Compounded tirzepatide for weight loss: Is it available? Is it safe?

Key Points

• The FDA ended compounded tirzepatide availability after March 19, 2025
• A court upheld the FDA's decision, and Eli Lilly filed lawsuits against online pharmacies selling unauthorized versions of tirzepatide
• Alternatives include branded tirzepatide (Mounjaro and Zepbound), semaglutide medications (Rybelsus, Ozempic, Wegovy), and oral diabetes medications
• Proper nutrition and exercise remain the foundation of any type 2 diabetes and weight loss plan

Millions of Americans are adjusting to a new reality. More affordable compounded versions of the popular weight loss medications Mounjaro and Zepbound became unavailable after an FDA decision, a lawsuit, and a final court ruling.

What led to the FDA initially permitting compounded tirzepatide and then reversing course? And what options exist for people who need a different way to manage type 2 diabetes and weight loss? But before we dive in, let’s learn what led to the high demand for tirzepatide in the first place.

What is tirzepatide?

Tirzepatide is the active ingredient in Mounjaro and Zepbound, medications that lower blood sugar levels and promote weight loss.

Tirzepatide works by mimicking two hormones your body naturally produces after eating: GLP-1 and GIP. These hormones slow digestion, tell your brain, "I'm full with less food," and help release insulin to clean up the glucose in your blood.

Because of this, tirzepatide has been shown to lower blood sugar levels and help people lose up to 22.5% of their body weight. Some users report even higher weight loss results.

As a result, Mounjaro and Zepbound were highly sought after. This surge in demand created a nationwide drug shortage, which briefly opened the door for compounded versions as an alternative.

What is compounded tirzepatide, and why does it matter?

Compounding is when pharmacies create customized versions of medications by mixing ingredients to meet a specific person’s needs.

Reasons for using compounded drugs include:

• When someone has an allergy to an ingredient in a commercial drug
• A person needs a medication with a different formulation (like a pill version of an injection, due to medical reasons)
• There’s a shortage of FDA-approved medications

While compounded drugs are typically less expensive than branded versions, they do not undergo the same rigorous FDA approval process as commercial drugs. Since each pharmacy makes its own, there is no stringent regulatory oversight and quality control measures like those for FDA-approved medications.

This issue is at the heart of the controversy over compounded tirzepatide.

What happened to compounded tirzepatide?

When the manufacturer of Mounjaro and Zepbound couldn’t keep up with the initial demand, the FDA temporarily granted compounding pharmacies the right to produce compounded tirzepatide.

Some pharmacies even formulated an oral tirzepatide that dissolved under the tongue. This allowed users to use the medication without having to deal with needles.

These versions flew off the shelves, with users paying out of pocket for these more affordable versions of tirzepatide. However, in December 2024, the FDA determined that the tirzepatide shortage was over after confirming that the manufacturer could meet the demand.

Why did the FDA stop compounded tirzepatide from being sold?

The FDA had only approved compounded tirzepatide on a temporary basis until the drug shortage could be taken care of. Additionally, the agency had received over 300 complaints of adverse events related to compounded tirzepatide.

To give tirzepatide users and compounding pharmacies time to prepare, the FDA provided a ramp-off transition period from December 2024 to March 19, 2025.

The impact on users

Without compounded tirzepatide, many people who had come to rely on this more affordable version were affected. After all, many had experienced benefits from the medication, reporting a lower appetite and weight loss.

And when the compounded versions were no longer available, they had to switch to Mounjaro, Zepbound, or other FDA-approved medications for type 2 diabetes and weight management.

However, it’s important to note that not all users of compounded tirzepatide were satisfied. As mentioned before, the FDA registered over 300 adverse events related to compounded tirzepatide. The agency also notes that there may be more since not all pharmacies are required to notify the FDA in case of an adverse reaction.

The legal battle

Several compounding pharmacies challenged the FDA in court. Ultimately, the courts upheld the FDA's decision, recognizing the agency's authority to regulate drug availability when shortages resolve.

Following this decision, Eli Lilly, the manufacturer of tirzepatide brands, Mounjaro and Zepbound, filed lawsuits against several telehealth providers they claimed were continuing to sell copycat compounded versions despite the ruling.

Options moving forward

For those who were using compounded tirzepatide, potential alternatives include:

• Injectable versions of tirzepatide: Mounjaro for type 2 diabetes and Zepbound for weight loss
• Injectable semaglutide: Ozempic for type 2 diabetes and Wegovy for weight loss
• Oral semaglutide (Rybelsus) for type 2 diabetes
• Oral diabetes medications like metformin
• Older-generation antiobesity medication

Note: This content is for educational purposes only. Please discuss alternatives to compounded tirzepatide with a healthcare provider.

Optimize weight loss and control blood sugar levels

Whether you’re taking tirzepatide, semaglutide, or even metformin, following a nutritious diet and exercising regularly is crucial to sustain weight loss and manage type 2 diabetes.

However, many of these medications suppress your appetite. Plus, they come with side effects including nausea, vomiting, diarrhea, and gastric discomfort.

How do you eat balanced meals and get the nutrition you need? What is the best diet plan for Mounjaro, Zepbound, Ozempic, and other diabetes weight loss medications?

Find a weight loss dietitian who accepts your insurance to personalize a tirzepatide diet plan.

Frequently Asked Questions (FAQs)

1. Is compounded tirzepatide still available?

The FDA prohibited the sale of compounded tirzepatide after March 19, 2025. However, some online pharmacies continue to sell the DIY version of the drug. There is ongoing litigation between the manufacturer of tirzepatide (Eli Lilly) and compounding pharmacies involved in selling compounded tirzepatide.

2. Is there a difference between compounded tirzepatide and Mounjaro?

Compounded tirzepatide is not subject to the same regulatory oversight and scrutiny as FDA-approved drugs like Mounjaro. So, while a pharmacy may claim that their compounded tirzepatide is the same, there is no way to guarantee the safety of the drug and the actual dosage in the final product. Some compounded tirzepatide versions may have additives, making them different from Mounjaro. There is also a high risk of counterfeit or fraudulent versions of tirzepatide being sold online, while Mounjaro is strictly regulated.

3. Why am I not losing weight on tirzepatide?

Not everyone loses weight on tirzepatide. You may not lose weight on tirzepatide for various reasons, including being on the starter dose of 2.5 mg, needing a different medication, underlying hormonal imbalances, inflammation, and insufficient protein and dietary fiber in your diet. Being under high chronic stress, poor sleep quality, and emotional eating patterns can also impact weight loss on tirzepatide.

Find a weight loss dietitian near you who accepts your insurance.

The views expressed by authors and contributors of such content are not endorsed or approved by Fay and are intended for informational purposes only. The content is reviewed by Fay only to confirm educational value and audience interest. You are encouraged to discuss any questions that you may have about your health with a healthcare provider.