Is ARA-290 Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• ARA-290 is not FDA-approved and is designated for research purposes only.
• It is not listed on the FDA's compounding bulk drug substance list, prohibiting its compounding in pharmacies.
• ARA-290 is available exclusively for research use and cannot be legally prescribed.
• Patients should verify the legality of clinics offering ARA-290 and be aware of potential red flags.

Current FDA Status

ARA-290, a synthetic peptide derived from erythropoietin, is not approved by the FDA for any medical indications. It is categorized as a research-use-only compound, primarily utilized in inflammation and tissue protection studies. The FDA has not included ARA-290 on its compounding bulk drug substance list, which categorizes substances into three groups based on their compounding legality (Federal Register Notice, 2025).

Compounding Status

As ARA-290 is not on the FDA's approved list for compounding, both 503A and 503B pharmacies are prohibited from compounding this peptide. The FDA's decision stems from the lack of sufficient safety and efficacy data, placing ARA-290 in a position where it cannot be legally compounded or prescribed for patient use.

Enforcement Actions

To date, there have been no specific DOJ prosecutions or FDA warning letters related to ARA-290. However, clinics and individuals involved in the unauthorized sale or distribution of non-approved peptides, including ARA-290, may face legal actions as part of broader enforcement against unapproved drug sales.

Prescription vs. Over-the-Counter vs. Research Use

ARA-290 is not available by prescription or over-the-counter. It is strictly designated for research use, meaning it can be sold to qualified research facilities for scientific investigation but not for human consumption or therapeutic use. "Research use only" legally implies that the compound is not intended for human or veterinary use and should be handled accordingly.

State-Level Variations

Currently, there are no known state-level variations in the regulation of ARA-290. However, state regulations can differ, and it is crucial for researchers and clinics to stay informed about local laws that may impact the handling and use of research peptides.

What "Off-Label" Actually Means

Off-label prescribing applies exclusively to FDA-approved drugs used for non-approved indications. Since ARA-290 is not FDA-approved for any indication, its use in any capacity outside of research is not considered off-label but rather the use of an unapproved drug.

What This Means for Patients

Patients considering peptide therapy should be diligent in verifying the legality of the clinic and treatment offered. Legitimate clinics will adhere to FDA regulations and will not offer ARA-290 for therapeutic use. Red flags include clinics claiming therapeutic benefits of ARA-290 or offering it for direct patient use.

Legal Alternatives

For those interested in peptides with similar research interests, legal alternatives may include FDA-approved drugs or peptides under clinical investigation for inflammation and tissue protection. Visit our clinic finder to locate clinics offering legal and approved treatments.

FAQ

Is ARA-290 FDA-approved?

No, ARA-290 is not FDA-approved and is available only for research purposes.

Can ARA-290 be legally compounded?

No, ARA-290 cannot be legally compounded as it is not on the FDA's approved list for compounding substances.

What does "research use only" mean for ARA-290?

"Research use only" means ARA-290 can be used solely for scientific research and is not intended for human or veterinary use.

Are there any legal cases involving ARA-290?

As of now, there are no specific legal cases involving ARA-290, but selling or distributing it for non-research purposes could result in legal action.

How can I verify a clinic's legality in offering peptide treatments?

Patients should ensure clinics are transparent about their compliance with FDA regulations and avoid those offering unapproved peptides for therapeutic use.

This content is for informational purposes only and does not constitute medical advice. Consult a licensed healthcare provider before starting any treatment. Legal status of peptides can change and was last verified February 2026.