21 CFR 251.21
§ 251.21 Consequences for violations.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 251.21, § 251.21 Consequences for violations, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86189
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.