,,ii  ,cal5d> ,no4 #bb  #aaf? ,,congress
  #a/ ,session  ,s4 #cdj  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates         
,febru>y #e1 #bjai ,mr4 ,leahy 7=       
himself1 ,mr4 ,grassley1 ,ms4 ,klobu*>1 
,mr4 ,lee1 ,mrs4 ,fe9/e91 ,ms4 ,baldw91 
,mr4 ,blum5?al1 ,mr4 ,book]1 ,mr4 ,br[n1
 ,ms4 ,coll9s1 ,mr4 ,cotton1 ,mr4 ,cruz1
 ,mr4 ,da9es1 ,mr4 ,durb91 ,ms4 ,ern/1  
,mrs4 ,fis*]1 ,ms4 ,hassan1 ,mr4 ,k5n$y1
 ,mr4 ,k+1 ,mr4 ,m55dez1 ,ms4 ,murk[ski1
 ,mr4 ,paul1 ,mr4 ,r\nds1 ,ms4 ,smi?1   
,ms4 ,/ab5[1 ,mr4 ,te/]1 ,mr4 ,:iteh\se1
 & ,mr4 ,"y7 introduc$ ! foll[+ bill2   
:i* 0 read ! fir/ "t  ,febru>y #f1 #bjai
 ,read ! second "t & plac$ on ! cal5d>  
,a ,,bill  ,to promote competition 9 !  
m>ket = drugs & biological products by  
facilitat+ ! timely entry ( l[]-co/     
g5]ic & biosimil> v]sions ( ^? drugs &  
biological products4  #a4 ,%ort title   
,?is ,act may be cit$ z ! ,creat+ &     
,re/or+ ,equal ,access to ,equival5t    
,samples ,act ( #bjai or ! ,,creates    
,act ( #bjai4  #b4 ,f9d+s ,congress f9ds

 ! foll[+3  7#a7 ,x is ! policy ( !     
,unit$ ,/ates to promote competition 9 !
 m>ket = drugs & biological products by 
facilitat+ ! timely entry ( l[-co/ g5]ic
 & biosimil> v]sions ( ^? drugs &       
biological products4  7#b7 ,s9ce _!     
enactm5t 9 #aihd & #bjaj1 respectively1 
! ,drug ,price ,competition & ,pat5t    
,t]m ,re/oration ,act ( #aihd 7,public  
,law #ih-dag2 #ih ,/at4 #aehe7 & !      
,biologics ,price ,competition &        
,innovation ,act ( #bjji 7subtitle ,a ( 
title ,,vii ( ,public ,law #aaa-adh2    
#abd ,/at4 #hjd71 h provid$ pa?ways =   
mak+ l[]-co/ v]sions ( previ\sly approv$
 drugs & previ\sly lic5s$ biological    
products available to ! p ( ! ,unit$    
,/ates 9 a timely mann]1 !reby l[]+     
ov]all prescription drug co/s = pati5ts 
& taxpay]s by billions ( doll>s ea* ye>4
  7#c7 ,9 ord] = ^! pa?ways to function 
z int5d$1 develop]s ( g5]ic drugs &     
biosimil> biological products 7ref]r$ to
 9 ?is section z g5]ic product          
develop]s7 mu/ be able to obta9         

quantities ( ! ref]5ce li/$ drug or     
biological product ) :i* ! g5]ic drug or
 biosimil> biological product is int5d$ 
to compete 7ref]r$ to 9 ?is section z a 
cov]$ product7 = purposes ( support+ an 
application = approval by ! ,food &     
,drug ,adm9i/ration1 includ+ = te/+ to  
%[ t-- 7,a7 a prospective g5]ic drug is 
bioequival5t to ! cov]$ product 9       
accordance ) subsection 7j7 ( section   
#eje ( ! ,f$]al1 ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or 
meets ! requirem5ts = approval ( an     
application submitt$ "u subsection      
7b77#b7 ( t section2 or  7,b7 a         
prospective biosimil> biological product
 is biosimil> to or int]*angeable ) its 
ref]5ce biological product "u section   
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k771 z applicable4  
7#d7 ,= drugs & biological products t   
are subject to a risk evaluation &      
mitigation /rategy1 ano!r ess5tial      
compon5t 9 ! creation ( l[-co/ g5]ic &  
biosimil> v]sions ( cov]$ products is ! 

