Is AOD-9604 Legal in Michigan?

What AOD-9604 is

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, which is why it is also called hGH fragment 176-191 [8]. It is not full-length growth hormone. An Australian company, Metabolic Pharmaceuticals, developed it as an obesity drug candidate, and phase IIa trials were under way by February 2002 [9]. It is not an FDA-approved drug [1].

A 2026 review reports that a 24-week oral AOD-9604 obesity study failed its primary weight-loss endpoint, and notes that this conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials [1]. There is no approved dose [1].

What the federal compounding rules say

FDA's stated conditions for state-licensed pharmacies and licensed physicians: they may compound using a bulk drug substance only if it complies with an applicable USP or NF monograph, is a component of an FDA-approved drug product when no monograph exists, or appears on FDA's list of bulk drug substances that can be used in compounding, with a valid certificate of analysis and a substance made by an FDA-registered establishment [4].

FDA's interim policy sorts nominated substances into three categories. For category 1 substances, FDA says it generally does not intend to take action against compounders, provided the policy's conditions are met [4]. AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, and it is absent from FDA's corresponding list for outsourcing facilities [2][3][4]. The category 1 policy therefore does not cover it [4].

Compounded drugs are not FDA-approved in any case; FDA does not verify their safety, effectiveness or quality before they are marketed [10].

What FDA recorded about safety

FDA's page on bulk substances that may present significant safety risks places AOD-9604 in the table of substances previously in category 2 whose nominators later withdrew them [5]. The recorded concerns: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration because of 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" [5]. Removal from category 2 was not a finding that it is safe [5].

AOD-9604 is not one of the six peptides in HHS's draft enforcement-discretion policy filed October 28, 2026, and it was not on the agenda of FDA's July 2026 advisory committee meeting [11][12][13].

FDA's GRAS Notice Inventory contains no AOD-9604 notice [14]. GRAS applies to food ingredients and is not an authorization to market an injectable as a drug [14].

Michigan law

MCL 333.17701 is a definitions section of the Michigan Public Health Code's pharmacy part [6]. It does not mention AOD-9604, peptides, bulk drug substances or compounding standards [6]. FDA states that state boards of pharmacy generally have primary day-to-day oversight of state-licensed pharmacies, so Michigan-specific requirements may also apply to a pharmacy [10]. This page does not resolve what those requirements are.

Sport

WADA's Prohibited List names AOD-9604 and hGH 176-191 under S2.2.3, growth hormone fragments, and prohibits them at all times, in and out of competition; S2 substances are non-Specified Substances [7]. It is on the 2026 List and stays on the 2027 List [7][15].