,,ii ,cal5d> ,no4 #ebd #aai? ,,congress #b;d ,session ,s4 #cgid ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,febru>y #e1 #bjbf,mr4 ,banks 7= himself & ,mr4 ,he9ri*7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,july #bg1 #bjbf,report$ by ,mr4 ,cassidy1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to fur!r regulate comp\nd+ ph>macies & outs\rc+ facilities1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,safegu>d+ ,am]icans f ,fraudul5t & ,exp]im5tal ,drugs ,act ( #bjbf or ! ,,safe ,drugs ,act ( #bjbf4 #b4 ,def9itions relat+ to comp\nd+ ( drug products ,section #ejc;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7b77 is am5d$-- 7#a7 by am5d+ p>agraph 7#a77;,d7 to read z foll[s3 7,d7 does n1 m ?an #bj times 9 a s+le mon?1 comp\nd any drug product t is ess5tially a copy ( a comm]cially available drug product4 2 & 7#b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ,def9itions 7,a7 ,= purposes ( p>agraph 7#a77;,d71 ! t]m ess5tially a copy ( a comm]cially available drug product means any drug product-- 7i7 t conta9s any active +r$i5t f\nd 9 a comm]cially available drug product2 & 7ii7 9 :i* !re is no *ange1 made = an id5tifi$ individual pati5t1 :i* produces = t pati5t a significant diff]5ce1 z det]m9$ by ! prescrib+ practition]1 betwe5 ! comp\nd$ drug product & ! comp>able comm]cially available drug product4 7,b7 ,= purposes ( subp>agraph 7,a71 ! t]m comm]cially available drug product includes any drug product t-- 7i7 is sold 9 ! comm]cial m>ketplace 9 ! ,unit$ ,/ates & manufactur$ 9 "o or m facilities requir$ to comply ) section #eja7;a77#b77;,b72 & 7ii7 is n includ$ 9 ! discont9u$ section ( ! li/ ( products describ$ 9 section #eje7;j77#g77;,a74 4 #c4 ,report+ requirem5t ,section #ejc;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is am5d$-- 7#a7 by r$esignat+ subsections 7d7 & 7e7 z subsections 7e7 & 7f71 respectively2 & 7#b7 by ins]t+ aft] subsection 7c7 ! foll[+3 7d7 ,report+ requirem5t 7#a7 ,9 g5]al ,= cal5d> ye> #bjbe & ea* cal5d> ye> !reaft]1 if a ph>macy1 facility1 or physician comp\nds1 m ?an #bj times 9 a s+le mon? = pati5ts :o reside outside ! ,/ate 9 :i* ! comp\nd+ occurs1 any drug product t conta9s any active +r$i5t f\nd 9 a comm]cially available drug product 7z def9$ 9 subsection 7b77#b77;,b771 su* ph>macy1 facility1 or physician %all submit a report to ! ,secret>y4 7#b7 ,cont5ts ,ea* report "u p>agraph 7#a7 %all id5tify-- 7,a7 ea* type ( drug product describ$ 9 p>agraph 7#a7 t is comp\nd$ = a pati5t describ$ 9 su* p>agraph2 & 7,b7 = ea* mon?1 ! total numb] ( times ea* su* type is s comp\nd$4 7#c7 ,tim+ ,= any cal5d> ye> = :i* p>agraph 7#a7 applies1 ! ph>macy1 facility1 or physician %all submit ! report "u su* p>agraph n lat] ?an ! end ( su* cal5d> ye>4 7#d7 ,=m & mann] ,a ph>macy1 facility1 or physician %all submit ea* report "u p>agraph 7#a7 9 su* =m & mann] z ! ,secret>y may prescribe4 7#e7 ,hospital ph>macy exclusion ,?is subsection does n apply to ! comp\nd+ ( any drug products = hospital pati5ts by a ph>macy locat$ on ! premises ( ! hospital4 4 #d4 ,l>ge-scale outs\rc+ facilities 7a7 ,inspections ,section #ejc;,b7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;b7b77 is am5d$ by add+ at ! end ! foll[+3 7#f7 ,inspections ( l>ge-scale outs\rc+ facilities 7,a7 ,9 g5]al ,9 ! case ( a l>ge-scale outs\rc+ facility1 ! risk-bas$ inspections "u p>agraph 7#d7 %all include-- 7i7 an inspection prior to su* facility comp\nd+ any drug product = ! fir/ "t2 & 7ii7 ! re9spection ( su* facility n less ?an bi5nially4 7,b7 ,l>ge-scale outs\rc+ facility def9$ ,= purposes ( ?is p>agraph1 ! t]m l>ge-scale outs\rc+ facility means any outs\rc+ facility t comp\nds1 m ?an #ajj times 9 a s+le cal5d> ye>1 any drug product4 4 7b7 ,regi/ration & report+ requirem5t ,section #eaj7;g77#a7 ( su* ,act 7#ba ,u4,s4,c4 #cfj7;g77#a77 is am5d$ by ins]t+ be=e ! semicolon at ! end ! foll[+3 1 except t ! exemption 9 ?is p>agraph %all n apply to any outs\rc+ facility 7z def9$ 9 section #ejc;,b7d77#d774 7c7 ,delay$ applicability ,! am5dm5ts made by subsections 7a7 & 7b7 apply beg9n+ #f mon?s aft] ! date ( enactm5t ( ?is ,act4 #e4 ,base e/abli%m5t fee ,section #gdd,k7c77#a77;,a77i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#fb7;c77#a77;,a77i77 is am5d$ by /rik+ #ae1jjj & ins]t+ a base am\nt deem$ appropriate by ! ,secret>y to fund activities to ensure ! safety ( comp\nd$ drug products4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,safegu>d+ ,am]icans f ,fraudul5t & ,exp]im5tal ,drugs ,act ( #bjbf or ! ,,safe ,drugs ,act ( #bjbf4 #b4 ,report+ requirem5t ,section #ejc;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is am5d$-- 7#a7 by r$esignat+ subsections 7d7 & 7e7 z subsections 7e7 & 7f71 respectively2 & 7#b7 by ins]t+ aft] subsection 7c7 ! foll[+3 7d7 ,report+ 7#a7 ,s]i\s adv]se ev5ts ,ea* lic5s$ ph>maci/ or lic5s$ physician :o comp\nds drug products "u ?is section & s5ds su* drug products1 or causes su* drug products to be s5t1 out ( ! ,/ate 9 :i* ! comp\nd+ occurs %all submit any report receiv$ by su* lic5s$ ph>maci/ or lic5s$ physician ( a s]i\s adv]se ev5t associat$ ) a comp\nd$ drug product1 9 accordance ) ! cont5t & =mat requirem5ts e/abli%$ ?r\gh guidance or "u section #caj4cje ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 to-- 7,a7 ! ,secret>y2 7,b7 ! ,/ate 9 :i* ! comp\nd+ occurs2 & 7,c7 ea* ,/ate to :i* su* drugs are s5t4 7#b7 ,int]/ate disp5s+ 7,a7 ,9 g5]al ,beg9n+ ) ! fir/ cal5d> ye> t beg9s aft] ! date ( enactm5t ( ! ,,safe ,drugs ,act ( #bjbf1 n lat] ?an ,janu>y #ae ( ea* cal5d> ye>1 ea* lic5s$ ph>maci/ or lic5s$ physician :o comp\nds drug products "u ?is section & s5ds1 or causes to be s5t1 out ( ! ,/ate 9 :i* ! comp\nd+ occurs1 m ?an #e p]c5t ( ! total annual am\nt ( drug products comp\nd$ by su* lic5s$ ph>maci/ or lic5s$ physician %all annually submit a report conta9+ ! in=mation describ$ 9 subp>agraph 7,b7 to ! ,secret>y & ! ,/ate to :i* su* drug products are s5t4 7,b7 ,cont5ts ,ea* report "u subp>agraph 7,a7 %all id5tify-- 7i7 ! "n1 address1 lic5se numb]1 & ,/ate ( lic5se ( ! lic5s$ ph>maci/ or lic5s$ physician :o comp\nd$ ! drug product2 & 7ii7 ! total numb] ( units ( comp\nd$ drug products1 by type ( product1 & by mon?1 s5t or caus$ to be s5t to ea* applicable ,/ate4 7,c7 ,=m & mann] ,a lic5s$ ph>maci/ or lic5s$ physician %all submit ea* report "u subp>agraph 7,a7 9 su* =m & mann] z ! ,secret>y may prescribe4 7,d7 ,in=mation %>+ ,! ,secret>y %all use an in=mation %>+ sy/em = purposes ( facilitat+ ! transmission ( reports "u subp>agraph 7,a7 f a lic5s$ ph>maci/ or lic5s$ physician to ! ,secret>y & ea* applicable ,/ate 9 a mann] t r$uces unnecess>y adm9i/rative burd54 7,e7 ,exclusion ,?is subsection %all n apply to ! comp\nd+ ( any drug products = hospital pati5ts by a ph>macy locat$ on ! premises ( ! hospital4 7#c7 ,rule ( con/ruction ,no?+ 9 ?is section %all be con/ru$ to preempt any requirem5t ( a ,/ate or political subdivision ( a ,/ate t requires additional1 m /r+5t1 or supplem5t>y report+ ) respect to a drug product comp\nd$ "u ?is section4 4 #c4 ,label+ ,section #ejc;,a7b77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7b77#c77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ 2 & & ins]t+ a semicolon2 7#b7 9 subp>agraph 7,b77ii71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 by ins]t+ aft] subp>agraph 7,b7 ! foll[+3 7,c7 ! label ( su* drug product includes-- 7i7 ! /atem5t3 ,?is m$ication has be5 comp\nd$ = disp5s+ to an individual pati5ts & has n be5 approv$ by ! ,food & ,drug ,adm9i/ration42 7ii7 ! foll[+ in=mation to facilitate adv]se ev5t report+3 www4fda4gov_/m$wat*1 & #a-hjj-;,,fda-#ajhh 7or any successor website or telephone numb]72 & 7iii7 su* o!r in=mation z ! ,secret>y may prescribe by ord]1 :i* may include in=mation to facilitate adv]se ev5t report+4 4 ,july #bg1 #bjbf,report$ ) an am5dm5t