Zdrowie i gospodarka · 19.12.2001
Exports: Notification and Recordkeeping Requirements
The Food and Drug Administration (FDA) is issuing a final rule that establishes the notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States. These regulations implement recent changes in the statutory requirements applicable to certain exports, and also codify recordkeeping requirements for exports of products that cannot be marketed or sold in the United States generally.