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