Is Compound Tirzepatide Ending? FDA Shortage List Updated 2024
What Is The FDA Shortage List and How It Affect Medication Compounding?
The FDA defines a drug shortage as a period when the demand or projected demand for a medically necessary drug in the United States exceeds its supply. When a shortage occurs, it can lead to the production of compounded medications as an alternative source. Here's a breakdown of the FDA's drug shortage criteria and related information:
| Aspect | Details |
|---|---|
| Criteria for FDA Shortage | Total supply of all versions of a drug product is inadequate to meet current or projected demand Demand increase for the drug Supply interruptions (e.g., manufacturing quality problems, delays, discontinuations) |
| Shortage Reporting Timeline | Manufacturers must notify FDA at least 6 months in advance, or as soon as possible, of a permanent discontinuance or interruption in manufacturing |
| Compounding During Shortages | Allowed under Section 503B of the FD&C Act Outsourcing facilities can compound drugs on FDA's drug shortage list |
| Shortage Resolution Efforts | FDA works with manufacturers to prevent or reduce impact of shortages Expedited reviews of manufacturing supplements to help restore production Requests for other firms to increase production |
Source: U.S. Food and Drug Administration. (2024). Drug Shortages. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
During a shortage, the FDA may allow the temporary distribution of a compounded drug product to meet patient needs. Compounded drugs are not FDA-approved but can serve as alternatives when manufactured drugs are unavailable. The FDA maintains a public database of current drug shortages and works closely with manufacturers to address supply issues and mitigate shortages.
Semaglutide and Tirzepatide on the FDA Drug Shortage List
Semaglutide (Wegovy, Ozempic) and tirzepatide (Mounjaro, Zepbound) are GLP-1 receptor agonists used for treating type 2 diabetes and obesity. Both medications have experienced shortages due to high demand and manufacturing constraints.
Semaglutide (Wegovy)
Wegovy first appeared on the FDA drug shortage list in May 2022. As of August 2024, three doses of Wegovy remain in limited availability:
- 0.25 mg/0.5 mL
- 0.5 mg/0.5 mL
- 1 mg/0.5 mL
The FDA database lists the estimated shortage duration for these doses as "TBD" (To Be Determined).
Tirzepatide (Mounjaro)
Mounjaro was added to the FDA drug shortage list in December 2022. However, as of August 4, 2024, the FDA has updated its drug shortage database to indicate that all doses of Mounjaro and Zepbound (the brand name for tirzepatide approved for weight loss) are now available. This includes:
- 2.5 mg/0.5 mL
- 5 mg/0.5 mL
- 7.5 mg/0.5 mL
- 10 mg/0.5 mL
- 12.5 mg/0.5 mL
- 15 mg/0.5 mL
This recent update suggests that Eli Lilly, the manufacturer of tirzepatide, has successfully increased production to meet demand. However, it's important to note that availability can fluctuate, and patients should consult with their healthcare providers for the most current information regarding access to these medications.
Get affordable doctor copay without paying insurance premiums
Join 39,000 people and get Mira, the best alternative to traditional insurance. Enroll and use immediately. Plans start at only $45/mo.
David Burke, PharmD, is a seasoned clinical pharmacist with over 10 years of experience in hospital and community pharmacy settings. He earned his Doctor of Pharmacy degree from the University of North Carolina at Chapel Hill.