; and (ii) by striking then such article shall be refused admission, except as provided in subsection (b) of this section and inserting or (5) such article is an article of concern (as defined in subsection (t)), or (6) such article is a controlled substance (as defined in section 102 of the Controlled Substances Act) for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act, or (7) such article is being imported or offered for import in violation of section 301(cc), then such article may be refused admission, and if it appears such article may not be imported into the United States pursuant to subsection (d) or it appears that the article is a counterfeit drug, then such article shall be refused admission . (B) Definition of article of concern Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended by adding at the end the following: (t) Article of concern defined For purposes of subsection (a), the term article of concern means an article that is or contains a drug or other substance— (1) for which, during the 24-month period prior to the article being imported or offered for import, the Secretary of Health and Human Services— (A) 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 (B) has made a determination, following the publication by the Attorney General of a notice in the Federal Register of the intention to issue an order temporarily or permanently scheduling such drug or substance in schedule I of section 202 of the Controlled Substances Act, that such article presents an imminent risk to the public health