---
kind: "section"
citation: "21 C.F.R. § 251.9"
title: "21"
number: "251.9"
heading: "Registration of Foreign Sellers."
url: "https://uscodex.org/cfr/21/251.9"
---

# §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](/cfr/21/510.md) 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.**

## Notes

### 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.