Compounded Tirzepatide

Tirzepatide is a once-weekly medication that activates two hormone receptors, GIP and GLP-1, to reduce appetite and improve blood sugar control. The FDA-approved brands are Zepbound® (chronic weight management and obstructive sleep apnea) and Mounjaro® (type 2 diabetes), both made by Eli Lilly.

Compounding means a licensed pharmacist prepares a medication for a specific patient, for example in a different dose or formulation, based on a prescription. Compounded medications are not FDA-approved, and the FDA does not review them for safety, effectiveness or quality before they are dispensed.

During the national shortage, the FDA allowed wider compounding of tirzepatide. The FDA determined the shortage was resolved and ended that flexibility for state-licensed (503A) pharmacies on February 18, 2025 and for outsourcing facilities (503B) on March 19, 2025.

Since then, 503A pharmacies may compound tirzepatide only in line with federal law: for an individual patient, on a valid prescription, and not as an "essentially a copy" of the approved product. That generally requires the prescriber to determine that a change makes a clinically significant difference for that patient. On April 30, 2026, the FDA also proposed not to include tirzepatide on the list of bulk substances that 503B outsourcing facilities may use.

Rules may keep changing. Your physician will explain what is available to you, and always has the option to prescribe a brand-name medication instead.

Treatment usually starts at 2.5 mg once weekly for 4 weeks, then increases in 2.5 mg steps at least 4 weeks apart, up to a maximum of 15 mg, based on how you respond. Compounded vials may be labeled in milligrams per milliliter, so the number of units you draw depends on the concentration. Always follow your label and your physician’s instructions; the FDA has received reports of dosing errors with compounded GLP-1 medications. Our dose calculator can help you check.