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GLP-1 Compounding: Court Backs US FDA Approach To Managing Drug Shortage List

 
• By Sue Sutter

A lengthy notice-and-comment rulemaking process is not congruent with the congressional mandate to keep an up-to-date list of drugs in short supply, US judge said, denying compounders' request to stay removal of the GLP-1 tirzepatide from the shortage list.

MIsaligned pencils
A court said the notice-and-comment rulemaking process is not aligned with Congress' mandate that the FDA keep an up-to-date list of drugs in shortage. (Shutterstock)

The US Food and Drug Administration may add or remove drugs from the shortage list without using the lengthy notice-and-comment rulemaking process, a federal judge ruled in a dispute involving the compounding of tirzepatide, the active ingredient in Eli Lilly’s Mounjaro and Zepbound.

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