21 CFR §251.9

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