In August 2017, AmerisourceBergen announced that it had reached an agreement in principle with the federal government to resolve a criminal investigation of Medical Initiatives Inc. (MII), AmerisourceBergen’s oncology distribution center subsidiary, regarding MII’s distribution of millions of misbranded oncology drug products between 2001 and 2014. According to the government, MII prepared pre-filled syringes in an unclean, unsterile environment and did not register as a re-packager or manufacturer with the U.S. Food and Drug Administration (FDA) as required by law. AmerisourceBergen agreed to pay $260 million and plead guilty to a strict liability misdemeanor offense under the federal Food, Drug and Cosmetic Act in connection with the failure of MII to duly register with the FDA. In November 2017, AmerisourceBergen paid $625 million to settle a related case brought under the False Claims Act (see AmerisourceBergen instance, “Medical Initiatives Syringe Program – Civil Settlement”).