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

What is AOD-9604 and what is its federal status?

AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus, which is why it is also called hGH fragment 176-191 [9]. It is not full-length growth hormone [9]. Metabolic Pharmaceuticals developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002, it never reached approval, and the obesity program was later dropped [5][6].

It is not an FDA-approved drug, yet it circulates outside regulated channels: AOD-9604 is sold on several internet websites, was found in confiscated vials in the USA, and was identified in preparations seized by Belgian authorities [9][10].

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

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in the 'nominated but withdrawn' table, which holds substances previously in category 2 whose nominators withdrew them [1]. FDA's stated concerns are 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 [1]. Removal from category 2 was not a finding that the substance is safe [1].

AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians (updated May 14, 2026) or on FDA's list for outsourcing facilities (updated March 21, 2025) [2][3][4]. Under category 1, FDA generally does not intend to act against compounders who meet the guidance conditions; that policy does not cover AOD-9604 [4]. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they reach patients [11].

Does the 2026 HHS peptide policy cover AOD-9604?

No. HHS's draft enforcement-discretion policy for compounded peptides, filed October 28, 2026 as Federal Register document 2026-22192 with publication scheduled for October 30, 2026, names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [7][8]. AOD-9604 is not one of them, and it was not on the agenda of FDA's July 2026 Pharmacy Compounding Advisory Committee meeting [12].

What did the human trials show?

The main human obesity study described in a 2026 review was a 24-week trial of oral AOD9604 (534 enrolled, 502 randomized) that failed to show a significant benefit on the primary weight-loss endpoint [6]. The review notes that conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials, and that there are no robust human data for visceral-fat reduction or other metabolic benefit [6]. A 2026 review of gray-market peptides notes that many unapproved peptides show favorable animal results while rigorous human safety data are scarce [13].

What does this mean in Tennessee?

FDA's listings do not say whether a Tennessee pharmacy may compound or dispense AOD-9604. Tennessee's own compounding and prescribing rules are a separate layer that FDA's pages do not address.