Is AOD-9604 Legal in Louisiana? Federal and State Rules Explained

At a glance

• Federal approval / Not an FDA-approved drug for any use [1]
• FDA compounding categories / In none of the three interim categories [2][3]
• FDA safety page / Listed in the 'nominated but withdrawn' table with stated concerns [4]
• HHS draft peptide policy / Not among the six peptides named in the October 2026 draft [5][6]
• Anti-doping / WADA prohibits it at all times under S2.2.3 [7]

What AOD-9604 is

AOD-9604 is a 16-amino-acid peptide: the C-terminal fragment of human growth hormone from amino acids 177 to 191, with an extra tyrosine at the N-terminus, which is why it also appears as hGH fragment 176-191 [8]. It is not full-length growth hormone, and a 2026 review notes that preclinical work found no growth hormone receptor binding [1].

Metabolic Pharmaceuticals developed it as an anti-obesity drug candidate; phase IIa trials were under way by February 2002, and it never reached approval [9][1].

The federal rules that bear on the question

FDA's page says a state-licensed pharmacy or physician may compound only with bulk substances that comply with a USP or National Formulary monograph, are components of an FDA-approved drug, or appear on FDA's list of bulk substances that can be used in compounding [3]. AOD-9604 is not an FDA-approved drug [1]. It appears in none of the three categories of FDA's interim policy [2][3].

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in the 'nominated but withdrawn' table, in content dated 04/22/2026. FDA says compounded drugs containing AOD-9604 may pose a significant immunogenicity risk for certain routes of administration, citing peptide impurities and characterization problems. FDA also says it has identified no or only limited safety information, and serious adverse events that may be associated with AOD-9604, though causality is not clear [4]. Removal from category 2 was not a finding that it is safe [4].

It is also absent from FDA's list for registered outsourcing facilities, updated March 21, 2025 [10]. HHS's draft enforcement-discretion policy for compounded peptides, filed October 28, 2026, names six peptides (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500), and AOD-9604 is not one of them [5][6]. It was not on the agenda of FDA's July 2026 Pharmacy Compounding Advisory Committee meeting [11].

A 2026 review of approved and unapproved peptides marketed direct to patients notes that rigorous human safety data are scarce and there is potential for serious harm [12].

Anti-doping status

WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3, growth hormone fragments. It is prohibited at all times, in and out of competition [7]. It is on the 2026 List and remains on the 2027 List in the tracked-changes version dated 26 August 2026 [7][13].

Frequently asked questions

›Is AOD-9604 FDA-approved?

No. Metabolic Pharmaceuticals took it into phase IIa trials for obesity by February 2002, but it never reached approval and the obesity program was dropped [9][1].

›Can a Louisiana pharmacy compound AOD-9604?

The federal facts do not give a Louisiana-specific answer. FDA's list of interim compounding categories does not include AOD-9604, and FDA lists it in a nominated-but-withdrawn table with stated safety concerns, including serious adverse events of unclear cause [4][2][3].

›Is AOD-9604 banned in sport?

Under WADA's Prohibited List it is. AOD-9604 and hGH 176-191 are named in class S2.2.3 and prohibited at all times, in and out of competition [7].

›Is AOD-9604 the same as growth hormone?

No. It is a 16-amino-acid fragment of human growth hormone, and preclinical work found no growth hormone receptor binding [8][1].

›Is AOD-9604 GRAS?

FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA letter on it. GRAS is a food-ingredient concept and would not make an injectable lawful as a drug [14].

References

1. Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, RuchaŁa M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration
2. U.S. Food and Drug Administration. U.S. Food and Drug Administration
3. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA
4. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
5. Official web page. Official web page
6. Official web page. Official web page
7. World Anti-Doping Agency. World Anti-Doping Agency
8. Cox HD, Smeal SJ, Hughes CM, Cox JE, Eichner D. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31-8. Detection and in vitro metabolism of AOD9604
9. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
10. U.S. Food and Drug Administration. U.S. Food and Drug Administration
11. U.S. Food and Drug Administration. U.S. Food and Drug Administration
12. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921-1935. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
13. World Anti-Doping Agency. World Anti-Doping Agency
14. GRAS Notices. GRAS Notices