Are you ready for Serialization? On November 27, 2013 President Obama signed into law the Drug Quality and Security Act (DQSA). Title II of DQSA outlines critical steps to build an electronic system to identify and trace prescription drugs that are distributed throughout the United States.
In cooperation with the US FDA many manufacturers, wholesale drug distributors, and pharmacies have systems in place and are working to enhance current capabilities of the system. DQSA is vital in this day in age for manufacturers, drug distributors and pharmacies for tracking and tracing drug distribution.
The system will help FDA and other governing agencies protect consumers. It will also improve detection and enhance removal of potentially dangerous drugs within the system by implementing the following details:
Product Identification: A unique barcode that can be easily read electronically.
Product Tracing: Information about a drug and who handled it during distribution within the US.
Product Verification: Systems that are able to verify the product identifier (barcode) during drug distribution.
Detection and Response: A protocol put in place by manufacturers, wholesale drug distributors and pharmacies that will illustrate guidelines for removal and quarantine of a product that is identified as potentially dangerous, counterfeit, or unapproved.
Notification: A system designed to notify FDA and affiliates of illegitimate practices of drug distribution.
Wholesale Licensing: Wholesale drug distributors to report license status to FDA. Information is loaded in a national data base.
Third-party logistics provider licensing: Those who provide storage and distribution of drug products are required to obtain US FDA licensing.