21 CFR § 251.21 - Consequences for violations.

---
identifier: "/us/cfr/t21/s251.21"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 251.21 - Consequences for violations."
title_number: 21
title_name: "Food and Drugs"
section_number: "251.21"
section_name: "Consequences for violations."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "251"
part_name: "SECTION 804 IMPORTATION PROGRAM"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384."
regulatory_source: "85 FR 62126, Oct. 1, 2020, unless otherwise noted."
cfr_part: "251"
---


# 251.21 Consequences for violations.

(a) An article that is imported or offered for import into the United States in violation of section 804 of the Federal Food, Drug, and Cosmetic Act or this part is subject to refusal under section 801 of the Federal Food, Drug, and Cosmetic Act.

(b) The importation of a prescription drug in violation of section 804 of the Federal Food, Drug, and Cosmetic Act; the falsification of any record required to be maintained or provided to FDA under section 804; or any other violation of this part is a prohibited act under section 301(aa) of the Federal Food, Drug, and Cosmetic Act.