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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).

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Export Recordkeeping Reg’s Implementation Period Too Short – CHPA, CTFA

Three months "is too short a time period" for companies to modify existing internal systems to meet new notification and recordkeeping requirements governing exported drugs, foods and cosmetics that cannot be sold domestically, the Consumer Healthcare Products Association tells FDA

Export Recordkeeping Reg’s Implementation Period Too Short – CHPA, CTFA

Three months "is too short a time period" for companies to modify existing internal systems to meet new notification and recordkeeping requirements governing exported drugs, foods and cosmetics that cannot be sold domestically, the Consumer Healthcare Products Association tells FDA

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