FDA Clarifies Compounding Rules as Tirzepatide Supply Stabilizes
The U.S. Food and Drug Administration (FDA) has announced that the shortage of tirzepatide (Mounjaro/Zepbound) has been resolved, marking a significant development in the ongoing GLP-1 medication supply challenges.
According to the FDA’s recent announcement, Eli Lilly’s supply of tirzepatide can now meet current and projected national demand. This resolution comes after roughly two years of shortage since 2022, when unprecedented demand led to supply constraints.
To ensure smooth patient care transition, the FDA has established these deadlines for the following facilities to stop distributing or dispensing compounded tirzepatide:
- State-licensed pharmacies (503A): 60-day grace period until February 18, 2025
- Outsourcing facilities (503B): 90-day grace period until March 19, 2025
Current Status of GLP-1 Medications
| Medication | Brand Name(s) | Status | Availability |
|---|---|---|---|
| Tirzepatide | Mounjaro/Zepbound | Resolved | Fully Available |
| Dulaglutide | Trulicity | In Shortage | All Presentations Available |
| Semaglutide | Ozempic/Wegovy | In Shortage | All Presentations Available |
| Liraglutide | Victoza | In Shortage | Limited Availability |
Key Takeaways
- Tirzepatide shortage has been officially resolved
- FDA emphasizes that compounded drugs are not FDA-approved and do not undergo the rigorous safety and effectiveness reviews required for approved medications.
- Other GLP-1 medications remain in various states of shortage
- Compounded drugs must not be “identical or nearly identical” to FDA-approved drugs unless the approved medication is on the FDA’s drug shortage list.
- FDA has established clear transition periods for compounding pharmacies with the deadline for state-licensed pharmacies and outsourcing facilities to cease compounding tirzepatide on February 18, 2025 and March 19, 2025, respectively
- Patients should maintain close communication with healthcare providers during any transition
References
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider for medical diagnosis and treatment. The information provided is current as of December 2024, but medical knowledge and availability status may change rapidly. Verify any critical information with your healthcare provider.
