,,ii  #aah? ,,congress  #a/ ,session    
,s4 #bfhc  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #bg1 #bjbc,mr4   
,scott ( ,florida introduc$ ! foll[+    
bill2 :i* 0 read twice & ref]r$ to !    
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to      
e/abli% requirem5ts = pur*as+ c]ta9     
g5]ic drugs f manufactur]s :o produce ! 
drug dome/ically4  #a4 ,%ort title ,?is 
,act may be cit$ z ! ,accel]at+ ,movem5t
 ( ,ess5tial ,rx ,items to ,create      
,access to ,national ,drug ,res\rces =  
,,u ,gov]nm5t ,s]vices ,act or !        
,,am]ican ,,drugs ,act4  #b4 ,,fda      
notification  7a7 ,9 g5]al ,! ,secret>y 
( ,heal? & ,human ,s]vices1 act+ ?r\gh !
 ,commission] ( ,food & ,drugs 7ref]r$  
to 9 ?is section z ! ,commission]71 %all
 issue notifications to ! ,adm9i/rator (
 ! ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices1 
! ,secret>y ( ,def5se1 & ! ,secret>y (  
,vet]ans ,affairs ^u a det]m9ation by ! 
,commission] t-- 7#a7 !re are at lea/ #b
 approv$ g5]ic drugs t are manufactur$  

dome/ically1 z describ$ 9 subsection    
7b71 ea* ( :i*-- 7,a7 is approv$        
pursuant to an application "u section   
#eje7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j772
 &  7,b7 ref]5ces ! same li/$ drug "u   
p>agraph 7#g7 ( su* section #eje7;j72 or
  7#b7 !re are few] ?an #b approv$ g5]ic
 drugs t are manufactur$ dome/ically--  
7,a7 approv$ pursuant to an application 
"u section #eje7;j7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j772 &  7,b7 t ref]5ce ! same li/$
 drug "u p>agraph 7#g7 ( su* section    
#eje7;j7 z ano!r drug approv$ "u su*    
section #eje7;j72  7#c7 p>agraph        
7#a77;,b7 may soon apply because !      
,commission] has be5 notifi$ t a hold] (
 an approv$ application = a g5]ic drug t
 is manufactur$ dome/ically1 z describ$ 
9 subsection 7b71 plans to discont9ue   
manufactur+1 or expects an int]ruption (
 ! manufacture (1 su* drug at an        
e/abli%m5t describ$ 9 subsection        
7b77#a77;,b72 or  7#d7 a g5]ic drug t is

 manufactur$ dome/ically1 z describ$ 9  
subsection 7b71 is 9 %ortage1 z def9$ 9 
section #ejf;,c7h77#b7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cef;c7h77#b774  7b7 ,g5]ic drug        
manufactur$ dome/ically describ$ ,9 ?is 
section1 a g5]ic drug t is manufactur$  
dome/ically-- 7#a7 is a drug-- 7,a7 t is
 approv$ "u section #eje7;j7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j772 &  7,b7 = :i* !re  
is at lea/ "o e/abli%m5t regi/]$ "u     
section #eaj7;b77#a7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj7;b77#a77 engag$ 9 ! manufacture ( !
 f9i%$ dosage =m ( ! drug2 &  7#b7      
excludes any au?oriz$ g5]ic drug1 z     
def9$ 9 section #eje7t77#c7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7t77#c774  7c7 ,special   
rule conc]n+ g5]ic drugs 9 %ortage ,a   
notification "u subsection 7a77#d7 t a  
g5]ic drug t is manufactur$ dome/ically1
 z describ$ 9 subsection 7b71 is 9      
%ortage1 %all apply only =-- 7#a7 an    

