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National Traceability System Moves into Implementation

December 6, 2013
Last week, President Obama signed into law the Drug Quality and Security Act (H.R. 3204), which created a single, uniform and national solution to safeguard the nation’s pharmaceutical supply chain against criminal counterfeiting. Inside Health Policy’s Alaina Busch highlighted implementation plans in this November 20 story, “Drug Security Bill Ushers In Compounder Market Shift, 10-Year Effort To Implement Rx Tracing,” which can be accessed here with a subscription. Below are details on implementation based on the article.

This legislation establishes uniform national standards for the supply chain, which will replace the currently fragmented and piecemeal system that varies from state to state. It strengthens the FDA’s ability to keep bad actors out of the system, and requires that prescription drug packaging use advanced technologies so a product’s source and distribution history can be traced nationwide from manufacturer to patient.

Attention now turns to implementing an interoperable drug tracing system within the next 10 years.

Through agency rulemaking, details of the new system will be determined and established. FDA is currently developing an implementation plan to release within the next couple of months to outline guidance, regulations, standards, and meetings in addition to estimated time frames. FDA is expected to provide guidance on how to identify suspect products and address package level tracing and interoperable electronic data exchange. FDA also will schedule at least five public meetings to discuss implementation issues, which must start no earlier than one year after enactment.

The system will be implemented through self-effectuating requirements and there will be benchmarks for supply chain stakeholders to hit along the way. The bill also includes higher national licensure standards for wholesale distributors.

Starting in 2015, manufacturers, re-packagers and wholesalers must pass transaction information, and pharmacies must meet this requirement beginning in July 2015. These stakeholders must also be able to quarantine and verify suspect products starting in 2015. Drug serialization starts in the fourth year, and members of the supply chain must be able to verify serial numbers in the later years of implementation, although implementation is staggered among stakeholders.

Stakeholders cite data issues as one of the bigger issues to be worked out as the supply chain transitions to a fully electronic, interoperable system. These issues include how the data is stored and for how long.

We will work with the FDA to ensure the rules and regulations provide the nationwide protection and security that patients and their families deserve.