Is AOD-9604 Legal in Georgia? Federal Rules, State Pharmacy Law, and How to Get It

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus, which is why it is also sold as hGH fragment 176-191 [4][7]. It is not full-length growth hormone, and preclinical work found no binding to the growth hormone receptor [4]. Metabolic Pharmaceuticals developed it as an anti-obesity drug candidate, with phase IIa trials underway by February 2002 [8]. A 24-week oral obesity study of the drug candidate (534 enrolled, 502 randomized) failed to show a significant benefit on its primary weight-loss endpoint, and there is no approved dose [4].

The federal rules that decide this in Georgia

Two questions decide whether a peptide reaches a patient as a prescription: is it an approved drug, and if not, may a pharmacy compound with it.

AOD-9604 is approved for nothing [4]. FDA keeps a list of bulk drug substances for state-licensed pharmacies and physicians, updated 14 May 2026, and a separate list for outsourcing facilities, updated 21 March 2025. AOD-9604 is in none of the three categories on either list [1][2].

FDA's interim policy sorts nominated substances into three categories. FDA says it does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians that compound with a category 1 substance when the policy's conditions are met [3]. AOD-9604 is outside that policy [1][3]. It does sit in FDA's table of substances previously placed in the higher-risk category whose nominators later withdrew them, and removal from that category was not a finding that it is safe [5].

Neither of the recent federal actions on peptides mentions it. AOD-9604 is not among the six peptides in HHS's draft enforcement-discretion policy for compounding, filed 28 October 2026 [9][10], and it was not on the agenda when FDA's Pharmacy Compounding Advisory Committee met in July 2026 [11]. Compounded drugs are not FDA-approved in any case: FDA does not review their safety, effectiveness or quality before they are marketed [12].

What FDA says about the safety risk

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 that it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear [5]. FDA gives no further detail on those events [5]. A 2026 review describes human evidence on AOD-9604 as limited and largely short-term [4], and a 2026 Sports Medicine review of unapproved peptides notes that rigorous human safety data are scarce and that there is potential for serious harm [13].

Does Georgia add anything?

Pharmacy oversight in Georgia sits mainly with the state board of pharmacy. FDA says state boards generally have primary responsibility for day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities, while FDA also conducts surveillance and for-cause inspections of those pharmacies [12]. Federal compounding rules apply in Georgia as they do elsewhere.

Banned in sport, sold online

WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3, banned at all times, in and out of competition, and it is on the 2026 List and stays on the 2027 List [6][14]. Anti-doping scientists validated urine detection for AOD-9604 and one of its stable metabolites [7]. The peptide is available on various internet sites and has been identified in confiscated vials in the USA [7]; Belgian authorities found it in seized pharmaceutical preparations [15].