{"data":{"id":"us/21-cfr-251.11","jurisdiction":"us","citation":"21 CFR 251.11","heading":"Official contact and U.S. agent for Foreign Sellers.","body":"(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:\n(1) Ensuring the accuracy of registration information as required by § 251.9; and\n(2) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications.\n(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:\n(i) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications;\n(ii) Responding to questions concerning those drugs that are imported or offered for import to the United States; and\n(iii) Assisting FDA in scheduling inspections.\n(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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"dc57a8bbcd5722a0ffec7bfb96ff534702e3642ce6420b695fdb25280a8a2794","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-251.10","next":"us/21-cfr-251.12"},"notice":"GroundRules: Original legal text. Not legal advice."}