{"id":631388,"date":"2025-02-13T12:27:44","date_gmt":"2025-02-13T17:27:44","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=631388"},"modified":"2025-02-17T13:59:15","modified_gmt":"2025-02-17T18:59:15","slug":"compounded-mounjaro-is-it-safe","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/compounded-mounjaro-is-it-safe\/","title":{"rendered":"Compounded Mounjaro: Is it safe?"},"content":{"rendered":"

Mounjaro<\/span><\/a> is a weekly injectable medicine that contains the active ingredient tirzepatide. It was approved by the Food and Drug Administration (FDA) in 2022 to help control <\/span>blood sugar levels<\/span><\/a> in adults with <\/span>Type 2 diabetes<\/span><\/a>, but healthcare providers often prescribe this medicine <\/span>off-label<\/span><\/a> (for a non-FDA-approved use) for weight loss in people with obesity (or overweight with certain medical conditions). With the exploding popularity of Mounjaro and Zepbound, you may have seen advertisements for affordable compounded versions of the drug\u2014maybe even without a prescription. You may have also seen ads for compounded versions of GLP-1 receptor agonists <\/span>Ozempic<\/span><\/a> and <\/span>Wegovy<\/span><\/a>.<\/span><\/p>\n

But are these products safe? The short answer is that compounded Mounjaro\u2014more specifically, compounded tirzepatide\u2014comes with risks, as it is not an FDA-approved drug and has not been tested for safety. Keep reading to learn more about compounded tirzepatide.\u00a0<\/span><\/p>\n

What is compounded tirzepatide?<\/span><\/h2>\n

According to the FDA, <\/span>compounded medications<\/span><\/a> are made by a pharmacist or healthcare provider in pharmacies or outsourcing facilities. An ingredient may be combined, mixed, or altered in order to make a drug specifically tailored to an individual patient. In the case of compounded tirzepatide, compounding facilities may add other ingredients, such as vitamin B-12, to the product. Compounded tirzepatide may be provided to the patient in various forms, such as oral or injectable (more on that below).\u00a0<\/span><\/p>\n

But, why would compounded tirzepatide need to be made if FDA-approved drugs like Mounjaro (or <\/span>Zepbound<\/span><\/a>, an FDA-approved weight-loss drug that also contains tirzepatide) are already available? The answer is that the FDA allows compounded drugs to be made when there is a shortage. When Mounjaro was first approved by the FDA, supply issues made it difficult for people to find the medicine at pharmacies. Although the FDA announced in October 2024 that the short supply issue was resolved, a pending lawsuit has prompted the FDA to reevaluate the shortage status. This means that compounding facilities can continue to make compounded tirzepatide and similar drugs, <\/span>for now<\/span><\/a>.\u00a0<\/span><\/p>\n

Compounded tirzepatide vs. Mounjaro<\/span><\/h2>\n

FDA-approved drugs like <\/span>Mounjaro<\/span><\/a> must undergo extensive testing in clinical trials for safety, efficacy, and quality before they are approved. Compounded drugs, such as compounded tirzepatide, do not have to go through this testing and are not FDA approved. Some of the differences between compounded tirzepatide and Mounjaro include:\u00a0<\/span><\/p>\n