Gartner Research

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

Published: 22 January 2015

ID: G00269549

Analyst(s): Andrew Stevens

Summary

Legislation for securing drugs across U.S. supply chains has undergone significant transition. Supply chain leaders responsible for compliance for U.S. revenue streams must develop immediate strategies for transactional reporting mandates that begin in 2015.

Table Of Contents

Analysis

  • 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

Gartner Recommended Reading

©2019 Gartner, Inc. and/or its affiliates. All rights reserved. Gartner is a registered trademark of Gartner, Inc. and its affiliates. This publication may not be reproduced or distributed in any form without Gartner’s prior written permission. It consists of the opinions of Gartner’s research organization, which should not be construed as statements of fact. While the information contained in this publication has been obtained from sources believed to be reliable, Gartner disclaims all warranties as to the accuracy, completeness or adequacy of such information. Although Gartner research may address legal and financial issues, Gartner does not provide legal or investment advice and its research should not be construed or used as such. Your access and use of this publication are governed by Gartner’s Usage Policy. Gartner prides itself on its reputation for independence and objectivity. Its research is produced independently by its research organization without input or influence from any third party. For further information, see Guiding Principles on Independence and Objectivity.

Already have a Gartner Account?

Become a client

Learn how to access this content as a Gartner client.