# 21 CFR § 251.9: Registration of Foreign Sellers

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-251.9

## Section

- **Citation:** 21 CFR § 251.9
- **Heading:** Registration of Foreign Sellers
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER C—DRUGS: GENERAL > PART 251—SECTION 804 IMPORTATION PROGRAM > Subpart C—Certain Requirements for Section 804 Importation Programs

## Text

(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.

## Nearby sections

- [21 CFR § 251.1 § 251.1 Scope of the part.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.1.md)
- [21 CFR § 251.2 § 251.2 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.2.md)
- [21 CFR § 251.3 § 251.3 SIP proposal submission requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.3.md)
- [21 CFR § 251.4 § 251.4 Review and authorization of importation program proposals.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.4.md)
- [21 CFR § 251.5 § 251.5 Pre-Import Request.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.5.md)
- [21 CFR § 251.6 § 251.6 Termination of authorized importation programs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.6.md)
- [21 CFR § 251.7 § 251.7 Suspension and revocation of authorized importation programs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.7.md)
- [21 CFR § 251.8 § 251.8 Modification or extension of authorized importation programs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.8.md)
- [21 CFR § 251.9 § 251.9 Registration of Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.9.md)
- [21 CFR § 251.10 § 251.10 Reviewing and updating registration information for Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.10.md)
- [21 CFR § 251.11 § 251.11 Official contact and U.S. agent for Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.11.md)
- [21 CFR § 251.12 § 251.12 Importer responsibilities.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.12.md)
- [21 CFR § 251.13 § 251.13 Labeling of eligible prescription drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.13.md)
- [21 CFR § 251.14 § 251.14 Supply chain security requirements for eligible prescription drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-251.14.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-251.9. Check the current official text before relying on it. Not legal advice.