Wednesday 9 December 2015

The Drug Supply Chain Security Act: Current Impact

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The Drug Supply Chain Security Act is the most 
complex pharma track and trace law ever passed.

by David Dills

Sr. Consultant, Regulatory & Compliance, Devices

NovusLife


On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013  (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation, one that eliminated the patchwork of state laws in addition to providing new regulations for compounding pharmacies.  This is the most complex pharma track and trace law ever passed.

The Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA, is the most complex pharma track and trace law every enacted.  Its many layers of complicated rules and regulations provide challenges that companies will need to untangle indeed. 
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