Nov 21 Update on Compounded Tirzepatide Availability and Ongoing FDA Reevaluation
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You might be aware that we were expecting an update on the lawsuit between the Outsourcing Facilities Association representing compounding pharmacies, and the U.S. Food and Drug Administration (FDA). Many have been nervous this would lead to the end of compounded tirzepatide due to the shortage.
TLDR: The update is that there will be another update on Dec 19, 2024.
FDA Updates:
The FDA is actively reassessing its prior decision regarding Tirzepatide. This reevaluation is a high priority for the agency, which aims to issue a revised decision promptly.
OFA Compounding Insights:
- Despite efforts to address shortages, branded GLP-1 agonist products, including Tirzepatide, remain in limited supply.
- Recent survey data highlights increasing difficulty for patients to access these branded products, underscoring the continued demand for compounded alternatives.
- Pharmacy distributors still report Tirzepatide as largely out-of-stock or available in only restricted quantities.
- Compounded formulations have continued to meet a critical market need, reflecting sustained or growing demand. These products are playing an essential role in providing patients with access to necessary treatments when branded versions are unavailable.
You can read the case full update here.
Next Steps:
GLP Winner plans to be a resource for you to navigate finding GLP-1 providers and sourcing the medication long-term. If the shortage goes away, we have options for the name brand manufactured medication. Our expectation is that many providers and compounding pharmacies will attempt to provide compounded tirzepatide after the shortage ends.
We remain committed to transparency and will keep you informed about any developments. Our goal is to ensure that patients can continue to access the medications they need safely and reliably.
If you’re considering getting several months of medication ahead of the December 19 update we made a bulk price comparison tool.
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