Is AOD-9604 Legal in Wisconsin? Federal Rules, State Law, and How to Get It

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone, hGH residues 177 to 191 plus an added tyrosine, which is why it is also sold as hGH fragment 176-191 [12]. Preclinical work found no binding to the growth hormone receptor [2]. Metabolic Pharmaceuticals developed it as an obesity drug candidate; phase IIa trials were under way by February 2002, it never reached approval, and the obesity program was later dropped [1][2].

What the federal rules say

AOD-9604 has no FDA-approved drug product [1][2]. FDA's page on bulk substances that may present significant safety risks lists it in the 'nominated but withdrawn' table. FDA's stated concerns: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration from 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.' Withdrawal was not a finding of safety [3].

It appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians (updated May 14, 2026), and it is absent from FDA's list for outsourcing facilities (updated March 21, 2025). FDA's category 1 policy, under which the agency generally takes no action against compounders that meet its conditions, does not cover it [4][5][8]. HHS's draft enforcement-discretion policy for compounded peptides names six peptides, and AOD-9604 is not one of them [9][10]. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before marketing [9][10].

What Wisconsin adds

Chapter 450 of the Wisconsin Statutes covers the pharmacy examining board, pharmacist and pharmacy licensure, and prescription drug labeling and dispensing. Chapter 448 covers medical practice and the medical examining board [6][7]. Their section headings are general licensing and practice topics, and none is specific to AOD-9604 or to peptides.

Is AOD-9604 prohibited in sport? Yes

WADA's Prohibited List names AOD-9604 and hGH 176-191 in S2.2.3, growth hormone fragments, prohibited at all times in and out of competition; it is on the 2026 List and stays on the 2027 List [11][13]. Anti-doping scientists have validated a urine method that detects the peptide and its stable metabolite [12].

What about 'GRAS' and interstate shipping?

FDA's GRAS Notice Inventory contains no AOD-9604 entry, and GRAS is a food-ingredient concept that would not make an injectable lawful as a drug [14]. FDA states that a drug must be the subject of an approved marketing application before it is transported across state lines, and that an IND is how a sponsor obtains an exemption for investigational use [15]. AOD-9604 has been identified in confiscated vials in the United States and in preparations seized by Belgian authorities [12][16].