Although export of un-approved drugs is prohibited by law, FDA has made exceptions for clinical supplies. Too much information to detail here, but please refer to CPG Sec. 442.100 (Compliance Policy Guide), available on the FDA website -
U S Food and Drug Administration Home Page------------------------------
Peter Smith
Principal
Smith GMP Consulting
Narragansett, Rhode Island
USA
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Original Message:
Sent: 06-Aug-2018 11:44
From: Anonymous Member
Subject: Exporting Drug
This message was posted by a user wishing to remain anonymous
We are looking to run a compassionate use study in France. To do this, we will need to ship study drug FROM the US to France.
Do you know what the FDA requirements are to ship drug in this scenario………………..I am guessing something from FDA to be able to clear Customs?
Is there any opportunity to ship under a Material Transfer Agreement ?
Many thanks in advance!
Anon