---
kind: "section"
citation: "21 C.F.R. § 251.21"
title: "21"
number: "251.21"
heading: "Consequences for violations."
url: "https://uscodex.org/cfr/21/251.21"
---

# §251.21. Consequences for violations.

- (a) An article that is imported or offered for import into the United States in violation of [section 804](/cfr/21/804.md) of the Federal Food, Drug, and Cosmetic Act or this part is subject to refusal under [section 801](/cfr/21/801.md) of the Federal Food, Drug, and Cosmetic Act.
- (b) The importation of a prescription drug in violation of [section 804](/cfr/21/804.md) of the Federal Food, Drug, and Cosmetic Act; the falsification of any record required to be maintained or provided to FDA under [section 804](/cfr/21/804.md); or any other violation of this part is a prohibited act under [section 301(aa)](/cfr/21/301.md?p=aa) of the Federal Food, Drug, and Cosmetic Act.

## Notes

### Authority

Authority: 21 U.S.C. 351, 352, 353, 355, 360, 360eee-1, 371, 374, 381, 384.

### Source

Source: 85 FR 62126, Oct. 1, 2020, unless otherwise noted.