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

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Ed Groleau
Keymaster

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

Importing drug that is not fully released is pretty common. Drugs are shipped under a quarantined status all the time in order to shrink timelines.

I’m a little confused with the situation. The “3rd party secondary packaging and labeling site of our collaborator” is a different company than the “collaborator’s CPO”? Assuming it is as long as you have an IND in place you should be able to import the drug to either location. Anyone else know of any restrictions preventing the shipment? I don’t think physically transporting the material is the issue. If the location you wan to ship it to is not in your IND as a manufacturing facility then you will not be able to use it. You can import to any location you want but it will sit there until your IND is updated.

Why not ship it to the listed location under quarantine? I’ve shipped unreleased drug substance all over to have it packaged and labeled and ready for CT use while the release testing of the bulk was still underway. There’s business but no quality risk doing that. If there’s a problem with the drug then money is wasted on the completed activities but if it never gets released then the quality process works and it doesn’t get used.