Sec. 7192. Detention, refusal, and destruction of drugs offered for importation
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Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended by adding at the end the following: An article shall not be treated as a drug pursuant to this subsection if— an electronic import entry for such article is submitted using an authorized electronic data interchange system; and such article is designated in such system as a drug, device, dietary supplement, or other product that is regulated under this Act. Subject to paragraph (1), for purposes of this section, an article described in this paragraph may be treated by the Secretary as a drug if it— is or contains an ingredient that is an active ingredient that is contained within— a drug that has been approved under section 505 of this Act; or a biological product that has been approved under section 351 of the Public Health Service Act; is or contains an ingredient that is an active ingredient in a drug or biological product if— an investigational use exemption has been authorized for such drug or biological product under section 505(i) of this Act or section 351(a) of the Public Health Service Act; substantial clinical investigation has been instituted for such drug or biological product; and the existence of such clinical investigation has been made public; or is or contains 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 subparagraph
(A)or (B). Except to the extent that an article may be treated as a drug pursuant to paragraph (2), this subsection shall not be construed as bearing on or being relevant to the question of whether any article is a drug as defined in section 201(g). . The first sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking and cosmetics and inserting cosmetics, and potential articles of concern (as defined in subsection (u)) . The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking then such article shall be refused admission and inserting or
(5)such article is an article of concern (as defined in subsection (u)), or
(6)such article is a drug that is being imported or offered for import in violation of section 301(cc), then such article shall be refused admission . Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ), as amended, is further amended by adding at the end the following: For purposes of subsection (a), the term article of concern means an article that is or contains a drug or other substance— for which, during the 24-month period prior to the article being imported or offered for import, the Secretary of Health and Human Services— has requested that, based on a determination that the drug or other substance appears to meet the requirements for temporary or permanent scheduling pursuant to section 201 of the Controlled Substances Act, the Attorney General initiate the process to control the drug or other substance in accordance with such Act; or has, following the publication by the Attorney General of a notice in the Federal Register of the intention to issue an order temporarily scheduling such drug or substance in schedule I of section 202 of the Controlled Substances Act pursuant to section 201(h) of such Act, made a determination that such article presents an imminent hazard to public safety; and with respect to which the Attorney General has not— scheduled the drug or other substance under such Act; or notified the Secretary of Health and Human Services that the Attorney General has made a determination not to schedule the drug or other substance under such Act. .
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Sec. 7192
Detention, refusal, and destruction of drugs offered for importation
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