Is AOD-9604 Legal in Washington State? How to Access It Through a Prescription

Does a Washington prescription make AOD-9604 legal?

A prescription does not make AOD-9604 FDA-approved. FDA says state-licensed pharmacies and physicians may compound only from bulk substances that meet its stated requirements: a USP or NF monograph, a component of an FDA-approved drug, or a place on FDA's list of bulk substances that compounders may use [4]. AOD-9604 is in none of the three categories on FDA's lists for state-licensed pharmacies and physicians or for outsourcing facilities, and FDA's category 1 policy, under which the agency generally does not act against compounders who meet stated conditions, does not cover it [2][3][4]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before marketing [7][8][11].

What FDA says about AOD-9604 specifically

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in its nominated-but-withdrawn table, which holds substances previously in category 2 that their nominators withdrew [1]. FDA's stated concerns are that compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration because of peptide impurities and characterization problems, that it has identified no or only limited safety information, and that 'FDA has also identified 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 is not among the six peptides in HHS's draft enforcement-discretion policy filed October 28, 2026 [7][8].

What the human evidence shows

A 2026 review reports that a 24-week study of AOD9604 as an oral anti-obesity drug candidate did not show a significant weight-loss benefit [6]. The review says this conclusion rests on sponsor-reported phase 2 results rather than a peer-reviewed randomized efficacy paper, and that robust human data for visceral-fat reduction or other metabolic benefit are lacking [6]. There is no approved dose, and no efficacy trials of injected gray-market products were found [6]. In obese Zucker rats, oral AOD-9604 at 500 microgram/kg daily for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls [12].

Washington State

Washington's Department of Health licenses pharmacists and pharmacies [10]. Its licensing page does not mention AOD-9604, so the federal position described above is the one that applies to a compounded product: not in any of FDA's three active categories, and listed by FDA in the nominated-but-withdrawn table with stated safety concerns [1][2][3][4].