Australia bans compounded tirzepatide, and Lilly cites the move in U.S. warnings

On May 21, 2024, the Australian government announced a complete ban on compounded tirzepatide and other compounded diabetes and weight-loss medicines, citing "increasing reports of patients coming to harm" from incretin medications, according to an open letter Eli Lilly and Company published on June 20, 2024 ^[1].

The letter says the Australian action followed "the hospitalization of a patient in Australia due to a serious adverse event" ^[1]. Australia's Minister for Health, Mark Butler, said: "You only have to look to the recent reports of individual impacted by large-scale compounding to reali[z]e the dangers posed. This action will protect Australians from harm and save lives" ^[1].

How the ban is being used in the U.S.

Lilly's open letter addresses practices around Mounjaro and Zepbound, the company's tirzepatide medicines, and cites Australia's ban inside its section on compounded tirzepatide ^[1]. Mounjaro is approved for adults with type 2 diabetes, and Zepbound for adults with obesity or excess weight plus a weight-related medical condition; both are given by under-the-skin injection ^[1].

Lilly states that Mounjaro and Zepbound are the only FDA-approved tirzepatide medicines, that it does not supply tirzepatide to compounding pharmacies, med-spas, wellness centers, online retailers or other manufacturers, and that it does not know where those sellers obtain the active ingredient ^[1]. The company says it will keep pursuing legal remedies against sellers who falsely claim their products are Mounjaro, Zepbound or "FDA-approved" tirzepatide, and that it supports state and federal regulators and law enforcement acting against sellers of unsafe or fake products ^[1].

What Lilly says it has found in compounded products

Lilly says it has found compounded drugs advertised as tirzepatide with safety, sterility and effectiveness problems. Some contained bacteria, high impurity levels, a different color (pink instead of colorless), or a different chemical structure from Lilly's approved medicines; in at least one instance, the letter says, the product was "nothing more than sugar alcohol" ^[1].

Lilly also says some online pharmacies advertise compounded pill, under-the-tongue and nasal spray versions of "tirzepatide," while FDA has approved tirzepatide only as an under-the-skin injection, and no regulator has evaluated the safety or effectiveness of oral or nasal forms ^[1]. Separately, the National Association of Boards of Pharmacy says it has identified thousands of websites promoting illegal sales of GLP-1 agonists, including fake or unsafe versions of Mounjaro, Zepbound and products labeled "tirzepatide," according to the letter ^[1].

Why it matters for patients

Compounded drugs are not FDA-approved, and FDA has stated that they "pose a higher risk to patients than FDA-approved drugs" and that unnecessary use "exposes patients to potentially serious health risks," the letter notes ^[1]. For injectable medicines, sterility is a central concern, because contamination in a product given by injection can cause serious injury ^[1].

Australia's ban is a national policy decision and does not by itself change U.S. rules. The letter does not say whether any U.S. regulator has announced a comparable ban on compounded tirzepatide, or how U.S. compounding rules would be affected.

The letter also draws a line between compounded products and products sold with labels such as "research purposes only" or "not for human consumption." Lilly says those markings indicate the products have not been purified to pharmaceutical-grade levels and that people should never put them into their bodies ^[1]. Products marketed simply as "tirzepatide," rather than Mounjaro or Zepbound, were not made by, studied by or sold by Lilly and are not FDA-approved, the company says ^[1].

What happens next

The letter does not state when Australia's ban took effect, what enforcement steps accompany it, or how many patients in Australia were affected before the announcement ^[1]. Lilly says it will report suspected counterfeit or unsafe tirzepatide products to regulators and encourages patients who think they received such a product to contact a healthcare provider, local law enforcement or their state board of pharmacy ^[1].