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

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At a glance

  • Federal approval / Not FDA-approved for any indication [1]
  • FDA list for state-licensed pharmacies and physicians / Appears in none of the three categories [2][4]
  • FDA list for outsourcing facilities / Does not appear [3]
  • FDA safety view / In the nominated-but-withdrawn table with stated safety concerns [5]
  • HHS draft peptide policy / Not one of the six peptides covered [6][7]
  • Anti-doping / WADA prohibits it at all times [8]

What Is AOD-9604?

AOD-9604, also sold as AOD9604 or hGH fragment 176-191, is a 16-amino-acid piece of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus [9]. It is not full-length growth hormone. An Australian company, Metabolic Pharmaceuticals, developed it as an anti-obesity candidate, with phase IIa trials under way by February 2002 [10]. It never reached approval and the obesity program was later dropped [10][1].

What Is Its Federal Status?

FDA's page says state-licensed pharmacists and physicians may compound from a bulk substance only if it complies with a USP or NF monograph, is a component of an FDA-approved drug product, or appears on FDA's list of bulk substances that can be used in compounding [4]. FDA's interim policy sorts nominated substances into three categories, and under category 1 FDA generally does not intend to act against compounders who meet the policy's conditions [4]. AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, so the category 1 policy does not extend to it [2][4]. It is also absent from FDA's list for outsourcing facilities [3].

These federal facts do not address South Carolina requirements, so they do not establish whether a particular route of access is lawful there, and they do not show a statewide ban.

What Safety Concerns Does FDA List?

FDA's page on bulk substances that may present significant safety risks when compounded places AOD-9604 in the nominated-but-withdrawn table, which holds substances previously in category 2 whose nominators withdrew them [5]. FDA's stated concerns are possible immunogenicity risk for certain routes of administration, peptide impurities and characterization problems, no or only limited safety information, and 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].

Is It Covered by the HHS Peptide Policy?

No. HHS filed a draft enforcement-discretion policy for compounding on October 28, 2026 covering six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 [6][7]. AOD-9604 is not among them, and it was not on the agenda of FDA's July 2026 advisory committee meeting [6][7][11].

Is It Banned in Sport?

Yes. WADA names AOD-9604 and hGH 176-191 in section S2.2.3 as growth hormone fragments and prohibits them at all times, in and out of competition [8]. It is on the 2026 List and remains on the 2027 List [8][12].

AOD-9604 has also been identified in confiscated vials in the US and in preparations seized by Belgian authorities [9][13].

Frequently asked questions

Is AOD-9604 legal in South Carolina?
AOD-9604 is not FDA-approved, and FDA's category 1 compounding policy does not cover it [1][2][3][4]. The federal facts do not address South Carolina rules, so they establish neither a lawful access route nor a statewide ban.
Is AOD-9604 FDA-approved?
No. Metabolic Pharmaceuticals developed it as an anti-obesity candidate, phase IIa trials were under way by February 2002, and it was never approved [10][1].
Is AOD-9604 GRAS?
FDA's GRAS Notice Inventory has no AOD-9604 notice, so there is no FDA no-questions letter [14]. GRAS is a food-ingredient concept and would not make an injectable lawful as a drug. The developer announced a conditional GRAS conclusion in 2012 from a panel it commissioned, for food or drink use at up to 1 mg per day; that was not an FDA review [14].
Is AOD-9604 banned in sport?
Yes. WADA names AOD-9604 and hGH 176-191 in section S2.2.3 and prohibits them at all times, on both the 2026 and 2027 Lists [8][12].
Is there an approved dose of AOD-9604?
No approved dose exists. A 2026 review describes a 24-week oral anti-obesity study, reported by the sponsor, that did not show a significant benefit on its primary weight-loss endpoint [1].
Is AOD-9604 the same as human growth hormone?
No. It is a 16-amino-acid fragment, hGH amino acids 177 to 191 with an added tyrosine, and preclinical work found no growth-hormone-receptor binding [1][9].

References

  1. Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, RuchaŁa M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  4. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA
  5. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  6. Official web page. Official web page
  7. Official web page. Official web page
  8. World Anti-Doping Agency. World Anti-Doping Agency
  9. Cox HD, Smeal SJ, Hughes CM, Cox JE, Eichner D. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31-8. Detection and in vitro metabolism of AOD9604
  10. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
  11. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  12. World Anti-Doping Agency. World Anti-Doping Agency
  13. Vanhee C, Moens G, Deconinck E, De Beer JO. Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604. Drug Test Anal. 2014;6(9):964-8. Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604
  14. GRAS Notices. GRAS Notices
Evidence overview for Is AOD-9604 Legal in South Carolina? How to Access It Legally