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

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone: residues 177 to 191 plus an N-terminal tyrosine, hence the name hGH fragment 176-191. It is not full-length growth hormone, and preclinical work found no growth-hormone-receptor binding [11][2].

Its developer, Metabolic, had phase IIa trials under way by February 2002, and the compound never reached approval [1][2]. A 24-week study of an oral formulation (534 enrolled, 502 randomized) failed to show a significant benefit on the primary weight-loss endpoint. That result is sponsor-reported, and there is no approved dose [2].

The federal position

Under FDA's rules, a state-licensed pharmacy or physician may compound only from a bulk substance that meets a USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA's list of bulk substances that can be used in compounding [5]. FDA's interim policy also sorts nominated substances into categories 1, 2 and 3, and FDA does not intend to act against compounding of category 1 substances when the guidance conditions are met [5]. AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, and it is not on FDA's list for outsourcing facilities [3][4]. The category 1 policy therefore does not cover it.

AOD-9604 does appear on one FDA page: the table of substances nominated but withdrawn, which holds substances previously in category 2 whose nominators pulled them [6]. FDA's stated concerns there 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 FDA has identified no, or only limited, safety information; and that FDA has identified serious adverse events that may be associated with AOD-9604, though causality is not clear. Removal from category 2 was not a finding that it is safe [6].

HHS's draft enforcement-discretion policy for compounded peptides, filed October 28, 2026, names six - BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 - not AOD-9604. The peptide was also absent from FDA's July 2026 advisory committee agenda [7][8][12].

Florida

The Florida provision cited here is F.S. 458.331, which lists grounds for disciplining a physician, including deceptive or fraudulent representations in the practice of medicine and failing to perform a statutory or legal obligation placed on a licensed physician [9]. It does not name AOD-9604, and it does not establish whether a Florida pharmacy can compound it [9].

What is documented instead

AOD-9604 circulates on the gray market: Belgian authorities identified it in seized pharmaceutical preparations and US investigators found it in confiscated vials [13][11]. WADA names AOD-9604 and hGH 176-191 in section S2.2.3, prohibited at all times, on both the 2026 and 2027 Lists [10][14].