Is CJC-1295 / Ipamorelin Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• CJC-1295 / Ipamorelin is not FDA-approved for any specific indication but is listed as a Category 1 compoundable substance.
• Compounding is permitted in 503A and 503B pharmacies under specific conditions.
• The peptide can be prescribed for research use only and is not available over-the-counter.
• Patients should verify the legitimacy of clinics offering this peptide and be aware of red flags.

Current FDA Status

CJC-1295 / Ipamorelin is not approved by the FDA for any therapeutic use. It is, however, included in the FDA's list of bulk drug substances that can be compounded, designated as Category 1. This means it is permitted for compounding in 503A and 503B pharmacies under certain conditions, as per the FDA's Federal Register notice (FDA-2024-D-0090).

Compounding Status

As a Category 1 substance, CJC-1295 / Ipamorelin can be compounded by 503A and 503B pharmacies, provided they comply with specific regulatory requirements. The FDA allows compounding of this peptide when it is prescribed by a licensed practitioner and prepared in a state-licensed pharmacy or federal facility. The conditions for compounding are outlined in the FDA's guidance on compounding (FDA-2024-D-0090).

Enforcement Actions

To date, there have been no significant enforcement actions specifically targeting CJC-1295 / Ipamorelin. However, the FDA has issued warning letters to certain compounding pharmacies for not adhering to compounding guidelines. It is crucial for pharmacies and clinics to comply with FDA regulations to avoid legal repercussions.

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

CJC-1295 / Ipamorelin is available by prescription only for research use. It cannot be sold over-the-counter. "Research use only" means that the peptide can be used in clinical or laboratory research settings but is not approved for general medical use. This designation is critical for understanding the legal limitations of its use.

State-Level Variations

While federal regulations govern the compounding and use of CJC-1295 / Ipamorelin, some states may have additional restrictions or enforcement priorities. It is advisable to check state-specific regulations or consult with a legal expert in your area to ensure compliance.

What "Off-Label" Actually Means

The term "off-label" applies only to drugs that have received FDA approval for at least one indication. Since CJC-1295 / Ipamorelin has not been FDA-approved, prescribing it does not fall under "off-label" use but rather as prescribing an unapproved drug.

What This Means for Patients

Patients considering CJC-1295 / Ipamorelin should consult healthcare providers to confirm the clinic's compliance with legal and regulatory standards. Red flags include clinics offering the peptide without a prescription, lack of transparency about sourcing, or claims of FDA approval.

Legal Alternatives

For those seeking alternatives, peptides like Tesamorelin, which is FDA-approved for specific uses, may be considered. Always discuss options with a healthcare provider to ensure safety and legality.

FAQ

Is CJC-1295 / Ipamorelin FDA-approved?

No, CJC-1295 / Ipamorelin is not FDA-approved for any indication but is allowed for compounding under Category 1.

Can I purchase CJC-1295 / Ipamorelin over-the-counter?

No, it is available by prescription only and primarily for research use.

What should I look for in a clinic offering CJC-1295 / Ipamorelin?

Ensure the clinic requires a prescription, complies with state and federal regulations, and provides clear sourcing information.

Are there any legal alternatives to CJC-1295 / Ipamorelin?

Yes, peptides like Tesamorelin are FDA-approved and may be considered as alternatives.

How often do legal statuses of peptides change?

Legal statuses can change frequently; this information was last verified in February 2026.

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.