FDA Designated Agent | U.S. Designated Agent

Designated Agent

The U.S. FDA has approved regulation that ALL Foreign Establishments whose products (Human Drugs, Animal Drugs, Biological Products, Devices and Foreign Food Establishments) are imported or offered for import into the United States MUST register with the FDA and MUST identify a United States Agent.


U.S. Agent Program for Pharmaceutical and Medical Device Manufacturers

ALL FOREIGN PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURERS MUST BE REGISTERED WITH THE FDA

WHY ARE U.S. AGENTS REQUIRED?

The FDA has given final approval to the regulatory requirement that all Foreign Establishments whose products (Human Drugs, Animal Drugs, Biological Products, and Devices) are imported or offered for import into the United States must identify a United States Agent. The U.S. agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place


 ALL FOREIGN FOOD FACILITIES MUST BE REGISTERED WITH THE FDA AND DESIGNATED A U.S. AGENT BY DECEMBER 12, 2003

WHY ARE U.S. AGENTS REQUIRED?

In response to the acts on September 11, 2001, the U.S. Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which President Bush signed into law June 12, 2002. Title III of this Act discusses the safety of the Food and Drug Supply to the U.S., of which the U.S. FDA is responsible for carrying out Subtitle A (Protection of the Food Supply) and Subtitle B (Protection of the Drug Supply). Given its responsibility, the FDA has proposed regulation that all food facilities (both domestic and foreign) be registered with the FDA by December 12, 2003. Domestic facilities that are not registered by this date may be subject to both civil and criminal penalties. Any foreign facilities not registered will have their goods held at the U.S. port of entry or moved to an FDA secure location.

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