Can you get tirzepatide from a compounding pharmacy?

Some pharmacies or clinics may supply compounded versions of medicines like tirzepatide (Mounjaro, Zepbound) and semaglutide (Ozempic, Wegovy) to patients, but the FDA has issued safety warnings about this practice. Concerns have risen over active ingredients, side effects and labeling of these compounded products.

Tirzepatide injection is only available as a prescription brand name product. It comes in pre-filled single-dose pens vials (Mounjaro) and / or single-dose pens (Zepbound), according to Eli Lilly, the manufacturer.

• Zepbound is approved by the FDA for weight loss in adults with obesity or who are overweight and have weight-related medical problems. Zepbound helps you to lose weight and maintain weight loss and should be combined with a reduced-calorie diet and exercise. It is also approved to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity.
• Mounjaro is used to help lower blood sugar in adults with type 2 diabetes and is also used together with diet and exercise.

Some people may receive a prescription for compounded medicine because they need a special formulation, to help save costs, or due to a drug shortage in their area. According to the drug shortages list from the FDA, injectable prescription tirzepatide is now available commercially, although shortages have occurred with this product and others like it in the past.

Related: How does Zepbound help treat sleep apnea?

Is compounded tirzepatide safe?

The FDA does not review compounded versions of prescription medications, including tirzepatide, for safety, effectiveness or quality. In addition, Eli Lilly, the manufacturer of tirzepatide states that they cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not their branded product (brand names: Mounjaro and Zepbound).

Eli Lilly has stated that they have filed lawsuits to protect patient safety and stop the unlawful sales of compounded tirzepatide, a non-FDA approved and fraudulent product.

Semaglutide example

In May 2023 the FDA raised some concerns about another compounded incretin mimetic, semaglutide (Ozempic and Wegovy) from Novo Nordisk.

According to the FDA there have been reports of side effects (“adverse events”) in patients who have used compounded version of semaglutide, a drug similar to tirzepatide and used to treat patients with type 2 diabetes, for cardiovascular risk reduction, and for weight loss management.

The FDA also reported that some compounding pharmacies were using different salt forms of semaglutide as the active ingredient. These include semaglutide acetate and semaglutide sodium, products that are not approved by the FDA and are different from the active ingredients found in Ozempic or Wegovy.

There are no generic options for tirzepatide in the U.S. and the active ingredient for compounding is not available from the manufacturer.

Novo Nordisk is also pursuing legal action against compounding pharmacies for selling adulterated and misbranded compounded drugs claiming to contain semaglutide.

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What exactly is drug compounding?

Drug compounding is a legal and a well-accepted practice in the United States, often done by licensed pharmacists or other healthcare providers. Drug compounding is the process of combining, mixing, or changing ingredients to create a medication specific for the needs of an individual patient.

A compounded version of an approved drug may be formulated if it meets certain conditions in the Federal Food, Drug and Cosmetic (FD&C) Act. For example, if an approved drug is in shortage, a compounded version can be legally prepared. However, compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.

Compounded medications require a prescription from a healthcare provider. Licensed compounding pharmacies in the U.S. can legally prepare compounded medications when adhering to guidelines from the FDA and their State Board of Pharmacy. Patients should only obtain medicines from state-licensed pharmacies or facilities registered with the FDA.

However, concerns have been raised about some compounding practices in the past, including sterility and other quality issues.

What can patients do?

Speak to your healthcare provider about the availability of FDA-approved, prescription injectable tirzepatide (Mounjaro or Zepbound) in your area. If there is a shortage, discuss what options you have for the safe use of a prescription drug for your condition. The FDA states that a patient should not use a compounded product if an approved medication like Mounjaro or Zepbound is available.

If you think you have received counterfeit tirzepatide or accessed it from an unauthorized source, contact your healthcare provider. Counterfeit drugs may contain the wrong ingredients, too little or too much drug, dangerous compounds, or no active ingredient at all.

Patients and healthcare providers can also report counterfeit tirzepatide by calling Eli Lilly at 1-800-545-5979.

FDA also encourages health care professionals, patients, and compounders to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program.

This is not all the information you need to know about compounded tirzepatide for safe and effective use and does not take the place of your doctor’s directions. Discuss this information and any questions you have with your doctor or other health care provider.

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