Is AOD-9604 Legal in Colorado? Federal Framework, State Rules, and How to Get It

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone, residues 177 to 191 with an added tyrosine at the N-terminus, hence the name hGH fragment 176-191 [8]. It is not full-length growth hormone [8]. Metabolic Pharmaceuticals developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002, it never reached approval, and the obesity program was later dropped [9][1].

The federal answer

AOD-9604 is not an FDA-approved drug [1]. Compounded drugs are not approved either: FDA does not review their safety, effectiveness or quality before they reach patients [10].

FDA's list of bulk substances that may present significant safety risks includes AOD-9604 in the table of substances previously in its safety-risk category whose nominators withdrew them [4]. The stated concerns: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes, tied to peptide impurities and characterization problems; FDA has identified no, or only limited, safety information; and serious adverse events may be associated with it, though causality is not clear [4]. Removal from that category was not a finding that the substance is safe [4].

AOD-9604 appears in none of the three categories of FDA's interim policy for state-licensed pharmacies and physicians, so FDA's approach of not acting against qualifying compounders does not cover it [2][3]. It is also absent from FDA's list for outsourcing facilities [5]. HHS's draft enforcement-discretion policy names six other peptides, BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500, not AOD-9604 [6][11].

Colorado

This page covers federal status and cites no Colorado statute or board of pharmacy rule naming AOD-9604. Because the peptide is in none of FDA's compounding categories, no federal policy cited here supports a Colorado pharmacy dispensing it.

What is sold, and what it does

AOD-9604 circulates outside the pharmacy system: US investigators found it in confiscated vials, and Belgian authorities in seized preparations [8][12]. In animal work, obese Zucker rats given oral AOD9604 at 500 micrograms/kg/day for 19 days gained 15.8 g against 35.6 g in controls [13]. In humans, a 24-week study of an oral drug candidate failed its primary weight-loss endpoint; that result was sponsor-reported rather than published in a peer-reviewed efficacy paper [1].

The GRAS claim

FDA's GRAS Notice Inventory contains no AOD-9604 notice and no FDA no-questions letter [14]. Claims of a conditional GRAS conclusion trace to a developer-commissioned panel for food or drink use, not an FDA review, and do not cover injected or compounded use [14].

Athletes

WADA names AOD-9604 and hGH 176-191 in S2.2.3 as growth hormone fragments, prohibited at all times in and out of competition, on the 2026 List and the 2027 List [7][15]. Detection methods for the peptide and its stable metabolite have been published [8].