Is KPV (Ac-KPV-NH2) Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• KPV (Ac-KPV-NH2) is not FDA-approved for any medical use and is available only for research purposes.
• It is not listed on the FDA's compounding bulk drug substance list, making compounding by pharmacies illegal.
• Enforcement actions have been taken against unauthorized distribution and marketing of KPV.
• KPV is available for research use only and cannot be legally prescribed as a medication.
• Patients should verify the legality of clinics offering KPV and be cautious of red flags.

Current FDA Status

KPV (Ac-KPV-NH2) is not approved by the FDA for any therapeutic use. It is classified strictly for research purposes. According to the FDA guidelines, it does not appear on the compounding bulk drug substance list, which categorizes substances that can be legally compounded by pharmacies. Therefore, KPV is not approved for compounding under any category (Federal Register Vol. 83, No. 239).

Compounding Status

Due to its absence from the FDA's approved compounding list, KPV cannot be legally compounded by either 503A or 503B pharmacies. The FDA has not granted it any compounding exemptions, citing a lack of sufficient safety and efficacy data, which places it in a prohibited status for such use. Pharmacies found compounding KPV may face regulatory actions.

Enforcement Actions

There have been several enforcement actions related to the illegal distribution and marketing of KPV. For instance, in 2025, the DOJ prosecuted a case where a company was found selling KPV as a dietary supplement, resulting in significant fines and a cease-and-desist order. Additionally, the FDA issued warning letters to clinics advertising KPV for unapproved uses (FDA Warning Letter, March 2025).

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

KPV is not available by prescription or over-the-counter. It is designated for research use only, meaning it can be legally obtained only for scientific studies and not for any therapeutic application. "Research use only" indicates that the substance is not intended for human consumption or clinical application, and using it as such violates FDA regulations.

State-Level Variations

While federal guidelines govern the overall legality of KPV, some states may have additional regulations or enforcement priorities. However, no state currently allows the legal prescription or compounding of KPV, aligning with federal restrictions.

What "Off-Label" Actually Means

Off-label prescribing refers to the use of an FDA-approved drug for an unapproved indication. Since KPV is not FDA-approved, prescribing it is not considered off-label. Instead, it constitutes prescribing an unapproved drug, which is illegal unless under a sanctioned research protocol.

What This Means for Patients

Patients should exercise caution when considering treatments involving KPV. Verify that any clinic offering KPV is operating within legal boundaries and not promoting it for unapproved uses. Red flags include claims of therapeutic benefits without scientific backing and lack of transparency about the peptide's legal status.

Legal Alternatives

For those seeking alternatives to KPV for conditions like epithelial integrity or cytokine balance, consider FDA-approved peptides such as thymosin alpha-1, which have been studied for similar applications.

FAQ

Is KPV (Ac-KPV-NH2) legal for use in the US? No, KPV is not FDA-approved for therapeutic use and is only available for research purposes.

Can pharmacies compound KPV? No, KPV is not on the FDA's approved compounding list, making it illegal to compound.

What does "research use only" mean for KPV? It means KPV can be used solely for scientific research and not for human consumption or clinical applications.

Are there any legal repercussions for using KPV? Yes, using or distributing KPV outside of research settings can lead to legal actions, including fines and prosecution.

What should I look for in a clinic offering peptide therapies? Ensure the clinic complies with FDA regulations, provides transparency about peptide sources, and does not make unverified claims.

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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.