{"data":{"id":"us/21-cfr-207.69","jurisdiction":"us","citation":"21 CFR 207.69","heading":"What are the requirements for an official contact and a United States agent?","body":"(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:\n(1) Ensuring the accuracy of registration and listing information; and\n(2) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications.\n(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:\n(1) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;\n(2) Responding to questions concerning those drugs that are imported or offered for import to the United States;\n(3) Assisting FDA in scheduling inspections; and\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER C—DRUGS: GENERAL","PART 207—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","Subpart F—Miscellaneous"],"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":"691600836af7d31cef243378e2c8e2c5df61ffe07f85dbd02a6fc3f0adc73900","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-207.65","next":"us/21-cfr-207.77"},"notice":"GroundRules: Original legal text. Not legal advice."}