FDA Export Rule Would Require Identification Of Destination Country
This article was originally published in The Tan Sheet
Executive Summary
FDA is proposing to require firms exporting Rx or OTC drugs or devices to so-called "tier-one" countries to identify to which country they are shipping under an April 2 proposed rule implementing the FDA Export Reform & Enhancement Act. The proposal was accompanied by a final guidance identical to one published in draft form last June ("The Tan Sheet" June 22, 1998, p. 19).