Is AICAR Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• AICAR is not FDA-approved and is available for research purposes only.
• It is not listed on the FDA's compounding bulk drug substance list, making compounding illegal.
• Enforcement actions have been taken against unauthorized sale and distribution of AICAR.
• AICAR cannot be prescribed or sold over-the-counter; it is strictly for research use.
• Patients should verify clinic legality and be aware of red flags in peptide therapy offerings.

Current FDA Status

AICAR, known scientifically as 5-Aminoimidazole-4-carboxamide ribonucleotide, is not FDA-approved for any therapeutic use. According to the FDA, AICAR is classified strictly as a research compound and is not listed on the FDA's compounding bulk drug substance list, which includes Category 1, 2, or 3 substances. As such, it cannot be compounded legally for human use (FDA.gov).

Compounding Status

The compounding of AICAR is prohibited under current regulations. Both 503A and 503B pharmacies, which are governed by the FDA's compounding regulations, are not permitted to compound AICAR due to its absence from the approved bulk substances list. The FDA has cited safety concerns and the lack of sufficient evidence for therapeutic efficacy as reasons for this restriction (Federal Register).

Enforcement Actions

There have been several enforcement actions regarding the illegal sale and distribution of AICAR. For instance, in 2024, the Department of Justice prosecuted a case against a company distributing AICAR as a supplement, resulting in significant fines and a cease-and-desist order. The FDA has also issued warning letters to entities marketing AICAR without appropriate authorization (DOJ.gov, FDA Warning Letters).

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

AICAR is not available by prescription or over-the-counter. It is designated for research use only, meaning it can be used legally only in controlled research environments. "Research use only" implies that the compound is intended solely for laboratory research and not for human or veterinary use outside of these settings (FDA.gov).

State-Level Variations

While federal regulations regarding AICAR are clear, some states may have additional restrictions or enforcement priorities. Healthcare providers and researchers should check state-specific regulations to ensure compliance.

What "Off-Label" Actually Means

The term "off-label" refers to the use of an FDA-approved drug for an unapproved indication. Since AICAR has never been approved by the FDA, its use does not qualify as off-label. Instead, it would be considered the use of an unapproved drug, which is illegal outside of research settings.

What This Means for Patients

Patients interested in peptide therapies should be cautious. Verify that any clinic offering peptide treatments is operating within legal boundaries. Red flags include promises of unproven benefits, lack of transparency about regulatory status, and the sale of compounds labeled as "research use only" for therapeutic purposes. Utilize the Peptide Clinic Finder to locate reputable clinics.

Legal Alternatives

For those seeking alternatives to AICAR's metabolic effects, legal peptides such as semaglutide, which is FDA-approved for specific indications, may be considered. Always consult with a licensed healthcare provider to explore safe and legal options.

FAQ

Q1: Is AICAR available for purchase online legally?
A1: No, AICAR is not legally available for purchase online for human use. It is restricted to research purposes only.

Q2: Can AICAR be compounded by pharmacies?
A2: No, AICAR cannot be compounded by pharmacies as it is not on the FDA's approved bulk drug substances list.

Q3: What should I do if a clinic offers AICAR treatments?
A3: Verify the clinic's compliance with legal regulations and consult a healthcare provider. Offering AICAR for treatment is illegal.

Q4: Are there any legal peptides with similar effects to AICAR?
A4: Yes, peptides like semaglutide are FDA-approved for certain uses and may offer similar metabolic benefits.

Q5: How can I ensure a peptide clinic is legitimate?
A5: Use the Peptide Clinic Finder and check for proper licensing and adherence to FDA regulations.

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