United States

Product Serialization and Traceability Mandates

May 18, 2014
From the Healthcare & Life Sciences Institute

In an effort to battle the increasing threats to patient safety posed by counterfeited, adulterated and diverted pharmaceutical products, regulatory agencies around the world are introducing new mandates to prevent their entry into the legitimate supply chain.

This document provides an overview of the various product serialization and traceability mandates that are aimed at securing the distribution channel for all legitimate, regulatory-approved, prescription drug products.

While global standards do exist for serialization and track and trace processes, there is presently no global regulation in place, resulting in each country/region applying these standards differently.

Nevertheless, product serialization and traceability technologies and processes offer potentially powerful tools in this battle to protect both patients as well as those dedicated to serving them.