Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Counterfeiters Move from “Lifestyle Drugs” to “Life-Saving Drugs”

Drug counterfeiting used to primarily include ‘lifestyle drugs’ such as Viagra, but now fraudulent lifesaving drugs are increasingly being produced, putting more patients at risk.

According to the European Alliance for Safe Medicines, 62% of medicines purchased online are fake or substandard.

In order to combat the large and potentially life threatening market for counterfeit drugs, the US Federal government passed the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act (DQSA), in November 2013. Legislation requires that each unit of sale be marked with a unique product identifier, lot number and expiration date.

In North America, the deadlines imposed for meeting DQSA will now come into force in 2018 with later deadlines for re-packagers and wholesalers. The regulation requires a transaction document and serialization of all prescription products, enabling the electronic transfer of specified transaction information and history through the supply chain.

The end result will be full product tracking across the supply chain with each product including a 2D Datamatrix barcode by 2023. While this staggered timeline for compliance will impact companies throughout the supply chain over a number of years, it is believed the biggest impact will be felt by the deadline impacting manufacturers. Though this legislation is directed at the US market, the impact will be felt equally in Mexico and Canada, both of which export to the United States.

Source: PMMI Business Intelligence, “Global Trends Impacting the Market for Packaging Machinery 2018.” Download the FREE full report below.

Learn more about the countdown to Serialization with HealthcarePackaging’s free playbook.

FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report