Is AOD-9604 Legal in California? FDA Status, Prescriptions, and How to Get It

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Key numbers

• 24-weekDuration of the oral AOD9604 weight-loss study that failed its primary endpointSource: pubmed.ncbi.nlm.nih.gov, as cited 2026-11-07
• 534 enrolledPeople enrolled in the 24-week oral AOD9604 weight-loss studySource: pubmed.ncbi.nlm.nih.gov, as cited 2026-11-07
• 502 randomizedParticipants randomized in the 24-week oral AOD9604 weight-loss studySource: pubmed.ncbi.nlm.nih.gov, as cited 2026-11-07

At a glance

• FDA approval / None, for any indication [4][5]
• FDA bulk list, state-licensed pharmacies / Not listed; in the nominated-but-withdrawn table [1][3]
• FDA bulk list, outsourcing facilities / Not listed [6]
• Approved dose / None exists [5]

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone, also called hGH fragment 176-191 [7]. It is not full-length growth hormone. Metabolic Pharmaceuticals developed it as an anti-obesity candidate, and phase IIa trials were under way by February 2002 [4][5].

Is AOD-9604 FDA-approved?

No. It never reached approval, and its obesity development program was later dropped [4][5]. A 2026 review describes a 24-week study with 534 enrolled and 502 randomized that tested oral AOD9604 and failed to show a significant benefit on the primary weight-loss endpoint. The review notes the conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed trials [5].

Can a California pharmacy compound it?

FDA says state-licensed pharmacies and physicians may compound only from bulk substances that meet set conditions. The substance must comply with an applicable USP or NF monograph if one exists, be a component of an FDA-approved drug where no monograph exists, or appear on FDA's list of bulk substances that can be used in compounding [2]. AOD-9604 does not appear on that list, and FDA's category 1 no-action policy does not cover it [1][2].

FDA's safety-risk page lists AOD-9604 in the table of substances previously in category 2 whose nominators withdrew them. The stated concerns are immunogenicity risk for certain routes, no or only limited safety information, and serious adverse events that may be associated with AOD-9604, though causality is not clear [3]. FDA does not present removal from category 2 as a finding that the substance is safe [3].

What about prescriptions and larger facilities?

FDA lists a valid patient-specific prescription as one condition for pharmacy compounding, not the only one [8][2]. Outsourcing facilities use a separate FDA bulk-substance list, and AOD-9604 is not on that list either [6]. A federal draft policy filed on 28 October 2026 would cover six other compounded peptides, not AOD-9604 [9][10]. FDA also states that compounded drugs are not FDA-approved, so FDA does not review their safety, effectiveness or quality before they reach patients [8].

Questions worth asking

Choose the questions you want to keep

Which FDA bulk substance list should my pharmacist check before compounding a peptide?Does the California State Board of Pharmacy have its own rules for compounded peptides?Does GRAS status make an injectable peptide lawful as a drug?

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Dr Ashley Froese on why peptide legality depends on prescriptions and unregulated sourcing

Dr. Froese says peptides are only sort of legal, since some need a prescription and she herself cannot prescribe most of them right now. She stresses that she will not point viewers toward buying research compounds, and she warns that they are often bought from sellers with little oversight. She argues that a certificate of analysis shown on a website does not prove purity, because these documents can be faked. In her view, the peptide market is largely unregulated, so purity varies widely and buyers should be cautious about where they get their supply.

Whether peptides are legal and who can prescribe themWhy certificates of analysis cannot guarantee purity

Who is speaking?

Dr. Ashley Froese. Primary care physician who runs a direct primary care clinic in Mesa, Arizona, as described in the video Background

Episode notes and full video

GRAS and human evidence

FDA's GRAS Notice Inventory returns no records for AOD9604 [11]. GRAS is a food-ingredient status and does not make an injectable lawful as a drug [11]. Human evidence is limited and largely short-term, and there is no approved dose [5]. A 2026 review of unapproved peptides concludes that rigorous human safety data are scarce and there is potential for serious harm [12].

Check what you know

3 quick questions. Pick an answer to see what this article says.

1. Has the FDA ever approved this peptide for any use?

No, it never reached approvalYes, for weight loss in adultsYes, but only as an injection

2. According to FDA, does removal of this substance from category 2 mean it is safe?

Yes, removal shows the substance is safeNo, FDA does not present removal as a finding of safetyYes, but only for injections

3. According to the article, what does FDA say about a valid patient-specific prescription for pharmacy compounding?

It is the only condition for compoundingIt is one condition, but not the only oneIt is not a condition for compounding

Score: 0 right, 0 of 3 answered

Frequently asked questions

›Is AOD-9604 legal in California?

It is not FDA-approved, it is not on FDA's bulk-substance list for state-licensed pharmacies, and FDA's category 1 no-action policy does not cover it [1][2]. FDA's pages describe no California-specific route for compounding it.

›Is AOD-9604 FDA-approved?

No. It never reached approval, and its obesity development program was later dropped [4][5]. A 24-week study of 502 randomized participants failed its primary weight-loss endpoint [5].

›Can a doctor prescribe AOD-9604 in California?

A prescription is only one condition FDA sets for compounded drugs [8]. The bulk substance must also be usable under FDA's conditions, and AOD-9604 is not on FDA's bulk-substance list and is outside the category 1 no-action policy [1][2].

References

1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
2. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA
3. 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
4. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
5. 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
6. U.S. Food and Drug Administration. U.S. Food and Drug Administration
7. 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
8. Human Drug Compounding Laws | FDA. Human Drug Compounding Laws | FDA
9. Official web page. Official web page
10. Official web page. Official web page
11. GRAS Notices. GRAS Notices
12. Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921-1935. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance
13. This Is Not Covered - Dr. Ashley Froese. Before You Start Peptides: A Doctor Answers Your Biggest Questions. Accessed 2026-11-11.