,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #egeb ,,in ,,the ,,house ,,of ,,representatives ,may #aj1 #bjah,mrs4 ,blackburn introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to the importation of certain drugs1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,stop ,illicit ,drug ,importation ,act of #bjah4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,detention1 refusal1 and destruction of drugs offered for importation4 ,sec4 #c4 ,seizure4 ,sec4 #d4 ,debarring violative individuals or companies4 #b4 ,detention1 refusal1 and destruction of drugs offered for importation 7a7 ,articles treated as drugs for purposes of importation ,section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is amended by adding at the end the following3 7t7 ,articles treated as drugs for purposes of this section 7#a7 ,in general ,for purposes of this section1 an article described in paragraph 7#b7 may be treated by the ,secretary as a drug4 7#b7 ,articles covered ,an article is described in this section if it-- 7,a7 is or contains an ingredient that is an active ingredient that is contained within-- 7i7 a drug that has been approved under section #eje of this ,act2 or 7ii7 a biological product that has been approved under section #cea of the ,public ,health ,service ,act2 7,b7 is or contains an ingredient that is an active ingredient in a drug or biological product if-- 7i7 an investigational use exemption is in effect for such drug or biological product under section #eje7;i7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act2 7ii7 substantial clinical investigation has been instituted for such drug or biological product2 and 7iii7 the existence of such clinical investigation has been made public2 or 7,c7 is or contains a chemical analog of an active ingredient in a drug or biological product described in paragraph 7,a7 or 7,b74 7#c7 ,effect ,except to the extent that an article may be treated as a drug pursuant to paragraph 7#a71 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 #bja7;g74 4 7b7 ,articles of concern 7#a7 ,delivery by ,treasury to ,,hhs ,the first sentence of section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended by striking and cosmetics and inserting cosmetics1 and potential articles of concern 7as defined in subsection 7u774 7#b7 ,refused admission ,the third sentence of section #hja7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is amended by striking then such article shall be refused admission and inserting or 7#e7 such article is an article of concern 7as defined in subsection 7u771 or 7#f7 such article is a drug that is being imported or offered for import in violation of section #cja7;cc71 then such article may 7in the case of drugs7 and shall 7in the case of other products7 be refused admission4 7#c7 ,definition of article of concern ,section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha71 as amended1 is further amended by adding at the end the following3 7u7 ,article of concern defined ,for purposes of subsection 7a71 the term article of concern means an article that is or contains a drug or other substance-- 7#a7 for which1 during the #bd-month period prior to the article being imported or offered for import1 the ,secretary of ,health and ,human ,services-- 7,a7 has requested that1 based on a determination that the drug or other substance appears to meet the requirements for temporary or permanent scheduling pursuant to section #bja of the ,controlled ,substances ,act1 the ,attorney ,general initiate the process to control the drug or other substance in accordance with such ,act2 or 7,b7 has1 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 #bjb of the ,controlled ,substances ,act pursuant to section #bja7;h7 of such ,act1 made a determination that such article presents an imminent hazard to public safety2 and 7#b7 with respect to which the ,attorney ,general has not-- 7,a7 scheduled the drug or other substance under such ,act2 or 7,b7 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 ,act4 4 #c4 ,seizure ,section #cjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7;b77 is amended by striking the first sentence and inserting the following3 ,the article1 equipment1 or other thing proceeded against shall be liable to seizure by process pursuant to the libel1 and the procedure in cases under this section shall conform1 as nearly as may be1 to the procedure in admiralty rather than the procedure used for civil asset forfeiture proceedings set forth in section #ihc of title #ah1 ,united ,states ,code4 ,on demand of either party any issue of fact joined in any such a case brought under this section shall be tried by jury4 ,a seizure brought under this section is not governed by ,rule ,g of the ,supplemental ,rules of ,admiralty or ,maritime ,claims and ,asset ,forfeiture ,actions4 ,exigent circumstances shall be deemed to exist for all seizures brought under this section1 and in such cases1 the summons and arrest warrant shall be issued by the clerk of the court without court review4 4 #d4 ,debarring violative individuals or companies 7a7 ,prohibited act ,section #cja7;cc7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;cc77 is amended-- 7#a7 by inserting after an article of food the following3 or a drug2 and 7#b7 by inserting after a person debarred the following3 from such activity4 7b7 ,debarment ,section #cjf7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking paragraph 7#b7 and inserting paragraph 7#b7 or 7#c72 7,b7 in subparagraph 7,b71 by striking or at the end2 7,c7 in subparagraph 7,c71 by striking the period at the end and inserting 1 or2 and 7,d7 by adding at the end the following3 7,d7 a person from importing or offering to import into the ,united ,states-- 7i7 a controlled substance as defined in section #ajb7f7 of the ,controlled ,substances ,act2 or 7ii7 any drug1 if such drug is declared to be valued at an amount that is #b1ejj or less 7or such higher amount as the ,secretary of the ,treasury may set by regulation pursuant to section #dih7;a77#a7 of the ,tariff ,act of #aicj71 or if such drug is entering the ,united ,states by mail4 2 and 7#b7 in paragraph 7#c7-- 7,a7 in the paragraph heading after food by inserting or drug2 7,b7 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii71 respectively1 and moving the indentation of each such clause #b ems to the right2 7,c7 after making the amendments required by subparagraph 7,b71 by striking ,a person is subject and inserting the following3 7,a7 ,food ,a person is subject 2 and 7,d7 by adding at the end the following3 7,b7 ,importation of drugs ,a person is subject to debarment under paragraph 7#a77;,d7 if-- 7i7 the person has been convicted of a felony for conduct relating to the importation into the ,united ,states of any drug or controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act72 or 7ii7 the person has engaged in a pattern of importing or offering for import articles of drug that are-- 7,i7 adulterated1 misbranded1 or in violation of section #eje2 or 7,,ii7 controlled substances whose importation is prohibited pursuant to section #dja7m7 of the ,tariff ,act of #aicj4 4