Source: http://www4.law.cornell.edu/uscode/text/21/381?quicktabs_8=4
Timestamp: 2013-12-11 05:07:57
Document Index: 425426774

Matched Legal Cases: ['§ 381', '§ 381', '§ 381', '§ 204', '§ 301', '§ 301', '§ 204', '§ 381', '§ 3812012112', '§ 3812012112', '§ 381', '§ 381', '§ 3812012112']

21 USC § 381 - Imports and exports | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter VIII › § 381	prevnext
21 USC § 381 - Imports and exports
such article is adulterated, misbranded, or in violation of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331
Such statement provides that such article is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) of this section or section 382 of this title, or with section 262
Notwithstanding subparagraph (A), the Secretary may refuse admission to an article that otherwise would be imported into the United States under such subparagraph if the Secretary determines that there is credible evidence or information indicating that such article is not intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) of this section or section 382 of this title, or with section 262
The importation into the United States of blood, blood components, source plasma, or source leukocytes or of a component, accessory, or part thereof is not permitted pursuant to paragraph (3) unless the importation complies with section 262
(a) of title 42 or the Secretary permits the importation under appropriate circumstances and conditions, as determined by the Secretary. The importation of tissue or a component or part of tissue is not permitted pursuant to paragraph (3) unless the importation complies with section 264 of title 42.
Not later than 18 months after July 9, 2012, the Secretary shall adopt final regulations implementing this subsection. Such requirements shall be appropriate for the type of import, such as whether the drug is for import into the United States for use in preclinical research or in a clinical investigation under an investigational new drug exemption under 355(i) [6]
the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article, then such article shall be refused admission, except as provided in subsection (b) of this section. With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of such section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph [1]
with respect to an article described in subsection (a) relating to the requirements of sections [2]
Registration statement If an article that is a drug or device is being imported or offered for import into the United States, and the importer, owner, or consignee of such article does not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 360
(b), title II, § 204(j)(2), title III, §§ 301(c), 303(a)–(c), 304(a), Jan. 4, 2011, 124 Stat. 3889, 3910, 3937, 3955–3957.)
Pub. L. 111–353, title III, § 301(c), (d),Jan. 4, 2011, 124 Stat. 3955, provided that, effective 2 years after Jan. 4, 2011, subsection (a) of this section is amended by inserting “or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title” after “or in violation of section 355 of this title”.
2011—Subsec. (a). Pub. L. 111–353, §§ 204(j)(2), 303(a), inserted “or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article,” in the third sentence before “then such article shall be refused admission” and inserted after the third sentence “With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission.”
21 USCDescription of ChangeSession YearPublic LawStatutes at Large § 381nt new2012112-144 [Sec.] 714(d)126 Stat. 1074 § 3812012112-144 [Sec.] 714(b)126 Stat. 1073 § 3812012112-144 [Sec.] 713126 Stat. 1072 § 381nt new2012112-144 [Sec.] 708(d)126 Stat. 1069 § 381nt new2012112-144 [Sec.] 708(c)126 Stat. 1069 § 3812012112-144 [Sec.] 708(a), (b)126 Stat. 1068 This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.19 CFR - Title 19—Customs Duties19 CFR 12 - SPECIAL CLASSES OF MERCHANDISE19 CFR 151 - EXAMINATION, SAMPLING, AND TESTING OF MERCHANDISE
20 CFR - Title 20—Employees' Benefits20 CFR 20720 CFR 51420 CFR 60720 CFR 61020 CFR 80720 CFR 80920 CFR 81220 CFR 81420 CFR 82020 CFR 1010 - APPLICATION OF PRIORITY OF SERVICE FOR COVERED PERSONS20 CFR 1020
21 CFR - Food and Drugs21 CFR 1 - GENERAL ENFORCEMENT REGULATIONS21 CFR 3 - PRODUCT JURISDICTION21 CFR 5 - ORGANIZATION21 CFR 7 - ENFORCEMENT POLICY21 CFR 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR 20 - PUBLIC INFORMATION21 CFR 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY21 CFR 50 - PROTECTION OF HUMAN SUBJECTS21 CFR 56 - INSTITUTIONAL REVIEW BOARDS21 CFR 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES21 CFR 71 - COLOR ADDITIVE PETITIONS21 CFR 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS21 CFR 118 - PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS21 CFR 120 - HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS21 CFR 123 - FISH AND FISHERY PRODUCTS21 CFR 189 - SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD21 CFR 203 - PRESCRIPTION DRUG MARKETING
103 CFR - Title 103103 CFR 1040103 CFR 1050
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