§207.69. What are the requirements for an official contact and a United States agent?
21 C.F.R. § 207.69
Official contact. Registrants subject to the registration requirements of this part must designate an official contact for each establishment. The official contact is responsible for:
Ensuring the accuracy of registration and listing information; and
Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications.
United States agent. Registrants of foreign establishments subject to this part must designate a single United States agent. The United States agent must reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the United States agent is not physically present. The United States agent is responsible for:
Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;
Responding to questions concerning those drugs that are imported or offered for import to the United States;
Assisting FDA in scheduling inspections; and
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source
Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.