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

What is AOD-9604?

AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine added at the N-terminus [11]. It is not full-length growth hormone [11]. Metabolic Pharmaceuticals developed it as an anti-obesity candidate, and phase IIa trials were underway by February 2002 [1]. It never reached approval, and the obesity program was later dropped [2]. FDA's GRAS Notice Inventory contains no AOD-9604 notice [12].

Is it on FDA's compounding lists?

Under FDA's rules for state-licensed pharmacies and physicians, a bulk substance must meet a USP or NF monograph, be a component of an FDA-approved drug, or appear on FDA's list of bulk substances that can be used in compounding [5]. AOD-9604 is in none of the three categories on FDA's list for state-licensed pharmacies and physicians [3]. Because it is not in category 1, FDA's category 1 interim policy does not cover it [3][5]. It is also absent from FDA's list for outsourcing facilities [4].

AOD-9604 does appear in FDA's 'nominated but withdrawn' table, which holds substances previously in category 2 [6]. FDA's stated concerns include immunogenicity risk for certain routes of administration from peptide impurities and characterization problems, no or only limited safety information, and serious adverse events that may be associated with AOD-9604, though causality is not clear [6]. Removal from category 2 was not a finding that it is safe [6].

What changed in federal peptide policy?

HHS filed a draft enforcement-discretion policy for six peptides on October 28, 2026: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [7][8]. AOD-9604 is not one of them [7][8], and it was not on the agenda of FDA's July 2026 Pharmacy Compounding Advisory Committee meeting [13]. Compounded drugs are not FDA-approved; FDA does not review their safety, effectiveness or quality before marketing [14].

What about North Carolina?

The federal findings above do not tell us what North Carolina law permits for a given use, and this page does not give a state-law conclusion. At the federal level, FDA says one condition for compounding by state-licensed pharmacies and physicians is a valid patient-specific prescription, and the bulk substance must also meet the monograph, approved-drug component or list condition [5][14]. FDA also describes an investigational new drug (IND) application as the way a sponsor or physician studies an unapproved drug in humans; that is a research pathway, not ordinary access through a prescription [18].

What does the human evidence show?

A 2026 review describes a 24-week oral human obesity study of AOD9604 (534 enrolled, 502 randomized) that failed to show a significant benefit on its primary weight-loss endpoint [2]. The review says this conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials, and that there are no robust data for visceral-fat reduction or other metabolic benefit in humans [2]. There is no approved dose [2]. In obese rats, oral AOD9604 at 500 microgram/kg daily for 19 days cut body-weight gain by more than half compared with controls [15]. In obese mice, 14 days of injected AOD9604 reduced body weight and fat [16]. The human obesity study tested an oral candidate, not an injected product [2].

What are the practical limits?

AOD-9604 has been identified in confiscated vials in the USA and in preparations seized by Belgian authorities [11][17]. FDA says it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear [6]. For athletes, WADA names AOD-9604 and hGH 176-191 in S2.2.3 and prohibits them at all times, in and out of competition [9][10].