Can I Still Get Compounded Tirzepatide?

On October 2, 2024, the FDA officially removed tirzepatide from the drug shortage list which means compounded tirzepatide is no longer available nationwide.  Naturally, the question is can I still get my compounded tirzepatide prescription? Unfortunately the answer is no.  

Tirzepatide, an effective medication for managing type 2 diabetes and aiding in weight loss, was available to patients in compounded form while listed on the FDA's drug shortage list. This allowed compounding pharmacies to step in fill the lack of patient supply while brand-name options were in limited supply.

However, with the FDA’s recent announcement that the tirzepatide shortage has been resolved, compounded versions of this medication are no longer permitted. This change has significant implications for patients who relied on compounding pharmacies to access their medication.

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What Is Compounded Tirzepatide?

Before we dive into the reasons for its discontinuation, it's important to understand what compounded medications are. Compounded drugs are specially formulated by licensed pharmacists to meet the specific needs of a patient or to address drug shortages. These medications are not commercially manufactured but are instead tailored to individual requirements, such as specific doses or ingredients. Compounding is especially useful when there are shortages of a particular medication, or when a patient has allergies to certain ingredients in the commercial version.

In the case of tirzepatide, compounded versions became available during the FDA-approved shortage period, when the manufacturer’s production could not keep up with the overwhelming demand for brand name tirzepatide drugs. Compounded tirzepatide provided an alternative for patients who couldn’t access the brand-name version.

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The End of Compounded Tirzepatide

The FDA regulates when compounding pharmacies can produce copies of FDA-approved drugs, and one of the key circumstances where this is allowed is during a drug shortage. When a drug like tirzepatide is listed as "in shortage," compounding pharmacies can legally produce and sell their versions to meet patient needs. This is exactly what happened when tirzepatide became a household name for treating type 2 diabetes and helping patients manage obesity.

However, once the shortage is declared resolved, as the FDA did with tirzepatide on October 2, 2024, compounded versions of the drug may no longer be fulfilled. This is due to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the compounding of commercially available FDA-approved drugs unless they are in shortage. Now that the tirzepatide is fully resolved, compounding pharmacies are no longer allowed to create compounded versions of the medication.

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Why Did the Shortage Happen?

Several factors contributed to the tirzepatide shortage that led to the temporary availability of compounded versions:

1. Unprecedented Demand: Tirzepatide’s launch was highly anticipated due to its dual mechanism of action, which targets both GLP-1 and GIP receptors. This made it incredibly effective for weight loss and diabetes management, which led to demand far exceeding initial projections. Patients looking for alternatives to existing medications, such as semaglutide (Ozempic®, Wegovy®), flocked to tirzepatide as soon as it was approved.
2. Production Capacity: Like many new drugs, the initial manufacturing capacity for tirzepatide was insufficient to meet the sudden and overwhelming demand. This caused delays and shortages, particularly of the higher doses of Mounjaro®, which were most effective for many patients.
3. Supply Chain Issues: Global supply chain disruptions, partly due to the COVID-19 pandemic, compounded the issue. Shortages of raw materials and production delays affected many pharmaceutical companies, including brand-name GLP-1 manufacturers.

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Due to these factors, tirzepatide was listed on the FDA’s drug shortage list in late 2022, allowing compounding pharmacies to offer their versions of the drug. This provided a critical alternative for many patients who had limited access to their medications.

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What Happens Now?

With the FDA now declaring that the tirzepatide shortage is resolved, the availability of compounded tirzepatide has come to an end. Patients who were using the compounded version will need to transition to either the brand-name versions (Mounjaro® or Zepbound®) or seek alternative treatments.

This poses several challenges:

• Increased Costs: One of the biggest concerns for patients is the significant cost difference between compounded tirzepatide and the brand-name drugs. Compounded versions were often much more affordable, making them a viable option for those without comprehensive insurance coverage.
• Potential Delays: Patients who need to switch to the FDA-approved versions may experience delays as they navigate insurance approvals, find new providers, or adjust to the higher costs. Some patients may face difficulty in getting their prescriptions filled promptly as demand for the brand-name drugs increases now that compounded options are no longer available.
• Access Challenges: Some patients may find it difficult to afford the brand-name versions even with insurance, depending on their coverage or deductible levels. This may lead to gaps in treatment, especially for those who were benefiting from tirzepatide's effectiveness in managing their conditions.

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What Are the Alternatives?

For patients who cannot afford brand-name tirzepatide or face difficulties transitioning, there are other options available:

• Semaglutide: Semaglutide, sold under the brand names Ozempic® and Wegovy®, is another GLP-1 receptor agonist that has been widely used to manage type 2 diabetes and obesity. Like tirzepatide, semaglutide helps control blood sugar and aids in weight loss by regulating appetite and slowing digestion. While semaglutide does not have the dual-action mechanism that tirzepatide does, it remains a highly effective treatment for many patients.
• Compounded Semaglutide: Semaglutide remains listed on the FDA’s drug shortage list.  As a result, compounding pharmacies are able to compound semaglutide to fill patient prescriptions. Compounded semaglutide may offer a more affordable alternative to both Mounjaro® and Zepbound®, making it a viable option for patients looking to continue their treatment without facing excessive costs.

