Wholesale Distributors

DSCSA & Serialization Regulatory Challenges for Wholesalers

As a wholesale distributor, you play a pivotal intermediary role in the supply chain, getting product from manufacturers to dispensers. As someone who both purchases and sells, you have a requirement in many markets, and the most complex one of all supply chain members in the US.

Wholesalers were subject to the January 1 lot level DSCSA deadline and should now be receiving transaction information from manufacturers and passing it along to dispensers. You may have discovered, as many supply chain companies did, that establishing the necessary connections with partners in order to exchange this data was more daunting than anticipated. Serialization will pose an even bigger challenge. And while wholesalers don’t share the November 2017 serialization deadline with manufacturers, many of you recognize the importance of working with them over the next few years to test end-to-end serialization and make any necessary adjustments in plenty of time. Your full serialization deadline will come later but even before then, you will need to be able to interact with serial numbers in the event of product returns or suspect product inquiries.

Brazil’s first deadline comes this December. Wholesalers have a shared responsibility to report all product events up to not only direct manufacturing partners but also indirect ones, posing even greater communication challenges. 

How TraceLink Can Help  

Wholesale distributors often work with a vast collection of partners, from large pharmaceuticals to small pharmacies. Managing these upstream and downstream relationships is increasingly challenging in a regulated environment. The TraceLink Life Sciences Cloud offers a platform where distributors can connect with manufacturers and dispensers alike and exchange data in many different formats, with partners whose technical capabilities may vary greatly. TraceLink also helps monitor regulatory developments for you, easing the challenges of compliance for the companies who are most burdened.

Achieving lot level transaction may have felt overwhelming, but it’s just the tip of the iceberg. When serialization comes into play – especially if you are operating in multiple markets – your task multiplies exponentially. TraceLink’s network provides an essential foundation to seamlessly manage business relationships and regulatory responsibilities. 

Visit Managing DSCSA as a Wholesale Distributor for further DSCSA and serialization resources. 

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