• Regulatory NewsRegulatory News

    Drugmakers Make Significant Headway in Track-and-Trace Compliance

    A new GS1 Healthcare report on the progress made in meeting the serialization requirements of the Drug Supply Chain Security Act (DSCSA) found significant progress, especially in comparison to reports from 2017 and 2018. Part of the reason for the progress can be attributed to a US Food and Drug Administration (FDA)  deadline extension  to November 2018 for certain product identifiers. “Of course, the compliance deadline really drove suppliers’ actions toward seria...
  • Plastic Packaging Leads to more than a Dozen Major Device Recalls for Cardinal Health

    A little piece of plastic is causing big headaches for Cardinal Health after its Medical Products and Services Division announced more than a dozen Class 1 recalls because of the potential for a device's plastic packaging to get stuck in its filter, obstructing airflow to a patient being operated on. The recalls affect at least 13 device kits manufactured by the company, the majority of which seem to be contained within or otherwise related to Cardinal's Presource PBDS ...
  • Judge Stops Company’s Drug Shipments in Florida

    • 02 March 2012
    A US District judge ordered Cardinal Health to stop shipping drugs from its Lakeland, FL, distribution center, according to a report in USA Today . The US Drug Enforcement Administration (DEA) had previously suspended the company's license to distribute prescription painkillers to Florida pharmacies. Judge Reggie Walton's decision upholds that suspension. A DEA investigation found Cardinal shipped 50 times as much oxycodone to four of its top pharmacies than it did t...