Is Tesamorelin Legal? FDA, Compounding and WADA Status
Tesamorelin's FDA status, compounding rules and anti-doping status, with a dated timeline of every change we track.
- FDA status
- Approved (Egrifta)
- 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
FDA approved (Egrifta)Tesamorelin is FDA approved (Egrifta). Products sold as research chemicals are not the approved drug and are not checked by the FDA.
| Country | Status | Source |
|---|---|---|
| United States | ApprovedApproved by FDA as Egrifta (original approval 10 Nov 2010), Theratechnologies, for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy (label quote). | api.fda.govchecked 2 Oct 2026 |
Timeline
- FDA warning letters to five research-peptide sellersEnforcement
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)Tesamorelin is named as a GHRH analogue in S2.2.4 (growth hormone releasing factors), prohibited at all times. Tesamorelin is also an FDA-approved medicine; an athlete would need a therapeutic use exemption.
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 "tesamorelin" on 2 Oct 2026. | medicines.org.ukchecked 2 Oct 2026 |
| Canada | Not marketedHealth Canada DPD lists Egrifta (tesamorelin) with status Cancelled Post Market, i.e. not currently marketed. | health-products.canada.cachecked 2 Oct 2026 |
| Australia | No approved product foundNo approved product found in an ARTG search for "tesamorelin" on 2 Oct 2026. | tga.gov.auchecked 2 Oct 2026 |
| European Union | Application withdrawnEMA lists Egrifta (tesamorelin) with status Application withdrawn; no centrally authorised tesamorelin product. | ema.europa.euchecked 2 Oct 2026 |
Common questions
Is Tesamorelin FDA approved?
Tesamorelin is FDA approved (Egrifta). Products sold as research chemicals are not the approved drug and are not checked by the FDA.
Is Tesamorelin 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 Tesamorelin banned by WADA?
Yes. Prohibited by WADA (S2.2.4), in and out of competition.
More on Tesamorelin
DosageDoses used in published studies, with the source for each.CalculatorVial, water and dose to syringe units.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.How to injectSites, syringe types and hygiene, step by step.
Sources
- 1World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
- 2United States: Approved by FDA as Egrifta (original approval 10 Nov 2010), Theratechnologies, for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy (label quote).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 "tesamorelin" on 2 Oct 2026.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
- 4Canada: Health Canada DPD lists Egrifta (tesamorelin) with status Cancelled Post Market, i.e. not currently marketed.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
- 5Australia: No approved product found in an ARTG search for "tesamorelin" on 2 Oct 2026.Therapeutic Goods Administration (Australia) · 2026tga.gov.auAccessed 2 Oct 2026
- 6European Union: EMA lists Egrifta (tesamorelin) with status Application withdrawn; no centrally authorised tesamorelin product.European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026
- 7FDA warning letters to five research-peptide sellersFDA warning letter (NuScience Peptides; 1 of 5) · 2026fda.govAccessed 2 Oct 2026
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