ability ( g5]ic product develop]s to jo9
 ! manufactur] ( ! cov]$ product 7ref]r$
 to 9 ?is section z ! lic5se hold]7 9 a 
s+le1 %>$ sy/em ( elem5ts to assure safe
 use & support+ agreem5ts z requir$ by  
section #eje-a ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71
 or secure a v>iance !refrom4  7#e7     
,contr>y to ! policy ( ! ,unit$ ,/ates  
to promote competition 9 ! m>ket = drugs
 & biological products by facilitat+ !  
timely entry ( l[]-co/ g5]ic & biosimil>
 v]sions ( ^? drugs & biological        
products1 c]ta9 lic5se hold]s are       
prev5t+ g5]ic product develop]s f obta9+
 quantities ( ! cov]$ product necess>y =
 ! g5]ic product develop] to support an 
application = approval by ! ,food &     
,drug ,adm9i/ration1 includ+ te/+ to %[ 
bioequival5ce1 biosimil>ity1 or         
int]*angeability to ! cov]$ product1 9  
"s in/ances bas$ on ! ju/ification t !  
cov]$ product is subject to a risk      
evaluation & mitigation /rategy )       
elem5ts to assure safe use "u section   

#eje-a ( ! ,f$]al ,food1 ,drug1 &       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a74  
7#f7 ,! ,director ( ! ,c5t] = ,drug     
,evaluation & ,rese>* ( ! ,food & ,drug 
,adm9i/ration has te/ifi$ t "s          
manufactur]s ( cov]$ products h us$ risk
 evaluation & mitigation /rategies &    
di/ribution re/rictions adopt$ by !     
manufactur] on _! own behalf z reasons  
to n sell quantities ( a cov]$ product  
to g5]ic product develop]s1 caus+ b>ri]s
 & delays 9 gett+ g5]ic products on !   
m>ket4 ,! ,food & ,drug ,adm9i/ration   
has report$ receiv+ significant numb]s (
 inquiries f g5]ic product develop]s :o 
7 unable to obta9 samples ( cov]$       
products to conduct necess>y te/+ &     
o!rwise meet requirem5ts = approval (   
g5]ic drugs4  7#g7 ,9 #bjah1 ! ,act+    
,*airman ( ! ,f$]al ,trade ,commission  
te/ifi$ t ! ,f$]al ,trade ,commission   
cont9ues to be v conc]n$ ab\t pot5tial  
abuses by manufactur]s ( br& drugs (    
risk evaluation & mitigation /rategies  
or o!r clos$ di/ribution sy/ems to imp$e

 g5]ic competition4  7#h7 ,also contr>y 
to ! policy ( ! ,unit$ ,/ates to promote
 competition 9 ! m>ket = drugs &        
biological products by facilitat+ !     
timely entry ( l[]-co/ g5]ic & biosimil>
 v]sions ( ^? drugs & biological        
products1 c]ta9 lic5se hold]s are imp$+ 
! prompt negotiation & developm5t on    
comm]cially reasonable t]ms ( a s+le1   
%>$ sy/em ( elem5ts to assure safe use1 
:i* may be necess>y = ! g5]ic product   
develop] to ga9 approval = its drug or  
lic5s+ = its biological product4  7#i7  
,:ile ! antitru/ laws may address !     
refusal by "s lic5se hold]s to provide  
quantities ( a cov]$ product to a g5]ic 
product develop]1 a m tailor$ legal     
pa?way w\ld help ensure t g5]ic product 
develop]s c obta9 necess>y quantities ( 
a cov]$ product 9 a timely way =        
purposes ( develop+ a g5]ic drug or     
biosimil> biological product1 facilitat+
 competition 9 ! m>ketplace = drugs &   
biological products4  7#aj7 ,! antitru/ 
laws may address actions by lic5se      

