,,ii #aaf? ,,congress #b;d ,session ,s4 #dage ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,july #b1 #bjbj,ms4 ,w>r5 7= h]self & ,ms4 ,smi?7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to secure ! supply ( drugs 9 ! ,unit$ ,/ates1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,ph>maceutical ,supply ,*a9 ,def5se & ,enhancem5t ,act4 #b4 ,li/+ ( critical drugs 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y1 act+ ?r\gh ! ,commission] ( ,food & ,drugs & 9 consultation ) ! ,secret>y ( ,def5se1 %all develop a confid5tial li/ ( drugs su* ,secret>y det]m9es to be critical to ! public heal? or national security4 ,su* li/ %all include ! "n ( ea* su* drug1 z well z all active ph>maceutical +r$i5ts & />t+ mat]ials requir$ = ! manufacture ( ! drug4 ,9 develop+ ! li/1 ! ,secret>y may consid] ! role ( %ortages 9 imp$+ access to drugs4 7b7 ,updates ,! ,secret>y %all update ! li/ describ$ 9 subsection 7a7 n less frequ5tly ?an once e #b ye>s4 7c7 ,submission ( li/ ,! ,secret>y %all submit ! li/ describ$ 9 subsection 7a71 includ+ any updates to su* li/ "u subsection 7b71 z a classifi$ matt]1 to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions1 ! ,committee on ,arm$ ,s]vices1 ! ,committee on ,=eign ,relations1 & ! ,committee on ,bank+1 ,h\s+1 & ,urban ,affairs ( ! ,s5ate1 & to ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,arm$ ,s]vices1 ! ,committee on ,=eign ,affairs1 & ! ,committee on ,f9ancial ,s]vices ( ! ,h\se ( ,repres5tatives4 7d7 ,int]im li/ ,dur+ ! p]iod betwe5 ! date ( enactm5t ( ?is ,act & ! date on :i* ! ,secret>y issues ! fir/ li/ "u subsection 7a71 ! ,secret>y1 9 consultation ) ! ,commission] ( ,food & ,drugs1 ! ,secret>y ( ,def5se1 & ! ,assi/ant ,secret>y = ,prep>$ness & ,response1 %all e/abli% an int]im li/ ( drugs t w be deem$ ! li/ "u subsection 7a7 until ! ,secret>y develops ! fir/ li/ "u subsection 7a74 ,su* int]im li/ %all include n few] ?an #cj drugs1 z well z ! active ph>maceutical +r$i5ts & />t+ mat]ials requir$ = ! manufacture ( su* drugs1 t are-- 7#a7 includ$ on ! mo/ rec5t li/ ( ess5tial m$ic9es issu$ by ! ,_w ,heal? ,organization2 or 7#b7 c\nt]measures & products t c\ld repl5i% ! /rategic national /ockpile4 7e7 ,comm5t p]iod ,n lat] ?an #fj days prior to ! submission ( ! li/ describ$ 9 subsection 7a71 ! ,secret>y %all e/abli% a comm5t p]iod dur+ :i* ! public may comm5t on :i* drugs %\ld be includ$ on ! li/ "u subsection 7a74 #c4 ,boo/+ dome/ic drug & active +r$i5t manufactur+ capacity 7a7 ,9 g5]al ,! ,secret>y1 act+ ?r\gh ! ,director ( ! ,biom$ical ,advanc$ ,rese>* & ,developm5t ,au?ority1 %all increase ! dome/ic capacity to manufacture active ph>maceutical +r$i5ts & />t+ mat]ials = drugs critical to ! public heal? & national security by ent]+ into ! contracts describ$ 9 subsection 7b74 7b7 ,contracts 7#a7 ,9 g5]al ,to c>ry out subsection 7a71 ! ,secret>y %all ent] into contracts1 n lat] ?an #f mon?s aft] ! date ( enactm5t ( ?is ,act1 z foll[s3 7,a7 ,! ,secret>y %all ent] into contracts ) companies & nonpr(it entities headqu>t]$ 9 ! ,unit$ ,/ates1 "u :i* su* companies use manufactur+ e/abli%m5ts locat$ 9 ! ,unit$ ,/ates to manufacture ! drugs includ$ on ! li/ "u section #b1 & ! requisite active ph>maceutical +r$i5ts & />t+ mat]ials ( su* drugs1 us+ advanc$ manufactur+1 includ+ cont9u\s manufactur+ :]e applicable4 7,b7 ,z a condition = ent]+ into contracts ) ! ,secret>y to manufacture drugs1 companies & nonpr(it entities %all-- 7i7 develop & ma9ta9 a r$undancy risk managem5t & cont9uity ( bus9ess plan 7review$ & approv$ by ! ,secret>y7 t id5tifies & evaluates risks to ! supply ( ! drug1 z applicable1 = ea* e/abli%m5t 9 :i* su* drug1 & ! requisite active ph>maceutical +r$i5ts & />t+ mat]ials ( su* drug1 is manufactur$2 7ii7 commit to implem5t+1 z appropriate1 risk managem5t & o!r /rategies to ensure t1 9 ! case ( pot5tial supply *a9 disruptions1 ! entity c cont9ue normal production ( ! drug1 & ! requisite active ph>maceutical +r$i5ts & />t+ mat]ials ( su* drug1 = #ah mon?s2 7iii7 commit to ma9ta9+1 to ! ext5t practicable 7z det]m9$ by ! ,secret>y7 = ea* drug1 & ! requisite active ph>maceutical +r$i5ts & />t+ mat]ials ( su* drug1 a #c-mon? supply 9 ord] to mitigate ! impact ( supply *a9 disruptions & %ortages2 7iv7 commit to sell+ drugs1 or ! requisite active ph>maceutical +r$i5ts & />t+ mat]ials ( su* drugs1 develop$ "u contract ) ! ,secret>y at fair & reasonable prices1 z det]m9$ by ! ,secret>y1 tak+ into consid]ation-- 7,i7 ! impact ( price on pati5t access to ! drug2 7,,ii7 ! co/ ( ! drug to ,f$]al or ,/ate heal? programs2 7,,iii7 ! co/ ( manufactur+ ! drug2 & 7,,iv7 ! impact ( price on m>ket competition = ! drug2 & 7v7 commit to mak+ ! prices describ$ 9 clause 7iv7 public4 7,c7 ,! contracts describ$ 9 ?is p>agraph %all conta9 cont9uity ( bus9ess agreem5ts demon/rat+1 9 advance ( receiv+ a contract1 ! company's ability to rapidly beg9 production4 7,d7 ,! ,secret>y %all ent] into contracts only ) companies headqu>t]$ 9 ! ,unit$ ,/ates t use manufactur+ e/abli%m5ts locat$ 9 ! ,unit$ ,/ates1 "u :i* su* companies exp& ! capabilities ( cont9u\s manufactur+ & o!r advanc$ manufactur+ = ! production ( ! active ph>maceutical +r$i5ts & />t+ mat]ials = ! drugs includ$ on ! li/ "u section #b4 7,e7 ,9 issu+ contracts "u ?is section1 ! ,secret>y %all prioritize-- 7i7 contracts design$ to enhance ! supply ( g5]ic drugs & biosimil> biological products & ! requisite active ph>maceutical +r$i5ts & />t+ mat]ials ( su* g5]ic drugs & biosimil> products2 & 7ii7 contracts design$ to enhance ! supply ( drugs1 & ! requisite active ph>maceutical +r$i5ts & />t+ mat]ials ( su* drugs1 t are n curr5tly manufactur$ 9 ! ,unit$ ,/ates4 7#b7 ,inspector ,g5]al review ,! ,inspector ,g5]al ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices %all conduct a review ( n few] ?an #a ( e #c contracts ent]$ into "u ?is section1 & ( ! entities ent]+ into su* contracts1 to ensure t contracts are be+ issu$ "u fair & reasonable t]ms & conditions1 includ+ facilitat+ ! procurem5t by ! ,f$]al ,gov]nm5t ( applicable products "u section #b & applicable drugs1 biological products1 & m$ical