Zdrowie i gospodarka · 02/04/1999
Exports: Notification and Recordkeeping Requirements
The Food and Drug Administration (FDA) is proposing new regulations that would establish the notification and recordkeeping requirements for persons exporting human drugs, biologics, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States. These regulations would implement recent changes in the statutory requirements applicable to certain exports, and would also codify recordkeeping requirements for exports of products that cannot be marketed or sold in the United States generally.