Title II of the Drug Quality and Security Act of 2013:

The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.


Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers/Pharmacies will be required to work in cooperation with FDA to develop the new system over the next 10 years.
The requirements to be met over the next 10 year are:

  • Product identification: Manufacturers and repackagers must put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and dispensers/pharmacies will be required provide information about a drug and who handled it each time it is sold.
  • Product verification: Manufacturers, wholesaler drug distributors, repackagers, and dispensers/pharmacies will be required to implement systems and processes to be able to verify the product identifier on certain prescription drug packages.
  • Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and dispensers/pharmacies to quarantine and investigate a drug that has been identified as “Suspect”.
  • Notification: Manufacturers, wholesaler drug distributors, repackagers, and dispensers/pharmacies to implement a system and process to notify the FDA and other stakeholders of an illegitimate drug.
  • Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA.
  • Third-party logistics provider licensing: Third-party logistic providers, to obtain a state or federal license..

    

Manufacturers have requirements in every country that has announced compliance laws. Since no two countries have adopted the same ones, they are faced with the challenge of having to satisfy many requirements in all countries that they operate in.


Wholesale Distributor are required to meet the regulations in many countries also.  Since they purchase and sell product, their requirements are the most complex one of all supply chain members in the US.


Repackagers primary focus is to repackage drugs into smaller units for resale. In doing so, they are both wholesale distributor and manufacturer functions and need to meet both compliance requirements of the law.


Dispensers/Pharmacies in the US have requirements that are relatively light compared to other supply chain members.  The significant responsibility is being able to receive transaction data, verify it, retain it for six years, and be able to retrieve that information the event of an inquiry.


The following table highlights certain deliverables described in the law. Estimated target dates are based on applicable statutory deadlines and may be listed as "TBD" (to be determined) when dependent on completion of other deliverables or activities. As FDA works with stakeholders to implement the provisions of the law, additional deliverables may be identified. FDA’s Center for Drug Evaluation and Research is the lead for the Drug Supply Chain Security Act Implementation and other agency components are actively engaged.                              













































For more information on the timelines visits the FDA site by clicking here

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Serialization / Track and Trace

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