21 CFR § 251.9 - Registration of Foreign Sellers.

---
identifier: "/us/cfr/t21/s251.9"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 251.9 - Registration of Foreign Sellers."
title_number: 21
title_name: "Food and Drugs"
section_number: "251.9"
section_name: "Registration of Foreign Sellers."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "251"
part_name: "SECTION 804 IMPORTATION PROGRAM"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384."
regulatory_source: "85 FR 62126, Oct. 1, 2020, unless otherwise noted."
cfr_part: "251"
---


# 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.