,i #aae? ,,congress #a/ ,session ,h4 ,r4 #agha ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #bi1 #bjag,mr4 ,donovan 7= himself & ,mr4 ,?omas ,j4 ,rooney ( ,florida7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committees on ! ,judici>y1 & ,ov]sight & ,gov]nm5t ,re=m1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to improve ! ability ( ! ,f$]al ,gov]nm5t to address syn!tic opioids1 & = o!r purposes4 #a4 ,%ort title2 table ( cont5ts 7a7 ,%ort title ,?is ,act may be cit$ z ! ,compreh5sive ,f5tanyl ,control ,act4 7b7 ,table ( cont5ts ,! table ( cont5ts ( ?is ,act is z foll[s3 ,sec4 #a4 ,%ort title2 table ( cont5ts4 ,sec4 #b4 ,f9d+s2 s5se ( ,congress4 ,sec4 #c4 ,enhanc$ p5alties4 ,sec4 #d4 ,endang]+ human life :ile illegally manufactur+ controll$ sub/ance4 ,sec4 #e4 ,tempor>y s*$ul+ ( syn!tic opioids4 ,sec4 #f4 ,tablet+ ma*9es1 encapsulat+ ma*9es1 & controll$ sub/ance c\nt]feit+ mat]ials4 ,sec4 #g4 ,label+ requirem5ts4 #b4 ,f9d+s2 s5se ( ,congress 7a7 ,f9d+s ,! ,congress f9ds z foll[s3 7#a7 ,f5tanyl is a dang]\s1 syn!tic opioid t's #ej to #ajj times m pot5t ?an h]o9 & morph9e & le?al 9 doses z small z approximately #b milligrams4 ,curr5t s5t5c+ enhancem5ts d n reflect ! dang] f5tanyl poses at l[] quantities comp>$ to o!r illicit sub/ances4 7#b7 ,because a le?al dose ( f5tanyl c be accid5tally inhal$ or absorb$ ?r\gh ! sk91 x's n j deadly to its us]s1 b x also ?reat5s ! lives ( law en=cem5t & cu/oms (ficials1 public heal? work]s1 fir/ respond]s & po/al work]s :o risk unkn[+ly com+ into contact ) f5tanyl 9 its diff]5t =ms4 7#c7 ,f #bjac to #bjad1 ! numb] ( drug seizures by law en=cem5t t te/$ positive = f5tanyl increas$ by #dbf p]c5t & syn!tic opioid-relat$ dea?s increas$ by #gi p]c5t1 ) ov] #gjj ov]dose dea?s relat$ to f5tanyl4 ,h[ev]1 due to v>iations 9 ,/ates' m$ical exam9] & coron] te/+ & report+ te*niques1 & dea?s attribut$ to h]o91 ?is figure is believ$ to be significantly high]4 7#d7 ,illicitly manufactur$ f5tanyl1 pill press ma*9es1 & o!r supplies ne$$ to manufacture c\nt]feit pills conta9+ f5tanyl are prim>ily s\rc$ f ,*9a & widely available = pur*ase on ! ,int]net4 ,traffick]s c typically pur*ase a kilogram ( f5tanyl p[d] = z little z #b1jjj f a ,*9ese suppli]1 trans=m x into hundr$s ( ?\s&s ( pills1 & sell ! c\nt]feit pills = millions ( doll>s 9 pr(it4 7#e7 ,9 #bjae1 ! ,drug ,en=cem5t ,adm9i/ration 7,,dea7 & ,c5t]s = ,disease ,control & ,prev5tion 7,,cdc7 issu$ nationwide al]ts id5tify+ f5tanyl z a ?reat to public heal? & safety & /at+ t ! rise ( c\nt]feit pills t conta9 f5tanyl 9 ! illicit drug m>ket w likely result 9 m opioid-dep5d5t individuals1 ov]doses1 & dea?s4 7#f7 ,! ,,dea has id5tifi$ two key *all5ges = us+ ! ,controll$ ,sub/ances ,analogue ,en=cem5t ,act ( #aihf 7#ba ,u4,s4,c4 #hja note7 to prosecute individuals = violations relat+ to f5tanyl3 7,a7 ,! law requires t ! sub/ance h a sub/antially simil> *emical /ructure to a controll$ sub/ance 9 ord] to be consid]$ an analogue1 yet ! ?re%old = sub/antially simil> has be5 cit$ by num]\s c\rts z difficult to apply4 7,b7 ,ea* case requires additional inve/igation to det]m9e :e!r ! sub/ance 9 "q 0 int5d$ = human consumption & c !re=e be consid]$ an analogue4 7#g7 ,illicit f5tanyl manufactur]s are cont9u\sly manipulat+ ! *emical /ructures ( ! analogues 9 ord] to /ay