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

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What is AOD-9604's federal status?

AOD-9604 is not an FDA-approved drug [1][5]. It is a 16-amino-acid fragment of human growth hormone — hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus — hence the alternative name hGH fragment 176-191 [10]. Metabolic Pharmaceuticals, an Australian company, 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 [1][5].

The main human test described in the literature was a 24-week oral study: 534 people enrolled and 502 were randomized, and it failed to show a significant benefit on the primary weight-loss endpoint, on sponsor-reported phase 2 results [5].

Can a compounding pharmacy supply AOD-9604?

FDA lists AOD-9604 in the table of substances nominated for compounding and then withdrawn by the nominator; these were previously in category 2 [2]. FDA's stated concerns: 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 identified serious adverse events that may be associated with AOD-9604, though causality is not clear [2]. Removal from category 2 was not a finding that it is safe [2].

AOD-9604 is in no category on FDA's list for state-licensed pharmacies and physicians and is absent from FDA's list for outsourcing facilities, so the interim policy of generally not acting against compounders does not cover it [6][7][3]. It is also not one of the six peptides in HHS's draft enforcement-discretion policy filed in October 2026, and was not on the agenda of FDA's July 2026 advisory committee [4][11][12]. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before marketing [13].

Does Pennsylvania add anything?

This page does not establish any Pennsylvania-specific rule for AOD-9604. Under federal law, state-licensed pharmacies and physicians may compound only with bulk substances that meet USP or NF monograph requirements, are components of FDA-approved drugs, or appear on FDA's list of bulk substances that compounders may use [3].

Is AOD-9604 banned in sport?

Yes. WADA's Prohibited List names AOD-9604 and hGH 176-191 in S2.2.3, among growth hormone fragments, and prohibits them at all times, in and out of competition [8]. It is on the 2026 List and stays on the 2027 List [8][9].

What do the efficacy data show?

The animal data are the main support. In obese Zucker rats, oral AOD-9604 at 500 micrograms/kg/day for 19 days cut weight gain to 15.8 g versus 35.6 g in controls [14]. In obese mice, 14 days of injected peptide reduced body weight and fat; the long-term effect was not seen in mice lacking the beta-3 adrenergic receptor [15]. A 2026 review concludes human evidence is limited and largely short-term, with no robust data for visceral-fat reduction [5].