Several years ago, my company outsourced the manufacture of an injectable drug product to a non-US firm. The overseals on the vials have the text “FLIP OFF,” which was completely acceptable at the time but is no longer permitted due to the 2013 revision of USP <1>.
We imported the majority of the product prior to the change in USP <1>.
We now need to import a few more vials for laboratory testing.
I need to figure out whether we can import the vials as they are or whether we need to have them overlabeled to indicate that they are for laboratory use only.
Any advice will be appreciated.
Thank you!
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Michael Hellerstein
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