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As FDA stated in a November 2024 warning to the public about potentially non-sterile semaglutide and tirzepatide injections, [a]dministration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis. In fact, patient harm caused by contaminated spinal injections made by NECC was the impetus to create the 503B statute in the first place