Gartner Research

Assessment of Track-and-Trace and Serialization Legislation for Life Science Companies, United States

Published: 29 April 2016

ID: G00295585

Analyst(s): Andrew Stevens


U.S. Legislation (DSCSA) for securing drugs across U.S. supply chains continues to develop. Supply chain leaders and their trading partners responsible for serialization compliance must balance immediate reporting mandates with longer-term serialization deployment strategies.

Table Of Contents


  • Introduction
  • Focus on the Upcoming DSCSA Mandates
  • Systems in Place for Verification of Suspect and Illegitimate Products
  • Exchange of Data Transactions
  • Suggested Next Steps
    • Within Your Organization
    • Across Your Wider Supply Chain Networks and Enterprises
  • Guidance Documents
  • The Compounding Quality Act
  • Exemptions and Special Definitions
  • Compare U.S. Laws With Others Across the Globe

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