[Ed Groleau]

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

Your details do clarify things but they don’t change my opinion. Shipping prior to release is a business risk. If both sides acknowledge and agree to the risk then it’s ok to make the shipment. If your CMO has a history of issues that ups the risk and needs to be considered. What’s more important? The timeline or the financial loss if the drug fails release?

So my reply to the initial question is still yes, you can ship the drug. There’s nothing to stop that from being successful but there are other potential downstream issues. I would point out the options and impact and let the people in charge of the money decide.