{"data":{"id":"us/21-cfr-251.9","jurisdiction":"us","citation":"21 CFR 251.9","heading":"Registration of Foreign Sellers.","body":"(a) Any Foreign Seller(s) designated in a SIP Proposal must be registered with FDA before FDA will authorize the SIP Proposal.\n(b) To register, a Foreign Seller must provide the following information:\n(1) Name of the owner or operator; if a partnership, the name of each partner; if a corporation, the name of each corporate officer and director, and the place of incorporation;\n(2) All names of the Foreign Seller, including names under which the Foreign Seller conducts business or names by which the Foreign Seller is known;\n(3) Physical address and telephone number(s) of the Foreign Seller;\n(4) Registration number, if previously assigned by FDA;\n(5) A unique facility identifier in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act;\n(6) All types of operations performed by the Foreign Seller;\n(7) Name, mailing address, telephone number, and email address of the official contact for the establishment; and\n(8) Name, mailing address, telephone number, and email address of:\n(i) The U.S. agent;\n(ii) The Importer to which the Foreign Seller plans to sell eligible prescription drugs; and\n(iii) Each SIP Sponsor with which the Foreign Seller works.","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":"238dabcb6f95ce199e43b378bc593bc8dd65b309d6189115847b108b5c502a9b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-251.8","next":"us/21-cfr-251.10"},"notice":"GroundRules: Original legal text. Not legal advice."}
