Code of Federal Regulations Title 21. Food and Drugs § 21.207.69 What are the requirements for an official contact and a United States agent?

(1) Ensuring the accuracy of registration and listing information;  and

(2) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications.

(1) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;

(2) Responding to questions concerning those drugs that are imported or offered for import to the United States;

(3) Assisting FDA in scheduling inspections;  and

(4) If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA's providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.