# 21 CFR § 251.10: Reviewing and updating registration information for Foreign Sellers

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-251.10

## Section

- **Citation:** 21 CFR § 251.10
- **Heading:** Reviewing and updating registration information for 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) Expedited updates. A Foreign Seller must update its registration information no later than 30 calendar days after:
(1) Closing or being sold;
(2) Changing its name or physical address; or
(3) Changing the name, mailing address, telephone number, or email address of the official contact or the U.S. agent. A Foreign Seller, official contact, or U.S. agent may notify FDA about a change of information for the designated official contact or U.S. agent, but only a Foreign Seller is permitted to designate a new official contact or U.S. agent.
(b) Annual review and update of registration information. A Foreign Seller must review and update all registration information required under § 251.9.
(1) The first review and update must occur during the period beginning on October 1 and ending December 31 of the year of initial registration, if the initial registration occurs prior to October 1. Subsequent reviews and updates must occur annually, during the period beginning on October 1 and ending December 31 of each calendar year.
(2) The updates must reflect new changes not previously required to be reported, along with a summary of the registration updates that were provided to FDA as required during the calendar year.
(3) If no changes have occurred since the last registration, a Foreign Seller must certify that no changes have occurred.

## 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-21-251.10. Check the current official text before relying on it. Not legal advice.