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Code · U.S. Code · Title 21 - FOOD AND DRUGS · CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT · SUBCHAPTER V— DRUGS AND DEVICES · § 360pp

§ 360pp. Enforcement

718 words·~3 min read·/usc/title-21/section-360pp

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(a)Jurisdiction of courts The district courts of the United States shall have jurisdiction, for cause shown, to restrain violations of section 360oo of this title and to restrain dealers and distributors of electronic products from selling or otherwise disposing of electronic products which do not conform to an applicable standard prescribed pursuant to section 360kk of this title except when such products are disposed of by returning them to the distributor or manufacturer from whom they were obtained. The district courts of the United States shall also have jurisdiction in accordance with section 1355 of title 28 to enforce the provisions of subsection
(b)of this section.
(b)Penalties
(1)Any person who violates section 360oo of this title shall be subject to a civil penalty of not more than $1,000. For purposes of this subsection, any such violation shall with respect to each electronic product involved, or with respect to each act or omission made unlawful by section 360oo of this title, constitute a separate violation, except that the maximum civil penalty imposed on any person under this subsection for any related series of violations shall not exceed $300,000.
(2)Any such civil penalty may on application be remitted or mitigated by the Secretary. In determining the amount of such penalty, or whether it should be remitted or mitigated and in what amount, the appropriateness of such penalty to the size of the business of the person charged and the gravity of the violation shall be considered. The amount of such penalty, when finally determined, may be deducted from any sums owing by the United States to the person charged.
(c)Venue; process Actions under subsections
(a)and
(b)of this section may be brought in the district court of the United States for the district wherein any act or omission or transaction constituting the violation occurred, or in such court for the district where the defendant is found or transacts business, and process in such cases may be served in any other district of which the defendant is an inhabitant or wherever the defendant may be found.
(d)Warnings Nothing in this part shall be construed as requiring the Secretary to report for the institution of proceedings minor violations of this part whenever he believes that the public interest will be adequately served by a suitable written notice or warning.
(e)Compliance with regulations Except as provided in the first sentence of section 360ss of this title, compliance with this part or any regulations issued thereunder shall not relieve any person from liability at common law or under statutory law.
(f)Additional remedies The remedies provided for in this part shall be in addition to and not in substitution for any other remedies provided by law.
(June 25, 1938, ch. 675, § 539, formerly act July 1, 1944, ch. 373, title III, § 539, formerly § 360C, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered § 539 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(G), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
Connections2 cite this · traces to 4
15 references not yet in our index
  • June 25, 1938, ch. 675, § 539
  • act July 1, 1944, ch. 373, title III, § 539
  • Pub. L. 90–602, § 2(3)
  • 82 Stat. 1184
  • Pub. L. 101–629, § 19(a)(1)(B)
  • 104 Stat. 4529
  • Pub. L. 103–80, § 4(a)(2)
  • 107 Stat. 779
  • section 263k of Title 42
  • Pub. L. 101–629
  • Pub. L. 103–80
  • Pub. L. 101–629, § 19(a)(4)
  • Pub. L. 101–629, § 19(a)(2)(G)(i)
  • Pub. L. 101–629, § 19(a)(2)(G)(ii)
  • section 4 of Pub. L. 90–602
Citation graph
cites case law
§ 360pp
Enforcement
Fed. Reg.×2
ActJune 25, 1938, ch. 675, § 539
Actact July 1, 1944, ch. 373, title III, § 539
Pub. L.Pub. L. 90–602, § 2(3)
Stat.82 Stat. 1184
Pub. L.Pub. L. 101–629, § 19(a)(1)(B)
Cites 19 · showing 9Cited by 2 across 1 source
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