devices at fair & reasonable prices4 ,! ,inspector ,g5]al %all make ea* su* review public &1 9 cases :]e su* a review id5tifies unreasonable prices1 submit recomm5dations to ,congress on h[ ! ,(fice %\ld improve its contract+ sy/ems to ensure reasonable pric+4 7#c7 ,fund+ ,to c>ry out ?is section1 !re are au?oriz$ to be appropriat$ #e1jjj1jjj1jjj = ! p]iod ( fiscal ye>s #bjbj & #bjbd4 ,n lat] ?an ,april #a1 #bjbd1 ! ,secret>y %all report to ! congressional committees li/$ "u section #b7;c7 ( ?is ,act1 & provide a recomm5dation = r5ewal ( fund+ "u ?is p>agraph4 7c7 ,f$]al procurem5t ( dome/ically manufactur$ drugs 7#a7 ,procurem5t ( drugs 7,a7 ,9 g5]al ,beg9n+ 9 fiscal ye> #bjbd1 :5 pur*as+ any drug includ$ on ! li/ "u section #b1 ! ,secret>y ( ,def5se1 ! ,secret>y ( ,vet]ans ,affairs1 ! ,director ( ! ,bureau ( ,prisons1 &1 = purposes ( ma9ta9+ ! /rategic national /ockpile1 ! ,secret>y ( ,heal? & ,human ,s]vices1 %all give priority to supplies ( ! drug manufactur$ 9 ! ,unit$ ,/ates 7includ+ all active ph>maceutical +r$i5t & />t+ mat]ials ( ! drug7 t is ( high quality4 7,b7 ,use ( rema9+ funds ,9 ! case t a ,f$]al ag5cy describ$ 9 ?is p>agraph t1 aft] pur*as+ all drugs on ! li/ "u section #b ne$$ by su* ag5cy = a fiscal ye>1 has funds appropriat$ "u p>agraph 7#b7 = t fiscal ye> rema9+1 su* ,f$]al ag5cy may use ! rema9+ funds to pur*ase drugs :olly manufactur$ 9 ! ,unit$ ,/ates t are n includ$ on ! li/ "u section #b4 7#b7 ,fund+ 7,a7 ,9 g5]al ,!re are au?oriz$ to be appropriat$ to ea* ( ! ,secret>y ( ,def5se1 ! ,secret>y ( ,vet]ans ,affairs1 ! ,bureau ( ,prisons1 & ! ,secret>y ( ,heal? & ,human ,s]vices1 #a1jjj1jjj1jjj = ! p]iod ( fiscal ye>s #bjbd & #bjbh1 to be us$ to pur*ase drugs manufactur$ 9 ! ,unit$ ,/ates1 z describ$ 9 p>agraph 7#a74 7,b7 ,rev]sion ,all funds t are appropriat$ "u ?is p>agraph = a fiscal ye>1 b n exp5d$ by ! end ( ! fiscal ye>1 %all rev]t to ! ,g5]al ,fund ( ! ,treasury4 7,c7 ,no div]sion or transf] ( funds ,no fund+ appropriat$ "u ?is section %all be div]t$1 transf]r$1 or o!rwise made available = purposes beyond :at is describ$ 9 ?is ,act4 7#c7 ,,nih au?orization ,!re are au?oriz$ to be appropriat$ to ! ,director ( ! ,national ,in/itutes ( ,heal?1 = ea* fiscal ye> = :i* am\nts are appropriat$ "u p>agraph 7#b7 b n exp5d$ 9 full1 an am\nt equal to ! am\nt t rev]ts to ! ,treasury = su* ye>1 z describ$ 9 p>agraph 7#b74 ,su* am\nts %all be us$ by ! ,director ( ! ,national ,in/itutes ( ,heal? to c>ry out biom$ical rese>*4 #d4 ,supply *a9 transp>5cy 7a7 ,dome/ic suppli]s to ,f$]al programs ,ea* dome/ic manufactur] ( a drug t supplies su* drug to ! ,dep>tm5t ( ,def5se1 ! ,dep>tm5t ( ,vet]ans ,affairs1 ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 or ! ,bureau ( ,prisons1 or a dome/ic manufactur] ( an active +r$i5t ( a drug s suppli$1 %all-- 7#a7 report annually to ! ,secret>y & ! ag5cy receiv+ su* drug on-- 7,a7 :e!r any +r$i5ts ( su* drug is s\rc$1 ei!r :olly or 9 "p1 f a =eign c\ntry2 7,b7 9 ! case ( an active ph>maceutical +r$i5t or key />t+ mat]ial t ! manufactur] procures