,i #aaf? ,,congress #b;d ,session ,h4 ,r4 #fjhj ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #d1 #bjbj,mr4 ,pet]s 7= himself1 ,mr4 ,engel1 ,ms4 ,e%oo1 ,mr4 ,gu?rie1 ,mr4 ,s*rad]1 ,mr4 ,mc,caul1 ,mr4 ,hudson1 & ,mr4 ,bilirakis7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to r$uce drug %ortages1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,prev5t+ ,drug ,%ortages ,act4 #b4 ,additional manufactur] report+ requirem5ts 9 response to supply disruptions 7a7 ,expansion ,to include active ph>maceutical +r$i5ts ,subsection 7a7 ( section #ejf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is am5d$-- 7#a7 9 ! matt] prec$+ p>agraph 7#a71 by ins]t+ or its active ph>maceutical +r$i5ts aft] a drug2 & 7#b7 9 ! matt] foll[+ p>agraph 7#b7-- 7,a7 by ins]t+ or its active ph>maceutical +r$i5ts be=e t is likely2 7,b7 or its active ph>maceutical +r$i5t or +r$i5ts aft] t drug2 & 7,c7 by add+ at ! end ! foll[+3 ,notification "u ?is subsection %all include full disclosure ( ! problems result+ 9 ! supply disruption1 ! s\rce ( ! active ph>maceutical +r$i5t1 any alt]native s\rces = ! active ph>maceutical +r$i5t t are kn[n or contact$ by manufactur]1 in=mation conc]n+ ! ext5t ( ! supply disruption1 ! expect$ duration ( ! supply disruption1 ! expect$ impact to di/ribution & availability 9 ph>macies1 & su* o!r in=mation z ! ,secret>y may require44 7b7 ,manufactur+ report+ ,section #ejf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is am5d$ by add+ at ! end ! foll[+3 7j7 ,manufactur] report+ ,ea* manufactur] ( a drug describ$ 9 subsection 7a7 or ( any active ph>maceutical +r$i5t ( su* a drug %all report 9 su* manufactur]'s annual e/abli%m5t regi/ration & product li/+ "u subsections 7b7 & 7j7 ( section #eaj ! specific facilities 9 :i* su* drug or +r$i5t is manufactur$ 7includ+ ! volume manufactur$ at ea* su* facility7 to help ensure un9t]rupt$ supply ( ! drug or +r$i5t4 ,in=mation obta9$ ?r\gh report+ "u ?is section %all be ma9ta9$ by ! ,secret>y 9 a confid5tial & int]nal mann] & %all be trade secret &_/or confid5tial comm]cial or f9ancial in=mation pursuant to section #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates ,code4 4 7c7 ,consum] notification ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all develop & submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate legislative & regulatory recomm5dations = consum] notification 9 ! case ( a drug %ortage1 discont9uance1 or int]ruption ( ! manufacture ( a drug describ$ 9 section #ejf;,c7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7a771 includ+ recomm5dations = notification to pati5ts & physicians1 ph>maci/s1 & o!r practition]s au?oriz$ "u applicable ,/ate law to prescribe or disp5se drugs4 7d7 ,effective date ,! am5dm5ts made by ?is section %all take effect on ! date t is #ahj days aft] ! date ( enactm5t ( ?is ,act4 #c4 ,,gao report on intra-ag5cy coord9ation 7a7 ,9 g5]al ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate a report exam9+ ! ,food & ,drug ,adm9i/ration's intra-ag5cy coord9ation1 communication1 & decision mak+ 9 assess+ drug %ortage risks1 & tak+ corrective action4 7b7 ,cont5t ,! report %all include-- 7#a7 consid]ation (-- 7,a7 risks associat$ ) violations ( curr5t good manufactur+ practices2 7,b7 corrective & prev5tative actions ) respect to su* violations reque/$ by ! ,food & ,drug ,adm9i/ration2 7,c7 ! effects ( pot5tial manufactur+ sl[-d[ns or %ut-d[ns on pot5tial drug %ortages1 includ+ ! discont9uance ( drug manufactur+ & m>ket+2 7,d7 ef=ts to prioritize review ( applications = drugs t ! ,secret>y has det]m9$ "u section #ejf;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7 to be 9 %ortage2 & 7,e7 ef=ts to prioritize inspections ( facilities necess>y = approval ( applications = drugs describ$ 9 subp>agraph 7,d72 7#b7 a description ( h[ ! ,food & ,drug ,adm9i/ration proactively coord9ates /rategies to mitigate ! consequ5ces ( ! violations1 sl[-d[ns1 & %ut-d[ns describ$ 9 p>agraph 7#a7 across ag5cies2 & 7#c7 an evaluation ( *anges 9 relevant ,food & ,drug ,adm9i/ration practices t su* ag5cy has propos$ b n yet implem5t$4 #d4 ,improv+ critical infra/ructure by requir+ risk managem5t plans 7a7 ,risk managem5t plans ,section #ejf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c71 z am5d$ by section #b7;b71 is fur!r am5d$ by add+ at ! end ! foll[+3 7k7 ,risk managem5t plans ,! ,secret>y may require a manufactur] ( a drug describ$ 9 subsection 7a7 to conduct p]iodic risk assessm5ts-- 7#a7 to id5tify vuln]abilities 9 ! manufactur+ supply *a9 ( su* manufactur]2 & 7#b7 to develop plans to mitigate ! risks associat$ ) any vuln]abilities s id5tifi$4 4 7b7 ,guidance ,n lat] ?an #ah mon?s aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all f9alize guidance implem5t+ subsection 7l7 ( section #ejf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z add$ by subsection 7a74 ,su* guidance %all include guidance on-- 7#a7 examples ( :at may be consid]$ a vuln]ability 9 ! manufactur+ supply *a9 9 conduct+ a risk assessm5t pursuant to su* subsection2 7#b7 ! timeframe )9 :i* a manufactur] mu/ conduct su* an assessm5t & provide a response to ! ,food & ,drug ,adm9i/ration2 7#c7 expectations ( ! ,secret>y ( ,heal? & ,human ,s]vices = a manufactur] to mitigate 9 a reasonable mann] any risks associat$ ) vuln]abilities 9 ! manufactur+ supply *a9 id5tifi$ 9 su* an assessm5t2 & 7#d7 h[ ! ,secret>y w coord9ate ) o!r ,f$]al ag5cies to communicate & resolve any su* vuln]abilities4