Current through October 31, 2024
Section 251.9 - Registration of Foreign Sellers(a) Any Foreign Seller(s) designated in a SIP Proposal must be registered with FDA before FDA will authorize the SIP Proposal.(b) To register, a Foreign Seller must provide the following information: (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;(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;(3) Physical address and telephone number(s) of the Foreign Seller;(4) Registration number, if previously assigned by FDA;(5) A unique facility identifier in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act;(6) All types of operations performed by the Foreign Seller;(7) Name, mailing address, telephone number, and email address of the official contact for the establishment; and(8) Name, mailing address, telephone number, and email address of:(ii) The Importer to which the Foreign Seller plans to sell eligible prescription drugs; and(iii) Each SIP Sponsor with which the Foreign Seller works.