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

Where does AOD-9604 sit in FDA's compounding lists?

AOD-9604 was previously in category 2 of FDA's interim policies and now sits in the 'nominated but withdrawn' table, which holds substances their nominators withdrew [4]. Removal from category 2 was not a finding that it is safe. FDA's stated concerns remain: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration, 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' [4].

It appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, updated May 14, 2026, and is absent from the outsourcing facility list updated March 21, 2025 [5][6][7]. The category 1 policy, under which FDA generally does not act against compounders that meet certain conditions, therefore does not cover it [7]. Nor is it one of the six peptides in HHS's draft enforcement-discretion policy, filed October 28, 2026, or on the agenda of FDA's July 2026 advisory committee [10][11][12]. Claims that it is GRAS do not hold: FDA's GRAS Notice Inventory has no AOD-9604 entry, and GRAS concerns food ingredients, not injected drugs [8].

Is there a Texas-specific rule?

This page identifies no Texas statute or Texas State Board of Pharmacy rule that names AOD-9604 or makes it available. The federal position above is the one that can be documented. A patient-specific prescription is only one condition of federal compounding law, not a route by itself, and the category 1 interim policy does not cover AOD-9604 [7].

There is also no approved dose [2]. The human obesity study described in a 2026 review tested an oral drug candidate, and no efficacy trials of injected gray-market products were found [2]. The injected-drug studies are in animals: obese mice and, for joint claims, rabbits with knee osteoarthritis [13][15].

What does the human evidence show?

A 2026 peer-reviewed review reports that a 24-week study (534 enrolled, 502 randomized) of AOD9604 as an oral anti-obesity candidate failed to show a significant benefit on its primary weight-loss endpoint. It notes that this conclusion rests on sponsor-reported phase 2 results rather than published randomized trials, and it found no robust human data for visceral-fat reduction or other metabolic benefit [2].

The animal data are stronger. In obese Zucker rats, oral AOD9604 at 500 microgram/kg/day for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls [14]. In obese mice, 14 days of injected AOD9604 reduced body weight and fat [15].

What else should someone considering it know?

FDA gives no details of the serious adverse events it has identified, and a 2026 review concludes human evidence is limited and largely short-term [4][2]. With no approved product, there is no FDA-reviewed label setting out warnings, interactions or monitoring. Athletes should know WADA names AOD-9604 and hGH 176-191 in S2.2.3, prohibited at all times in and out of competition. It is on the 2026 List and stays on the 2027 List [9][16].