hold]s :o imp$e ! prompt negotiation &  
developm5t ( a s+le1 %>$ sy/em ( elem5ts
 to assure safe use1 & ! ,food & ,drug  
,adm9i/ration has "s au?ority to waive !
 requirem5t ( a s+le1 %>$ sy/em4 ,cle>] 
regulatory au?ority to approve diff]5t  
sy/ems t meet ! /atutory requirem5ts to 
ensure pati5t safety1 h[ev]1 w\ld limit 
! effectiv5ess ( bad fai? negotiations  
ov] s+le1 %>$ sy/ems to delay g5]ic     
approval4 ,at ! same "t1 cle>]          
regulatory au?ority w\ld ensure all     
sy/ems protect pati5t safety4  #c4      
,actions = delays ( g5]ic drugs &       
biosimil> biological products  7a7      
,def9itions ,9 ?is section-- 7#a7 ! t]m 
comm]cially reasonable1 m>ket-bas$ t]ms 
means--  7,a7 a non-discrim9atory price 
= ! sale ( ! cov]$ product at or bel[1 b
 n great] ?an1 ! mo/ rec5t :olesale     
acquisition co/ = ! drug1 z def9$ 9     
section #ahdg;,a7c77#f77;,b7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciew-#c;a7c77#f77;,b772  7,b7 a s*$ule
 = deliv]y t results 9 ! transf] ( !    

cov]$ product to ! eligible product     
develop] consi/5t ) ! tim+ "u subsection
 7b77#b77;,a77iv72 &  7,c7 no additional
 conditions are impos$ on ! sale ( !    
cov]$ product2  7#b7 ! t]m cov]$        
product--  7,a7 means-- 7i7 any drug    
approv$ "u subsection 7c7 or 7j7 (      
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
biological product lic5s$ "u subsection 
7a7 or 7k7 ( section #cea ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb72  7ii7 any comb9ation ( a drug or 
biological product describ$ 9 clause    
7i72 or  7iii7 :5 reasonably necess>y to
 support approval ( an application "u   
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or 
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb71 z applicable1
 or o!rwise meet ! requirem5ts =        
approval "u ei!r su* section1 any       
product1 includ+ any device1 t is m>ket$
 or int5d$ = use ) su* a drug or        
biological product2 &  7,b7 does n      

include any drug or biological product t
 appe>s on ! drug %ortage li/ 9 effect  
"u section #ejf;,e ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;e71 unless ! %ortage w n be        
promptly resolv$-- 7i7 z demon/rat$ by !
 fact t ! drug or biological product has
 be5 9 %ortage = m ?an #f mon?s2 or     
7ii7 z o!rwise det]m9$ by ! ,secret>y2  
7#c7 ! t]m device has ! mean+ giv5 ! t]m
 9 section #bja ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 
7#d7 ! t]m eligible product develop]    
means a p]son t seeks to develop a      
product = approval pursuant to an       
application = approval "u subsection    
7b77#b7 or 7j7 ( section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7 or = lic5s+ pursuant to 
an application "u section #cea7k7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k772  7#e7 ! t]m lic5se  
hold] means ! hold] ( an application    
approv$ "u subsection 7c7 or 7j7 (      
section #eje ( ! ,f$]al ,food1 ,drug1 & 

,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or !
 hold] ( a lic5se "u subsection 7a7 or  
7k7 ( section #cea ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a   
cov]$ product2  7#f7 ! t]m ,,rems means 
a risk evaluation & mitigation /rategy  
"u section #eje-a ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee-a72  7#g7 ! t]m ,,rems ) ,,etasu   
means a ,,rems t conta9s elem5ts to     
assure safe use "u section #eje-a7;f7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee-a7;f772  7#h7 ! t]m 
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices2  7#i7 ! t]m s+le1 %>$  
sy/em ( elem5ts to assure safe use means
 a s+le1 %>$ sy/em ( elem5ts to assure  
safe use "u section #eje-a7;f7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee-a7;f772 &  7#aj7 !  
t]m suffici5t quantities means an am\nt 
( a cov]$ product t all[s ! eligible    
product develop] to-- 7,a7 conduct te/+ 
to support an application "u--  7i7     
subsection 7b77#b7 or 7j7 ( section #eje

