Is tirzepatide shortage removed? What Patients and Providers Need to Know

October 9, 2025 •

4 min read

The U.S. Food and Drug Administration (FDA) officially determined that the shortage of tirzepatide injections was resolved in December 2024, after nearly two years of supply issues due to overwhelming demand. This definitive end to the tirzepatide shortage carries significant implications for patients, providers, and the compounding pharmacy industry.

Quick Summary

The FDA has resolved the tirzepatide injection shortage for Mounjaro and Zepbound, ending compounding privileges. Branded product availability is improved, but access and cost concerns persist for many.

Key Points

Shortage Officially Resolved: The FDA removed tirzepatide (Mounjaro, Zepbound) from its drug shortage list in December 2024, citing sufficient manufacturer supply.
End of Compounding: The resolution of the shortage has ended the temporary legal allowance for compounding pharmacies to produce copies of tirzepatide. Enforcement deadlines passed in early 2025.
Increased Brand Name Availability: FDA-approved Mounjaro and Zepbound are now generally available, though localized, intermittent supply issues may still occur as distribution stabilizes.
Transition Challenges: Patients who relied on cheaper compounded versions now face the challenge of accessing and affording the more expensive, FDA-approved products.
Focus on Patient Access: With supply stabilized, the emphasis shifts to ensuring patient access through insurance coverage, manufacturer assistance programs, and robust supply chains.
Prioritize Safety: The move reinforces the importance of using FDA-approved medications, which are subject to rigorous safety and efficacy testing, over unregulated compounded versions.

The Resolution of the Tirzepatide Shortage

For nearly two years, a significant shortage of tirzepatide injections, sold under the brand names Mounjaro and Zepbound, created challenges for patients with type 2 diabetes and those seeking weight-loss treatment. The supply issue began in December 2022 for Mounjaro and April 2024 for Zepbound, driven by soaring demand. The supply crisis led many patients to rely on compounded versions of the medication, produced by special pharmacies under a temporary allowance from the FDA during the shortage period.

Following extensive data review, the FDA first announced the shortage was resolved in October 2024. This decision was challenged by the Outsourcing Facilities Association (OFA), representing compounding pharmacies, who filed a lawsuit arguing the shortage was still ongoing. The FDA re-evaluated its determination and, in December 2024, definitively upheld its original conclusion that manufacturer supply could meet market demand. Court rulings in early 2025 further reinforced the FDA's stance.

A Timeline of the Tirzepatide Availability

Understanding the chronology of events is key to grasping the current landscape:

May 2022: The FDA approves Mounjaro (tirzepatide) for the treatment of type 2 diabetes.
December 2022: Mounjaro is first added to the FDA's drug shortage list due to increased demand. Compounding of tirzepatide begins under FDA enforcement discretion.
November 2023: The FDA approves Zepbound (tirzepatide) for chronic weight management.
April 2024: Zepbound is also added to the FDA's drug shortage list.
October 2, 2024: The FDA initially announces the tirzepatide shortage is resolved.
October 2024: The Outsourcing Facilities Association (OFA) sues the FDA, challenging the decision.
December 19, 2024: After re-evaluation, the FDA reaffirms its decision that the tirzepatide shortage is resolved. The FDA sets deadlines for compounders to cease production.
February/March 2025: Enforcement deadlines pass for compounding pharmacies to stop creating versions of tirzepatide.
Early May 2025: Court rulings uphold the FDA's decision, finalizing the cessation of compounded tirzepatide sales.
September 2025: Eli Lilly is manufacturing tirzepatide at full capacity, though localized supply disruptions may still occur as distribution stabilizes.

The Compounding Controversy

The end of the shortage was particularly disruptive for patients using compounded tirzepatide. Compounding pharmacies were permitted to make their own versions of the drug during the shortage, often at a lower cost. This was a stopgap measure, and once the branded product was no longer in shortage, the FDA ended this allowance to ensure patient safety and product integrity. Compounded drugs are not subject to the same rigorous safety, efficacy, and manufacturing standards as FDA-approved products, and the FDA has cited reports of adverse events linked to them.

This shift forced many patients, particularly those who were uninsured or underinsured, to confront a significant price increase and navigate the challenges of transitioning to the more expensive, branded Mounjaro or Zepbound. Eli Lilly has responded by expanding manufacturing and offering direct-to-patient programs to improve access.

