C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 1—GENERAL ENFORCEMENT REGULATIONS › Subpart E—Imports and Exports

21 C.F.R. § 1.97

Bonds

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(a) The bond requirements under section 801(b) of the Federal Food, Drug, and Cosmetic Act may be satisfied by the owner or consignee executing, on the appropriate U.S. Customs and Border Protection form, a single-transaction or continuous bond, containing a condition for the redelivery of the merchandise or any part thereof upon demand of U.S. Customs and Border Protection and containing a provision for the performance of conditions as may legally be imposed for the relabeling or other action necessary to bring the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic, in such manner as is prescribed for such bond in the customs regulations in force on the date of request for authorization. The bond shall be filed with U.S. Customs and Border Protection.

(b) U.S. Customs and Border Protection may cancel the liability for liquidated damages incurred under the above-mentioned provisions of such a bond, if U.S. Customs and Border Protection receives an application for relief therefrom, upon the payment of a lesser amount or upon such other terms and conditions as shall be deemed appropriate under the law and in view of the circumstances, but U.S. Customs and Border Protection shall not act under this regulation unless the Food and Drug Administration division director is in full agreement with the action.

[85 FR 50782, Aug. 18, 2020]
Notes of Decisions
Cited in 2 cases, 1987–1989 · leading case: United States v. Toshoku Am., Inc., 670 F. Supp. 1006 (Ct. Intl. Trade 1987).
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United States v. Toshoku Am., Inc., 670 F. Supp. 1006 (Ct. Intl. Trade 1987). “21 C.F.R. § 1.97 states that a bond required by 21 U.”
United States v. Toshoku Am., Inc., 879 F.2d 815 (Fed. Cir. 1989). “21 C.F.R. § 1.97 . D. Having considered the framework of section 381, the parallel between section 381(a) and paragraph 4 of the appended entry bond is clear.”
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