 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee72 or  7ii7     
section #cea7k7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 & 
7,b7 fulfill any regulatory requirem5ts 
relat+ to approval ( su* an application4
  7b7 ,civil action = failure ,to       
provide suffici5t quantities ( a cov]$  
product  7#a7 ,9 g5]al ,an eligible     
product develop] may br+ a civil action 
aga9/ ! lic5se hold] = a cov]$ product  
seek+ relief "u ?is subsection 9 an     
appropriate di/rict c\rt ( ! ,unit$     
,/ates alleg+ t ! lic5se hold] has      
decl9$ to provide suffici5t quantities (
 ! cov]$ product to ! eligible product  
develop] on comm]cially reasonable1     
m>ket-bas$ t]ms4  7#b7 ,elem5ts  7,a7 ,9
 g5]al ,to prevail 9 a civil action     
br\ght "u p>agraph 7#a71 an eligible    
product develop] %all prove1 by a       
prepond]ance ( ! evid5ce-- 7i7 t--  7,i7
 ! cov]$ product is n subject to a      
,,rems ) ,,etasu2 or  7,,ii7 if ! cov]$ 
product is subject to a ,,rems )        

,,etasu--  7aa7 ! eligible product      
develop] has obta9$ a cov]$ product     
au?orization f ! ,secret>y 9 accordance 
) subp>agraph 7,b72 &  7bb7 ! eligible  
product develop] has provid$ a copy ( ! 
cov]$ product au?orization to ! lic5se  
hold]2  7ii7 t1 z ( ! date on :i* !     
civil action is fil$1 ! product develop]
 has n obta9$ suffici5t quantities ( !  
cov]$ product on comm]cially reasonable1
 m>ket-bas$ t]ms2  7iii7 t ! eligible   
product develop] has reque/$ to pur*ase 
suffici5t quantities ( ! cov]$ product f
 ! lic5se hold]2 &  7iv7 t ! lic5se     
hold] has n deliv]$ to ! eligible       
product develop] suffici5t quantities ( 
! cov]$ product on comm]cially          
reasonable1 m>ket-bas$ t]ms-- 7,i7 = a  
cov]$ product t is n subject to a ,,rems
 ) ,,etasu1 by ! date t is #ca days aft]
 ! date on :i* ! lic5se hold] receiv$ ! 
reque/ = ! cov]$ product2 &  7,,ii7 = a 
cov]$ product t is subject to a ,,rems )
 ,,etasu1 by #ca days aft] ! lat] (--   
7aa7 ! date on :i* ! lic5se hold]       

receiv$ ! reque/ = ! cov]$ product2 or  
7bb7 ! date on :i* ! lic5se hold]       
receiv$ a copy ( ! cov]$ product        
au?orization issu$ by ! ,secret>y 9     
accordance ) subp>agraph 7,b74  7,b7    
,au?orization = cov]$ product subject to
 a ,,rems ) ,,etasu  7i7 ,reque/ ,an    
eligible product develop] may submit to 
! ,secret>y a writt5 reque/ = ! eligible
 product develop] to be au?oriz$ to     
obta9 suffici5t quantities ( an         
individual cov]$ product subject to a   
,,rems ) ,,etasu4  7ii7 ,au?orization ,n
 lat] ?an #abj days aft] ! date on :i* a
 reque/ "u clause 7i7 is receiv$1 !     
,secret>y %all1 by writt5 notice1       
au?orize ! eligible product develop] to 
obta9 suffici5t quantities ( an         
individual cov]$ product subject to a   
,,rems ) ,,etasu = purposes (-- 7,i7    
developm5t & te/+ t does n involve human
 cl9ical trials1 if ! eligible product  
develop] has agre$ to comply ) any      
conditions ! ,secret>y det]m9es         
necess>y2 or  7,,ii7 developm5t & te/+ t

 involves human cl9ical trials1 if !    
eligible product develop] has-- 7aa7    
7,,aa7 submitt$ protocols1 in=m$ cons5t 
docum5ts1 & in=mational mat]ials = te/+ 
t include protections t provide safety  
protections comp>able to ^? provid$ by !
 ,,rems = ! cov]$ product2 or 7,,bb7    
o!rwise satisfi$ ! ,secret>y t su*      
protections w be provid$2 &  7bb7 met   
any o!r requirem5ts ! ,secret>y may     
e/abli%4  7iii7 ,notice ,a cov]$ product
 au?orization issu$ "u ?is subp>agraph  
%all /ate t ! provision ( ! cov]$       
product by ! lic5se hold] "u ! t]ms ( ! 
au?orization w n be a violation ( !     
,,rems = ! cov]$ product4  7#c7         
,affirmative def5se ,9 a civil action   
br\ght "u p>agraph 7#a71 x %all be an   
affirmative def5se1 on :i* ! def5dant   
has ! burd5 ( p]suasion by a            
prepond]ance ( ! evid5ce--  7,a7 t1 on !
 date on :i* ! eligible product develop]
 reque/$ to pur*ase suffici5t quantities
 ( ! cov]$ product f ! lic5se hold]--   
7i7 nei!r ! lic5se hold] nor any ( its  

