§251.11. Official contact and U.S. agent for Foreign Sellers.
21 C.F.R. § 251.11
Official contact. A Foreign Seller subject to the registration requirements of this part must designate an official contact. The official contact is responsible for:
Ensuring the accuracy of registration information as required by § 251.9; and
Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications.
U.S. agent.
A Foreign Seller must designate a single U.S. agent. The U.S. 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 U.S. agent is not physically present. The U.S. 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; and
Assisting FDA in scheduling inspections.
FDA may provide certain information and/or documents to the U.S. agent. The provision of information and/or documents by FDA to the U.S. agent is equivalent to providing the same information and/or documents to the Foreign Seller.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384.
Source
Source: 85 FR 62126, Oct. 1, 2020, unless otherwise noted.