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Key Takeaways
- Rigin (Palmitoyl Tetrapeptide-7) is not FDA-approved and is designated for research purposes only.
- It is not included on the FDA's compounding bulk drug substance list, restricting its use in compounding pharmacies.
- Available legally only for research use, not for therapeutic or over-the-counter sale.
- Patients should ensure clinics are operating legally and be aware of potential red flags.
Current FDA Status
Rigin (Palmitoyl Tetrapeptide-7) is currently not approved by the FDA for any therapeutic use. As of the latest update, it is classified strictly for research purposes. This classification means that it cannot be marketed or sold as part of any therapeutic regimen. The FDA's stance is outlined in the Federal Register, where Rigin is not listed among the approved bulk drug substances for compounding, indicating its absence from Category 1, 2, or 3 lists (Federal Register, Vol. 85, No. 242).
Compounding Status
Given its exclusion from the FDA's approved bulk drug substances list, Rigin cannot be compounded by 503A or 503B pharmacies for patient use. The FDA's decision is based on the lack of sufficient safety and efficacy data, which places Rigin in a regulatory gray area where compounding is prohibited under current guidelines. Pharmacies found compounding this peptide may face regulatory action.
Enforcement Actions
There have been no specific Department of Justice (DOJ) prosecutions or FDA warning letters related to Rigin as of February 2026. However, the FDA has issued general guidance and warning letters to facilities compounding unapproved peptides. These actions highlight the agency's commitment to enforcing regulations around non-approved substances.
Prescription vs. Over-the-Counter vs. Research Use
Rigin is available legally only for research purposes, meaning it cannot be prescribed or sold over-the-counter for therapeutic use. "Research use only" implies that the peptide can be used in laboratory settings for experimental purposes but not for human application outside of a controlled research environment. This legal definition restricts its availability and use significantly.
State-Level Variations
Currently, there are no significant state-level regulations that differ from federal guidelines regarding Rigin. However, state boards of pharmacy may have additional enforcement policies, so it is advisable for practitioners to verify local regulations.
What "Off-Label" Actually Means
The term "off-label" applies exclusively to FDA-approved drugs used for non-approved indications. Since Rigin is not FDA-approved for any indication, its use cannot be classified as off-label. Instead, prescribing or using Rigin would be considered administering an unapproved drug.
What This Means for Patients
Patients should exercise caution and verify that any clinic offering Rigin adheres to legal standards. Clinics should not claim therapeutic benefits for Rigin, and patients should be wary of any such claims. Red flags include a lack of transparency about the peptide's legal status or claims of therapeutic efficacy without supporting evidence.
Legal Alternatives
For those seeking alternatives to Rigin for skin-related applications, peptides such as Matrixyl 3000, which is used in cosmetic formulations, may be considered. These alternatives often have a clearer regulatory status and are available in approved cosmetic products.
FAQ
Is Rigin (Palmitoyl Tetrapeptide-7) FDA-approved?
No, Rigin is not FDA-approved for any use.
Can Rigin be compounded by pharmacies?
No, it cannot be compounded as it is not on the FDA's approved bulk drug substances list.
Is Rigin available for purchase over-the-counter?
No, it is available strictly for research use and not for over-the-counter sale.
What does "research use only" mean for Rigin?
It means that Rigin can be used in laboratory settings for experimental research, not for human application outside of research.
Are there any legal alternatives to Rigin?
Yes, legal alternatives like Matrixyl 3000 are available for cosmetic 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 can change and was last verified 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.
