§ 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: (i) The U.S. agent; (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.