An overview for healthcare providers on the Mounjaro (tirzepatide) shortage timeline, FDA resolution, compounding enforcement, and what prescribers need to know about patient access in 2026.
The tirzepatide supply situation has evolved significantly over the past two years. What began as a severe national shortage has transitioned into an officially resolved supply issue — but one that still creates day-to-day headaches for prescribers and patients alike. If you're fielding questions from patients, navigating prior authorizations, or trying to keep up with the regulatory landscape around compounding, this is the briefing you need.
This guide covers the full timeline, current FDA status, compounding enforcement, pricing realities, and practical resources for your practice.
Understanding the full arc of the tirzepatide shortage helps contextualize where things stand today and what to expect going forward.
December 2022: The FDA adds tirzepatide to the official drug shortage list as demand for Mounjaro rapidly outpaces Eli Lilly's manufacturing capacity. Patients begin reporting widespread difficulty filling prescriptions across all dose strengths.
2023–2024: The shortage intensifies as GLP-1 medications become the fastest-growing drug class in the United States. Compounding pharmacies begin producing tirzepatide under the FDA's shortage provisions, creating a parallel supply channel at significantly lower cost. Telehealth platforms build entire business models around compounded tirzepatide access.
October 2, 2024: The FDA officially removes tirzepatide from the shortage list, determining that Eli Lilly's supply can meet national demand. This decision has immediate implications for compounding: under federal law, compounders can only produce copies of commercially available drugs when those drugs are in shortage.
October 7, 2024: The Outsourcing Facilities Association files a lawsuit challenging the FDA's decision, arguing the shortage determination was premature. Five days later, a court remands the decision back to the FDA for further evaluation.
December 19, 2024: The FDA issues a declaratory order reaffirming that the tirzepatide shortage is resolved. The agency provides detailed data on Eli Lilly's production capacity and establishes grace periods for compounding pharmacies to wind down production.
February 18, 2025: Enforcement deadline for 503A compounding pharmacies (traditional compounders with individual prescriptions). These pharmacies must stop producing tirzepatide.
March 19, 2025: Enforcement deadline for 503B outsourcing facilities (larger-scale compounders). All compounded tirzepatide production must cease.
May 2025: The U.S. District Court for the Northern District of Texas upholds the FDA's shortage resolution, effectively ending the legal challenge from compounding interests.
Current (2026): All six Mounjaro dose strengths are available nationally. Compounded tirzepatide is no longer legally produced. Localized supply disruptions persist at the pharmacy level.
The FDA's determination has several direct implications for how you manage patients on tirzepatide.
If you have patients who were accessing compounded tirzepatide — whether through a local compounding pharmacy or a telehealth platform — those channels are closed. You'll need to transition these patients to FDA-approved Mounjaro or Zepbound. This transition requires attention to dosing (compounded formulations may have used different concentrations), cost management (branded products are substantially more expensive), and insurance verification.
The FDA has specifically flagged safety concerns with some compounded tirzepatide products, including formulations using tirzepatide salt forms rather than the FDA-approved free-base form. If patients report different side effect profiles after transitioning, dosing discrepancies from their previous compounded product may be a factor.
Many insurers have tightened prior authorization requirements for GLP-1 medications as utilization has surged. Expect step therapy requirements (trying metformin or other agents first for type 2 diabetes), BMI documentation thresholds for weight management indications, periodic re-authorization with documented clinical outcomes, and potential preferred product requirements that favor semaglutide over tirzepatide or vice versa depending on the payer.
Building a PA workflow into your practice — including template letters of medical necessity — saves significant time over handling these on a case-by-case basis.
Mounjaro is FDA-approved for type 2 diabetes. Zepbound (same active ingredient) is approved for chronic weight management and obstructive sleep apnea. Insurance coverage often depends on which product is prescribed for which indication. Prescribing Mounjaro off-label for weight management may result in claim denials that Zepbound would avoid, and vice versa for diabetes indications.
Despite the official shortage resolution, the gap between national supply data and what your patients experience at the pharmacy counter remains significant.
Mounjaro moves from Eli Lilly's manufacturing facilities to the three major wholesalers — McKesson, Cardinal Health, and AmerisourceBergen — and then to individual pharmacies. Each step introduces potential bottlenecks. Wholesalers allocate product based on historical purchasing patterns, so pharmacies that didn't previously carry Mounjaro may have difficulty establishing adequate supply. Pharmacies that serve many GLP-1 patients can exhaust their allocation early in a cycle.
Not all dose strengths are equally available at every pharmacy. Maintenance doses (5mg, 7.5mg, 10mg, 12.5mg, 15mg) generally have better availability than the 2.5mg starter dose, though this has improved considerably since the peak shortage. If you're initiating a new patient, confirming availability of the starting dose before sending the prescription prevents frustration.
Availability varies meaningfully by geography. Urban areas with high prescribing volumes may see more frequent stockouts. Rural areas may have fewer pharmacy options overall. Practices that serve patients across a wide geographic area should be aware that availability can differ significantly even between neighboring towns.
Cost is often the more significant barrier than physical availability. Here's what the pricing landscape looks like in 2026.
List price: Approximately $950–$1,150 per 28-day supply, depending on dose strength and pharmacy.
With Lilly savings card: As low as $25 per 28-day fill for eligible commercially insured patients. This is the single most impactful intervention you can make for many patients — ensuring they're enrolled in this program.
Medicare Part D: Mounjaro is covered under most Part D plans for the type 2 diabetes indication, though copays vary widely. The savings card cannot be used with government insurance.
Uninsured/underinsured: The Lilly Cares patient assistance program may provide Mounjaro at no cost for qualifying patients. Encourage eligible patients to apply early, as processing takes time.
Several resources can help you manage the medication access component of GLP-1 prescribing more efficiently.
Medfinder provider portal: Search for Mounjaro availability across pharmacies in your patient's area. You can initiate searches on behalf of patients and send prescriptions directly to pharmacies with confirmed stock. This eliminates the cycle of patients calling your office after being turned away from the pharmacy.
FDA drug shortage database: Monitor the official status of tirzepatide and other medications at accessdata.fda.gov. Search by active ingredient (tirzepatide) rather than brand name for the most complete results.
Eli Lilly savings and support: Direct patients to the Mounjaro savings card and Lilly Cares programs. Your staff can assist with enrollment as part of the prescribing workflow.
Several developments may affect the tirzepatide landscape in 2026 and beyond.
Eli Lilly continues to expand manufacturing capacity. As production stabilizes further, localized disruptions should become less frequent. However, demand for GLP-1 medications shows no signs of plateauing, so supply-demand equilibrium may take time to achieve fully.
The oral GLP-1 market is expanding. Oral Wegovy's approval in December 2025 provides a new option for patients who prefer not to inject, and Eli Lilly has oral tirzepatide formulations in late-stage development. These could eventually reduce pressure on the injectable supply chain.
Payer coverage policies continue to evolve. As outcomes data for GLP-1 medications strengthens — particularly around cardiovascular benefits and MASH — coverage may broaden, but so will utilization management tools like prior authorization and step therapy.
The tirzepatide shortage story is one of unprecedented demand meeting a complex regulatory and manufacturing landscape. While the acute crisis is behind us, the practical challenges of getting patients their medication continue to require provider attention and advocacy.
Staying current on the supply landscape, building efficient workflows for medication access, and leveraging tools like the Medfinder provider portal positions your practice to deliver better outcomes for patients who depend on these medications.
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