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At Eden, we understand the frustration that comes with these sudden changes, and we are here to support you in finding affordable, effective alternatives. If you were using compounded tirzepatide and are now facing difficulties with the transition, we recommend considering seeking medical treatment for compounded semaglutide. It offers similar benefits for weight loss and blood sugar control at an accessible price point, ensuring that you can continue your journey toward better health.

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Conclusion

While you can no longer get compounded tirzepatide, you do have options. The end of compounded tirzepatide availability may feel like a setback, especially for those who depended on its affordability, but alternatives like compounded semaglutide offer a promising path forward. At Eden, we are committed to helping you navigate these changes and ensuring that you have access to the care you need at a price you can afford.

If you have any questions or concerns about transitioning to compounded semaglutide or other treatment options, please don’t hesitate to reach out to our team. We are here to support you every step of the way.

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Frequently Asked Questions

Compounded Tirzepatide is no longer available, what does that mean for me?

When name-brand FDA-approved drugs are on the FDA shortage list, compounding pharmacies can meet the needs of patients around the country as deemed medically appropriate by their healthcare providers. Since both Mounjaro® and Zepbound®, which contain the active ingredient of tirzepatide, were deemed in short supply through October 2, that allowed compounding pharmacies (like the trusted ones in Eden’s network) to create compounded tirzepatide at an affordable price and deliver it to prescribed patients. Based on your provider’s recommendation, you may have other options such as compounded semaglutide programs or name brand tirzepatide options. Read more about the tirzepatide shortage announcement.

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What are my options with Eden to continue treatment after my current supply?

Orders placed through October 2, will be fulfilled.  For auto-refills and to discuss alternative options, please reach out to your doctor through the Care Portal. Upon medical review from your Eden network doctor, you may have a number of options including the ones listed below. We’re here for you no matter what. Current Eden pricing is below: 

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Compounded semaglutide ($296/mo) The active ingredient in Ozempic® and Wegovy®.

Zepbound® (tirzepatide) ($1,399/mo without insurance) FDA-approved for weight management for patients with obesity.

Mounjaro® (tirzepatide) ($1,399/mo without insurance) FDA-approved for type 2 diabetes and improved glycemic control.

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Can I access compounded tirzepatide from other companies?


Due to the shortage ending nationwide, U.S. companies can no longer market compounded tirzepatide and compounding pharmacies can no longer ship it to U.S. patients. While you may see offers for compounded tirzepatide from other companies, it violates FDA regulations to fulfill them except in limited circumstances.

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What if I placed a recent order for compounded tirzepatide?


Due to the FDA lifting the shortage, orders that were placed after October 2, will not be fulfilled. Based on your doctor’s recommendation, a switch to another GLP-1 alternative may be available to you.
Please reach out to your doctor through your care portal to ensure continued care as there are options for you.

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What should I do with any compounded tirzepatide I still have?

The shortage resolution does not affect products already at home or shipped.  You should continue to abide by all safety instructions on your medication, including the best-use date and to only use multi-dose vials for up to 28 days after it was first punctured. 

I see other options for compounded tirzepatide only, are these legal?

We care passionate about opening up access to safe and affordable health programs for millions of Americans and will keep fighting to do so. There are a lot of alternative options available for weight management but you need to be aware of any unlicensed online companies and providers that are still offering compounded tirzepatide because it is a direct violation of FDA regulation, meaning those sources are not operating legally. 

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I have insurance, how can I get Tirzepatide?

At Eden we do not take or submit for insurance reimbursement. This allows us to keep our prices low and offer the same service to all patients

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What happens if compounded tirzepatide comes back on shortage, can I return to Eden to receive compounded tirzepatide?

Eden complies with all legal requirements for compounded medications.  In the event that our partner pharmacies are able to fulfill orders in the future we will update our website with more information. 

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I saw an ad for another company that is still offering compounded tirzepatide, why isn’t Eden?

The FDA’s determinations on October 2 prohibit compounding pharmacies from compounding tirzepatide.  Different companies may be slower or faster to respond to changes.  Eden closely complies with all regulations regarding safety and shortages.  At this point, new prescriptions (whether or not the patient has used tirzepatide in the past) cannot be legally fulfilled by compounding pharmacies.  Please be advised that this will be a nationwide impact and will affect all compounding pharmacies from all providers.

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I have an existing tirzepatide prescription that was written by the doctor but I haven’t received it yet.  Will my order be shipped?

• Orders accepted by the pharmacy by 11:59pm on October 2, 2024 will be shipped. 
• Orders received by the pharmacy after 11:59pm on October 2 will be canceled automatically.  Members will receive a cancellation email confirming this cancellation as our team updates our order processing.