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Counterfeiting Results in DQSA Legislation Headaches

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

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 here.

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