Source: https://www.law.cornell.edu/uscode/text/21/335a
Timestamp: 2016-10-28 23:47:21
Document Index: 123637994

Matched Legal Cases: ['§ 335', '§\u202f306', '§\u202f2', '§\u202f125', '§\u202f304', '§\u202f203', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f304', '§\u202f7', '§\u202f1']

21 U.S. Code § 335a - Debarment, temporary denial of approval, and suspension | US Law | LII / Legal Information Institute
(2) IndividualsIf the Secretary finds that an individual has been convicted of a felony under Federal law for conduct—
(1) In generalThe Secretary, on the Secretary’s own initiative or in response to a petition, may, in accordance with paragraph (2), debar—
(2) Persons subject to permissive debarment; certain drug applicationsThe following persons are subject to debarment under subparagraph (A) or (B) of paragraph (1):
(A) Corporations, partnerships, and associationsAny person other than an individual that the Secretary finds has been convicted—
(3) Persons subject to permissive debarment; food importationA person is subject to debarment under paragraph (1)(C) if—
(1) Effect of debarmentThe Secretary—
(A) In generalThe Secretary shall debar a person under subsection (a) or (b) for the following periods:
(3) ConsiderationsIn determining the appropriateness and the period of a debarment of a person under subsection (b) and any period of debarment beyond the minimum specified in subparagraph (A)(i) of paragraph (2), the Secretary shall consider where applicable—
(ii) ApplicationUpon application submitted under paragraph (1), the Secretary shall terminate the debarment of a person if the Secretary finds that—
(B) CorporationsUpon an application submitted under subparagraph (A), the Secretary may take the action described in subparagraph (D) if the Secretary, after an informal hearing, finds that—
all individuals who were involved in the commission of the offense or who knew or should have known of the offense have been removed from employment involving the development or approval of any drug subject to sections [1] 355 of this title,
(D) Secretarial actionThe action referred to in subparagraphs (B) and (C) is—
(1) In generalThe Secretary, on the Secretary’s own initiative or in response to a petition, may, in accordance with paragraph (3), refuse by order, for the period prescribed by paragraph (2), to approve any abbreviated drug application submitted by any person—
(A) In generalExcept as provided in subparagraph (B), a denial of approval of an application of a person under paragraph (1) shall be in effect for a period determined by the Secretary but not to exceed 18 months beginning on the date the Secretary finds that the conditions described in subparagraphs (A), (B), and (C) of paragraph (1) exist. The Secretary shall terminate such denial—
(h) Termination of suspensionThe Secretary shall withdraw an order of suspension of the distribution of a drug under subsection (g) if the person with respect to whom the order was issued demonstrates in a petition to the Secretary—
(k) CertificationAny application for approval of a drug product shall include—
(1) ConvictionFor purposes of this section, a person is considered to have been convicted of a criminal offense—
(2) Debarment periodThe Secretary shall debar a person under paragraph (1) for the following periods:
(June 25, 1938, ch. 675, § 306, as added Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105–115, title I, § 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107–188, title III, § 304(a)–(c), June 12, 2002, 116 Stat. 665, 666; Pub. L. 107–250, title II, § 203, Oct. 26, 2002, 116 Stat. 1610.)
2002—Subsec. (a). Pub. L. 107–188, § 304(b)(1), substituted “Mandatory debarment; certain drug applications” for “Mandatory debarment” in heading.
Subsec. (b). Pub. L. 107–188, § 304(b)(2)(A), substituted “Permissive debarment; certain drug applications; food imports” for “Permissive debarment” in heading.
Subsec. (b)(1)(C). Pub. L. 107–188, § 304(a)(1), added subpar. (C).
Subsec. (b)(2). Pub. L. 107–188, § 304(b)(2)(B), substituted “permissive debarment; certain drug applications” for “permissive debarment” in heading.
Pub. L. 107–188, § 304(a)(2)(A), inserted “subparagraph (A) or (B) of” before “paragraph (1)” in introductory provisions.
Subsec. (b)(3), (4). Pub. L. 107–188, § 304(a)(2)(B), (C), added par. (3) and redesignated former par. (3) as (4).
Subsec. (c)(2)(A)(iii). Pub. L. 107–188, § 304(b)(3), substituted “paragraph (2) or (3) of subsection (b)” for “subsection (b)(2)”.
Subsec. (d)(3)(A)(i). Pub. L. 107–188, § 304(b)(4)(A), substituted “subsection (a)(1) or paragraph (2)(A) or (3) of subsection (b)” for “subsection (a)(1) or (b)(2)(A)”.
Subsec. (d)(3)(A)(ii)(II). Pub. L. 107–188, § 304(b)(4)(B), inserted “in applicable cases,” before “sufficient audits”.
Subsec. (d)(3)(B)(i). Pub. L. 107–188, § 304(b)(4)(C), inserted “or subsection (b)(3)” after “subsection (b)(2)(B)”.
Subsec. (d)(3)(B)(ii). Pub. L. 107–188, § 304(b)(4)(C), (D), inserted “or subsection (b)(3)” after “subsection (b)(2)(B)” and “or the food importation process, as the case may be” before period.
Subsec. (l)(2). Pub. L. 107–188, § 304(c), in first sentence struck out “and” after “subsection (b)(2),” and inserted “, and subsection (b)(3)(A)” after “subsection (b)(2)(B)” and in second sentence inserted “, subsection (b)(3)(B),” after “subsection (b)(2)(B)”.
Pub. L. 102–282, § 7, May 13, 1992, 106 Stat. 162, provided that: “No amendment made by this Act [enacting this section and sections 335b 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.”
Pub. L. 102–282, § 1(c), May 13, 1992, 106 Stat. 149, provided that: “The Congress finds that—
there is substantial evidence that significant corruption occurred in the Food and Drug Administration’s process of approving drugs under abbreviated drug applications,
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
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.”
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