§251.9. Registration of Foreign Sellers.
21 C.F.R. § 251.9
Any Foreign Seller(s) designated in a SIP Proposal must be registered with FDA before FDA will authorize the SIP Proposal.
To register, a Foreign Seller must provide the following information:
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;
All names of the Foreign Seller, including names under which the Foreign Seller conducts business or names by which the Foreign Seller is known;
Physical address and telephone number(s) of the Foreign Seller;
Registration number, if previously assigned by FDA;
A unique facility identifier in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act;
All types of operations performed by the Foreign Seller;
Name, mailing address, telephone number, and email address of the official contact for the establishment; and
Name, mailing address, telephone number, and email address of—
The U.S. agent;
The Importer to which the Foreign Seller plans to sell eligible prescription drugs; and
Each SIP Sponsor with which the Foreign Seller works.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384.
Source
Source: 85 FR 62126, Oct. 1, 2020, unless otherwise noted.