ag5ts1 :olesal]s1 or di/ributors 0      
engag$ 9 ! manufactur+ or comm]cial     
m>ket+ ( ! cov]$ product2 &  7ii7 nei!r 
! lic5se hold] nor any ( its ag5ts1     
:olesal]s1 or di/ributors o!rwise _h    
access to inv5tory ( ! cov]$ product to 
supply to ! eligible product develop] on
 comm]cially reasonable1 m>ket-bas$     
t]ms2 or  7,b7 t--  7i7 ! lic5se hold]  
sells ! cov]$ product ?r\gh ag5ts1      
di/ributors1 or :olesal]s2  7ii7 !      
lic5se hold] has plac$ no re/rictions1  
explicit or implicit1 on its ag5ts1     
di/ributors1 or :olesal]s to sell cov]$ 
products to eligible product develop]s2 
&  7iii7 ! cov]$ product c be pur*as$ by
 ! eligible product develop] 9 suffici5t
 quantities on comm]cially reasonable1  
m>ket-bas$ t]ms f ! ag5ts1 di/ributors1 
or :olesal]s ( ! lic5se hold]4  7#d7    
,rem$ies  7,a7 ,9 g5]al ,if an eligible 
product develop] prevails 9 a civil     
action br\ght "u p>agraph 7#a71 ! c\rt  
%all--  7i7 ord] ! lic5se hold] to      
provide to ! eligible product develop]  

)\t delay suffici5t quantities ( ! cov]$
 product on comm]cially reasonable1     
m>ket-bas$ t]ms2  7ii7 aw>d to !        
eligible product develop] reasonable    
attorney's fees & co/s ( ! civil action2
 &  7iii7 aw>d to ! eligible product    
develop] a monet>y am\nt suffici5t to   
det] ! lic5se hold] f fail+ to provide  
o!r eligible product develop]s )        
suffici5t quantities ( a cov]$ product  
on comm]cially reasonable1 m>ket-bas$   
t]ms1 if ! c\rt f9ds1 by a prepond]ance 
( ! evid5ce-- 7,i7 t ! lic5se hold]     
delay$ provid+ suffici5t quantities ( ! 
cov]$ product to ! eligible product     
develop] )\t a legitimate bus9ess       
ju/ification2 or  7,,ii7 t ! lic5se     
hold] fail$ to comply ) an ord] issu$ "u
 clause 7i74  7,b7 ,maximum monet>y     
am\nt ,a monet>y am\nt aw>d$ "u         
subp>agraph 7,a77iii7 %all n be great]  
?an ! rev5ue t ! lic5se hold] e>n$ on ! 
cov]$ product dur+ ! p]iod--  7i7 beg9n+
 on-- 7,i7 = a cov]$ product t is n     
subject to a ,,rems ) ,,etasu1 ! date t 

is #ca days aft] ! date on :i* ! lic5se 
hold] receiv$ ! reque/2 or  7,,ii7 = a  
cov]$ product t is subject to a ,,rems )
 ,,etasu1 ! date t is #ca days aft] !   
lat] (-- 7aa7 ! date on :i* ! lic5se    
hold] receiv$ ! reque/2 or  7bb7 ! date 
on :i* ! lic5se hold] receiv$ a copy ( !
 cov]$ product au?orization issu$ by !  
,secret>y 9 accordance ) p>agraph       
7#b77;,b72 &  7ii7 end+ on ! date on :i*
 ! eligible product develop] receiv$    
suffici5t quantities ( ! cov]$ product4 
7,c7 ,avoidance ( delay ,! c\rt may     
issue an ord] "u subp>agraph 7,a77i7    
be=e conduct+ fur!r proce$+s t may be   
necess>y to det]m9e :e!r ! eligible     
product develop] is entitl$ to an aw>d  
"u clause 7ii7 or 7iii7 ( subp>agraph   
7,a71 or ! am\nt ( any su* aw>d4  7c7   
,limitation ( liability ,a lic5se hold] 
= a cov]$ product %all n be liable = any
 claim "u ,f$]al1 ,/ate1 or local law   
aris+ out ( ! failure ( an eligible     
product develop] to foll[ adequate      
safegu>ds to assure safe use ( ! cov]$  

