Is 5-Amino-1MQ Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• 5-Amino-1MQ is not FDA-approved for any medical use and is designated for research purposes only.
• Compounding of 5-Amino-1MQ is prohibited in both 503A and 503B pharmacies due to its Category 2 designation by the FDA.
• No prescription or over-the-counter availability exists; it is strictly for research use.
• State-level regulations may vary, but federal law prohibits its sale for human consumption.
• Patients should verify clinic legality and be aware of red flags indicating non-compliance with regulations.

Current FDA Status

5-Amino-1MQ is currently not approved by the FDA for any medical indications. It is classified as a research compound, primarily used to investigate epigenetic and redox control mechanisms, cellular metabolism, and aging. As of the latest update, it is not listed on the FDA's compounding bulk drug substance list, falling under Category 2, which indicates it is not eligible for compounding due to insufficient safety and efficacy data (FDA Federal Register).

Compounding Status

The FDA prohibits the compounding of 5-Amino-1MQ in both 503A and 503B pharmacies. This prohibition stems from its Category 2 designation, which highlights concerns over the peptide's safety profile and lack of substantial evidence supporting its therapeutic use. Pharmacies found compounding this substance may face regulatory actions, including warning letters and potential fines.

Enforcement Actions

To date, there have been no specific DOJ prosecutions related to 5-Amino-1MQ. However, the FDA has issued warning letters to entities marketing unapproved peptides, including those similar to 5-Amino-1MQ. These enforcement actions underscore the agency's commitment to regulating unauthorized drug sales and protecting public health (FDA Warning Letters).

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

5-Amino-1MQ is not available by prescription or over-the-counter. Its legal use is confined to research purposes, meaning it can be sold only to qualified researchers or institutions for non-human studies. "Research use only" denotes that the substance is not intended for human consumption or therapeutic applications, and any such use would be illegal.

State-Level Variations

While federal regulations prohibit the use of 5-Amino-1MQ for human consumption, some states may have additional restrictions or enforcement priorities. It is crucial for researchers and potential users to consult state-specific regulations to ensure compliance.

What "Off-Label" Actually Means

The term "off-label" applies to FDA-approved drugs being prescribed for unapproved uses. Since 5-Amino-1MQ has never received FDA approval, it cannot be prescribed off-label. Any use outside of sanctioned research constitutes the use of an unapproved drug, which is illegal.

What This Means for Patients

Patients interested in therapies involving 5-Amino-1MQ should exercise caution. Ensuring a clinic's legal operation involves verifying their compliance with FDA regulations and confirming they do not offer unapproved substances for human use. Red flags include clinics promising therapeutic benefits from 5-Amino-1MQ or failing to provide clear regulatory compliance documentation.

Legal Alternatives

For those seeking legal alternatives to 5-Amino-1MQ, other peptides with similar investigational profiles may be considered. Peptides like NAD+ precursors or other FDA-approved compounds may offer legal avenues for addressing similar biological pathways.

FAQ

Is 5-Amino-1MQ FDA-approved?

No, 5-Amino-1MQ is not FDA-approved for any medical use and is designated for research purposes only.

Can 5-Amino-1MQ be legally compounded?

No, it is prohibited from compounding under both 503A and 503B pharmacy regulations due to its Category 2 status.

What does "research use only" mean for 5-Amino-1MQ?

"Research use only" means it can be used solely for non-human scientific studies and not for human consumption or therapeutic purposes.

Are there any legal alternatives to 5-Amino-1MQ?

Yes, other peptides or compounds with FDA approval or investigational new drug status may serve as legal alternatives for similar research purposes.

Can I purchase 5-Amino-1MQ for personal use?

No, purchasing 5-Amino-1MQ for personal use is illegal under current 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.