MyPeptideMatch
Key Takeaways
- Tirzepatide is FDA-approved for weight loss and type 2 diabetes management.
- It is not on the FDA's bulk drug substance list for compounding, restricting its legal compounding options.
- The peptide is only available via prescription and cannot be sold for research use or over-the-counter.
- Patients must verify clinic legality and watch for red flags such as non-prescription sales.
Current FDA Status
Tirzepatide, a dual GIP/GLP-1 receptor agonist, is FDA-approved for the treatment of type 2 diabetes and weight loss. The FDA's approval is based on clinical trials demonstrating its efficacy in these conditions (FDA Reference: NDA 215866). However, tirzepatide is not included in the FDA's compounding bulk drug substance list, specifically within Category 1, 2, or 3 (Federal Register Vol. 85, No. 191).
Compounding Status
Given its absence from the FDA's bulk drug substance list, tirzepatide cannot be legally compounded by 503A or 503B pharmacies. The FDA has cited concerns about safety and the availability of approved formulations as reasons for this restriction. Pharmacies are thus prohibited from compounding tirzepatide, ensuring that patients receive only FDA-approved versions.
Enforcement Actions
There have been notable enforcement actions concerning the illegal sale and compounding of tirzepatide. The FDA has issued several warning letters to compounding pharmacies that attempted to produce tirzepatide without compliance. For instance, in December 2025, a New York-based pharmacy received a warning letter for compounding tirzepatide illegally, which led to its closure (FDA Warning Letter 625762).
Prescription vs. Over-the-Counter vs. Research Use
Tirzepatide is available strictly via prescription. It is not approved for over-the-counter sales and cannot be marketed for research use only. The term "research use only" legally implies that the product is not intended for human consumption and cannot be sold for personal health use.
