§ 251.9. Registration of Foreign Sellers.
194 words·~1 min read·
/us/cfr/t21/s§ 251.9·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.