f a s+le s\rce 9 a s+le =eign c\ntry1 z applicable-- 7i7 n less ?an #b alt]native s\rces ( any active ph>maceutical +r$i5t or key />t+ mat]ial2 7ii7 #a su* alt]native s\rce1 if only #a su* alt]native s\rce is available2 or 7iii7 a /atem5t t no su* alt]native s\rces are available2 & 7,c7 an assessm5t ( ! resili5ce & capacity ( ! alt]nate s\rces id5tifi$ "u subp>agraph 7,b72 & 7#b7 develop cont9uity ( bus9ess plans to prev5t ! disruption ( any drug li/$ "u section #b1 includ+ any active or inactive +r$i5ts ( su* drug1 :i* ! ,secret>y may audit4 7b7 ,=eign drug suppli]s 7#a7 ,e/abli%m5ts 9 a =eign c\ntry ,section #eaj7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;i77 is am5d$ by ins]t+ at ! end ! foll[+3 7#e7 ,! requirem5ts ( p>agraphs 7#a7 & 7#b7 %all apply to e/abli%m5ts )9 a =eign c\ntry engag$ 9 ! manufacture1 prep>ation1 propagation1 comp\nd+1 or process+ ( any drug t is requir$ to be li/$ pursuant to subsection 7j71 or ( any active ph>maceutical +r$i5t ( su* a drug4 ,su* requirem5ts %all apply reg>dless ( :e!r ! drug or active ph>maceutical +r$i5t und]goes fur!r manufacture1 prep>ation1 propagation1 comp\nd+1 or process+ at a sep>ate e/abli%m5t or e/abli%m5ts outside ! ,unit$ ,/ates prior to be+ import$ or (f]$ = import into ! ,unit$ ,/ates4 4 7#b7 ,li/+ ( drugs ,section #eaj7;j77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77#a77 is am5d$-- 7,a7 9 subp>agraph 7,d71 by /rik+ & at ! end2 7,b7 9 subp>agraph 7,e71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7,c7 by add+ at ! end ! foll[+ new subp>agraph3 7,f7 9 ! case ( a drug conta9$ 9 ! applicable li/1 a c]tification t ! regi/rant has-- 7i7 id5tifi$ e o!r e/abli%m5t :]e manufactur+ is p]=m$ = ! drug by ! regi/rant2 & 7ii7 notifi$ ea* kn[n =eign e/abli%m5t engag$ 9 ! manufacture1 prep>ation1 propagation1 comp\nd+1 or process+ ( ! drug or ! active ph>maceutical +r$i5t ( ! drug ( ! inclusion ( ! drug 9 ! li/ & ! obligation to regi/] pursuant to subsection 7i77#e74 4 7c7 ,reports to ,congress & ! public 7#a7 ,classifi$ report to ,congress ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act & annually !reaft]1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ,def5se1 %all submit a classifi$ report to ,congress on ! ,nation's reliance on importation ( active & inactive +r$i5ts ( drugs includ$ on ! li/ "u section #b4 7#b7 ,public reports ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act & annually !reaft]1 ! ,secret>y1 9 consultation ) ! ,secret>y ( ,def5se1 %all prep>e an unclassifi$ summ>y ( ! report describ$ 9 p>agraph 7#a71 & %all make su* summ>y publicly available on ! int]net websites ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices & ! ,dep>tm5t ( ,def5se = purposes ( und]/&+ ! ,nation's dep5d5cy on =eign manufactur]s ( drugs4 ,su* summ>ies %all n include ! names ( any drugs1 active ph>maceutical +r$i5ts1 or />t+ mat]ials4 7#c7 ,cont5t ,! reports "u p>agraph 7#a7 %all include-- 7,a7 all br& "n & g5]ic drugs1 & ! active & inactive +r$i5ts ( su* drugs t-- 7i7 are n :olly produc$ 9 ! ,unit$ ,/ates2 