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.
- 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
Current status
Compounded by prescriptionNo. Sermorelin is not FDA approved for any use.
| Country | Status | Source |
|---|---|---|
| United States | DiscontinuedThe 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
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:
| Country | Status | Source |
|---|---|---|
| United Kingdom | No 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 |
| Canada | No 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 |
| Australia | No approved product foundNo approved product found in an ARTG search for "sermorelin" on 2 Oct 2026. | tga.gov.auchecked 2 Oct 2026 |
| European Union | No centrally authorised EU medicine foundEMA medicines list, searched 2 Oct 2026 | ema.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
- 1World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
- 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
- 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
- 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
- 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
- 6EMA medicines export (centrally authorised medicines) (searched 2 Oct 2026)European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026
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