Sec. 7194. Debarring violative individuals or companies
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Section 301(cc) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(cc) ) is amended— by inserting after an article of food the following: or a drug ; and by inserting after a person debarred the following: from such activity . Section 306(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a(b) ) is amended— in paragraph (1)— in the matter preceding subparagraph (A), by striking paragraph
(2)and inserting paragraph
(2)or
(3); in subparagraph (B), by striking or at the end; in subparagraph (C), by striking the period at the end and inserting , or ; and by adding at the end the following: a person from importing or offering to import into the United States— a controlled substance as defined in section 102(6) of the Controlled Substances Act; or any drug, if such drug is declared to be valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930), or if such drug is entering the United States by mail. ; and in paragraph (3)— in the paragraph heading after by inserting food ; or drug by redesignating subparagraphs
(A)and
(B)as clauses
(i)and (ii), respectively, and moving the indentation of each such clause 2 ems to the right; after making the amendments required by subparagraph (B), by striking A person is subject and inserting the following: A person is subject ; and by adding at the end the following: A person is subject to debarment under paragraph (1)(D) if— the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); or the person has engaged in a pattern of importing or offering for import articles of drug that are— adulterated, misbranded, or in violation of section 505; and present a threat of serious adverse health consequences or death to humans or animals; or controlled substances whose importation is prohibited pursuant to section 401(m) of the Tariff Act of 1930. For purposes of subparagraph (B), the term pattern of importing or offering for import articles of drug means importing or offering for import articles of drug described in subclause
(I)or
(II)of subparagraph (B)(ii) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer. .
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