Repackager Regulatory Challenges

As part of your mission to make bulk manufactured drugs more accessible to patients by repackaging them in smaller units, you buy product and transform it into a new entity for resale. In doing so, you perform both wholesale distributor and manufacturer functions and need to meet both segments' compliance requirements in the eyes of the law.

That introduces complexity from both a lot level and a serialization perspective. Under DSCSA lot level requirements, you receive T3 information when you buy product from the original manufacturer. Once you’ve repackaged it, it is considered new product so when you sell it, you must create new T3 to send downstream to whomever is purchasing from you. At the same time, you’ll need to retain the T3 information you received from the original manufacturer for archiving purposes.

When serialization takes effect, you will receive serialized product from the manufacturer. But you will also need to generate new serial numbers for your repackaged product, and the relationship between the parent and repurposed products will need to be archived. All in all, your dual role creates complexity. 

How TraceLink Can Help

You have two sets of requirements to master, plus a high volume of data and transactions to store. You also have a complex web of upstream and downstream relationships.

The TraceLink Life Sciences Cloud helps you keep track of regulations. TraceLink stays on top of requirements for all supply chain segments and insure that our system meets them. 

We run on the Amazon Web Services cloud, the ideal platform to meet your high volume data needs. As your number of received and newly generated T3 information and serial numbers grow, our solution will seamlessly scale to store that data plus all the associated events.You will never need to worry about server capacity or computing power with TraceLink’s flexible solution.

And there is no better place to interact with partners than the TraceLink network, where more than 200,000 supply chain companies come together. Once you integrate with the network, you are connected to all those companies for easy exchange of transaction documentation and serial number collaboration. 

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