LightInAugust41
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Hi all --
Within the next few weeks, I will embark upon a project at work to transition our depot facility from one which engages in secondary packaging and distribution of investigational drugs/supplies to clinical sites, to one which supplies these items directly to patients. I am curious if anyone here works in a similar environment, providing investigational drugs directly to patient homes. If so, do the same rules that apply to commercial products (e.g. those distributed from mail order pharmacies) apply also to investigational drugs? If anyone has any insight into this, or could point me in the right direction, I would really appreciate it. The state regulations and FDA guidances provide no nuance for investigational drugs (none that I've encountered, at least).
PS: We are located in Pennsylvania, if this helps
Thank you in advance!
Mike
Within the next few weeks, I will embark upon a project at work to transition our depot facility from one which engages in secondary packaging and distribution of investigational drugs/supplies to clinical sites, to one which supplies these items directly to patients. I am curious if anyone here works in a similar environment, providing investigational drugs directly to patient homes. If so, do the same rules that apply to commercial products (e.g. those distributed from mail order pharmacies) apply also to investigational drugs? If anyone has any insight into this, or could point me in the right direction, I would really appreciate it. The state regulations and FDA guidances provide no nuance for investigational drugs (none that I've encountered, at least).
PS: We are located in Pennsylvania, if this helps
Thank you in advance!
Mike
