The Shift from Compounded to FDA-Approved Tirzepatide
During a period of national shortage between 2022 and 2024, the FDA temporarily allowed compounding pharmacies to create versions of tirzepatide (used in brand-name Mounjaro and Zepbound) to ensure patient access. This temporary measure ended in 2025.
The Resolution of the National Shortage
In late 2024, the FDA confirmed that Eli Lilly had increased production to meet the demand for tirzepatide, resolving the national shortage. This removed the primary reason for allowing widespread compounding.
End of Compounding Deadlines
The FDA set deadlines for compounding pharmacies to stop producing tirzepatide copies. State-licensed pharmacies (Section 503A) stopped by February 18, 2025, and outsourcing facilities (Section 503B) by March 19, 2025. Court decisions in May 2025 supported the FDA's action, confirming the end of general compounded tirzepatide sales.
The Rationale Behind the FDA's Decision
The FDA's decision was largely due to patient safety concerns, as compounded drugs lack the stringent testing and quality control of FDA-approved medications. Risks included inconsistent potency and potential contamination. The FDA received adverse event reports linked to compounded tirzepatide.
Navigating the Transition: Options for Patients
With compounded tirzepatide no longer widely available, patients must transition to FDA-approved alternatives. Here are the options and things to consider:
FDA-Approved Tirzepatide (Mounjaro and Zepbound)
Mounjaro (for type 2 diabetes) and Zepbound (for weight loss) are the safe and legal ways to get tirzepatide.
Cost and Access
The cost of brand-name tirzepatide can be high without insurance. Patients can explore options like manufacturer savings programs from Eli Lilly, checking insurance coverage, or using the LillyDirect platform for potential savings and easier access.
Limited Compounding for Specific Clinical Needs
Compounding remains legal in very specific situations. A compounded version may be prescribed if a healthcare provider documents a clear clinical need, such as an allergy to an inactive ingredient in the FDA-approved product. The FDA does not consider cost a valid reason for compounding a commercially available drug.
Comparison: Compounded vs. FDA-Approved Tirzepatide
| Feature | FDA-Approved Tirzepatide (Mounjaro/Zepbound) | Compounded Tirzepatide (Pre-March 2025) |
|---|---|---|
| Regulatory Status | FDA-approved, with rigorous testing for safety and efficacy. | Not FDA-approved; prepared in individual pharmacies with less oversight. |
| Availability | Available through traditional prescriptions and LillyDirect, now that the shortage is resolved. | Generally no longer available after March 19, 2025, except in limited cases of specific clinical need. |
| Cost | Can be significantly higher, often exceeding $1,000 without insurance. Manufacturer savings programs are available. | Often significantly cheaper, ranging from $100-$400 monthly during the shortage. |
| Consistency & Quality | Consistent, high-quality, and reliable dosing due to strict manufacturing standards. | Inconsistent dosing and quality due to varying pharmacy practices. Higher risk of contaminants and substandard ingredients. |
| Ingredients | The precise, FDA-reviewed tirzepatide molecule and approved inactive ingredients. | May contain unauthorized salt forms or other investigational drugs not approved for human use. |
| Safety & Side Effects | Safety profile evaluated during clinical trials. Adverse events are carefully monitored by the FDA. | Higher risk of adverse events due to lack of regulated testing. Hundreds of adverse events were reported to the FDA. |
Conclusion
As of March 2025, purchasing compounded tirzepatide is generally no longer possible due to the FDA's declaration that the national shortage of FDA-approved Mounjaro and Zepbound is resolved. While limited compounding for specific clinical needs is still allowed, it is not for general use. Patients previously using compounded versions should work with their healthcare providers to switch to the FDA-approved medications and explore options like manufacturer assistance programs to manage costs. The FDA's action emphasizes the importance of using regulated, FDA-approved medications for safety and effectiveness.
Frequently Asked Questions
1. Is compounded tirzepatide still available to purchase? Generally, no, compounded tirzepatide is no longer available. The FDA ended the temporary allowance in March 2025 after the national drug shortage was resolved.
2. What should I do if I was using compounded tirzepatide? Speak with your healthcare provider immediately to discuss transitioning to the FDA-approved versions, Mounjaro or Zepbound, and explore cost management options.
3. Is there any way to get compounded tirzepatide? A healthcare provider may prescribe a compounded version in very limited cases with a documented clinical reason, like an allergy to an ingredient in the FDA-approved product. Cost is not a valid reason.
4. Why did the FDA stop the sale of compounded tirzepatide? The FDA stopped sales because the national shortage that allowed compounding has been resolved. The decision prioritizes patient safety, as compounded drugs lack the rigorous testing of FDA-approved medications.
5. What are the risks of using compounded tirzepatide? Risks include inconsistent dosing, contamination, and the use of unauthorized ingredients. Hundreds of adverse event reports were linked to compounded versions.
6. What is the difference between Mounjaro, Zepbound, and compounded tirzepatide? Mounjaro and Zepbound are FDA-approved, brand-name versions of tirzepatide with strict quality controls. Compounded tirzepatide was a less regulated version available during the shortage.
7. How can I afford Mounjaro or Zepbound if they are more expensive? Explore manufacturer savings programs, patient assistance programs, and check insurance coverage. The LillyDirect platform may also offer savings.
8. What does the resolution of the FDA court case mean? Court rulings in May 2025 upheld the FDA's authority to end tirzepatide compounding, solidifying the requirement to transition to FDA-approved products.