7ii7 are exclusively produc$1 or utilize active or inactive +r$i5ts produc$ abroad2 7iii7 are critical to ! public heal? & national security ( ! p ( ! ,unit$ ,/ates1 z det]m9$ by ! ,secret>y1 9 consultation ) ! ,secret>y ( ,def5se1 & includ+ any drugs includ$ 9 ! li/ "u section #b2 or 7iv7 are procur$ 9 any quantity by ! ,dep>tm5t ( ,def5se = use by s]vice memb]s or vet]ans or by ! ,dep>tm5t ( ,heal? & ,human ,s]vices = ! /rategic national /ockpile2 7,b7 a li/ ( pot5tial1 alt]native s\rces = any f9i%$ drug or active or inactive +r$i5t ( a drug1 t is s\rc$ f a s+le manufactur] ) e/abli%m5ts 9 ! ,unit$ ,/ates2 & 7,c7 assess ! resili5cy & capacity ( alt]native s\rces ( any drug describ$ 9 subp>agraph 7,a71 & :e!r any su* alt]native s\rce c\ld be reli$ on to support dome/ic dem& = su* drug4 7d7 ,manufactur] compliance 7#a7 ,failure to notify ( a p]man5t discont9uance or an int]ruption ,section #cja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at ! end ! foll[+3 7fff7 ,! failure ( a manufactur] ( a drug describ$ 9 section #ejf;,c7a71 or an active ph>maceutical +r$i5t ( su* a drug1 to notify ! ,secret>y ( a p]man5t discont9uance or an int]ruption1 & ! reasons = su* discont9uance or int]ruption1 z requir$ by section #ejf;,c4 4 7#b7 ,exemption f p5alty ,section #cjc7;c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;c77 is am5d$ by ins]t+ be=e ! p]iod at ! end ! foll[+3 or 7#f7 = hav+ violat$ section #cja7;fff7 if su* p]son made a good fai? det]m9ation t ! discont9uance or int]ruption 0 n likely to lead to a mean+ful disruption 9 ! supply ( t drug 9 ! ,unit$ ,/ates4 7e7 ,regi/ry ( active +r$i5ts ,!re is au?oriz$ to be appropriat$ to ! ,secret>y ( ,heal? & ,human ,s]vices #bj1jjj1jjj = fiscal ye> #bjba1 = purposes ( e/abli%+1 9 consultation ) ! ,commission] ( ,food & ,drugs1 an onl9e regi/ry ( active ph>maceutical +r$i5ts & key />t+ mat]ials us+ in=mation report$ "u subsection 7a7 & pursuant to a regi/ration "u section #eaj7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;i774 7f7 ,food & ,drug ,adm9i/ration inspections ,!re are au?oriz$ to be appropriat$ su* funds z may be necess>y to ensure t ! ,commission] ( ,food & ,drugs is able to conduct inspections & evaluations ( new e/abli%m5ts e/abli%$ us+ funds made available "u ?is ,act4 #e4 ,ov]sight ( =eign ph>maceutical inve/m5t 7a7 ,9 g5]al ,n lat] ?an #a ye> aft] ! date ( ! enactm5t ( ?is ,act1 & annually !reaft]1 ! ,f$]al ,trade ,commission1 9 consultation ) ! ,secret>y ( ! ,treasury act+ ?r\gh ! ,committee on ,=eign ,inve/m5t 9 ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! ,committee71 %all submit to ! appropriate congressional committees1 ! ,secret>y ( ,heal? & ,human ,s]vices1 & ! ,commission] ( ,food & ,drugs1 a report on =eign inve/m5t 9 ! ph>maceutical indu/ry ( ! ,unit$ ,/ates4 7b7 ,elem5ts ,! report requir$ by subsection 7a7 %all include ! foll[+3 7#a7 ,an assessm5t (-- 7,a7 ! supply *a9 ( ! ph>maceutical indu/ry ( ! ,unit$ ,/ates & ! effect ( conc5tration & reliance on =eign manufactur+ )9 t indu/ry2 7,b7 ! effect ( =eign