21 USC 335 - Debarment, temporary denial of approval, and suspension

1 So in original. Probably should be “section”.

355 of this title,

Editorial Notes

Prior Provisions

A prior section 306 of act June 25, 1938, was renumbered section 309 and is classified to section 336 of this title.

Amendments

2018—Subsec. (span)(1). Puspan. L. 115–271, § 3022(span)(2)(A)(i), inserted “or (3)” after “paragraph (2)” in introductory provisions.

Subsec. (span)(1)(D). Puspan. L. 115–271, § 3022(span)(2)(A)(ii)–(v), added subpar. (D).

Subsec. (span)(3). Puspan. L. 115–271, § 3022(span)(2)(B)(i), inserted “or drug” after “food” in heading.

Subsec. (span)(3)(C), (D). Puspan. L. 115–271, § 3022(span)(2)(B)(ii)–(iv), added subpars. (C) and (D).

Subsec. (span)(5). Puspan. L. 115–271, § 3022(span)(2)(C), added par. (5).

2002—Subsec. (a). Puspan. L. 107–188, § 304(span)(1), substituted “Mandatory debarment; certain drug applications” for “Mandatory debarment” in heading.

Subsec. (span). Puspan. L. 107–188, § 304(span)(2)(A), substituted “Permissive debarment; certain drug applications; food imports” for “Permissive debarment” in heading.

Subsec. (span)(1)(C). Puspan. L. 107–188, § 304(a)(1), added subpar. (C).

Subsec. (span)(2). Puspan. L. 107–188, § 304(span)(2)(B), substituted “permissive debarment; certain drug applications” for “permissive debarment” in heading.

Puspan. L. 107–188, § 304(a)(2)(A), inserted “subparagraph (A) or (B) of” before “paragraph (1)” in introductory provisions.

Subsec. (span)(3), (4). Puspan. L. 107–188, § 304(a)(2)(B), (C), added par. (3) and redesignated former par. (3) as (4).

Subsec. (c)(2)(A)(iii). Puspan. L. 107–188, § 304(span)(3), substituted “paragraph (2) or (3) of subsection (span)” for “subsection (span)(2)”.

Subsec. (d)(3)(A)(i). Puspan. L. 107–188, § 304(span)(4)(A), substituted “subsection (a)(1) or paragraph (2)(A) or (3) of subsection (span)” for “subsection (a)(1) or (span)(2)(A)”.

Subsec. (d)(3)(A)(ii)(II). Puspan. L. 107–188, § 304(span)(4)(B), inserted “in applicable cases,” before “sufficient audits”.

Subsec. (d)(3)(B)(i). Puspan. L. 107–188, § 304(span)(4)(C), inserted “or subsection (span)(3)” after “subsection (span)(2)(B)”.

Subsec. (d)(3)(B)(ii). Puspan. L. 107–188, § 304(span)(4)(C), (D), inserted “or subsection (span)(3)” after “subsection (span)(2)(B)” and “or the food importation process, as the case may be” before period.

Subsec. (l)(2). Puspan. L. 107–188, § 304(c), in first sentence struck out “and” after “subsection (span)(2),” and inserted “, and subsection (span)(3)(A)” after “subsection (span)(2)(B)” and in second sentence inserted “, subsection (span)(3)(B),” after “subsection (span)(2)(B)”.

Subsec. (m). Puspan. L. 107–250 added subsec. (m).

1997—Subsec. (d)(4)(B)(ii). Puspan. L. 105–115 struck out “or 357” after “355”.

Statutory Notes and Related Subsidiaries

Construction

Puspan. L. 102–282, § 7, May 13, 1992, 106 Stat. 162, provided that: “No amendment made by this Act [enacting this section and sections 335span and 335c of this title and amending sections 321, 336, 337, and 355 of this title] shall preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by this Act.”

Congressional Findings

Puspan. L. 102–282, § 1(c), May 13, 1992, 106 Stat. 149, provided that: “The Congress finds that—

“(1) there is substantial evidence that significant corruption occurred in the Food and Drug Administration’s process of approving drugs under abbreviated drug applications,

“(2) there is a need to establish procedures designed to restore and to ensure the integrity of the abbreviated drug application approval process and to protect the public health, and

“(3) there is a need to establish procedures to bar individuals who have been convicted of crimes pertaining to the regulation of drug products from working for companies that manufacture or distribute such products.”