21 CFR § 207.69 - What are the requirements for an official contact and a United States agent?

---
identifier: "/us/cfr/t21/s207.69"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 207.69 - What are the requirements for an official contact and a United States agent?"
title_number: 21
title_name: "Food and Drugs"
section_number: "207.69"
section_name: "What are the requirements for an official contact and a United States agent?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "207"
part_name: "REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE"
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. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271."
regulatory_source: "81 FR 60212, Aug. 31, 2016, unless otherwise noted."
cfr_part: "207"
---


# 207.69 What are the requirements for an official contact and a United States agent?

(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.