Is AOD-9604 Legal? FDA Status, Prescription & Compounding
Current regulatory status of AOD-9604 in the United States: FDA approval, Section 503A compounding eligibility, prescription requirements, and WADA anti-doping status.
Educational content only. This page is compiled from published research for reference and is not medical advice, diagnosis, or treatment. Readers should verify claims against primary sources and consult a qualified healthcare provider before making any health decisions. Full disclaimer.
FDA Regulatory Status
Not FDA-approved. Has GRAS (Generally Recognized as Safe) status as a food additive only. Not approved as a drug.
Source: PeptideMark FDA Peptide Tracker — compiled from FDA.gov bulk substances guidance and 503A nominations.
Prescription & Legal Access
AOD-9604 has no FDA-approved retail pathway for human consumption. Products sold labeled "for research use only" are not authorized for personal use. No legitimate U.S. prescription pathway exists outside of FDA-approved indications or authorized clinical trials.
Section 503A Compounding
Section 503A of the Federal Food, Drug, and Cosmetic Act governs which substances compounding pharmacies may use. Substances are placed into one of three categories: Category 1 (eligible for compounding), Category 2 (significant safety concerns — prohibited), or Category 3 (under review).
WADA & Anti-Doping Status
The World Anti-Doping Agency (WADA) lists AOD-9604 on its Prohibited List, making it banned both in and out of competition for athletes subject to WADA-governed sports. Use by tested athletes will result in an anti-doping rule violation regardless of therapeutic intent.
Frequently Asked Questions
Is AOD-9604 FDA approved?
No. AOD-9604 is not FDA approved for any human indication and is available only for research use.
Do I need a prescription for AOD-9604?
AOD-9604 has no legal retail pathway for human consumption in the U.S. Products labeled "for research only" are not authorized for personal use, and no legitimate U.S. prescription pathway exists outside of FDA-approved indications or authorized clinical trials.
Can compounding pharmacies make AOD-9604?
AOD-9604 is not on the FDA's approved list of bulk substances for 503A compounding. Its eligibility remains under review or limited to research contexts.
Is AOD-9604 banned by WADA?
Yes. AOD-9604 is prohibited by the World Anti-Doping Agency (WADA) both in and out of competition. Athletes subject to WADA testing should not use it.
Is it legal to buy AOD-9604 online?
Products marketed as "AOD-9604 for research use only" are widely sold online but are not authorized for human consumption. Purchasing these products for personal use may violate FDA regulations and carries significant quality, purity, and legal risk. There is no FDA-sanctioned retail pathway for non-prescription human use.