AmerisourceBergen pleaded guilty Wednesday to a federal misdemeanor charge for selling prefilled syringes of oncology drugs that were packaged in a facility not registered with the Food and Drug Administration, reports Reuters.
Here are four things to know.
1. Between 2001 and 2014, two AmerisourceBergen subsidiaries — Oncology Supply Co. and the now shuttered Medical Initiatives — packaged millions of syringes in an unapproved facility, according to a from the U.S. Department of Justice.
2. The DOJ also said Medical Initiatives prepared syringes by transferring excess drugs from glass vials into the plastic syringes in an "unclean, unsterile environment," according to the DOJ release. Prosecutors claim the wholesaler refrained from registering the facility with the FDA to avoid regulatory oversight.
3. AmerisourceBergen, which disclosed the deal with the DOJ in August, will pay $260 million in penalties.
4. The U.S. Attorney's Office in Brooklyn, which brought the criminal charge, may also pursue civil claims against the wholesaler under the False Claims Act. AmerisourceBergen is free to contest claims for all criminal information to which it did not plead guilty in future legal matters.
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