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

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13 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • FDA approval / None; not an approved drug [1]
  • FDA list for state-licensed pharmacies / In none of the three categories [2]
  • FDA outsourcing-facility list / Not listed [3]
  • FDA safety concerns / Immunogenicity risk, limited safety data, serious adverse events of unclear causality [5]
  • HHS peptide draft policy / Not among the six named peptides [6]
  • Human evidence / 24-week oral obesity study failed its primary weight-loss endpoint [7]

Is AOD-9604 legal in Virginia?

AOD-9604 is not an FDA-approved drug [1][7]. 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 — not full-length growth hormone [8]. It was developed as an obesity drug candidate, with phase IIa trials under way by February 2002; it never reached approval [1][7].

AOD-9604 sits in FDA's table of bulk substances previously in category 2 that their nominators withdrew, and FDA's concerns are published alongside it: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration (peptide impurities and characterization problems), FDA has identified no or only limited safety information, and FDA says it has identified 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].

What the federal compounding rules require

FDA's page says state-licensed physicians and pharmacists compounding under the federal rules for pharmacy compounding may only use bulk substances that comply with a USP or NF monograph, are components of FDA-approved drug products, or appear on FDA's list of bulk substances that can be used in compounding [4]. AOD-9604 is in none of the three categories on FDA's list for state-licensed pharmacies and physicians, so FDA's category 1 policy — under which the agency generally does not intend to act against qualifying compounders — does not cover it. It is also absent from FDA's list for outsourcing facilities [2][3][4].

HHS's draft enforcement-discretion policy for compounded peptides, filed October 28, 2026 as Federal Register document 2026-22192, names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. AOD-9604 is not one of them [6]. Sellers sometimes call it GRAS, but FDA's GRAS Notice Inventory contains no AOD-9604 notice, and GRAS is a food-ingredient concept that would not make an injectable lawful as a drug [9].

What the human evidence shows

A 24-week human study tested an oral formulation of AOD-9604 for obesity; it enrolled 534 people and randomized 502. It failed to show a significant benefit on the primary weight-loss endpoint, and the sponsor dropped the obesity program [7]. A 2026 review notes that this conclusion rests on sponsor-reported phase 2 results with no peer-reviewed randomized efficacy paper, and that there is no approved dose [7].

The fat-loss reputation comes from rodents: in obese Zucker rats, oral AOD9604 at 500 microgram/kg per day for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls [10]. Vials do circulate — Belgian authorities identified AOD-9604 in seized preparations and US investigators found it in confiscated vials [11][8]. WADA's Prohibited List names AOD-9604 and hGH 176-191 in S2.2.3, prohibited at all times, on the 2026 and 2027 Lists [12][13].

Frequently asked questions

Is AOD-9604 legal in Virginia?
It is not an FDA-approved drug and appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, so FDA's category 1 no-action policy does not cover it [2][4]. A lawful compounding route is not established.
Can a Virginia pharmacy compound AOD-9604?
FDA's page says a state-licensed pharmacy compounding under the federal rules for pharmacy compounding may only use a bulk substance that has 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 [4]. AOD-9604 is in none of the three categories on FDA's list, so the category 1 no-action policy does not cover it [2][4].
Does AOD-9604 work for weight loss?
The fat-loss evidence is from rodents. The 24-week oral human study that enrolled 534 people and randomized 502 failed its primary weight-loss endpoint, and the sponsor dropped the program [7]. The peptide never reached FDA approval [1].
What does the FDA say about safety?
FDA states that compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration and that it has identified serious adverse events that may be associated with AOD-9604, though causality is not clear [5].

References

  1. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
  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 Under Section 503A of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding Under Section 503A 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. 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
  8. 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
  9. GRAS Notices. GRAS Notices
  10. Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res. 2000;53(6):274-8. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone
  11. 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
  12. World Anti-Doping Agency. World Anti-Doping Agency
  13. World Anti-Doping Agency. World Anti-Doping Agency
Evidence overview for Is AOD-9604 Legal in Virginia? How to Access It Legally