Is AOD-9604 Legal in South Carolina?

What is AOD-9604?

AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the front, which is why it is also sold as hGH fragment 176-191 [11][2]. Metabolic Pharmaceuticals developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002 and it never reached approval [1][2].

Is there human evidence that it works?

Thin. A 2026 review describes a 24-week oral obesity study, 534 enrolled and 502 randomized, that failed to show a significant benefit on its primary weight-loss endpoint [2]. The review notes that this conclusion rests on sponsor-reported phase 2 results, because no peer-reviewed efficacy paper was found [2]. Injected gray-market products have no efficacy trials that we know of, and there is no approved dose [2]. Rodent results were stronger: in obese rats, 500 microgram/kg/day orally for 19 days cut weight gain to 15.8 g versus 35.6 g in controls [12].

What does FDA say about compounding it?

FDA's page on bulk substances that may present significant safety risks when compounded (content dated 04/22/2026) lists AOD-9604 in the 'nominated but withdrawn' table, which holds substances previously placed in a safety-risk category that their nominators withdrew [3]. FDA's stated concerns: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration, FDA has identified no or only limited safety information, and FDA has identified serious adverse events that may be associated with AOD-9604, though causality is not clear [3]. Withdrawal was not a finding of safety [3].

AOD-9604 is absent from FDA's list of bulk substances for state-licensed pharmacies and physicians (updated May 14, 2026) and from FDA's list for outsourcing facilities (updated March 21, 2025) [4][5][6]. FDA's interim no-action policy covers only substances in its first category, meaning those nominated with enough information for FDA to evaluate and not appearing on another list [6]. AOD-9604 is not in that group.

HHS's draft enforcement-discretion policy for peptide compounding, filed October 28, 2026, names six peptides (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500) and not AOD-9604 [7][8]. FDA's July 2026 advisory committee agenda did not include it [13]. Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before marketing [14].

Does South Carolina law change this?

This page has no South Carolina statute, board rule or enforcement source, so it cannot say whether state law separately permits or restricts possessing or compounding AOD-9604. The federal position above is the only legal status that can be stated.

Is it banned in sport?

Yes. WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3, growth hormone fragments, prohibited at all times in and out of competition; it is on the 2026 List and remains on the tracked-changes version of the 2027 List [9][10]. Anti-doping scientists have published urine detection methods for the peptide and a stable metabolite [11].

Does GRAS status make it legal?

No. FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA 'no questions' letter for it, and GRAS is a food-ingredient concept that would not make an injectable lawful as a drug [15]. Claims of GRAS status trace back to the developer, which announced a 'conditional GRAS' conclusion by a panel it commissioned, for food or drink use at up to 1 mg per day; that was not an FDA review [15]. Gray-market supply is real: Belgian authorities identified AOD-9604 in seized preparations, and US investigators found it in confiscated vials [16][11].