,,ii #aaf? ,,congress #b;d ,session ,s4 #cech ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,m>* #ai1 #bjbj,mr4 ,rubio 7= himself1 ,ms4 ,w>r51 ,mr4 ,cram]1 ,mr4 ,murphy1 & ,mr4 ,ka9e7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to require ! ,secret>y ( ,def5se to submit to ,congress a report on ! reliance by ! ,dep>tm5t ( ,def5se on imports ( c]ta9 ph>maceutical products made 9 "p or 9 :ole 9 c]ta9 c\ntries1 to e/abli% po/m>ket report+ requirem5ts = ph>maceuticals1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/r5g!n+ ,am]ica's ,supply ,*a9 & ,national ,security ,act4 #b4 ,report on reliance by ,dep>tm5t ( ,def5se on ph>maceutical products f c]ta9 c\ntries 7a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( ! enactm5t ( ?is ,act1 ! ,secret>y ( ,def5se1 9 coord9ation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 %all submit to ! appropriate congressional committees a classifi$ report on ! reliance by ! ,dep>tm5t ( ,def5se on imports ( c]ta9 ph>maceutical products made 9 "p or 9 :ole 9 a cov]$ c\ntry4 7b7 ,elem5ts ,! report requir$ by subsection 7a7 %all-- 7#a7 analyze ! p]c5t ( ph>maceutical products us$ by ! ,dep>tm5t ( ,def5se t are made 9 "p or 9 :ole 9 a cov]$ c\ntry1 includ+-- 7,a7 drugs2 7,b7 active +r$i5ts2 7,c7 raw ph>maceutical compon5ts2 7,d7 nonprescription drugs int5d$ = human use2 & 7,e7 any o!r ph>maceutical product1 or its compon5ts1 z ! ,secret>y consid]s appropriate2 7#b7 assess ! products id5tifi$ "u p>agraph 7#a7 to det]m9e-- 7,a7 :e!r ! ,dep>tm5t ( ,def5se c procure ! product f o!r s\rces2 7,b7 :e!r reliance by ! ,dep>tm5t ( ,def5se on ! product is likely1 or has significant pot5tial1 to be us$ = a milit>y1 geopolitical1 or economic advantage aga9/ ! ,unit$ ,/ates2 7,c7 :e!r reliance on ! product creates a risk = ! ,unit$ ,/ates2 & 7,d7 :at impact !re w\ld be if access to ! product 0 t]m9at$2 7#c7 set =? recomm5dations to ensure t by #bjbe no ph>maceutical products pur*as$ = b5efici>ies ( heal? c>e f ! ,dep>tm5t ( ,def5se or any associat$ program are made 9 "p or 9 :ole 9 a cov]$ c\ntry2 7#d7 assess ! resili5ce & capacity ( ! curr5t supply *a9 & indu/rial base to support national def5se if no ph>maceutical products pur*as$ = b5efici>ies ( heal? c>e f ! ,dep>tm5t ( ,def5se or any associat$ program are made 9 "p or 9 :ole 9 a cov]$ c\ntry1 includ+ ) respect to-- 7,a7 ! manufactur+ capacity ( ! ,unit$ ,/ates2 7,b7 gaps 9 dome/ic manufactur+ capabilities1 includ+ non-exi/5t1 ext9ct1 ?reat5$1 & s+le-po9t-(-failure capabilities2 & 7,c7 supply *a9s ) s+le po9ts ( failure & limit$ resili5cy2 7#e7 set =? recomm5dations-- 7,a7 to div]sify supply ( ph>maceutical products away f complete dep5d5cy on s\rces ( supply 9 c\ntries t are competitors ( ! ,unit$ ,/ates or politically un/able t may cut (f supply 9 ! ,unit$ ,/ates2 7,b7 to address critical bottl5ecks 9 ! supply ( ph>maceutical products 9 ! ,unit$ ,/ates2 & 7,c7 to mitigate s+le po9ts ( failure & limit$ resili5ce ( supply *a9s = ph>maceutical products 9 ! ,unit$ ,/ates2 & 7#f7 set =? recomm5dations = legislative & adm9i/rative action necess>y to avoid1 or prep>e =1 cont+5cies id5tifi$ 9 ! report4 7c7 ,publication ( unclassifi$ summ>y ,concurr5t ) ! submittal ( ! report requir$ by subsection 7a71 ! ,secret>y ( ,def5se %all publi% on a publicly