,,ii #aah? ,,congress #b;d ,session ,s4 #ecfh ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,novemb] #ba1 #bjbd,mr4 ,ka9e 7= himself & ,mr4 ,cotton7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to exp& drug %ortage notification practices to include surges 9 dem& = a drug1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,end ,drug ,%ortages ,act4 #b4 ,drug %ortage notification practices ,section #ejf;,c ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is am5d$-- 7#a7 9 ! section head+1 by ins]t+ or surge 9 dem& = aft] production (2 7#b7 9 subsection 7a71 9 ! matt] foll[+ p>agraph 7#b7-- 7,a7 by /rik+ or an int]ruption ( ! manufacture ( ! drug & ins]t+ 1 an int]ruption ( ! manufacture ( ! drug1 or a surge 9 dem& = ! drug2 7,b7 by /rik+ su* discont9uance or int]ruption & ins]t+ su* discont9uance1 int]ruption1 or surge 9 dem&2 7,c7 by /rik+ ! discont9uation or int]ruption & ins]t+ ! discont9uation1 int]ruption1 or surge 9 dem&2 & 7,d7 by /rik+ su* discont9uation or int]ruption2 ! expect$ duration ( ! int]ruption2 & ins]t+ su* discont9uation1 int]ruption1 or surge 9 dem&2 ! expect$ duration ( ! int]ruption or surge 9 dem&2 7#c7 9 subsection 7b71 by /rik+ p>agraphs 7#a7 & 7#b7 & ins]t+ ! foll[+3 7#a7 9 ! case ( a notice ( a discont9uance or int]ruption 9 ! manufacture ( a drug-- 7,a7 at lea/ #f mon?s prior to ! date ( ! discont9uance or int]ruption2 or 7,b7 if compliance ) subp>agraph 7,a7 is n possible1 z soon z practicable2 or 7#b7 9 ! case ( a notice ( a surge 9 dem& = a drug1 z soon z practicable4 2 7#d7 9 subsection 7c7-- 7,a7 by /rik+ discont9uance or int]ruption & ins]t+ discont9uance1 int]ruption1 or surge 9 dem&2 & 7,b7 by ins]t+ & outs\rc+ facilities 7z def9$ 9 section #ejc;,b7d77 aft] pati5t organizations2 & 7#e7 9 subsection 7h7-- 7,a7 9 p>agraph 7#a71 by /rik+ & t is subject to section #ejc7;b77#a7 & ins]t+ or ! active ph>maceutical +r$i5t ( su* a drug2 7,b7 by am5d+ p>agraph 7#b71 to read z foll[s3 7#b7 ! t]m drug %ortage or %ortage1 ) respect to a drug1 means a p]iod ( "t ) ! dem& or project$ dem& = ! drug )9 ! ,unit$ ,/ates exce$s ! supply ( ! drug1 tak+ into consid]ation-- 7,a7 h[ ! drug is prep>$ or disp5s$1 includ+ ! r\te ( adm9i/ration & dosage =m2 & 7,b7 in=mation report$ by manufactur]s1 heal? c>e pr(essionals1 & pati5ts2 2 7,c7 9 p>agraph 7#c77;,b71 by /rik+ ! p]iod & ins]t+ 2 &2 & 7,d7 by add+ at ! end ! foll[+3 7#d7 ! t]m surge means an increase 9 dem& or project$ dem& = a drug t ! manufactur] likely w be unable to meet )\t mean+ful %ortfall or delay4 4 #c4 ,outs\rc+ facility comp\nd+ ,section #ejc;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;b7 is am5d$-- 7#a7 by r$esignat+ ! #b subsections 7d7 7relat+ to def9itions & relat+ to obligation to pay fees7 z subsections 7e7 & 7f71 respectively2 & 7#b7 by ins]t+ aft] subsection 7c7 ! foll[+3 7d7 ,li/ ( id5tifi$ bulk drug sub/ances ,! ,secret>y %all make publicly available annual updates on ! evaluation ( bulk drug sub/ances = purposes ( ! li/ ma9ta9$ "u subsection 7a77#b77;,a77i74 4 #d4 ,hospital & heal? sy/em comp\nd+ ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all f9alize ! draft guidance entitl$ ,hospital & ,heal? ,sy/em ,comp\nd+ ,"u ,section #ejc;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act3 ,guidance = ,indu/ry issu$ 9 ,octob] #bjba1 & ensure t su* guidance is consi/5t ) ! mo/ curr5t rese>* & be/ cl9ical practices = ph>macy comp\nd+ relat+ to implem5t+ section #ejc;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a74