,i #aai? ,,congress #a/ ,session ,h4 ,r4 #ecaf ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #aa1 #bjbe,mrs4 ,h>%b>g] 7= h]self & ,mr4 ,c>t] ( ,georgia7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to ensure pati5ts h access to c]ta9 %ortage & urg5t-use comp\nd$ m$ications1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,drug ,%ortage ,comp\nd+ ,pati5t ,access ,act ( #bjbe4 #b4 ,ph>macy comp\nd+ 7a7 ,comp\nd+ = urg5t adm9i/ration to pati5ts ,section #ejc;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7a77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ or at ! end2 7#b7 9 p>agraph 7#b77;,b77ii77,,ii71 by /rik+ ! p]iod at ! end & ins]t+ 2 or2 & 7#c7 by add+ at ! end ! foll[+3 7#c7 not)/&+ ! requirem5t 9 ! matt] prec$+ p>agraph 7#a7 t ! drug product is comp\nd$ = an id5tifi$ individual pati5t bas$ on a valid prescription ord] or notation describ$ 9 su* matt]1 is by a lic5s$ ph>maci/ or lic5s$ physician & ! comp\nd$ drug product is comp\nd$ = di/ribution 9 limit$ quantities to a lic5s$ prescrib] = urg5t adm9i/ration to a pati5t 9 a hospital or o!r cl9ical sett+1 provid$ t all ( ! foll[+ are met3 7,a7 ,! drug product appe>$ on ! drug %ortage li/ 9 effect "u section #ejf;,e at any "t dur+ ! #fj-;day p]iod end+ on ! date ( ! comp\nd+1 di/ribution1 or disp5s+ ( ! drug product4 7,b7 ,! lic5s$ prescrib] c]tifies by notation on ! ord] to ! comp\nd+ ph>maci/ or physician t ! lic5s$ prescrib] has made reasonable attempts to obta91 & has n be5 able to obta91 to address ! urg5t m$ical ne$ a drug product t is comp\nd$ by an outs\rc+ facility 9 accordance ) section #ejc;,b ) ! same active +r$i5t & ! same r\te ( adm9i/ration4 7,c7 ,! comp\nd$ drug product is label$ ) a beyond-use-date 9 accordance ) applicable ,unit$ ,/ates ,ph>macopeia /&>ds4 7,d7 ,! lic5s$ ph>maci/ or lic5s$ physician m>ks ! packag+ ( ! comp\nd$ drug product ) text-- 7i7 indicat+ t ! drug product is provid$ to ! hospital or o!r cl9ical sett+ only = urg5t adm9i/ration to a pati5t2 & 7ii7 reque/+ t ! hospital or o!r cl9ical sett+ provide to ! comp\nd+ ph>maci/ or physician ! records t id5tify ! pati5t or pati5ts to :om ! drug products 7 adm9i/]$ )9-- 7,i7 #g days ( ea* su* pati5t receiv+ su* m$ication2 or 7,,ii7 #g days ( ea* su* pati5t be+ dis*>g$4 7,e7 ,^u receipt ( records reque/$ pursuant to subp>agraph 7,d77ii71 ! lic5s$ ph>maci/ or lic5s$ physician ensures t ! pati5t in=mation 9 su* records is l9k$ ) ! respective ord]4 7,f7 ,! lic5s$ ph>maci/ or lic5s$ physician reports adv]se ev5ts associat$ ) ! comp\nd$ drug product z soon z possible b n lat] ?an #ae days aft] becom+ aw>e ( su* ev5ts to ! ,med,watch ,adv]se ,ev5t ,report+ program ( ! ,food & ,drug ,adm9i/ration 7or any successor program74 4 7b7 ,def9ition ,p>agraph 7#b7 ( section #ejc;,a7b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7b77#b77 is am5d$ to read z foll[s3 7#b7 ,def9ition ,= purposes ( p>agraph 7#a77;,d71 ! t]m ess5tially a copy ( a comm]cially available drug product does n include-- 7,a7 a drug product 9 :i* !re is a *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 & ! comp>able comm]cially available drug product2 or 7,b7 a drug product t meets ea* ( ! foll[+ conditions3 7i7 ,at any "t dur+ ! #fj-;day p]iod end+ on ! date ( ! comp\nd+1 di/ribution1 or disp5s+1 ! drug product appe>$ on ! drug %ortage li/ 9 effect "u section #ejf;,e4 7ii7 ,if ! drug product is n comp\nd$ = an id5tifi$ individual pati5t bas$ on a valid prescription ord] or notation1 not)/&+ su* requirem5t 9 ! matt] prec$+ p>agraph 7#a7 ( subsection 7a71 ! drug product-- 7,i7 is label$ 9 accordance subp>agraphs 7,c7 & 7,d7 ( subsection 7a77#c72 & 7,,ii7 is docum5t$ by ! comp\nd+ ph>maci/ or physician 9 accordance ) subp>agraphs 7,e7 & 7,f7 ( subsection 7a77#c74 4 #c4 ,mitigat+ drug %ortages ?r\gh improv$ report+ ,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]ruption1 ! s\rce & ins]t+ su* discont9uation1 int]ruption1 or surge 9 dem&1 ! s\rce2 & 7,e7 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$i5t ( su* a drug2 7,b7 by am5d+ p>agraph 7#b7 to read z foll[s3 7#b7 ! t]m drug %ortage or %ortage1 ) respect to a drug1 means a p]iod ( "t ) ! dem& or project$ 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 4 7,c7 9 p>agraph 7#c77;,b71 by /rik+ ! p]iod at ! end & 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 #d4 ,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 9 subsection 7a77#b77;,a77ii7-- 7,a7 by /rik+ appe>s & ins]t+ appe>$2 & 7,b7 by /rik+ at ! "t ( & ins]t+ at any "t dur+ ! #ahj-;day p]iod end+ on ! date ( 2 7#b7 9 subsection 7a77#aj77;,a77iii7-- 7,a7 9 subclause 7,,viii71 by /rik+ ! semicolon at ! end & ins]t+ 2 &2 7,b7 by /rik+ subclause 7,,ix72 & 7,c7 by r$esignat+ subclause 7,x7 z subclause 7,,ix72 7#c7 by r$esignat+ ! #b subsections 7d7 7relat+ to def9itions & relat+ to obligation to pay fees7 z subsections 7e7 & 7f71 respectively2 & 7#d7 by ins]t+ aft] subsection 7c7 ! foll[+3 7d7 ,li/ ( id5tifi$ 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 2 #e4 ,cl>ify+ provisions2 label+ requirem5t ,section #ejc;,a ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is am5d$-- 7#a7 by /rik+ subsection 7b77#c77;,b7 & ! matt] foll[+ su* subsection & ins]t+ ! foll[+3 7,b7 su* drug product is label$ z foll[s3 ,?is m$ication has be5 comp\nd$ = disp5s+ to an individual pati5t & has n be5 approv$ by ! ,food & ,drug ,adm9i/ration4 2 & 7#b7 9 subsection 7b77#a77;,a77i77,i7 by /rik+ ,national ,=mul>y monograph & ins]t+ ,national ,=mul>y drug or diet>y supplem5t monograph4