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


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

Thank you for your reply! I realize that my original question was not very clear, so here are some additional details:

We are Company A, and we have a partnership with Company B where they use our drugs in their trials. We generally provide them with unlabeled bulk bottles of brite stock, which have been fully DP released, for them to label and package. In this case, we would be shipping brite stock ahead of the completion of DP testing for release, which can take 8-10 weeks. We, Company A, routinely do this for our own purposes, but I don’t think this is the “right” thing to do on behalf of our partner Company B, for a few key reasons:

-We are two separate legal entities; we, Company A, use Packager A, which is listed in our IND. They, Company B, use Packager B, which is not listed in our IND. We do not have a reciprocal QA agreement at this point in time whereby we would include Packager B in our IND as an amendment, and we have no plans to qualify Packager B for our own purposes.
-Our umbrella insurance does not cover Packager B as a location; legally, per our MSA with our DP CMO, we as Company A take custody of the material when it leaves their facility. So if we were to deliver it to Packager B ahead of formal release, we have no recourse from a cost recovery perspective if there ends up being an issue with the batch during the release process.
-Related to the above, our DP CMO has had a history of manufacturing issues and subsequent investigations, the last of which resulted in the loss of an entire batch. If the brite stock leaves the facility ahead of release, we have no way to do a 100% inspection or other avenues of investigation in the event that there is an issue.

Would any of these additional points shift your guidance?