---
kind: "section"
citation: "21 C.F.R. § 251.11"
title: "21"
number: "251.11"
heading: "Official contact and U.S. agent for Foreign Sellers."
url: "https://uscodex.org/cfr/21/251.11"
---

# §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](/cfr/21/251.9.md); 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.

## Notes

### 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.