vialauditThe Roundup
SERMORELIN·US LEGAL STATUS·LAST CHECKED 12 OCT 2026

Is Sermorelin legal?

Not as a drug. Sermorelin has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. Pharmacies cannot compound it.

RESEARCH-LABELLED SALE
Unapproved drug
PHARMACY COMPOUNDING
No
PRESCRIPTION
No approved product
WADA 2026
Prohibited (S2.2.4)

DESCRIBES THE LAW · NOT LEGAL ADVICE · NO DOSING INFORMATION

Federal, compounding and sport status

CHECKED 12 OCT 2026

Federal status

FDA approval
withdrawn · brand: Geref, Geref Diagnostic · NDA 019863; NDA 020443
Indications: historical: diagnostic for GH deficiency; idiopathic GH deficiency in children
DEA scheduling
not scheduled
503A compounding
FDA interim category: Not in any FDA category
503A Bulks List: not on list
Not in any of FDA's interim categories (14 May 2026 list). Pharmacies that compound sermorelin rely on its status as a component of a formerly approved drug (Geref, withdrawn for commercial reasons, 78 FR 14130). We found no FDA statement on that basis either way.
FDA Warning Letters
  • Jan 26, 2022 — Innoveix Pharmaceuticals Inc. (cited: sermorelin, ipamorelin, aod-9604) · LETTER ↗
Shortage status
not currently on shortage list
Sale framing
Research-use-only posture: Sits in an unusual posture — previously approved, withdrawn for commercial reasons, still compoundable. Vendors marketing for human use without prescription violate FDCA.
Personal possession: Not federally criminalized.

Sport-body status

WADA 2026
prohibited · class S2.2.4 · in and out of competition
Named under S2.2.4 (GHRH and its analogues).
USADA
NCAA

What we couldn’t verify

State rules

NONE FOUND

We found no state statute, board rule or enforcement action that names Sermorelin. The federal position above applies in all 50 states and DC.

What changed at the last check

4 CHANGES
DateFieldWasNowWhy
12 Oct 2026WADA 2026prohibited (S2.2)prohibited (S2.2.4)Named under S2.2.4 (GHRH and its analogues). source ↗
12 Oct 2026FL state noteFlorida § 893.03(3) lists 'GHRH' generically as Schedule III; sermorelin (a GHRH 1 29 fragment) sits in a state scheduleremovedRemoved. Florida Statutes §893.03 (2025) names no peptide, GHRH analogue or GH secretagogue in Schedule III; the earlier entry was wrong. source ↗
12 Oct 2026TX state noteTexas H&SC § 481.104 HGH analog framework may reach sermorelin under generous reading; not explicitly listed on Texas DSremovedRemoved. Texas lists human growth hormone itself as a controlled substance, but not GHRH analogues or secretagogues; no Texas rule specific to this compound was found. source ↗
12 Oct 2026503A interim categoryCategory 1not in any categoryCorrected: sermorelin does not appear in FDA's 14 May 2026 Category 1 list. source ↗

Questions

3 ANSWERS
Is Sermorelin legal in the US?

Not as a drug. Sermorelin has no FDA approval, so selling it for human use breaks federal drug law, and a 'research use only' label does not protect a seller whose site signals human use. It is not a controlled substance, and possessing it is not a federal crime. Pharmacies cannot compound it.

Can a pharmacy compound Sermorelin?

Not in any of FDA's interim categories (14 May 2026 list). Pharmacies that compound sermorelin rely on its status as a component of a formerly approved drug (Geref, withdrawn for commercial reasons, 78 FR 14130). We found no FDA statement on that basis either way.

Is Sermorelin banned in sport?

Yes. It is prohibited at all times under WADA 2026 class S2.2.4. Named under S2.2.4 (GHRH and its analogues).

Sources

7 DOCUMENTS
  1. FDA approval record
  2. DEA controlled-substance schedules
  3. FDA 503A compounding position
  4. FDA warning letter to Innoveix Pharmaceuticals Inc., 26 Jan 2022
  5. WADA 2026 Prohibited List
  6. Source for: FL state note
  7. Source for: TX state note
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