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

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See the public record for AOD-9604

What AOD-9604 is

AOD-9604 is a 16-amino-acid piece of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus, which is why it also circulates as hGH fragment 176-191 [11]. It is not full-length growth hormone. Metabolic Pharmaceuticals developed it as an anti-obesity candidate, with phase IIa trials underway by February 2002; it never reached approval and the obesity program was later dropped [4][5].

Is it legal to compound in California?

FDA's page says state-licensed pharmacies and physicians may compound only with a bulk substance that has a USP or National Formulary monograph, is a component of an FDA-approved drug product, or appears on FDA's bulks list [3]. AOD-9604 appears in none of the three categories on FDA's interim-policy list for state-licensed pharmacies and physicians, in none of the categories on the list for outsourcing facilities, and FDA's category 1 policy does not cover it [1][2][3]. California's own rules on top of this federal baseline are outside what this page covers.

FDA's page on bulk substances that may raise significant safety risks, in content dated April 22, 2026, lists AOD-9604 among substances previously in category 2 whose nominators withdrew them [6]. The concerns recorded there are immunogenicity risk from peptide impurities and characterization problems for certain routes of administration, no or only limited safety information, and serious adverse events that may be associated with AOD-9604, though causality is not clear [6]. Removal from category 2 was not a finding that it is safe [6].

HHS's October 2026 draft enforcement-discretion policy for compounded peptides names six peptides — BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 — and AOD-9604 is not among them [7][8]. Compounded drugs are not FDA-approved; FDA does not verify their safety, effectiveness or quality before they are marketed [12].

Is there human evidence that it works?

One 24-week study — 534 people enrolled, 502 randomized — tested oral AOD9604 as an obesity drug and failed to show a significant benefit on the primary weight-loss endpoint [5]. A 2026 review notes that result rests on sponsor-reported phase 2 data rather than peer-reviewed randomized trials [5]. No dose has been approved [5].

What else applies

WADA's Prohibited List names AOD-9604 and hGH 176-191 in S2.2.3, growth hormone fragments, and prohibits them at all times, in and out of competition; it is on the 2026 List and stays on the 2027 List [9][10]. A 2026 review of gray-market peptides concluded that rigorous human safety data are scarce and there is potential for serious harm [13].