compounding

More than 50 warning letters to GLP-1 compounders and manufacturers

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The FDA issued over 50 warning letters to US and international companies compounding or manufacturing semaglutide and tirzepatide. The cited conduct centered on marketing compounded GLP-1s as “generic versions” of the approved drugs, or making direct comparative claims against them. Sources: FDA warning letter database ยท Wilson Sonsini analysis

Court declines to force tirzepatide back onto the shortage list

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The US District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction, which had sought to prevent the FDA from keeping tirzepatide off the drug shortage list. Consequential for the compounding market: shortage status is the legal basis for much large-scale compounding of a drug, so the … Read more