,i #aac? ,,congress #b;d ,session ,h4 ,r4 #ehgd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #aa1 #bjad ,mr4 ,israel introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to increase crim9al p5alties = ! sale or trade ( prescription drugs kn[+ly caus$ to be adult]at$ or misbr&$1 to e/abli% recall au?ority reg>d+ drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ,tim ,fagan's ,law or ! ,c\nt]feit ,drug ,en=cem5t ,act ( #bjad4 #b4 ,sale or trade ( prescription drugs kn[+ly caus$ to be adult]at$ or misbr&$2 misrepres5tation z approv$ drugs 7a7 ,crim9al p5alty ,section #cjc7;a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;a77 is am5d$ by add+ at ! end ! foll[+ p>agraphs3 7#c7 ,not)/&+ p>agraph 7#a7 or 7#b71 9 ! case ( a p]son :o violates subsection 7a71 7b71 or 7c7 ( section #cja ) respect to a drug t is subject to section #ejc7;b77#a77;,b71 if ! p]son kn[+ly caus$ ! drug to be adult]at$ or misbr&$ & sells or trades ! drug1 or ! p]son pur*ases or trades = ! drug kn[+ or hav+ reason to "k t ! drug 0 kn[+ly caus$ to be adult]at$ or misbr&$1 ! p]son %all be f9$ 9 accordance ) title #ah1 ,unit$ ,/ates ,code1 or imprison$ = any t]m ( ye>s or = life1 or bo?4 7#d7 ,not)/&+ p>agraph 7#a7 or 7#b71 9 ! case ( a p]son :o violates section #cja7;d7 ) respect to a drug1 if ! p]son caus$ ! drug to be misrepres5t$ z a drug t is subject to section #ejc7;b77#a77;,b7 & = :i* an approv$ application is 9 effect "u section #eje & ! p]son sells or trades ! drug1 or ! p]son pur*ases or trades = ! drug kn[+ or hav+ reason to "k t ! drug 0 kn[+ly caus$ to be s misrepres5t$1 ! p]son %all be f9$ 9 accordance ) title #ah1 ,unit$ ,/ates ,code1 or imprison$ = any t]m ( ye>s or = life1 or bo?4 4 7b7 ,notification ( ,food & ,drug ,adm9i/ration by manufactur]s ,section #eje7k7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7k77 is am5d$ by add+ at ! end ! foll[+ p>agraph3 7#f7 ,a manufactur] ( a drug t receives or o!rwise becomes aw>e ( in=mation t reasonably sugge/s t a violation describ$ 9 p>agraph 7#c7 or 7#d7 ( section #cjc7;a7 may h occurr$ ) respect to ! drug %all report su* in=mation to ! ,secret>y n lat] ?an #dh h\rs aft] fir/ receiv+ or o!rwise becom+ aw>e ( ! in=mation4 4 #c4 ,use ( te*nologies = prev5t+ c\nt]feit+ ( drugs ,section #ejb ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at ! end ! foll[+3 7dd7 ,if x is a drug & x is n manufactur$ 9 accordance ) any regulations ( ! ,secret>y requir+ ! use ( te*nologies t ! ,secret>y has det]m9$ are te*nically feasible & w assi/ 9 prev5t+ violations ( ?is ,act to :i* p>agraphs 7#c7 & 7#d7 ( section #cjc7;a7 apply 7relat+ to ! kn[+ adult]ation or misbr&+ ( drugs & ! kn[+ misrepres5tation ( drugs74 4 #d4 ,c\nt]feit drugs2 increas$ fund+ = inspections1 exam9ations1 & inve/igations ,= ! purpose ( increas+ ! capacity ( ! ,food & ,drug ,adm9i/ration to conduct inspections1 exam9ations1 & inve/igations "u ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to violations describ$ 9 p>agraphs 7#c7 & 7#d7 ( section #cjc7;a7 ( su* ,act1 !re is au?oriz$ to be appropriat$ #fj1jjj1jjj = ea* ( ! fiscal ye>s #bjae ?r\gh #bjah1 9 addition to o!r au?orizations ( appropriations t are available = su* purpose4 #e4 ,public education