Is AOD-9604 Legal? FDA, Compounding and WADA Status
AOD-9604's FDA status, compounding rules and anti-doping status, with a dated timeline of every change we track.
- FDA status
- Not approved
- research chemical
- PCAC vote
- Not reviewed
- not on the Jul 2026 PCAC agenda
- WADA
- Prohibited (S2.2.3)
- In and out of competition
Current status
Not FDA approved · research chemicalNo. AOD-9604 is not FDA approved for any use.
| Country | Status | Source |
|---|---|---|
| United States | No approved product foundNo FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "aod-9604" returned no matches 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.
FDA compounding record: AOD-9604 appears in FDA's table of bulk drug substances previously in category 2 and withdrawn by the nominators. · fda.gov, checked 2 Oct 2026
Sport and drug testing
Prohibited by WADA (S2.2.3)AOD-9604 is named as a growth hormone fragment in S2.2.3, 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 "aod-9604" 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 "aod-9604" on 2 Oct 2026. | health-products.canada.cachecked 2 Oct 2026 |
| European Union | No centrally authorised EU medicine foundEMA medicines list, searched 2 Oct 2026 | ema.europa.euchecked 2 Oct 2026 |
What regulators' own records return for AOD-9604
The US Drugs@FDA lookup for AOD-9604 as an active ingredient returned a not-found error, so no approved product appears in that database.[2]
The UK Electronic Medicines Compendium search for AOD-9604 on the same date returned no results.[4]
Health Canada's drug product database returned zero active-ingredient records for AOD-9604.[5]
FDA's compounding safety notes
FDA's table of bulk drug substances flags AOD-9604 for possible immunogenicity and for peptide-impurity and characterization problems when compounded.[3]
The same entry says FDA identified serious adverse events that may be associated with AOD-9604, with causality unclear.[3]
Sport: the prohibited list
The WADA Prohibited List names AOD-9604 as a growth hormone fragment, a class banned at all times.[1]
Common questions
Is AOD-9604 FDA approved?
No approved product appears: the Drugs@FDA query for the ingredient came back with no matches.[2]
Is AOD-9604 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 AOD-9604 banned by WADA?
Yes. Prohibited by WADA (S2.2.3), in and out of competition.
Is there an official AOD-9604 dosing schedule?
With no approved product in the US, UK or Canada records checked on 2 October 2026, there is no regulator-issued dosing schedule to cite.
Calculated from drugs fda matches 0; emc results 0; health canada records 0; date 2026-10-02. Formula: approved products found in the 3 databases = 0 + 0 + 0 = 0
More on AOD-9604
Sources
- 1World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
- 2United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "aod-9604" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
- 3US compounding: AOD-9604 appears in FDA's table of bulk drug substances previously in category 2 and withdrawn by the nominators.U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
- 4United Kingdom: No approved product found in an emc (UK SmPC compendium) search for "aod-9604" on 2 Oct 2026.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
- 5Canada: No product found in a Health Canada Drug Product Database search for ingredient "aod-9604" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 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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