Export Reform and Enhancement Act

The FDA Export Reform and Enhancement Act of 1996 eliminated many, but far from all, of the restrictions on FDA export of unapproved new drugs. For example, although unapproved new drugs may be exported to any of the 25 listed countries for investigational use, these drugs may not be shipped to any other country for the same purpose without FDA approval - which can take a year or more. No other country in the world controls exports in the same way as the United States, and thus a pharmaceutical establishment may be located anywhere other than the United States without fear of unreasonable limitations on international trade. Accordingly, it is essential for any United States or foreign company... 

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