# 21 CFR § 251.6: Termination of authorized importation programs

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-251.6

## Section

- **Citation:** 21 CFR § 251.6
- **Heading:** Termination of authorized importation programs
- **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 B—Section 804 Importation Program Proposals and Pre-Import Requests

## Text

(a) Unless an extension is granted under this part, authorization for a SIP automatically terminates after 2 years, or a shorter period of time if a shorter period of time is specified in the authorization for the SIP.
(b) The authorization period for a SIP begins when the Importer, or its authorized customs broker, files an electronic import entry for consumption for its first shipment of drugs under the SIP.
(c) Notwithstanding paragraph (a) of this section, authorization for a SIP terminates if the Importer, or its authorized customs broker, does not file an electronic import entry for consumption for a shipment of eligible prescription drugs under the SIP within 1 year of the date that the SIP was authorized.
(d) FDA will terminate authorization of a SIP upon request from the SIP Sponsor.
(e) An eligible prescription drug cannot be shipped into the United States under this part, and is subject to refusal of admission into the United States, if the authorization of the SIP has terminated.

## 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-21-251.6. Check the current official text before relying on it. Not legal advice.