Navigating the Transition from Compounded Tirzepatide

For individuals transitioning from compounded tirzepatide to a branded product, several steps are necessary to ensure a smooth and safe process:

Consult with a Healthcare Provider: Your provider can guide you on the appropriate transition plan, including dosage adjustments and insurance considerations. This is the most crucial step to ensure continuity of care and safety.
Verify Insurance Coverage: Contact your insurance provider to understand the coverage for Mounjaro or Zepbound. Coverage for weight-loss medications can vary significantly between plans.
Explore Financial Assistance: Look into patient assistance programs offered by the manufacturer, Eli Lilly, which may include savings cards or other discounts to help with the cost. Details are often available on the brand name product websites or through programs like LillyDirect.
Confirm Pharmacy Availability: While the national shortage is resolved, intermittent, localized supply chain disruptions can still occur. It's wise to contact your pharmacy before a refill is due to confirm stock. If a specific dose is unavailable, the pharmacy can check with alternative distributors or you can explore different pharmacies.
Address Lifestyle Changes: Continue focusing on diet and exercise. The medications are most effective as part of a broader lifestyle modification plan.

Compounded vs. FDA-Approved Tirzepatide


Feature	FDA-Approved (Mounjaro/Zepbound)	Compounded (No Longer Widely Available)
Regulation	FDA-regulated for safety, purity, and efficacy	Not FDA-regulated; production quality varies by pharmacy.
Efficacy	Proven effective through rigorous clinical trials.	Unverified efficacy; no consistent quality standards.
Safety	Subject to extensive safety testing and monitoring.	Higher potential for impurities, incorrect dosage, and adverse events.
Cost	Often high list price; dependent on insurance coverage.	Historically more affordable; used by many without insurance.
Availability	All doses now generally available through licensed distributors.	Access has ceased since deadlines passed in early 2025.

The Outlook for Tirzepatide

With the shortage officially in the past, the focus has shifted from supply constraints to patient access and affordability. Manufacturer Eli Lilly has ramped up production significantly and continues to increase capacity. The legal challenges from compounding entities have largely concluded, solidifying the FDA's enforcement of regulations against compounded versions. The situation highlights the delicate balance between patient demand, manufacturer supply, and regulatory oversight in a rapidly evolving pharmaceutical market. Patients who relied on compounded drugs must now engage with their healthcare providers and insurance companies to secure access to the FDA-approved and rigorously tested product. The transition, while potentially difficult due to cost and logistical hurdles, ensures that patients are receiving a consistently reliable and safe medication.

Conclusion

Yes, the tirzepatide shortage has been removed. The FDA formally ended the shortage designation in December 2024, confirming manufacturer Eli Lilly's ability to meet national demand for its branded products Mounjaro and Zepbound. This action ceased the legal authorization for widespread compounding of tirzepatide, with enforcement deadlines passing in early 2025. While this marks a positive step towards stable and safe access to the medication, it also presents a major challenge for patients who previously relied on more affordable compounded options. The pharmaceutical industry and regulators are now focused on maintaining a steady supply and addressing long-term accessibility concerns for patients transitioning to the branded, FDA-approved medications.

LillyDirect is a direct-to-patient service offered by Eli Lilly for accessing medications like Zepbound and Mounjaro.

Frequently Asked Questions

Yes, the tirzepatide shortage was officially removed by the FDA in December 2024, following a reevaluation of manufacturer supply that determined it could meet market demand.

The end of the shortage means compounding pharmacies can no longer legally produce copies of tirzepatide under the shortage exception. All pharmacies had to cease regular production of compounded tirzepatide in early 2025.

Yes, the manufacturer, Eli Lilly, has confirmed it can meet demand, and the FDA considers the brand-name versions generally available. However, patients may still experience intermittent, localized supply issues as the distribution channels stabilize.

You should immediately speak with your healthcare provider to discuss a transition to an FDA-approved version of tirzepatide, such as Mounjaro or Zepbound. Your provider can assist with dosage and insurance considerations.

Under U.S. law, compounding pharmacies can produce copies of a commercially available drug only when it is on the FDA's official drug shortage list. This exception is intended to ensure access during temporary supply issues.

Yes, Eli Lilly offers patient assistance programs and savings cards for Mounjaro and Zepbound to help eligible patients with costs. Information is available on the branded product websites and through LillyDirect.

The FDA has noted that compounded versions of tirzepatide are not subject to the same safety and quality standards as FDA-approved drugs. Risks include inconsistent dosing, impurities, and potential adverse health events.