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

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HealthRX.com

No FDA-listed compounding route exists for AOD-9604

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From the public record

FDA product listings naming AOD-9604

The FDA NDC Directory holds 5 listings naming AOD-9604 from 5 firms: 5 bulk ingredient listings and 0 finished product listings, 0 under an FDA-approved application. A listing is a registration by a firm, not an FDA approval.

FDA product listings naming AOD-9604: the figures
MeasureValueNote
Listings naming AOD-96045
Bulk ingredient listings5raw material registrations, not finished medicines
Of those, bulk ingredient for human prescription compounding1
Finished product listings0
Listings under an FDA-approved application0
Firms with a listing5

Source: FDA, National Drug Code Directory via openFDA, data as of Nov 11, 2026

How this was calculated

Searched ingredient and product names in the NDC Directory download for the exact name variants, then counted listings by FDA marketing category and by listing firm.

Scope: Current NDC Directory listings whose ingredient or product name contains AOD-9604 or AOD 9604 or AOD9604

Firms submit listings themselves. A listing does not mean FDA has reviewed the substance for safety or effectiveness, or that it may lawfully be compounded.

Download the data (CSV)

At a glance

  • FDA approval / None; the obesity program was dropped [1][2]
  • FDA compounding lists / In none of the three categories for state-licensed pharmacies and physicians; absent from the outsourcing-facility list [3][4][5]
  • FDA safety view / In the nominated-but-withdrawn table; immunogenicity and serious adverse events of unclear cause noted [6]
  • HHS draft peptide policy (Oct 2026) / Does not include AOD-9604 [7][8]
  • Sport / Banned at all times by WADA, section S2.2.3 [10][11]
  • Human weight-loss data / 24-week oral study, 502 randomized, failed primary endpoint [2]
  • Approved dose / None [2]

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus, which is why it is also sold as hGH fragment 176-191 [12][2]. It is not full-length growth hormone. An Australian company, Metabolic Pharmaceuticals, developed it as an anti-obesity candidate; phase IIa trials were under way by February 2002, it never reached approval, and the obesity program was later dropped [1][2].

The federal position

FDA's page on bulk drug substances says a state-licensed pharmacy may compound only with a bulk substance that complies with a USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA's bulks list [5]. AOD-9604 appears in none of the three interim categories on FDA's list for state-licensed pharmacies and physicians (updated May 14, 2026) and is absent from the list for outsourcing facilities (updated March 21, 2025). FDA's category 1 no-action policy does not cover it [3][4][5].

Where it does appear is FDA's page on bulk substances that may present significant safety risks, in the nominated-but-withdrawn table [6]. FDA's stated concerns: compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration due to peptide impurities and characterization problems; FDA has identified no, or only limited, safety information; and 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].

Two 2026 actions leave it out. HHS filed a draft enforcement-discretion policy covering six compounded peptides (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500) on October 28, 2026; AOD-9604 is not among them [7][8]. FDA's Pharmacy Compounding Advisory Committee, meeting July 23-24, 2026, took up those peptides plus emideltide; AOD-9604 was not on the agenda [13].

Questions worth asking

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What Pennsylvania adds

Pennsylvania's State Board of Pharmacy licenses, registers, certifies and disciplines pharmacies, pharmacists and pharmacy technicians, and decides case by case whether a licensee departed from a professional standard [9]. Its cited page does not name AOD-9604, so it does not establish a Pennsylvania-specific rule or pathway for the peptide; the federal position above is the one that applies.

AOD-9604 has been identified in confiscated vials in the United States and in pharmaceutical preparations seized by Belgian authorities, which shows it circulates outside licensed supply [12][14].

Human data, dosing and sport

A 2026 review describes a 24-week study of oral AOD9604, 534 enrolled and 502 randomized, that failed to show a significant benefit on the primary weight-loss endpoint. The review notes this rests on sponsor-reported phase 2 results rather than peer-reviewed trials, with no robust human data for visceral-fat reduction or other metabolic benefit [2]. There is no approved dose [2].

WADA's Prohibited List names AOD-9604 and hGH 176-191 in S2.2.3, prohibited at all times in and out of competition, on both the 2026 and 2027 Lists [10][11].

Check what you know

Think you have it? Try 4 quick questions and see what the article says.

1. According to the article, what is the FDA status of AOD-9604?

Question 1 of 4

Score: 0 right, 0 of 4 answered

Frequently asked questions

Is AOD-9604 legal in Pennsylvania?
There is no FDA-approved AOD-9604 product. It is in none of the three categories on FDA's list for state-licensed pharmacies and physicians, it is absent from FDA's list for outsourcing facilities, and it is not in HHS's October 2026 draft peptide policy [2][3][4][7]. Pennsylvania's pharmacy board page does not name it [9].
Can a compounding pharmacy make AOD-9604 for me?
FDA's page on bulk substances describes three routes for a state-licensed pharmacy to use a bulk substance: a USP or NF monograph, being a component of an FDA-approved drug, or appearing on FDA's bulks list [5]. AOD-9604 is in none of the three interim categories, and the category 1 no-action policy does not cover it [3][5].
Is AOD-9604 an FDA-approved drug?
No. It never reached approval, and the obesity program was dropped [1][2].
Is AOD-9604 GRAS?
FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA no-questions letter for it [15]. The developer announced in 2012 a conditional GRAS conclusion, reached by a panel it commissioned, for use as a food or drink ingredient at up to 1 mg per day. That was not an FDA review, and it does not cover injected or compounded drug use.
Is AOD-9604 the same as HGH?
No. It is a 16-amino-acid fragment (hGH amino acids 177 to 191 with an added N-terminal tyrosine), not full-length growth hormone, and preclinical work found no growth-hormone-receptor binding [12][2].

Reader questions

What people actually ask

Short answers drawn from the sources this article cites.

Where can I get AOD-9604 peptide online?

No approved AOD-9604 product exists, and it has no FDA-listed compounding route in Pennsylvania or anywhere else in the US. It appears in none of the three FDA categories for state-licensed pharmacies and physicians, and it is absent from the outsourcing-facility list. It has been found in confiscated vials and in preparations seized by Belgian authorities, which shows it circulates outside licensed supply.

How long does it take for an AOD-9604 to work?

No time to effect is established. The only human weight-loss data is a 24-week oral study with 502 randomized participants, which failed to show a significant benefit on the primary weight-loss endpoint. There is no approved dose.

References

Show all 15 referencesHide references
  1. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40.
  2. 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.
  3. U.S. Food and Drug Administration.
  4. U.S. Food and Drug Administration.
  5. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA.
  6. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA.
  7. Official web page.
  8. Official web page.
  9. Pharmacy | Department of State | Commonwealth of Pennsylvania.
  10. World Anti-Doping Agency.
  11. World Anti-Doping Agency.
  12. 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.
  13. U.S. Food and Drug Administration.
  14. 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.
  15. GRAS Notices.
Evidence overview for Is AOD-9604 Legal in Pennsylvania? How to Access It Legally