# 21 C.F.R. § 251.11 (2026): Official contact and U.S. agent for Foreign Sellers

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P251_S251_11

## Section

- **Citation:** 21 C.F.R. § 251.11 (2026)
- **Heading:** Official contact and U.S. agent for 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 / § 251.11: § 251.11   Official contact and U.S. agent for Foreign Sellers.

## Text

(a) Official contact. A Foreign Seller subject to the registration requirements of this part must designate an official contact. The official contact is responsible for: (1) Ensuring the accuracy of registration information as required by § 251.9; and (2) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications. (b) U.S. agent. (1) A Foreign Seller must designate a single U.S. agent. The U.S. agent must reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the U.S. agent is not physically present. The U.S. agent is responsible for: (i) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications; (ii) Responding to questions concerning those drugs that are imported or offered for import to the United States; and (iii) Assisting FDA in scheduling inspections. (2) FDA may provide certain information and/or documents to the U.S. agent. The provision of information and/or documents by FDA to the U.S. agent is equivalent to providing the same information and/or documents to the Foreign Seller.

## 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_11. Check the current official text before relying on it. Not legal advice.