Is AOD-9604 Legal in Florida? How to Access It Legally

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone, hGH 177 to 191 with an extra tyrosine at the N-terminus, which is why it is also called hGH fragment 176-191 [11][1]. 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 dropped [6][1]. Preclinical work found no growth hormone receptor binding [12][1].

Where it sits in FDA's compounding rules

FDA's page on bulk substances that may present significant safety risks when compounded, content dated 04/22/2026, lists AOD-9604 in its 'nominated but withdrawn' table, which holds substances previously in category 2 whose nominators withdrew them. FDA's stated concerns are immunogenicity risk for certain routes of administration, no or only limited safety information, and serious adverse events that may be associated with AOD-9604 though causality is not clear; removal from category 2 was not a finding that it is safe [2].

It appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, updated May 14, 2026, and in none of the entries on FDA's list for outsourcing facilities, updated March 21, 2025. FDA's category 1 policy, under which the agency generally does not intend to act against compounders that meet certain conditions, does not cover it [3][4][5]. It is not one of the six peptides named in HHS's draft enforcement-discretion policy for compounding, filed October 28, 2026 [7][8]. Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before they are marketed [13].

What the evidence shows

A 24-week study of AOD9604 as an oral anti-obesity candidate enrolled 534 people and randomized 502; it failed to show a significant benefit on the primary weight-loss endpoint, a conclusion a 2026 review says rests on sponsor-reported phase 2 results rather than peer-reviewed trials [1]. The animal results differ: obese Zucker rats given 500 microgram/kg daily by mouth for 19 days gained 15.8 g versus 35.6 g in controls [14], and obese mice given it intraperitoneally for 14 days lost weight and fat, an effect not seen long-term in mice lacking the beta-3 adrenergic receptor [15]. A 2026 review of unapproved sports peptides reports favorable animal results but scarce rigorous human safety data and potential for serious harm [16].

Claims that AOD-9604 is GRAS do not come from FDA: the agency's GRAS Notice Inventory contains no AOD-9604 notice, and a GRAS conclusion would not make an injectable lawful as a drug [17].

Safety and anti-doping

FDA states it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear, and gives no details [2]. WADA names AOD-9604 and hGH 176-191 in section S2.2.3 as growth hormone fragments, prohibited at all times in and out of competition, on both the 2026 List in force since January 1, 2026, and the 2027 List [9][10].