Importing non-released drug product into the US and delivering it to a partner

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Importing non-released drug product into the US and delivering it to a partner

My organization has a partnership whereby we ship our unlabeled product (in primary packaging) to the 3rd party secondary packaging and labeling site of our collaborator. Due to timing constraints, my CMC lead is suggesting that we can import and ship unreleased drug product into the US and deliver it directly to our collaborator’s CPO. This CPO is not part of our supply chain or included in any of our regulatory filings.

Outside of the risk of issues with our product possibly not passing release spec criteria after it is delivered, and the issues of insurance/liability in the event of a problem with the shipment, and the lack of documentation to support receipt at the CPO, I’m relatively certain that this is non-compliant from a customs perspective. Has anyone ever evaluated doing something similar?

(I think this is a resoundingly terrible idea, FWIW, but I’m up against someone who claims we are not willing to “think outside of the box”. Halp!)

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