U.S. Judge Bars Copies of Tirzepatide Weight Loss Drugs
A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly’s popular weight-loss and diabetes drugs Zepbound and Mounjaro in the United States.
The decision was filed late on March 5th in response to an October lawsuit from a compounding industry group against the U.S. Food and Drug Administration’s decision last year that there was no longer a shortage of the medicines’ active ingredient, tirzepatide.
Eli Lilly said that the decision “marks the end of the road for mass compounding” of its drugs, and that it would work with regulators and law enforcement to stop the sale of these copies.
Read more at Reuters >>
As a result of the court ruling, this marks the end of the FDA enforcement discretion as follows:
- Small-scale compounders (i.e. 503A facilities), licensed by individual states and physician compounding, must stop producing compounded tirzepatide immediately.
- Larger-scale federally licensed compounders (503B outsourcing facilities) have until March 19, 2025, to wind down their production and distribution of compounded tirzepatide.
National health care law firm ByrdAdatto describes the implications for health care providers.
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