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

What AOD-9604 actually is

AOD-9604 is a fragment of human growth hormone: amino acids 177 to 191 with an extra tyrosine at the N-terminus, which is why it also circulates as hGH fragment 176-191. It is not full-length growth hormone [8][2]. An Australian company, Metabolic Pharmaceuticals, developed it as an obesity drug candidate, and phase IIa trials were under way by February 2002 [1]. It never reached approval [1][2].

Where it sits in the federal compounding rules

AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, and it is not on FDA's list of bulk substances for outsourcing facilities [4][6][5]. FDA's interim policy, under which the agency generally does not act against compounders using nominated substances in category 1, therefore does not cover it [4][5].

FDA also publishes a page on bulk substances that may present significant safety risks. AOD-9604 appears there in the table of nominations that were withdrawn, meaning it had been in category 2 and its nominator pulled it [3]. FDA's stated concerns: compounded drugs containing AOD-9604 may pose a significant immunogenicity risk for certain routes of administration due to peptide impurities and characterization problems; FDA has identified no, or only limited, safety information; and FDA 'has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear' [3]. Removal from category 2 was not a finding that the substance is safe [3].

Does it work for weight loss?

The main human test was a 24-week study of oral AOD9604 as an anti-obesity drug candidate: 534 people enrolled and 502 were randomized, and it failed to show a significant benefit on the primary weight-loss endpoint [2]. That result is sponsor-reported phase 2 data rather than a peer-reviewed randomized trial, and there are no robust human data for visceral-fat reduction or other metabolic benefit [2].

The animal work is real but preclinical. In obese Zucker rats, oral AOD9604 at 500 micrograms/kg daily for 19 days cut weight gain to 15.8 g versus 35.6 g in controls [9]. In obese mice, 14 days of injected AOD9604 reduced body weight and fat, and the long-term effect was not seen in mice lacking the beta-3 adrenergic receptor [10]. There is no approved dose; the human trial tested an oral candidate [2].

What is known about safety

FDA says it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear, and gives no details [3]. A 2026 review concludes human evidence is limited and largely short-term [2], and a separate 2026 review of unapproved peptides notes that many look favorable in animals while rigorous human safety data are scarce and serious harm is possible [11].

Buying it online, and the sports ban

AOD-9604 circulates on the gray market; Belgian authorities and US investigators have identified it in seized or confiscated vials [12][8]. Claims that it is GRAS trace back to the developer, not to FDA: FDA's GRAS Notice Inventory contains no AOD-9604 notice, and GRAS is a food-ingredient concept that would not make an injectable lawful as a drug [13].

For athletes, WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3, prohibited at all times, in and out of competition. It is on the 2026 List, in force since January 1, 2026, and stays on the 2027 List [7][14].