Is BPC-157, TB-500, KPV, GHK-Cu 80mg (Klow Blend) Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• BPC-157, TB-500, KPV, and GHK-Cu 80mg (Klow Blend) are not FDA-approved for any medical indications and are available for research purposes only.
• These peptides are not included in the FDA's compounding bulk drug substance list, restricting their use in 503A and 503B compounding pharmacies.
• Legal pathways include research use only; they cannot be prescribed or sold over-the-counter for human use.
• Patients should verify the legal operation of clinics and be aware of red flags such as unsolicited offers or claims of FDA approval.

Current FDA Status

As of 2026, BPC-157, TB-500, KPV, and GHK-Cu 80mg (Klow Blend) are not FDA-approved for any therapeutic use. These peptides are categorized under research use only, meaning they can be utilized solely for laboratory research and not for human consumption. The FDA has not included these substances in any of its compounding bulk drug substance lists (Category 1, 2, or 3), which are detailed in Federal Register notices and FDA documentation. For more information on the regulatory framework, refer to the FDA's guidelines on unapproved drugs FDA.gov.

Compounding Status

Due to their exclusion from the FDA's compounding bulk drug substance list, neither 503A nor 503B pharmacies are authorized to compound these peptides. The FDA's restrictions are based on safety concerns and the lack of sufficient evidence supporting their efficacy and safety in humans. Pharmacies compounding these substances may face regulatory actions, including warning letters or legal penalties.

Enforcement Actions

There have been several enforcement actions related to the sale and distribution of these peptides. For example, the FDA issued warning letters to companies marketing BPC-157 as a dietary supplement in 2025, citing violations of the Federal Food, Drug, and Cosmetic Act. Additionally, the Department of Justice has prosecuted cases involving the unlawful distribution of these peptides for human use, underscoring the importance of adhering to legal guidelines.

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

BPC-157, TB-500, KPV, and GHK-Cu 80mg (Klow Blend) are available for research use only, which legally means they are intended for laboratory research and not for human consumption. They cannot be prescribed by healthcare providers or sold over-the-counter. The "research use only" designation prohibits their use in clinical settings or personal health regimens.

State-Level Variations

While federal regulations are clear, some states may have additional restrictions or enforcement actions related to these peptides. However, as of 2026, there are no significant state-level variations that alter the federal stance on these substances.

What "Off-Label" Actually Means

The term "off-label" applies to FDA-approved drugs used for non-approved indications. Since BPC-157, TB-500, KPV, and GHK-Cu 80mg (Klow Blend) are not FDA-approved, they cannot be prescribed off-label. Any use outside of research is considered the use of an unapproved drug.

What This Means for Patients

Patients interested in peptide therapy should ensure that any clinic they consider is compliant with regulatory standards. Clinics should not offer these peptides for therapeutic use, and claims of FDA approval should be treated with skepticism. Verify clinic credentials and be cautious of red flags such as unsolicited offers or misleading marketing claims.

Legal Alternatives

For those seeking alternatives, peptides such as semaglutide and liraglutide are FDA-approved for specific indications and may offer similar benefits under medical supervision.

FAQ

Is BPC-157 legal for human use?
No, BPC-157 is not FDA-approved for human use and is available for research purposes only.

Can these peptides be compounded by pharmacies?
No, they cannot be compounded by 503A or 503B pharmacies due to their absence from the FDA's approved compounding lists.

What does "research use only" mean?
It means the peptides can be used solely for laboratory research and not for human or clinical use.

Are there any legal actions against companies selling these peptides?
Yes, the FDA has issued warning letters and the DOJ has prosecuted cases involving the illegal sale of these peptides.

Can I obtain these peptides with a prescription?
No, they are not available by prescription as they are not FDA-approved for any medical 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 in February 2026.