inve/m5t 9 ! ph>maceutical indu/ry ( ! ,unit$ ,/ates on dome/ic capacity to produce drugs & active & inactive +r$i5ts ( drugs2 & 7,c7 ! effect ( =eign inve/m5t 9 te*nologies or o!r products = sequ5c+ or /orage ( ,,dna1 includ+ g5ome & exome analysis1 9 ! ,unit$ ,/ates1 includ+ ! effect ( su* inve/m5t on ! capacity to sequ5ce or /ore ,,dna 9 ! ,unit$ ,/ates4 7#b7 ,! numb] ( reviews & inve/igations conduct$ by ! ,committee1 9 ea* ( ! #aj fiscal ye>s prec$+ ! ye> 9 :i* ! /udy is conduct$1 ) respect to cov]$ transactions 7z def9$ 9 section #gba7;a7 ( ! ,def5se ,production ,act ( #aiej 7#ej ,u4,s4,c4 #defe7;a777-- 7,a7 9 ! ph>maceutical indu/ry ( ! ,unit$ ,/ates2 or 7,b7 relat+ to ! sequ5c+ or /orage ( ,,dna 9 ! ,unit$ ,/ates4 7#c7 ,a %ort description ( ea* su* review or inve/igation1 includ+ :e!r ! transaction 0 approv$ or prohibit$4 7c7 ,au?ority ,! ,f$]al ,trade ,commission %all h au?ority "u section #f ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #df7 to conduct ! /udies requir$ to prep>e ! report requir$ by subsection 7a74 7d7 ,publication ,! ,f$]al ,trade ,commission %all publi% an unclassifi$ summ>y ( ! report requir$ by subsection 7a7 on a publicly available int]net website ( ! ,commission4 7e7 ,appropriate congressional committees def9$ ,9 ?is section1 ! t]m appropriate congressional committees means-- 7#a7 ! ,committee on ,bank+1 ,h\s+1 & ,urban ,affairs1 ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions1 ! ,committee on ,arm$ ,s]vices1 ! ,committee on ,=eign ,relations1 ! ,committee on ,comm]ce1 ,sci5ce1 & ,transportation1 & ! ,committee on ,appropriations ( ! ,s5ate2 & 7#b7 ! ,committee on ,f9ancial ,s]vices1 ! ,committee on ,en]gy & ,comm]ce1 ! ,committee on ,arm$ ,s]vices1 ! ,committee on ,=eign ,affairs1 & ! ,committee on ,appropriations ( ! ,h\se ( ,repres5tatives4 #f4 ,def9itions ,9 ?is ,act-- 7#a7 advanc$ manufactur+ means an approa* = ! manufactur+ ( ph>maceuticals t incorporates novel te*nology1 or uses an e/abli%$ te*nique or te*nology 9 a new or innovative way 7su* z cont9u\s manufactur+ :]e ! input mat]ials are cont9u\sly trans=m$ )9 ! process by #b or m unit op]ations71 t enhances drug quality or improves ! manufactur+ process2 7#b7 ! t]m cont9u\s manufactur+-- 7,a7 means a process :]e ! input mat]ials are cont9u\sly f$ into & trans=m$ )9 ! process1 & ! process$ output mat]ials are cont9u\sly remov$ f ! sy/em2 & 7,b7 consi/s ( an integrat$ process t consi/s ( a s]ies ( #b or m unit op]ations2 7#c7 ! t]m drug has ! mean+ giv5 su* t]m 9 section #bja7;g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g772 7#d7 ! t]m ,secret>y1 unless o!rwise specifi$1 means ! ,secret>y ( ,heal? & ,human ,s]vices2 7#e7 ! t]m />t+ mat]ial means a raw mat]ial1 int]m$iate1 or a drug sub/ance t is us$ 9 ! production ( a drug sub/ance & t is incorporat$ z a significant /ructural fragm5t into ! /ructure ( ! drug sub/ance2 & 7#f7 ! t]m /rategic national /ockpile means ! /ockpile ma9ta9$ by ! ,secret>y "u section #cai;,f-#b ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bdg;d-#f;b74