Mounjaro International Purchase Legalities: What U.S. Patients Need to Know in 2026

What Mounjaro is approved for

Mounjaro is tirzepatide, a dual GIP and GLP-1 receptor agonist given as a once-weekly subcutaneous injection [1]. The label lists two uses: type 2 diabetes, as an adjunct to diet and exercise in adults and in children 10 and older, and reduction of major cardiovascular events (cardiovascular death, non-fatal heart attack, non-fatal stroke) in adults with type 2 diabetes at high risk for those events [1].

What FDA says about compounded tirzepatide

FDA states that compounded drugs are not FDA approved and that the agency does not review them for safety, effectiveness or quality before they are marketed [2]. Its stated position is that compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug [2].

Where compounding stands in 2026

FDA determined on 2024-12-19 that the tirzepatide shortage was resolved [3]. Enforcement discretion for state-licensed pharmacies ended after a court denied a preliminary injunction on 2025-03-05, and for outsourcing facilities on 2025-03-19 [3]. For a state-licensed pharmacy, FDA says a compounded product that is essentially a copy of an approved drug must not be made regularly or in inordinate amounts, unless the prescriber documents a significant difference for an identified patient. FDA also says it does not intend to take action against a compounder that fills four or fewer prescriptions for that product in a calendar month [3].

FDA says outsourcing facilities generally cannot compound from bulk substances unless the substance is on the bulk-substance list or the drug is on FDA's shortage list, and that tirzepatide is on neither [3]. FDA proposed excluding tirzepatide from that list on April 30, 2026, with comments open to June 29, 2026, and as of the last FDA update it had not issued a final decision [4].

Refrigeration and storage of injectable GLP-1 drugs

FDA notes that injectable GLP-1 drugs require refrigeration as stated in their package inserts, and says it has received complaints of compounded GLP-1 drugs arriving warm or with inadequate ice packs [2]. FDA recommends not using any injectable GLP-1 drug that arrives warm or with insufficient refrigeration, since this can affect the drug's quality. For multi-dose vials it recommends discarding the vial 28 days after first use even if medication remains in it [2]. FDA also lists a green list import alert, numbered 66-80, aimed at stopping GLP-1 active ingredients at the border [2].

What FDA lists as warning signs when buying online

FDA's published red flags include a seller that claims a compounded drug is the same as an FDA-approved drug, offers deep discounts or prices that seem too good to be true, does not require screening and a prescription from a licensed doctor before providing medicine, or has no licensed doctor available for questions after purchase [2]. FDA also flags medicine that looks different from what was pictured or previously received, packaging that arrives broken or damaged or without instructions for use, and labels with spelling errors or incorrect pharmacy addresses [2].