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Is AOD-9604 Legal in Maryland?

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HealthRX.com

AOD-9604 has no federal approval or compounding listing

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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 / Not approved for any use [1][2]
  • FDA compounding-risk page / Listed in the 'nominated but withdrawn' table; concerns include immunogenicity, limited safety data and serious adverse events of unclear causality [3]
  • State-licensed pharmacy list / In none of the three categories; the category 1 policy does not cover it [4][6]
  • Outsourcing-facility list / Not listed [5]
  • HHS draft peptide policy / Not one of the six named peptides [7][8]
  • Sport / WADA prohibits AOD-9604 at all times [9][10]

What is AOD-9604?

AOD-9604 is a 16-amino-acid modified 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 called hGH fragment 176-191 [11][2]. It is not full-length growth hormone. Metabolic Pharmaceuticals developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002, and it never reached FDA approval [1][2].

The human efficacy record is thin. A 2026 review states that a 24-week oral study (534 enrolled, 502 randomized) failed to show a significant benefit on the primary weight-loss endpoint, and the review says that conclusion rests on sponsor-reported phase 2 results [2].

Is AOD-9604 on FDA's compounding lists?

No. FDA's list for state-licensed pharmacies and physicians has three categories; AOD-9604 appears in none of them, so the category 1 no-action policy does not apply [4][6]. FDA's list for outsourcing facilities does not include it either [5]. AOD-9604 is not one of the six peptides named in HHS's draft enforcement-discretion policy for compounding [7][8].

FDA's safety-risk page places AOD-9604 in the 'nominated but withdrawn' table, which holds substances previously in category 2 whose nominators withdrew them. FDA's stated concerns are immunogenicity risk for certain routes of administration due to peptide impurities and characterization problems, no or limited safety information, and 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 [3].

Does a prescription make it legal?

FDA describes a valid patient-specific prescription as one of the conditions for the state-licensed compounding exemption; a prescription alone does not make a product FDA-approved [12]. FDA also states that compounded drugs are not FDA-approved and that it does not review their safety, effectiveness or quality before they reach patients [12]. On the federal record, there is no approved AOD-9604 product, and AOD-9604 has no listed bulk-substance route for compounding.

What about the GRAS claim?

FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA 'no questions' letter for it [13]. The developer announced in 2012 a 'conditional GRAS' conclusion 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 does not cover injected or compounded drug use [13]. GRAS is a food-ingredient concept, not a drug approval [14].

What does Maryland law say?

No Maryland statute or Board of Pharmacy rule specific to AOD-9604 is established here, so a Maryland yes-or-no answer cannot be given. What can be stated is the federal position: AOD-9604 is not approved and is outside FDA's compounding lists [1][2][4][5][6].

Is AOD-9604 banned in sport?

Yes. WADA's Prohibited List names AOD-9604 and hGH 176-191 in its growth-hormone-fragment section and prohibits them at all times, in and out of competition [9][10].

Check what you know

Think you have it? Try 5 quick questions and see what the article says.

1. Is AOD-9604 one of the six peptides named in HHS's draft enforcement-discretion policy for compounding?

Question 1 of 5

Score: 0 right, 0 of 5 answered

Frequently asked questions

Is AOD-9604 legal in Maryland?
AOD-9604 is not FDA-approved and is outside FDA's compounding lists, so there is no listed federal compounding route [1][2][4][5][6]. A Maryland-specific legal answer is not established by the federal record.
Is AOD-9604 FDA-approved?
No. AOD-9604 never received FDA approval as a drug [1][2]. FDA's GRAS Notice Inventory has no AOD-9604 notice, and the developer's conditional GRAS panel was not an FDA review [13].
Can a state-licensed pharmacy compound AOD-9604?
FDA says a state-licensed pharmacy may compound only with a bulk substance that meets a USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA's bulks list. AOD-9604 is not approved and is not in any of the three categories on FDA's list [4][6].
Did FDA declare AOD-9604 safe through GRAS?
No. FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA no-questions letter [13]. The developer's 2012 conditional GRAS conclusion came from a panel it commissioned and covered food or drink use at up to 1 mg per day, not injected drug use [13].
Is AOD-9604 banned in sport?
Yes. WADA names AOD-9604 and hGH 176-191 in its growth-hormone-fragment section and prohibits them at all times, in and out of competition [9][10].

Reader questions

What people actually ask

Short answers drawn from the sources this article cites.

What peptides are legal in the USA?

Only AOD-9604 is covered here, and on the federal record it is not a legal option: it is not FDA-approved and appears in none of FDA's compounding categories. It is also not one of the six peptides named in HHS's draft enforcement-discretion policy for compounding.

Will peptides fail a drug test?

Whether a drug test would detect AOD-9604 is not established. What is stated is that WADA's Prohibited List names AOD-9604 and hGH 176-191 and prohibits them at all times, in and out of competition.

References

Show all 14 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. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA.
  4. U.S. Food and Drug Administration.
  5. U.S. Food and Drug Administration.
  6. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA.
  7. Official web page.
  8. Official web page.
  9. World Anti-Doping Agency.
  10. World Anti-Doping Agency.
  11. 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.
  12. Human Drug Compounding Laws | FDA.
  13. GRAS Notices.
  14. Generally Recognized as Safe (GRAS) | FDA.
Evidence overview for Is AOD-9604 Legal in Maryland?