Drug, supplement component "import for export" allowed with notification, records -- FDA.
This article was originally published in The Tan Sheet
Executive Summary
NON-U.S. APPROVED USES OF EXPORTED DRUGS REQUIRE SPECIAL LABELING statement in the language of the foreign country in which the product is marketed, FDA determines in a draft guidance published in the June 12 Federal Register. Information about uses unapproved in the U.S. also should be accompanied by a statement on the labeling noting that fact, the agency suggests in its "Draft Guidance for Industry on Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996."