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Title 21 → Chapter I → Subchapter C → Part 251 → Subpart C → §251.21

Title 21: Food and Drugs
PART 251—SECTION 804 IMPORTATION PROGRAM
Subpart C—Certain Requirements for Section 804 Importation Programs

§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.

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