MyPeptideMatch
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.
