Is AOD-9604 Legal in North Carolina?

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 front [10]. An Australian company developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002, and it never reached approval [11][1]. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before they reach patients [12].

What FDA's compounding lists show

Under FDA's compounding framework, state-licensed pharmacists and physicians may use a bulk substance only when it meets an applicable USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA's list of permitted bulk substances [5]. AOD-9604 does not appear in the cited FDA categories, and it is absent from FDA's outsourcing-facility list [3][4].

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in the table of nominations withdrawn, which holds substances previously placed in its higher-risk group [2]. FDA's stated concerns: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration (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' [2]. Moving it out of that higher-risk group was not a finding that it is safe [2]. AOD-9604 is also not among the six peptides in HHS's draft enforcement-discretion policy for compounding: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [6][7].

North Carolina

The federal records on this page show only that AOD-9604 is not FDA-approved and is absent from the FDA compounding categories and the outsourcing-facility list [11][1][3][4][5]. They do not settle whether a particular activity involving it is legal under North Carolina law.

Sport and testing

WADA names AOD-9604 and hGH 176-191 in section S2.2.3, growth hormone fragments, and prohibits them at all times, in and out of competition; both appear on the 2026 List and the tracked-changes 2027 List [8][9].

What the human evidence shows

A 24-week human study of oral AOD9604 enrolled 534 participants, with 502 randomized, and failed to show a significant benefit on the primary weight-loss endpoint [1]. That conclusion rests on sponsor-reported phase 2 results rather than a peer-reviewed efficacy paper [1]. There is no approved dose [1]. In animals, obese Zucker rats given oral AOD9604 at 500 microgram/kg/day for 19 days gained 15.8 g versus 35.6 g in controls [13].