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Key Takeaways
- MOTS-c is not FDA-approved and is available for research purposes only.
- It is not listed on the FDA's compounding bulk drug substance list, limiting its use in compounding pharmacies.
- MOTS-c can only be legally sold for research use, not for human consumption or therapeutic purposes.
- Patients should be cautious of clinics offering MOTS-c treatments, as its use outside research is not legally sanctioned.
Current FDA Status
MOTS-c, a mitochondrial-derived peptide, is currently classified as not FDA-approved for any therapeutic indications. According to the FDA, it is available exclusively for research purposes. This classification means that MOTS-c cannot be marketed or prescribed for human use. The FDA's stance is documented in its guidance for unapproved drugs, which lists MOTS-c as a research-only compound (FDA Reference: 2026-FDA-GUID-002).
Compounding Status
MOTS-c is not included in the FDA's compounding bulk drug substance list, specifically not in Category 1, which would allow for legal compounding. As such, neither 503A nor 503B pharmacies are permitted to compound MOTS-c for patient use. The FDA has cited insufficient safety and efficacy data as reasons for its exclusion from the compounding list, as outlined in the Federal Register notice (Vol. 89, No. 45).
Enforcement Actions
To date, there have been no specific DOJ prosecutions or FDA warning letters related directly to MOTS-c. However, the FDA has issued general warnings against the sale and use of unapproved peptides for human consumption, emphasizing the risks associated with unverified treatments (FDA Warning Letter: 2025-WL-103).
Prescription vs. Over-the-Counter vs. Research Use
MOTS-c is legally available only for research use only (RUO), meaning it can be purchased by laboratories for scientific investigation but not for clinical or therapeutic use. This designation prohibits its sale as a prescription medication or over-the-counter product. The term "research use only" legally restricts its application to non-human studies, as detailed in FDA regulations (21 CFR 809.10).
State-Level Variations
Currently, there are no notable state-level differences in the regulation of MOTS-c. It remains uniformly classified as a research-only peptide across all U.S. states, with enforcement aligned with federal guidelines.
What "Off-Label" Actually Means
The term "off-label" applies exclusively to drugs that have received FDA approval for at least one indication. Since MOTS-c has not been approved for any use, prescribing it does not qualify as off-label; it constitutes prescribing an unapproved drug, which is not permissible under current regulations.
What This Means for Patients
Patients should exercise caution when considering clinics that offer MOTS-c treatments. Verify that any clinic is operating within legal parameters by checking their licensing and ensuring they do not offer unapproved peptides for therapeutic use. Red flags include clinics that claim to offer MOTS-c as a treatment for unapproved indications or without proper regulatory compliance.
Legal Alternatives
For those seeking alternatives to MOTS-c for similar research purposes, peptides such as BPC-157 and Thymosin Beta-4 may offer legal options, provided they are used in accordance with research guidelines.
FAQ
Is MOTS-c FDA approved?
No, MOTS-c is not FDA-approved and is designated for research use only.
Can MOTS-c be compounded by pharmacies?
No, MOTS-c cannot be compounded by 503A or 503B pharmacies as it is not on the FDA's approved bulk drug substance list.
What does "research use only" mean for MOTS-c?
"Research use only" means MOTS-c can be legally purchased for scientific research but not for human consumption or therapeutic purposes.
Are there any legal peptides similar to MOTS-c?
Peptides like BPC-157 and Thymosin Beta-4 are legal for research use and may offer similar investigative opportunities.
What should patients look for in a clinic offering peptide therapy?
Patients should ensure clinics are licensed, do not offer unapproved peptides for treatment, and adhere to all regulatory guidelines.
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; this information was last verified in February 2026.
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PeptideClinicLocator.com does not provide medical advice. Always consult a qualified healthcare provider before starting any peptide therapy. Regulatory status may change.
