In April 2012 a presentation on FDA's activities to combat counterfeit drugs from Ilisa Bernstein, Director, Office of Compliance, CDER, FDA, was published. The document provides the definition of a counterfeit drug according to U.S. law and presents the reasons why complexity of the supply chain keeps on increasing:
As a first-step measure to ensure patient safety Ilisa Bernstein suggests to build "Supply Chain Integrity". Moreover, the document mentions FDA's new Office of Drug Security, Integrity, and Recalls which has been equipped with additional resources. The FDA also intends to improve transparency and accountability of the supply chain. The system used currently - the Pedigree System - should be replaced in the future by a Track&Trace and Authentification system with a unique serial number on each drug package. The presentation shows where the Track and Trace system can help making the supply chain more safe. Author: |
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