Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Is anyone familiar with the requirements for distributing US FDA approved Rx drug products in US Virgin Island? Any manufacturer/distributor/wholesaler licensing is required? Is there a need to obtain a domestic agent?

Thanks
MR

Hi MR,

I don't know with 100% certainty, but I would imagine that if you have approval, you should be okay to distribute without any additional complication given that the Virgin Islands are under FDA jurisdiction.

"FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions"  (What does FDA do?)

Hopefully someone else has some insight on this topic!

-Liz

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Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
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Original Message:
Sent: 15-May-2017 16:59
From: Anonymous Member
Subject: Distribution/licensing requirement for US Virgin Island

This message was posted by a user wishing to remain anonymous

Hello,

Is anyone familiar with the requirements for distributing US FDA approved Rx drug products in US Virgin Island? Any manufacturer/distributor/wholesaler licensing is required? Is there a need to obtain a domestic agent?

Thanks
MR