available int]net website ( ! ,dep>tm5t ( ,def5se an unclassifi$ summ>y ( ! report4 7d7 ,def9itions ,9 ?is section3 7#a7 ,appropriate congressional committees ,! t]m appropriate congressional committees means-- 7,a7 ! ,committee on ,arm$ ,s]vices1 ! ,select ,committee on ,intellig5ce1 ! ,committee on ,f9ance1 ! ,committee on ,bank+1 ,h\s+1 & ,urban ,affairs1 & ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate2 & 7,b7 ! ,committee on ,arm$ ,s]vices1 ! ,p]man5t ,select ,committee on ,intellig5ce1 ! ,committee on ,ways & ,means1 ! ,committee on ,f9ancial ,s]vices1 & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives4 7#b7 ,cov]$ c\ntry ,! t]m cov]$ c\ntry means-- 7,a7 ,*9a2 & 7,b7 any o!r c\ntry z det]m9$ by ! ,secret>y ( ,def5se = national security purposes4 7#c7 ,drug ,! t]m drug means a product subject to regulation "u section #eje or section #hjb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee or #chb7 or "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#d7 ,nonprescription drug ,! t]m nonprescription drug has ! mean+ giv5 t t]m 9 section #gfj7;a77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;aa7a77#b774 #c4 ,modification ( rules ( orig9 = ph>maceutical products 7a7 ,trade agreem5ts ,section #cjh7d77;,b7 ( ! ,trade ,agreem5ts ,act ( #aigi 7#ai ,u4,s4,c4 #beah7d77;,b77 is am5d$-- 7#a7 9 clause 7i71 by /rik+ in/rum5tality1 or & ins]t+ in/rum5tality12 7#b7 9 clause 7ii7-- 7,a7 by ins]t+ 1 o!r ?an an active ph>maceutical +r$i5t1 aft] "p ( mat]ials2 & 7,b7 by /rik+ ! p]iod at ! end & ins]t+ 1 or2 & 7#c7 by ins]t+ be=e ! p]iod at ! end ! foll[+3 7iii7 9 ! case ( an article :i* consi/s ( an active ph>maceutical +r$i5t1 ! ph>maceutical +r$i5t is :olly ! gr[?1 product1 or manufacture ( t c\ntry or in/rum5tality4 7b7 ,f$]al ,acquisition ,regulation ,n lat] ?an #ahj days aft] ! date ( ! enactm5t ( ?is ,act1 ! ,presid5t %all prescribe regulations to update sections #eb4bbe-e & #be4jjc ( title #dh1 ,code ( ,f$]al ,regulations 7or successor regulations7 to be consi/5t ) rules ( orig9 det]m9ations = active ph>maceutical +r$i5ts made "u section #cjh7d77;,b7 ( ! ,trade ,agreem5ts ,act ( #aigi 7#ai ,u4,s4,c4 #beah7d77;,b771 z am5d$ by subsection 7a74 #d4 ,po/m>ket report+ requirem5ts = ph>maceuticals 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all ensure t ea* hold] ( an approv$ application "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 annually submit1 z "p ( ! po/m>ket annual report requir$ by ! ,secret>y "u section #cad4ha7;b77#b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation71 ! foll[+ in=mation3 7#a7 ,! names & addresses ( ! s\rces ( active & inactive +r$i5ts ( ! drug4 7#b7 ,= ea* active & inactive +r$i5t ( ! drug1 ! p]c5tage ( ! aggregate am\nt ( su* +r$i5t us$ 9 ! manufacture ( ! drug dur+ ! report+ p]iod t is f ea* ( ! s\rces id5tifi$ "u p>agraph 7#a74 7b7 ,disclosure ( ,in=mation ,! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 annually provide ! in=mation report$ 9 p>agraphs 7#a7 & 7#b7 ( subsection 7a7 to ! ,secret>y ( ,def5se = purposes ( und]/&+ ! dep5d5cy on =eign manufactur]s ( drugs us$ by memb]s ( ! ,arm$ ,=ces2 & 7#b7 publi% ! in=mation report$ "u su* p>agraphs on a publicly available int]net website ( ! ,f$]al ,gov]nm5t 9 a s+le1 aggregate =m1 )\t disclos+ propriet>y in=mation4