,,iib #aae? ,,congress #b;d ,session ,h4 ,r4 #egeb ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,june #ad1 #bjah,receiv$2 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,,an ,,act ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to ! importation ( c]ta9 drugs1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,/op ,illicit ,drug ,importation ,act ( #bjah4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,det5tion1 refusal1 & de/ruction ( drugs (f]$ = importation4 ,sec4 #c4 ,seizure4 ,sec4 #d4 ,deb>r+ violative individuals or companies4 #b4 ,det5tion1 refusal1 & de/ruction ( drugs (f]$ = importation 7a7 ,articles treat$ z drugs = purposes ( importation ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is am5d$ by add+ at ! end ! foll[+3 7t7 ,articles treat$ z drugs = purposes ( ?is section 7#a7 ,label$ articles ,an article %all n be treat$ z a drug pursuant to ?is subsection if-- 7,a7 an electronic import entry = su* article is submitt$ us+ an au?oriz$ electronic data int]*ange sy/em2 & 7,b7 su* article is designat$ 9 su* sy/em z a drug1 device1 diet>y supplem5t1 or o!r product t is regulat$ "u ?is ,act4 7#b7 ,articles cov]$ ,subject to p>agraph 7#a71 = purposes ( ?is section1 an article describ$ 9 ?is p>agraph may be treat$ by ! ,secret>y z a drug if x-- 7,a7 is or conta9s an +r$i5t t is an active +r$i5t t is conta9$ )9-- 7i7 a drug t has be5 approv$ "u section #eje ( ?is ,act2 or 7ii7 a biological product t has be5 approv$ "u section #cea ( ! ,public ,heal? ,s]vice ,act2 7,b7 is or conta9s an +r$i5t t is an active +r$i5t 9 a drug or biological product if-- 7i7 an inve/igational use exemption has be5 au?oriz$ = su* drug or biological product "u section #eje7;i7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 7ii7 sub/antial cl9ical inve/igation has be5 in/itut$ = su* drug or biological product2 & 7iii7 ! exi/5ce ( su* cl9ical inve/igation has be5 made public2 or 7,c7 is or conta9s a sub/ance t has a *emical /ructure t is sub/antially simil> to ! *emical /ructure ( an active +r$i5t 9 a drug or biological product describ$ 9 subp>agraph 7,a7 or 7,b74 7#c7 ,effect ,except to ! ext5t t an article may be treat$ z a drug pursuant to p>agraph 7#b71 ?is subsection %all n be con/ru$ z be>+ on or be+ relevant to ! "q ( :e!r any article is a drug z def9$ 9 section #bja7;g74 4 7b7 ,articles ( conc]n 7#a7 ,deliv]y by ,treasury to ,,hhs ,! fir/ s5t5ce ( section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$ by /rik+ & cosmetics & ins]t+ cosmetics1 & pot5tial articles ( conc]n 7z def9$ 9 subsection 7u774 7#b7 ,refus$ admission ,! ?ird s5t5ce ( section #hja7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a77 is am5d$ by /rik+ !n su* article %all be refus$ admission & ins]t+ or 7#e7 su* article is an article ( conc]n 7z def9$ 9 subsection 7u771 or 7#f7 su* article is a drug t is be+ import$ or (f]$ = import 9 violation ( section #cja7;cc71 !n su* article %all be refus$ admission4 7#c7 ,def9ition ( article ( conc]n ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha71 z am5d$1 is fur!r am5d$ by add+ at ! end ! foll[+3 7u7 ,article ( conc]n def9$ ,= purposes ( subsection 7a71 ! t]m article ( conc]n means an article t is or conta9s a drug or o!r sub/ance-- 7#a7 = :i*1 dur+ ! #bd-mon? p]iod prior to ! article be+ import$ or (f]$ = import1 ! ,secret>y ( ,heal? & ,human ,s]vices-- 7,a7 has reque/$ t1 bas$ on a det]m9ation t ! drug or o!r sub/ance appe>s to meet ! requirem5ts = tempor>y or p]man5t s*$ul+ pursuant to section #bja ( ! ,controll$ ,sub/ances ,act1 ! ,attorney ,g5]al initiate ! process to control ! drug or o!r sub/ance 9 accordance ) su* ,act2 or 7,b7 has1 foll[+ ! publication by ! ,attorney ,g5]al ( a notice 9 ! ,f$]al ,regi/] ( ! int5tion to