Sec. 1305. Restricting entrance of illicit drugs
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The Secretary, acting through the Commissioner of Food and Drugs, upon discovering or receiving, in a package being offered for import, a controlled substance that is offered for import in violation of any requirement of the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law, shall transfer such package to the U.S.
Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.). 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 inserting or
(3)after paragraph
(2); in subparagraph (A), by striking the comma at the end and inserting a semicolon; in subparagraph (B), by striking , or and inserting a semicolon; in subparagraph (C), by striking the period and inserting ; or ; and by adding at the end the following: a person from importing or offering for import into the United States a drug. ; and in paragraph (3)— in the heading, by striking ; Food in subparagraph (A), by striking ; or and inserting a semicolon; in subparagraph (B), by striking the period and inserting a semicolon; and by adding at the end the following: 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); the person has engaged in a pattern of importing or offering for import— controlled substances that are prohibited from importation under section 401(m) of the Tariff Act of 1930 (19 U.S.C. 1401(m)); or adulterated or misbranded drugs that are— not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary. . Section 301(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended by inserting or a drug after food . Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended— by striking the second sentence; by striking If it appears and inserting Subject to subsection (b), if it appears ; by striking regarding such article, then such article shall be refused and inserting the following: regarding such article, or
(5)such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses
(1)through
(5)may be refused admission. If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission. ; by striking this Act, then such article shall be refused admission and inserting this Act, then such article may be refused admission ; and by striking Clause
(2)of the third sentence and all that follows through the period at the end and inserting the following: Neither clause
(2)nor clause
(5)of the second sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act. . Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following— For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article— is not— accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, or a dietary supplement; and is an ingredient that presents significant public health concern and is, or contains— an active ingredient in a drug— that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or for which— an investigational use exemption is in effect under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and a substantial clinical investigation has been instituted, and such investigation has been made public; or a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause
(I)or
(II)of clause (i). This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1). .
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Sec. 1305
Restricting entrance of illicit drugs
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