reg>d+ c\nt]feit drugs 7a7 ,9 g5]al ,! ,secret>y ( ,heal? & ,human ,s]vices %all c>ry out a program to educate ! public & heal? c>e pr(essionals on c\nt]feit drugs1 includ+ te*niques to id5tify drugs z c\nt]feit4 7b7 ,au?orization ( appropriations ,= ! purpose ( c>ry+ out subsection 7a71 !re is au?oriz$ to be appropriat$ #e1jjj1jjj = ea* ( ! fiscal ye>s #bjae ?r\gh #bjah1 9 addition to o!r au?orizations ( appropriations t are available = su* purpose4 #f4 ,recall au?ority reg>d+ drugs ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by ins]t+ aft] section #ejf;,f ! foll[+ section3 #ejf;,g4 ,recall au?ority 7a7 ,ord] ,to cease di/ribution ( drug2 notification ( heal? pr(essionals 7#a7 ,9 g5]al ,if ! ,secret>y f9ds t a drug int5d$ = human use may con/itute a ?reat to ! public heal?1 ! ,secret>y %all issue an ord] requir+ ! appropriate p]son 7includ+ ! manufactur]s1 import]s1 di/ributors1 or retail]s ( ! drug7-- 7,a7 to imm$iately cease di/ribution ( ! drug2 & 7,b7 to imm$iately notify heal? pr(essionals ( ! ord] & to in/ruct su* pr(essionals to cease adm9i/]+1 di/ribut+1 sell+1 or prescrib+ ! drug4 7#b7 ,in=mal he>+ ,an ord] "u p>agraph 7#a7 %all provide ! p]son subject to ! ord] ) an opportunity = an in=mal he>+1 to be held n lat] ?an #aj days aft] ! date ( ! issuance ( ! ord]1 on ! actions requir$ by ! ord] & on :e!r ! ord] %\ld be am5d$ to require a recall ( ! drug involv$4 ,if1 aft] provid+ an opportunity = su* a he>+1 ! ,secret>y det]m9es t inadequate gr\nds exi/ to support ! actions requir$ by ! ord]1 ! ,secret>y %all vacate ! ord]4 7b7 ,ord] ,to recall drug 7#a7 ,9 g5]al ,if1 aft] provid+ an opportunity = an in=mal he>+ "u subsection 7a77#b71 ! ,secret>y det]m9es t ! ord] %\ld be am5d$ to include a recall ( ! drug ) respect to :i* ! ord] 0 issu$1 ! ,secret>y %all1 except z provid$ 9 p>agraphs 7#b7 & 7#c71 am5d ! ord] to require a recall4 ,! ,secret>y %all specify a timetable 9 :i* ! drug recall w occur & %all require p]iodic reports to ! ,secret>y describ+ ! progress ( ! recall4 7#b7 ,c]ta9 actions ,an am5d$ ord] "u p>agraph 7#a7-- 7,a7 %all n require recall ( a drug f individuals2 & 7,b7 %all provide = notice to individuals subject to ! risks associat$ ) ! use ( ! drug4 7#c7 ,assi/ance ( heal? pr(essionals ,9 provid+ ! notice requir$ by p>agraph 7#b77;,b71 ! ,secret>y may use ! assi/ance ( heal? pr(essionals :o adm9i/]$ ! drug involv$ to individuals or prescrib$ ! drug = individuals4 ,if a significant numb] ( su* individuals _c be id5tifi$1 ! ,secret>y %all notify su* individuals pursuant to section #gje7;b74 4 #g4 ,au?ority to issue subpo5as ) respect to prev5t+ ?reats to ! public heal? ,section #cjc ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;a77 is am5d$ by add+ at ! end ! foll[+ subsection3 7h7 ,! ,secret>y & ! ,attorney ,g5]al %all develop & implem5t a proc$ure ?r\gh :i* ! ,*ief ,c\nsel 9 ! ,food & ,drug ,adm9i/ration is au?oriz$ to issue subpo5as reg>d+ inve/igations "u ?is ,act ( acts or omissions t may con/itute a ?reat to ! public heal?1 includ+ inve/igations ( alleg$ violations to :i* p>agraph 7#c7 or 7#d7 ( subsection 7a7 apply & alleg$ violations ) respect to :i* ! ,secret>y is consid]+ ! use ( au?orities "u section #cjd4 4