From a stability perspective nothing should be repackaged without data to support the new packaging. But that get’s more complicated when factoring in how late in original packaging’s shelf life the repackaging occurs. I don’t really have an answer for your specific question, but I can say that our stance was always, “If they’re going to repackage that, it’s on them.” We were aware that wholesale distributors were repackaging into very different containers that our stability data supported, but we had not control over their processes. We hoped they had some stability programs to support their practices, but we never were privy to that information. That said, some in-use data might help support some handling at the pharmacy, but I’ve never heard of an in-use study covering a repackaging process. Still, I guess it could be done, but ultimately not the manufacturers responsibility, I would think.
