Track and Trace Bill Becomes Law

The countdown is on.  Pharmaceutical companies doing business in the United States have less than four years to implement the requirements of a federal track and trace law.  The law is part of the Drug Quality and Security Act that was signed into law by President Obama on November 27.

The Drug Quality and Security Act requires pharmaceutical companies to adopt a track and trace system for their medicines. Individual packs of drugs will need serial numbers by November 27, 2017.  In 10 years, medicine will need to be traceable as it makes its way from the manufacturer to a pharmacy.

The law also creates stricter license requirements for distributors and third parties who transport drugs. The FDA will also maintain a database of wholesalers that will be available to the public through its website.

Federal track and trace requirements will replace similar state laws.  In fact, California’s ePedigree law was set to take effect on January 1, 2015.  The federal law gives pharmaceutical companies more time to comply with trace and trace legislation.

Pharmaceutical companies need to develop a strategy to conform to the Drug Quality and Security Act.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet the regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made.

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