product dur+ developm5t or te/+         
activities describ$ 9 ?is section1      
includ+ transportation1 h&l+1 use1 or   
disposal ( ! cov]$ product by ! eligible
 product develop]4  7d7 ,no violation ( 
,,rems ,! provision ( samples ( a drug  
pursuant to an au?orization "u          
subsection 7b77#b77;,b7 %all n be       
consid]$ a violation ( ! requirem5ts (  
any risk evaluation & mitigation /rategy
 t may be 9 place "u section #eje-a ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee-a7 = su* drug4  7e7 
,rule ( con/ruction  7#a7 ,def9ition ,9 
?is subsection1 ! t]m antitru/ laws--   
7,a7 has ! mean+ giv5 ! t]m 9 subsection
 7a7 ( ! fir/ section ( ! ,clayton ,act 
7#ae ,u4,s4,c4 #ab72 &  7,b7 includes   
section #e ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t  
su* section applies to unfair me?ods (  
competition4  7#b7 ,antitru/ laws ,no?+ 
9 ?is section %all be con/ru$ to limit !
 op]ation ( any provision ( ! antitru/  
laws4  #d4 ,,rems approval process =    

subsequ5t fil]s ,section #eje-a ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee-a7 is am5d$--  7#a7 
9 subsection 7g77#d77;,b7-- 7,a7 9      
clause 7i7 by /rik+ or aft] ! semicolon2
  7,b7 9 clause 7ii7 by /rik+ ! p]iod at
 ! end & ins]t+ 2 or2 &  7,c7 by add+ at
 ! end ! foll[+3  7iii7 accommodate     
diff]5t1 comp>able approv$ risk         
evaluation & mitigation /rategies = a   
drug t is ! subject ( an application "u 
section #eje7;j71 & ! applicable li/$   
drug4  2  7#b7 9 subsection 7i77#a71 by 
/rik+ subp>agraph 7,c7 & ins]t+ !       
foll[+3  7,c7  7i7 ,elem5ts to assure   
safe use1 if requir$ "u subsection 7f7 =
 ! li/$ drug1 :i*1 subject to clause    
7ii71 = a drug t is ! subject ( an      
application "u section #eje7;j7 may     
use-- 7,i7 a s+le1 %>$ sy/em ) ! li/$   
drug "u subsection 7f72 or  7,,ii7 a    
diff]5t1 comp>able aspect ( ! elem5ts to
 assure safe use "u subsection 7f74     
7ii7 ,! ,secret>y may require a drug t  
is ! subject ( an application "u section

 #eje7;j7 & ! li/$ drug to use a s+le1  
%>$ sy/em "u subsection 7f71 if !       
,secret>y det]m9es t no diff]5t1        
comp>able aspect ( ! elem5ts to assure  
safe use c\ld satisfy ! requirem5ts (   
subsection 7f74  2 &  7#c7 by add+ at ! 
end ! foll[+3  7l7 ,sep>ate ,,rems ,:5  
us$ 9 ?is section1 ! t]ms 8diff]5t1     
comp>able aspect ( ! elem5ts to assure  
safe use0 or 8diff]5t1 comp>able approv$
 risk evaluation & mitigation /rategies0
 means a risk evaluation & mitigation   
/rategy = a drug t is ! subject ( an    
application "u section #eje7;j7 t uses  
diff]5t me?ods or op]ational means ?an !
 /rategy requir$ "u subsection 7a7 = !  
applicable li/$ drug1 or o!r application
 "u section #eje7;j7 ) ! same su* li/$  
drug1 b a*ieves ! same level ( safety z 
su* /rategy4  4  ,febru>y #f1 #bjai     
,read ! second "t & plac$ on ! cal5d>