• 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...
  • Regulatory NewsRegulatory News

    Companies Collaborate on DSCSA Guideline as Deadlines Approach

    Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013. In preparation for that deadline and others over the next seven years, a diverse group of 44 companies – from manufacturers to wholesalers to solution providers – came together to develo...