21 CFR § 251.11 - Official contact and U.S. agent for Foreign Sellers.
---
identifier: "/us/cfr/t21/s251.11"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 251.11 - Official contact and U.S. agent for Foreign Sellers."
title_number: 21
title_name: "Food and Drugs"
section_number: "251.11"
section_name: "Official contact and U.S. agent for Foreign Sellers."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "251"
part_name: "SECTION 804 IMPORTATION PROGRAM"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384."
regulatory_source: "85 FR 62126, Oct. 1, 2020, unless otherwise noted."
cfr_part: "251"
---
# 251.11 Official contact and U.S. agent for Foreign Sellers.
(a) *Official contact.* A Foreign Seller subject to the registration requirements of this part must designate an official contact. The official contact is responsible for:
(1) Ensuring the accuracy of registration information as required by § 251.9; and
(2) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications.
(b) *U.S. agent.* (1) 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:
(i) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications;
(ii) Responding to questions concerning those drugs that are imported or offered for import to the United States; and
(iii) Assisting FDA in scheduling inspections.
(2) 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.