Folks –
I have a Sponsor that has an open IND, and is manufacturing IP (a small molecule in gelatin capsules) in Canada and importing to the US for labeling and distribution. The importer is saying that an import permit is required. I have never experienced this previously. As long as there is an end user statement along with the origin and BSE/TSE statement for the gelatin capsules, I have had no issue.
My understanding is that a USDA/APHIS permit is only required if the importer were bringing in bulk gelatin capsules from Canada (elsewhere).
Does anyone have any other experience recently?
Best,
Greg