# 21 CFR § 251.1: Scope of the part

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-251.1

## Section

- **Citation:** 21 CFR § 251.1
- **Heading:** Scope of the part
- **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 A—General Provisions

## Text

(a) This part sets forth the procedures that Section 804 Importation Program sponsors (SIP Sponsors) must follow when submitting plans to implement time-limited programs to begin importation of drugs from Canada under section 804 of the Federal Food, Drug, and Cosmetic Act. This part also sets forth certain requirements that are necessary for such programs to be authorized by the Food and Drug Administration (FDA). Additionally, this part sets forth requirements for eligible prescription drugs and requirements for entities that engage in importation of eligible prescription drugs.
(b) This part includes provisions that exempt eligible prescription drugs that meet certain requirements from section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act. This part also includes provisions that exempt certain transactions involving eligible prescription drugs from certain requirements in section 582 of the Federal Food, Drug, and Cosmetic Act.

## 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-21-251.1. Check the current official text before relying on it. Not legal advice.