issue an ord] tempor>ily s*$ul+ su* drug or sub/ance 9 s*$ule ,i ( section #bjb ( ! ,controll$ ,sub/ances ,act pursuant to section #bja7;h7 ( su* ,act1 made a det]m9ation t su* article pres5ts an imm95t haz>d to public safety2 & 7#b7 ) respect to :i* ! ,attorney ,g5]al has n-- 7,a7 s*$ul$ ! drug or o!r sub/ance "u su* ,act2 or 7,b7 notifi$ ! ,secret>y ( ,heal? & ,human ,s]vices t ! ,attorney ,g5]al has made a det]m9ation n to s*$ule ! drug or o!r sub/ance "u su* ,act4 4 #c4 ,seizure ,section #cjd7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7;b77 is am5d$ by /rik+ ! fir/ s5t5ce & ins]t+ ! foll[+3 ,! article1 equipm5t1 or o!r ?+ proce$$ aga9/ %all be liable to seizure by process pursuant to ! libel1 & ! proc$ure 9 cases "u ?is section %all con=m1 z ne>ly z may be1 to ! proc$ure 9 admiralty r ?an ! proc$ure us$ = civil asset =feiture proce$+s set =? 9 section #ihc ( title #ah1 ,unit$ ,/ates ,code4 ,on dem& ( ei!r p>ty any issue ( fact jo9$ 9 any su* a case br\ght "u ?is section %all be tri$ by jury4 ,a seizure br\ght "u ?is section is n gov]n$ by ,rule ,g ( ! ,supplem5tal ,rules ( ,admiralty or ,m>itime ,claims & ,asset ,=feiture ,actions4 ,exig5t circum/ances %all be deem$ to exi/ = all seizures br\ght "u ?is section1 & 9 su* cases1 ! summons & arre/ w>rant %all be issu$ by ! cl]k ( ! c\rt )\t c\rt review4 4 #d4 ,deb>r+ violative individuals or companies 7a7 ,prohibit$ act ,section #cja7;cc7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;cc77 is am5d$-- 7#a7 by ins]t+ aft] an article ( food ! foll[+3 or a drug2 & 7#b7 by ins]t+ aft] a p]son deb>r$ ! foll[+3 f su* activity4 7b7 ,deb>m5t ,section #cjf7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7b77 is am5d$-- 7#a7 9 p>agraph 7#a7-- 7,a7 9 ! matt] prec$+ subp>agraph 7,a71 by /rik+ p>agraph 7#b7 & ins]t+ p>agraph 7#b7 or 7#c72 7,b7 9 subp>agraph 7,b71 by /rik+ or at ! end2 7,c7 9 subp>agraph 7,c71 by /rik+ ! p]iod at ! end & ins]t+ 1 or2 & 7,d7 by add+ at ! end ! foll[+3 7,d7 a p]son f import+ or (f]+ to import into ! ,unit$ ,/ates-- 7i7 a controll$ sub/ance z def9$ 9 section #ajb7f7 ( ! ,controll$ ,sub/ances ,act2 or 7ii7 any drug1 if su* drug is decl>$ to be valu$ at an am\nt t is #b1ejj or less 7or su* high] am\nt z ! ,secret>y ( ! ,treasury may set by regulation pursuant to section #dih7;a77#a7 ( ! ,t>iff ,act ( #aicj71 or if su* drug is ent]+ ! ,unit$ ,/ates by mail4 2 & 7#b7 9 p>agraph 7#c7-- 7,a7 9 ! p>agraph head+ aft] food by ins]t+ or drug2 7,b7 by r$esignat+ subp>agraphs 7,a7 & 7,b7 z clauses 7i7 & 7ii71 respectively1 & mov+ ! ind5tation ( ea* su* clause two ems to ! "r2 7,c7 aft] mak+ ! am5dm5ts requir$ by subp>agraph 7,b71 by /rik+ ,a p]son is subject & ins]t+ ! foll[+3 7,a7 ,food ,a p]son is subject 2 & 7,d7 by add+ at ! end ! foll[+3 7,b7 ,importation ( drugs ,a p]son is subject to deb>m5t "u p>agraph 7#a77;,d7 if-- 7i7 ! p]son has be5 convict$ ( a felony = conduct relat+ to ! importation into ! ,unit$ ,/ates ( any drug or controll$ sub/ance 7z def9$ 9 section #ajb ( ! ,controll$ ,sub/ances ,act72 or 7ii7 ! p]son has engag$ 9 a patt]n ( import+ or (f]+ = import articles ( drug t are-- 7,i7 7aa7 adult]at$1 misbr&$1 or 9 violation ( section #eje2 & 7bb7 pres5t a ?reat ( s]i\s adv]se heal? consequ5ces or dea? to humans or animals2 or 7,,ii7 controll$ sub/ances ^: importation is prohibit$ pursuant to section #dja7m7 ( ! ,t>iff ,act ( #aicj4 7,c7 ,def9ition ,= purposes ( subp>agraph 7,b71 ! t]m patt]n ( import+ or (f]+ = import articles ( drug means import+ or (f]+ = import articles ( drug describ$ 9 subclause 7,i7 or 7,,ii7 ( subp>agraph 7,b77ii7 9 an am\nt1 frequ5cy1 or dosage t is inconsi/5t ) p]sonal or h\sehold use by ! import]4 4 ,pass$ ! ,h\se ( ,repres5tatives ,june #ac1 #bjah4,k>5 ,l4 ,haas1,cl]k