# 21 C.F.R. § 251.9 (2026): Registration of Foreign Sellers

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_9

## Section

- **Citation:** 21 C.F.R. § 251.9 (2026)
- **Heading:** Registration of Foreign Sellers
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 251 / Subpart C / § 251.9: § 251.9   Registration of Foreign Sellers.

## 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 C.F.R. § 251.9 (2026) § 251.9   Registration of Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_9.md)
- [21 C.F.R. § 251.10 (2026) § 251.10   Reviewing and updating registration information for Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_10.md)
- [21 C.F.R. § 251.11 (2026) § 251.11   Official contact and U.S. agent for Foreign Sellers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_11.md)
- [21 C.F.R. § 251.12 (2026) § 251.12   Importer responsibilities.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_12.md)
- [21 C.F.R. § 251.13 (2026) § 251.13   Labeling of eligible prescription drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_13.md)
- [21 C.F.R. § 251.14 (2026) § 251.14   Supply chain security requirements for eligible prescription drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_14.md)
- [21 C.F.R. § 251.15 (2026) § 251.15   Qualifying laboratory requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_15.md)
- [21 C.F.R. § 251.16 (2026) § 251.16   Laboratory testing requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_16.md)
- [21 C.F.R. § 251.17 (2026) § 251.17   Importation requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_17.md)
- [21 C.F.R. § 251.18 (2026) § 251.18   Post-importation requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_18.md)
- [21 C.F.R. § 251.19 (2026) § 251.19   Reports to FDA.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_19.md)
- [21 C.F.R. § 251.20 (2026) § 251.20   Severability.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_20.md)
- [21 C.F.R. § 251.21 (2026) § 251.21   Consequences for violations.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_21.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_9. Check the current official text before relying on it. Not legal advice.