§ 207.69. What are the requirements for an official contact and a United States agent?
205 words·~1 min read·
/us/cfr/t21/s§ 207.69·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)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:
(1)Ensuring the accuracy of registration and listing information; and
(2)Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications.
(b)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:
(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.
Connections1 cite this
Cited by 1 section
Citation graph
cites case law
§ 207.69
What are the requirements for an official contact and a United States agent?
Fed. Reg.×1
Cites 0Cited by 1 across 1 source