,i #aac? ,,congress #a/ ,session ,h4 ,r4 #aieh ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #ad1 #bjac ,mr4 ,cumm+s introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to prohibit :olesal]s f pur*as+ prescription drugs f ph>macies1 & to enhance in=mation & transp>5cy reg>d+ drug :olesal]s engag$ 9 int]/ate comm]ce4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,gray ,m>ket ,drug ,re=m & ,transp>5cy ,act ( #bjac4 #b4 ,prohibition aga9/ :olesale di/ributors pur*as+ prescription drugs f ph>macies 7a7 ,prohibit$ act ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at ! end ! foll[+3 7ccc7 ,! pur*ase or receipt by any p]son requir$ to report "u section #eaj7;b77#d7 7relat+ to :olesale di/ributors ( prescription drugs7 ( any drug subject to section #ejc7;b77#a7 f a ph>macy or ph>maci/1 except t ?is p>agraph does n apply to ! return ( a drug to ! :olesale di/ributor f :i* ! p>ticul> drug 0 pur*as$4 4 7b7 ,misbr&+ ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7bb7 ,if x is pur*as$ or receiv$ 9 violation ( section #cja7;aaa7 7prohibit+ ! pur*ase or receipt ( prescription drugs by :olesale di/ributors f ph>maci/s74 4 #c4 ,report+ by :olesale di/ributors ( prescription drugs 7a7 ,report+ requirem5t 7#a7 ,9 g5]al ,section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is am5d$-- 7,a7 9 subsection 7b71 by add+ at ! end ! foll[+3 7#d7 ,on or be=e ,decemb] #ca ( ea* ye>1 e p]son engag$ 9 ! :olesale di/ribution 9 int]/ate comm]ce ( drugs subject to section #ejc7;b77#a7 %all report to ! ,secret>y su* p]son's "n1 contact in=mation = su* p]son's pr9cipal (fic] 7or ! designee !re(71 su* p]son's places ( bus9ess1 su* p]son's lic5s+ in=mation 7includ+ ! type ( lic5se & expiration date7 = ea* ,/ate 9 :i* su* p]son is s engag$1 & su* o!r in=mation z ! ,secret>y deems appropriate4 2 7,b7 9 subsection 7c7-- 7i7 by /rik+ ! second p]iod at ! end2 & 7ii7 by add+ at ! end ! foll[+3 ,e p]son ^u fir/ engag+ 9 ! :olesale di/ribution 9 int]/ate comm]ce ( drugs subject to section #ejc7;b77#a7 %all imm$iately report to ! ,secret>y ! in=mation describ$ 9 subsection 7b77#d74 7,c7 9 subsection 7d71 by add+ at ! end ! foll[+3 ,e p]son duly report+ 9 accordance ) ! =ego+ subsections %all imm$iately report to ! ,secret>y ) respect to any additional e/abli%m5t :i* ! p]son owns or op]ates 9 any ,/ate & 9 :i* ! p]son beg9s ! :olesale di/ribution 9 int]/ate comm]ce ( drugs subject to section #ejc7;b77#a744 7#b7 ,report+ numb] ,subsection 7e7 ( section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is am5d$-- 7,a7 by /rik+ regi/ration numb] & ins]t+ regi/ration or report+ numb]2 & 7,b7 by ins]t+ or report+ 9 accordance ) subsections 7b77#d71 7c71 or 7d7 aft] regi/]$ 9 accordance ) ?is section4 7#c7 ,public availability2 database ,subsection 7f7 ( section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is am5d$-- 7,a7 by /rik+ 7f7 & ins]t+ 7f77#a72 & 7,b7 by add+ at ! end ! foll[+3 7#b7 7,a7 ,! ,secret>y1 act+ directly or by ent]+ into a contract ) a private entity1 %all e/abli% & ma9ta9 a database includ+ all in=mation report$ "u subsection 7b77#d71 ! second s5t5ce ( subsection 7c71 & ! second s5t5ce ( subsection 7d74 7,b7 ,subject to subp>agraph 7,c71 ! ,secret>y %all make ! in=mation 9 su* database publicly available1 includ+ on ! public ,website ( ! ,food & ,drug ,adm9i/ration4 7,c7 ,! ,secret>y may *oose to re/rict ! ,secret>y's disclosure ( any in=mation report$ "u subsection 7b77#d71 7c71 or 7d7-- 7i7 t relates to a /orage facility2 & 7ii7 ^: disclosure w\ld1 z det]m9$ by ! ,secret>y1 compromise ! security ( su* facility4 4 7#d7 ,con=m+ am5dm5ts 7,a7 ,section #cja7p7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7p77 is am5d$ by ins]t+ ! failure to report 9 accordance ) subsection 7b77#d71 7c71 or 7d7 ( section #eaj1 aft] ,! failure to regi/] 9 accordance ) section #eaj or #ije14 7,b7 ,section #ejb7o7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7o77 is am5d$ by ins]t+ if x 0 di/ribut$ 9 int]/ate comm]ce by a p]son 9 violation ( ! report+ requirem5ts ( subsection 7b77#d71 7c71 or 7d7 ( section #eaj1 be=e if x 0 n includ$4 7,c7 ,section #eaj ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is am5d$-- 7i7 9 subsection 7g7-- 7,i7 9 p>agraph 7#c71 by add+ or at ! end2 7,,ii7 by /rik+ p>agraph 7#d72 7,,iii7 by r$esignat+ p>agraph 7#e7 z p>agraph 7#d72 7,,iv7 9 p>agraph 7#d7 7z s r$esignat$71 by ins]t+ or report+1 z applicable1 aft] regi/ration2 & 7,v7 by /rik+ ! matt] foll[+ p>agraph 7#d7 7z s r$esignat$72 7ii7 9 subsection 7h71 by add+ at ! end ! foll[+3 7#g7 ,:olesale di/ributors ,e e/abli%m5t 9 any ,/ate us$ by a p]son requir$ to report "u subsection 7b77#d71 7c71 or 7d7 = ! :olesale di/ribution 9 int]/ate comm]ce ( drugs subject to section #ejc7;b77#a7 %all be subject to inspection pursuant to section #gjd4 2 & 7iii7 9 subsection 7j71 by add+ at ! end ! foll[+3 7#e7 ,! provisions ( ?is subsection %all apply ) respect to a p]son requir$ to report "u subsection 7b77#d71 7c71 or 7d7 = ! :olesale di/ribution 9 int]/ate comm]ce ( drugs subject to section #ejc7;b77#a7 to ! same ext5t & 9 ! same mann] z su* provisions apply to p]sons requir$ to regi/] "u subsection 7b71 7c71 7d71 or 7i71 except t-- 7,a7 any ref]5ce to manufactur+ %all be treat$ z a ref]5ce to :olesale di/ribution2 & 7,b7 any ref]5ce to a drug %all be treat$ z a ref]5ce to a drug subject to section #ejc7;b77#a74 2 & 7,d7 9 subsection 7p77#a71 by /rik+ ,regi/rations & li/+s "u ?is section & ins]t+ ,regi/rations & li/+s "u ?is section1 & reports "u subsection 7b77#d71 7c71 & 7d7 be=e %all be submitt$4 7b7 ,in=mation on ,/ate actions aga9/ :olesale di/ributors ( prescription drugs ,p>agraph 7#b7 ( section #eaj7;f7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;f771 z add$ by subsection 7a77#c77;,b7 ( ?is section1 is am5d$-- 7#a7 9 subp>agraph 7,a71 by add+ at ! end ( ! subp>agraph ! foll[+3 ,su* database %all also include in=mation on actions 7su* z susp5sion or revocation ( lic5s+7 tak5 by ,/ates aga9/ p]sons engag$ 9 :olesale di/ribution ( drugs subject to section #ejc7;b77#a742 & 7#b7 by add+ at ! end ! foll[+3 7,d7 ,! ,secret>y %all enc\rage ,/ates to report ! type ( in=mation describ$ 9 ! second s5t5ce ( subp>agraph 7,a7 to ! ,food & ,drug ,adm9i/ration-- 7i7 9 a consi/5t mann]2 & 7ii7 on a volunt>y basis4 4 7c7 ,fees = report+ ,sub*apt] ,c ( *apt] ,,vii 7#ba ,u4,s4,c4 #cgi;f et seq47 is am5d$ by add+ at ! end ! foll[+3 #i ,fees relat+ to :olesale di/ributors ( prescription drugs #gdd,k4 ,au?ority to assess & collect fees 7a7 ,9 g5]al ,= fiscal ye> #bjac & ea* subsequ5t fiscal ye>1 ! ,secret>y %all assess & collect fees "u ?is section f ea* p]son t reports "u section #eaj7;b77#d7 to engage 9 ! :olesale di/ribution 9 int]/ate comm]ce ( drugs subject to section #ejc7;b77#a74 7b7 ,e/abli%m5t ( am\nt 7#a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ! ,gray ,m>ket ,drug ,re=m & ,transp>5cy ,act ( #bjac1 ! ,secret>y %all promulgate a f9al regulation e/abli%+ ! am\nt ( fees "u ?is section = ! p]iod ( fiscal ye>s #bjad ?r\gh #bjah s z to g5]ate a total rev5ue am\nt n exce$+ ! ,secret>y's e/imate ( #ajj p]c5t ( ! co/s describ$ 9 subsection 7c7 dur+ su* p]iod4 7#b7 ,consid]ation ,9 e/abli%+ ! am\nt ( fees "u ?is section1 ! ,secret>y %all take into consid]ation ! am\nt ( annual rev5ues ( a p]son to be assess$ su* fees 9 comp>ison ) ! am\nt ( annual rev5ues ( o!r p]sons to be assess$ su* fees4 7c7 ,co/s ,to be fund$ ?r\gh fees ,! fees au?oriz$ by ?is section %all only be collect$ & available to pay ! co/s incurr$ by ! ,food & ,drug ,adm9i/ration 9-- 7#a7 implem5t+ ! report+ requirem5t "u section #eaj7;b77#d72 & 7#b7 e/abli%+ & ma9ta9+ an up-to-date database ( ! in=mation collect$ pursuant to su* requirem5t4 7d7 ,cr$it+ & availability fees ,fees au?oriz$ "u subsection 7a7 %all be collect$ & available = obligation only to ! ext5t & 9 ! am\nt provid$ 9 advance 9 appropriation ,acts4 ,su* fees are au?oriz$ to rema9 available until exp5d$4 ,su* sums z may be necess>y may be transf]r$ f ! ,food & ,drug ,adm9i/ration sal>ies & exp5ses appropriation acc\nt )\t fiscal ye> limitation to su* appropriation acc\nt = sal>ies & exp5ses ) su* fiscal ye> limitation4 ,! sums transf]r$ %all be available solely = ! co/s describ$ 9 subsection 7c74 7e7 ,au?orization ( appropriations ,= ea* ( ! fiscal ye>s #bjad ?r\gh #bjah1 !re is au?oriz$ to be appropriat$ = fees "u ?is section an am\nt equal to ! total rev5ue am\nt det]m9$ "u subsection 7b7 = ! fiscal ye>4 7f7 ,(fset ,if ! sum ( ! cumulative am\nt ( fees collect$ "u ?is section = ! fiscal ye>s #bjad ?r\gh #bjaf & ! am\nt ( fees e/imat$ to be collect$ "u ?is section = fiscal ye> #bjag exce$s ! cumulative am\nt appropriat$ pursuant to subsection 7e7 = ! fiscal ye>s #bjad ?r\gh #bjag1 ! excess %all be cr$it$ to ! appropriation acc\nt ( ! ,food & ,drug ,adm9i/ration z provid$ 9 subsection 7d71 & %all be subtract$ f ! am\nt ( fees t w\ld o!rwise be au?oriz$ to be collect$ "u ?is section pursuant to appropriation ,acts = fiscal ye> #bjah4 4 #d4 ,id5tification ( sales price = drugs 9 %ortage 7a7 ,id5tification ( sales price = drugs 9 %ortage ,p>agraph 7#a7 ( section #ejc7;e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;e77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by ins]t+ be=e ! p]iod at ! end ! foll[+3 1 ! am\nt paid = su* drug by ! p]son receiv+ x if su* drug is 9 %ortage at ! "t ( ! sale1 & ! am\nt paid = su* drug = any prior sale t occurr$ at a "t :5 su* drug 0 9 %ortage2 & 7#b7 by add+ at ! end ! foll[+ new subp>agraph3 7,c7 ,9 ?is p>agraph1 ! t]m 9 %ortage means li/$ on ! public ,website ( ! ,food & ,drug ,adm9i/ration1 at ! "t ( ! sale to be id5tifi$ 9 ! /atem5t requir$ by subp>agraph 7,a71 z be+ 9 %ortage4 4 7b7 ,applicability ,! am5dm5t made by subsection 7a7 applies only ) respect to sales ( a drug occurr+ on or aft] ! date t is #a ye> aft] ! date ( ! enactm5t ( ?is ,act4