Challenges of Implementing U.S. and Global Serialization Mandates Compel Industry Cooperation

Pharmaceutical companies are reaching a clear understanding that they will have to work closely together, and with their supply chain partners, to address the serialization and tracing requirements of the Drug Supply Chain Security Act (DSCSA) as they unfold in stages through 2023.

The need for industry cooperation in understanding and dealing with the complex web of implementation challenges presented by DSCSA was a key theme among the experts participating in a panel session at the Generic Pharmaceutical Association (GPhA) Fall Technical Conference held in November in Bethesda, Maryland.

The panelists explored where the DSCSA implementation challenges lie, the progress and learnings thus far in preparing for compliance, and the problems that remain to be addressed as the second phase of the requirements come into play in the 2017 to 2023 period.

Leading the panel discussions was Leavitt Partners Collaborative Advocates Senior Director Eric Marshall. The other four panelists were: ● Mylan Global Serialization Program Senior Director Mark Gutmann ● Sagent Pharmaceuticals Regulatory Affairs Director Mary Anne Anderson ● OmniMedia Associates Managing Partner Brian Rezach, and ● Allergan US Order and Fulfillment Management Executive Director Mary Woods.

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