulatory status by country
CountryStatusSource
United StatesDiscontinuedThe only Drugs@FDA record for sermorelin is Geref (EMD Serono), with marketing status Discontinued; no currently marketed FDA-approved sermorelin product was found on 2 Oct 2026.api.fda.govchecked 2 Oct 2026

Timeline

No FDA, advisory-committee or WADA action specific to Sermorelin 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.

Sport and drug testing

Prohibited by WADA (S2.2.4)

Sermorelin is named as a GHRH analogue in S2.2.4 (growth hormone releasing factors), prohibited at all times.

Outside the US

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

Sermorelin: regulatory status by country
CountryStatusSource
United KingdomNo approved product foundNo approved product found in an emc (UK SmPC compendium) search for "sermorelin" 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 "sermorelin" on 2 Oct 2026.health-products.canada.cachecked 2 Oct 2026
AustraliaNo approved product foundNo approved product found in an ARTG search for "sermorelin" 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 Sermorelin FDA approved?

No. Sermorelin is not FDA approved for any use.

Is Sermorelin legal to buy?

It is not an approved drug. Online sellers label it "for research use only, not for human use"; the FDA sent warning letters to five such sellers on 24 Aug 2026. Whether a pharmacy may compound it depends on its FDA bulk-substance status. Rules differ by country.

Is Sermorelin banned by WADA?

Yes. Prohibited by WADA (S2.2.4), in and out of competition.

More on Sermorelin

Sources

  1. 1World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
  2. 2United States: The only Drugs@FDA record for sermorelin is Geref (EMD Serono), with marketing status Discontinued; no currently marketed FDA-approved sermorelin product was found on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
  3. 3United Kingdom: No approved product found in an emc (UK SmPC compendium) search for "sermorelin" on 2 Oct 2026.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
  4. 4Canada: No product found in a Health Canada Drug Product Database search for ingredient "sermorelin" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
  5. 5Australia: No approved product found in an ARTG search for "sermorelin" on 2 Oct 2026.Therapeutic Goods Administration (Australia) · 2026tga.gov.auAccessed 2 Oct 2026
  6. 6EMA medicines export (centrally authorised medicines) (searched 2 Oct 2026)European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026

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