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FDA Rescinds Tirzepatide Shortage, Sparks Legal Battle

1/3/2025

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Summary

Story summary

The FDA has removed tirzepatide from its drug shortage list, leading to a lawsuit from the Outsourcing Facilities Association over ongoing shortages.
The FDA will reconsider its decision, pausing the lawsuit and permitting compounding pharmacies to produce the drug.
Eli Lilly argues that compounded versions pose safety risks and claims their products are readily available.
The FDA's enforcement discretion allows compounding until its review concludes, but future production may be restricted if no shortage is confirmed.
Compounded semaglutide remains available amid ongoing supply issues from Novo Nordisk.

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Story summary

The FDA has removed tirzepatide from its drug shortage list, leading to a lawsuit from the Outsourcing Facilities Association over ongoing shortages.
The FDA will reconsider its decision, pausing the lawsuit and permitting compounding pharmacies to produce the drug.
Eli Lilly argues that compounded versions pose safety risks and claims their products are readily available.
The FDA's enforcement discretion allows compounding until its review concludes, but future production may be restricted if no shortage is confirmed.
Compounded semaglutide remains available amid ongoing supply issues from Novo Nordisk.