Is AOD-9604 Legal in Arizona? 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: residues 177 to 191 with an extra tyrosine at the N-terminus, which is why it also appears as hGH fragment 176-191 [10]. An Australian company, Metabolic Pharmaceuticals, developed it as an obesity drug candidate, with phase IIa trials underway by February 2002; it was never approved [1][2].

Where AOD-9604 stands on FDA compounding lists

FDA says a state-licensed pharmacist or physician may compound only with bulk substances that meet a USP or NF monograph, are components of FDA-approved drug products, or appear on FDA's list of bulk substances that can be used in compounding [5]. AOD-9604 is in none of the three interim-policy categories [3][5], and it is not on FDA's list for registered outsourcing facilities [4]. FDA's interim policy of generally not acting against compounders using certain nominated substances (category 1) does not cover it [5].

FDA lists AOD-9604 in its table of substances whose nominations were withdrawn after earlier placement in category 2. It describes these concerns: 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 it, though causality is not clear [7]. Removal from category 2 was not a finding that it is safe [7]. HHS's draft enforcement-discretion policy for compounded peptides, filed October 28, 2026, names six peptides (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500) and not AOD-9604 [6][8]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before they reach patients [11].

What human evidence shows

A 2026 review reports that a 24-week study (534 enrolled, 502 randomized) of oral AOD9604 as an anti-obesity drug candidate showed no significant benefit on the primary weight-loss endpoint, based on sponsor-reported phase 2 results rather than peer-reviewed trials [2]. The lipolytic data come from animals: in obese Zucker rats, oral AOD9604 500 microgram/kg daily for 19 days cut weight gain to 15.8 g versus 35.6 g in controls [12]. The human obesity study tested an oral product, and no efficacy trial of injected AOD-9604 in people has been identified [2]. An intra-articular formulation has been tested only in rabbits with knee osteoarthritis [13].

The GRAS claim

FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA no-questions letter for it [14]. The developer announced a conditional GRAS conclusion from a panel it commissioned; that was not an FDA review, and GRAS is a food-ingredient concept that would not make an injectable lawful as a drug [14].