Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C—DRUGS: GENERAL
PART 251—SECTION 804 IMPORTATION PROGRAM
Subpart C—Certain Requirements for Section 804 Importation Programs

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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