ahead ( rese>*]s & law en=cem5t1 ?us mak+ prosecut+ ^! crimes ov]ly on]\s4 ,fur!rmore1 ! spe$ at :i* ^! alt]ations c be made outpace ! curr5t au?orities ( ! ,dep>tm5t ( ,ju/ice to s*$ule new comp\nds & analogues "u ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hja et seq474 7b7 ,s5se ( ,congress ,x is ! s5se ( ! ,congress t-- 7#a7 ! traffick+ 9 f5tanyl & o!r syn!tic opioids repres5ts a public heal? em]g5cy 9 ! ,unit$ ,/ates & requires a compreh5sive legislative response2 7#b7 ! ,unit$ ,/ates ,gov]nm5t %\ld use all available measures to r$uce ! availability ( illicit f5tanyl1 its *emical precursors1 & ! equipm5t by :i* f5tanyl may be mill$ into c\nt]feit prescription pills2 7#c7 ! ,unit$ ,/ates ,gov]nm5t %\ld make grants available = ,/ate & local m$ical exam9]s & coron]s to scre5 = f5tanyl 9 suspect$ opioid ov]dose cases 9 regions report+ increases 9 f5tanyl seizures1 f5tanyl-relat$ ov]dose fatalities1 or unusually high spikes 9 h]o9 or unspecifi$ drug ov]dose fatalities2 7#d7 ,/ate & local law en=cem5t %\ld1 if safe & possible1 prioritize & exp$ite te/+ ( drug samples tak5 f drug ov]dose sc5es & %>e ! data on f5tanyl drug seizures ) local heal? dep>tm5ts1 coron]s1 & m$ical exam9]s2 7#e7 grants made available to address ! opioid epidemic %\ld be us$ to improve ,/ates' surveillance ( f5tanyl-relat$ dea?s & to exp& access to naloxone = fir/ respond]s1 law en=cem5t1 & heal? c>e p]sonnel giv5 t multiple doses ( naloxone mu/ be adm9i/]$ p] ov]dose ev5t2 & 7#f7 ! ,unit$ ,/ates ,gov]nm5t1 includ+ ! ,secret>y ( ,/ate1 ! ,attorney ,g5]al1 ! ,secret>y ( ,homel& ,security1 & ! ,director ( ! ,(fice ( ,national ,drug ,control ,policy1 %\ld use ! broad diplomatic & law en=cem5t res\rces ( ! ,unit$ ,/ates1 9 p>tn]%ip ) ! ,gov]nm5ts ( ,mexico & ,*9a1 to /op ! traffick+ ( illicit f5tanyl into ! ,unit$ ,/ates4 #c4 ,enhanc$ p5alties 7a7 ,controll$ ,sub/ances ,act am5dm5ts ,! ,controll$ ,sub/ances ,act is am5d$-- 7#a7 9 section #dja7;b77#a7 7#ba ,u4,s4,c4 #hda7;b77#a77-- 7,a7 9 subp>agraph 7,a77vi7-- 7i7 by /rik+ #djj grams & ins]t+ #bj grams2 & 7ii7 by /rik+ #ajj grams & ins]t+ #e grams2 & 7,b7 9 subp>agraph 7,b77vi7-- 7i7 by /rik+ #dj grams & ins]t+ #b grams2 & 7ii7 by /rik+ #aj grams & ins]t+ #j4e grams2 & 7#b7 by add+ at ! end ( section #dja7;b7 7#ba ,u4,s4,c4 #hda7;b77 ! foll[+3 7#h7 ,9 ! case ( a violation ( subsection 7a71 if ! mixture or sub/ance conta9s a detectable am\nt ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide or any analogue ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide & also conta9s a detectable am\nt ( ano!r controll$ sub/ance1 !n a c\rt %all-- 7,a7 n impose a t]m ( probation2 7,b7 9 addition to ! t]m ( puni%m5t = ! violation ( ?is section1 impose a t]m ( imprisonm5t n to exce$ #e ye>s2 & 7,c7 no t]m ( imprisonm5t impos$ on a p]son "u subp>agraph 7,b7 %all run concurr5tly ) any t]m ( imprisonm5t impos$ on ! p]son "u any o!r provision ( law4 7#i7 ,9 ! case ( a violation ( subsection 7a71 if ! mixture or sub/ance conta9+ a detectable am\nt ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide or any analogue ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide 0 repres5t$ to be or sold z ano!r controll$ sub/ance1 !n a c\rt %all-- 7,a7 n impose a t]m ( probation2 7,b7 9 addition to ! t]m ( puni%m5t = ! violation ( ?is section1 impose a t]m ( imprisonm5t n to exce$ #e ye>s2 & 7,c7 no t]m ( imprisonm5t impos$ on a p]son "u subp>agraph 7,b7 %all run concurr5tly ) any t]m ( imprisonm5t impos$ on ! p]son "u any o!r provision ( law4 4 7b7 ,controll$ sub/ances import & export act am5dm5ts ,section #ajaj7;b7 ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ifj7;b77 is am5d$ by add+ at ! end ! foll[+3 7#h7 ,9 ! case ( a violation ( subsection 7a71 if ! mixture or sub/ance conta9+ a detectable am\nt ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide or any analogue ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide also conta9s a detectable am\nt ( ano!r controll$ sub/ance1 !n a c\rt %all-- 7,a7 n impose a t]m ( probation2 7,b7 9 addition to ! t]m ( puni%m5t = ! violation ( ?is section1 impose a t]m ( imprisonm5t n to exce$ #e ye>s2 & 7,c7 no t]m ( imprisonm5t impos$ on a p]son "u subp>agraph 7,b7 %all run concurr5tly ) any t]m ( imprisonm5t impos$ on ! p]son "u any o!r provision ( law4 7#i7 ,9 ! case ( a violation ( subsection 7a71 if ! mixture or sub/ance conta9+ a detectable am\nt ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide or any analogue ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide 0 repres5t$ to be or sold z ano!r controll$ sub/ance1 !n a c\rt %all-- 7,a7 n impose a t]m ( probation2 7,b7 9 addition to ! t]m ( puni%m5t = ! violation ( ?is section1 impose a t]m ( imprisonm5t n to exce$ #e ye>s2 & 7,c7 no t]m ( imprisonm5t impos$ on a p]son "u subp>agraph 7,b7 %all run concurr5tly ) any t]m ( imprisonm5t impos$ on ! p]son "u any o!r provision ( law4 4 #d4 ,endang]+ human life :ile illegally manufactur+ controll$ sub/ance ,section #dag ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #heh7 is am5d$ to read z foll[s3 #dag4 ,endang]+ human life :ile illegally manufactur+ controll$ sub/ance 7a7 ,9 g5]al ,:oev]1 :ile manufactur+ a controll$ sub/ance 9 violation ( ?is title1 or attempt+ to d s1 or transport+ or caus+ to be transport$ mat]ials1 includ+ *emicals1 to d s1 creates a sub/antial risk ( h>m to human life %all be f9$ 9 accordance ) title #ah1 ,unit$ ,/ates ,code1 or imprison$ n m ?an #aj ye>s1 or bo?4 7b7 ,rebuttable presumption ,= purposes ( ?is section1 !re %all be rebuttable presumption t any violation ( subsection 7a7 involv+ a detectable am\nt ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide1 any analogue ( ,n-ph5yl-#a-7b-ph5yle?yl7-#d-pip]id9yl propanamide1 or ! imm$iate precursor ( su* a sub/ance1 creates a sub/antial risk ( h>m to human life4 4 #e4 ,tempor>y s*$ul+ ( syn!tic opioids ,section #bja ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 is am5d$ by add+ at ! end ! foll[+3 7k7 ,tempor>y & p]man5t s*$ul+ ( rec5tly em]g$ syn!tic opioids 7#a7 ,9 g5]al ,! ,attorney ,g5]al may issue a tempor>y ord] add+ a drug or o!r sub/ance to ! def9ition ( syn!tic opioids if ! ,attorney ,g5]al f9ds t-- 7,a7 ! drug or o!r sub/ance satisfies ! crit]ia = be+ consid]$ a syn!tic opioid b is n li/$ 9 t section or by regulation ( ! ,attorney ,g5]al z be+ a syn!tic opioid2 & 7,b7 add+ su* drug or o!r sub/ance to ! def9ition ( syn!tic opioids w assi/ 9 prev5t+ abuse or misuse ( ! drug or o!r sub/ance4 7#b7 ,effective date2 duration ,an ord] issu$ "u p>agraph 7#a7 %all n take effect until #cj days aft] ! date ( ! publication by ! ,attorney ,g5]al ( a notice 9 ! ,f$]al ,regi/] ( ! int5tion to issue su* ord] & ! gr\nds ^u :i* su* ord] is to be issu$4 ,! ord] %all expire n lat] ?an #bd mon?s aft] ! date x becomes effective1 except t ! ,attorney ,g5]al may1 dur+ ! p5d5cy ( proce$+s "u p>agraph 7#f71 ext5d ! tempor>y s*$ul+ ord] = up to #f mon?s4 7#c7 ,notice ,! ,attorney ,g5]al %all transmit notice ( an ord] propos$ to be issu$ "u p>agraph 7#a7 to ! ,secret>y ( ,heal? & ,human ,s]vices4 ,9 issu+ an ord] "u p>agraph 7#a71 ! ,attorney ,g5]al %all take into consid]ation any comm5ts submitt$ by ! ,secret>y 9 response to a notice transmitt$ pursuant to ?is p>agraph4 7#d7 ,effect ( p]man5t s*$ul+ ,a tempor>y s*$ul+ ord] issu$ "u p>agraph 7#a7 %all be vacat$ ^u ! issuance ( a p]man5t s*$ul+ ord] "u p>agraph 7#f74 7#e7 ,judicial review ,an ord] issu$ "u p>agraph 7#a7 is n subject to judicial review4 7#f7 ,p]man5t s*$ul+ ,! ,attorney ,g5]al may1 by rule1 issue a p]man5t ord] add+ a drug or o!r sub/ance to ! def9ition ( syn!tic opioids if su* drug or o!r sub/ance satisfies ! crit]ia = be+ consid]$ a syn!tic opioid4 ,su* rulemak+ may be comm5c$ simultane\sly ) ! issuance ( ! tempor>y ord] issu$ "u p>agraph 7#a74 4 #f4 ,tablet+ ma*9es1 encapsulat+ ma*9es1 & controll$ sub/ance c\nt]feit+ mat]ials 7a7 ,mailability 7#a7 ,9 g5]al ,*apt] #cj ( title #ci1 ,unit$ ,/ates ,code1 is am5d$ by ins]t+ aft] section #cjjb;a1 ! foll[+ new section3 #cjjb;b4 ,nonmailability ( tablet+ ma*9es1 encapsulat+ ma*9es1 & controll$ sub/ance c\nt]feit+ mat]ials 7a7 ,any tablet+ ma*9e1 encapsulat+ ma*9e1 or controll$ sub/ance c\nt]feit+ mat]ial is nonmailable matt]1 %all n be c>ri$ or deliv]$ by mail1 & %all be dispos$ ( z ! ,po/al ,s]vice directs1 unless su* device or mat]ial is mail$-- 7#a7 to a regulat$ p]son 7z def9$ 9 section #ajb7ch7 ( ! ,controll$ ,sub/ances ,act72 or 7#b7 to a p]son regi/]$ to manufacture a controll$ sub/ance by ! ,attorney ,g5]al pursuant to section #cjb ( ! ,controll$ ,sub/ances ,act4 7b7 ,= ! purpose ( ?is section-- 7#a7 ! t]m controll$ sub/ance c\nt]feit+ mat]ial means any pun*1 die1 plate1 /one1 or o!r ?+ describ$ section #djc7;a77#e7 ( ! ,controll$ ,sub/ances ,act2 7#b7 ! t]m encapsulat+ ma*9e means any manual1 semiautomatic1 or fully automatic equipm5t :i* may be us$ to fill %ells or capsules ) any p[d]$1 granul>1 semisolid1 or liquid mat]ial2 & 7#c7 ! t]m tablet+ ma*9e means any manual1 semiautomatic1 or fully automatic equipm5t :i* may be us$ = ! compaction or mold+ ( p[d]$ or granul> solids1 or semisolid mat]ial1 to produce coh]5t solid tablets4 4 7#b7 ,cl]ical am5dm5t ,! table ( sections = *apt] #cj ( title #ci1 ,unit$ ,/ates ,code1 is am5d$ by ins]t+ aft] ! item relat+ to section #cjjb;a ! foll[+ new item3 #cjjb;b4 ,nonmailability ( tablet+ ma*9es1 encapsulat+ ma*9es1 & controll$ sub/ance c\nt]feit+ mat]ials4 4 7b7 ,p5alty 7#a7 ,9 g5]al ,*apt] #hc ( title #ah1 ,unit$ ,/ates ,code1 is am5d$ by ins]t+ aft] section #agaf;,e ! foll[+ new section3 #agaf;,f4 ,nonmailability ( tablet+ ma*9es1 encapsulat+ ma*9es1 & controll$ sub/ance c\nt]feit+ mat]ials ,:oev] kn[+ly deposits = mail+ or deliv]y1 or kn[+ly causes to be deliv]$ by mail accord+ to ! direction !reon1 or at any place to :i* x is direct$ to be deliv]$ by ! p]son to :om x is address$1 any matt] decl>$ to be nonmailable by section #cjjb;c ( title #ci1 %all be f9$ "u ?is title or imprison$ n m ?an #a ye>1 or bo?4 4 7#b7 ,cl]ical am5dm5t ,! table ( sections = *apt] #hc ( title #ah1 ,unit$ ,/ates ,code1 is am5d$ by ins]t+ aft] ! item relat+ to section #agaf;,e ! foll[+ new item3 #agaf;,f4 ,nonmailability ( tablet+ ma*9es1 encapsulat+ ma*9es1 & controll$ sub/ance c\nt]feit+ mat]ials4 4 #g4 ,label+ requirem5ts 7a7 ,9 g5]al ,section #cje ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbe7 is am5d$ by add+ at ! end ! foll[+3 7f7 ,false ,label+ ( ,syn!tic ,opioids 7#a7 ,x %all be unlawful to import1 export1 manufacture1 di/ribute1 disp5se1 or possess ) int5t to manufacture1 di/ribute1 or disp5se1 a syn!tic opioid or product conta9+ a syn!tic opioid1 unless ! opioid or product be>s a label cle>ly id5tify+ a syn!tic opioid or product conta9+ a syn!tic opioid by ! nom5clature us$ by ! ,int]national ,union ( ,pure & ,appli$ ,*emi/ry 7,,iupac74 7#b7 7,a7 ,a product describ$ 9 subp>agraph 7,b7 is exempt f ! ,int]national ,union ( ,pure & ,appli$ ,*emi/ry nom5clature requirem5t ( ?is subsection if su* product is label$ 9 ! mann] requir$ "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 7,b7 ,a product is describ$ 9 ?is subp>agraph if ! product-- 7i7 is ! subject ( an approv$ application z describ$ 9 section #eje7;b7 or 7j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act2 or 7ii7 is exempt f ! provisions ( section #eje ( su* ,act relat+ to new drugs because-- 7,i7 x is int5d$ solely = inve/igational use z describ$ 9 section #eje7;i7 ( su* ,act2 & 7,,ii7 su* product is be+ us$ exclusively = purposes ( a cl9ical trial t is ! subject ( an effective inve/igational new drug application4 4 7b7 ,cl>ification ,to ,import & ,export /atute ,section #ajaj ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ifj7 is am5d$1 9 subsection 7a77#a71 by ins]t+ #cje1 be=e #ajjb4 7c7 ,civil p5alties ,section #djb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hdb7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#ae71 by /rik+ or at ! end2 7,b7 9 p>agraph 7#af71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7,c7 by ins]t+1 aft] p>agraph 7#af71 ! foll[+3 7#ag7 to violate subsection 7f7 ( section #hbe ( ?is title4 2 & 7#b7 9 subsection 7c77#a7-- 7,a7 by ins]t+1 9 subp>agraph 7,a71 aft] subp>agraph 7,b71 7,c71 /rik+ or 7,d7 & ins]t+ ! foll[+3 1 7,d71 7,e71 or 7,f72 & 7,b7 by ins]t+ aft] subp>agraph 7,d7 ! foll[+3 7,e7 ,9 ! case ( a violation ( p>agraph 7#ag7 ( subsection 7a7 ( ?is section by an import]1 export]1 manufactur]1 or di/ributor 7o!r ?an z provid$ 9 subp>agraph 7,f771 up to #ejj1jjj p] violation4 ,= purposes ( ?is subp>agraph1 a violation is def9$ z ea* in/ance ( importation1 exportation1 manufactur+1 di/ribution1 or possession ) int5t to manufacture or di/ribute1 9 violation ( p>agraph 7#ag7 ( subsection 7a74 7,f7 ,9 ! case ( a di/ribution1 disp5s+1 or possession ) int5t to di/ribute or disp5se 9 violation ( p>agraph 7#ag7 ( subsection 7a7 ( ?is section at ! retail level1 up to #a1jjj p] violation4 ,ea* package1 conta9] or o!r sep>ate unit conta9+ a syn!tic opioid t is di/ribut$1 disp5s$1 or possess$ ) int5t to di/ribute or disp5se at ! retail level 9 violation ( su* p>agraph 7#ag7 ( subsection 7a7 %all be consid]$ a sep>ate violation4 4