vialauditThe Roundup
AOD-9604·US LEGAL STATUS·LAST CHECKED 12 OCT 2026

Is AOD-9604 legal?

Not as a drug. AOD-9604 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 · PCAC voted against
PRESCRIPTION
No approved product
WADA 2026
Prohibited (S2.2.3)

DESCRIBES THE LAW · NOT LEGAL ADVICE · NO DOSING INFORMATION

Federal, compounding and sport status

CHECKED 12 OCT 2026

Federal status

FDA approval
no approval
DEA scheduling
not scheduled
503A compounding
FDA interim category: Nominated but withdrawn (off Category 2, not eligible)
503A Bulks List: voted no
Not eligible. The PCAC voted unanimously against it on 4 Dec 2024. FDA now lists it under 'nominated but withdrawn'; it is not in any category that permits compounding.
PCAC review history
  • Dec 4, 2024 · voted against · 12 no, 0 yes · SOURCE ↗
FDA Warning Letters
  • Jan 26, 2022 — Innoveix Pharmaceuticals Inc. (cited: aod-9604, sermorelin, ipamorelin) · LETTER ↗
Shortage status
not currently on shortage list
Sale framing
Research-use-only posture: Standard FDA posture — RUO does not protect sellers when human-use intent is evident.
Personal possession: Not federally scheduled; possession not federally criminalized.

Sport-body status

WADA 2026
prohibited · class S2.2.3 · in and out of competition
Named under S2.2.3 as a growth hormone fragment.
USADA
NCAA

What we couldn’t verify

State rules

NONE FOUND

We found no state statute, board rule or enforcement action that names AOD-9604. The federal position above applies in all 50 states and DC.

What changed at the last check

2 CHANGES
DateFieldWasNowWhy
12 Oct 2026WADA 2026prohibited (S2.2)prohibited (S2.2.3)Named under S2.2.3 as a growth hormone fragment. source ↗
12 Oct 2026OH state noteOhio Board of Pharmacy summary suspension orders named AOD 9604 as an unapproved drug not permitted to be compounded.removedRemoved. The entry described a OH action that does not name AOD-9604; it applied federal-level or class-wide facts by analogy. source ↗

Questions

3 ANSWERS
Is AOD-9604 legal in the US?

Not as a drug. AOD-9604 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 AOD-9604?

Not eligible. The PCAC voted unanimously against it on 4 Dec 2024. FDA now lists it under 'nominated but withdrawn'; it is not in any category that permits compounding.

Is AOD-9604 banned in sport?

Yes. It is prohibited at all times under WADA 2026 class S2.2.3. Named under S2.2.3 as a growth hormone fragment.

Sources

7 DOCUMENTS
  1. FDA approval record
  2. DEA controlled-substance schedules
  3. FDA 503A compounding position
  4. PCAC review, 4 Dec 2024
  5. FDA warning letter to Innoveix Pharmaceuticals Inc., 26 Jan 2022
  6. WADA 2026 Prohibited List
  7. Source for: OH state note
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