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Direct answer: FDA proposed not to include tirzepatide on the 503B bulks list because FDA did not find a clinical need for outsourcing facilities to compound tirzepatide from bulk substance

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Johnson 1 1 Alberta PROMs & EQ-5D Research & Support Unit (APERSU), School of Public Health, University of Alberta, Edmonton, Alberta, Canada, 2 Decision Analysis and Support Unit, SGH Warsaw School of Economics, Tenerife, Spain, 3 University of Technology Sydney, Sydney, Australia, 4 CUNY School of Medicine, New York, New York, USA, 5 EuroQol Research Foundation, Rotterdam, Netherlands Journal of Patient-Reported Outcomes 2026 , 10(Suppl 1) :1070 Aims The EQ-DAPHNIE study is a large-scale, multi-country initiative designed to collect representative data on self-reported health status from diverse populations through online panel surveys

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