initial p]iod ( n m ?an #ij days2 &     
7#b7 su* additional #cj-;day r5ewal     
p]iods z ! ,secret>y ( ,heal? & ,human  
,s]vices may indicate by-- 7,a7 submitt+
 to ,congress a notification ( int5t to 
r5ew ! notification "u subsection       
7a77#d72 &  7,b7 publicly po/+ in=mation
 ab\t ! %ortage1 ! /eps ! ,food & ,drug 
,adm9i/ration is tak+ to address !      
%ortage1 & an e/imat$ date by :i* !     
%ortage is expect$ to be resolv$4  #c4  
,exp$it$ consid]ation ( c]ta9 abbreviat$
 new drug applications ,*apt] ,v ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 ins]t+ aft] section #ejf,l ! foll[+3   
#ejf,m4 ,exp$it$ consid]ation ( c]ta9   
abbreviat$ new drug applications  7a7 ,9
 g5]al ,! ,secret>y may1 at ! reque/ ( a
 sponsor ( an application = an          
applicable drug1 exp$ite ! developm5t & 
review ( an abbreviat$ new drug         
application "u section #eje7;j7 = su*   
drug4  7b7 ,applicable drug ,= purposes 
( ?is section1 an applicable drug is a  

drug = :i* !re are few] ?an #b drugs    
approv$ "u section #eje7;j7 t are       
manufactur$ dome/ically1 z describ$ 9   
p>agraph 7#b71 ea* ( :i* is approv$     
pursuant to an application "u section   
#eje7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 
& ref]5ces ! same li/$ drug "u p>agraph 
7#g7 ( su* section #eje7;j74  7c7       
,actions ,9 exp$it+ ! developm5t &      
review ( an application "u subsection   
7a71 ! ,secret>y may1 z reque/$ by !    
applicant1 take actions includ+ !       
foll[+3 7#a7 ,hold meet+s ) ! applicant 
& ! review team ?r\gh\t ! developm5t ( !
 drug prior to submission ( !           
application = su* drug "u section       
#eje7;j74  7#b7 ,provide timely advice  
to1 & int]active communication )1 !     
applicant reg>d+ ! developm5t ( ! drug  
to ensure t ! developm5t program to ga!r
 ! data necess>y = approval is z        
effici5t z practicable4  7#c7 ,involve  
s5ior manag]s & exp]i5c$ review /aff1 z 
appropriate1 9 a collaborative1         

coord9at$ review ( su* application1     
includ+ ) respect to drug-device        
comb9ation products & o!r complex       
products4  7#d7 ,assign a               
cross-discipl9>y project lead-- 7,a7 to 
facilitate an effici5t review ( !       
developm5t program & application1       
includ+ manufactur+ inspections2 &  7,b7
 to s]ve z a sci5tific liaison betwe5 ! 
review team & ! applicant4  7d7 ,report+
 requirem5t ,n lat] ?an "o ye> aft] !   
date ( ! approval ( an application "u   
section #eje7;j7 ) respect to a drug =  
:i* ! developm5t & review is exp$it$ "u 
?is section1 ! sponsor ( su* drug %all  
report to ! ,secret>y on :e!r ! drug has
 be5 m>ket$ 9 int]/ate comm]ce s9ce !   
date ( su* approval4  4  #d4            
,prohibition ( paym5t "u ,m$ic>e "p ,b  
or cov]age "u ,m$ic>e "p ,d = c]ta9     
g5]ic drugs manufactur$ outside ( !     
,unit$ ,/ates  7a7 ,m$ic>e "p ,b        
,section #ahdb7o7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acieu7o77 is am5d$ 
by add+ at ! end ! foll[+ new p>agraph3 

7#i7 7,a7 ,paym5t %all only be made "u  
?is "p = a g5]ic drug furni%$ on or aft]
 ,janu>y #a1 #bjbe1 if x is a g5]ic drug
 manufactur$ dome/ically 7z describ$ 9  
section #b7;b7 ( ! ,accel]at+ ,movem5t (
 ,ess5tial ,rx ,items to ,create ,access
 to ,national ,drug ,res\rces = ,,u     
,gov]nm5t ,s]vices ,act74  7,b7         
,subp>agraph 7,a7 %all n apply1 )       
respect to a drug1 dur+ any p]iod = :i* 
! ,secret>y-- 7i7 has notifi$ !         
,adm9i/rator ( ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices pursuant to section   
#b7;a7 ( ! ,accel]at+ ,movem5t (        
,ess5tial ,rx ,items to ,create ,access 
to ,national ,drug ,res\rces = ,,u      
,gov]nm5t ,s]vices ,act t ! circum/ances
 "u p>agraph 7#b71 7#c71 or 7#d7 ( su*  
section apply2 or  7ii7 o!rwise det]m9es
 t access to ! drug is ess5tial to !    
heal? ( b5efici>ies "u ?is "p4  4  7b7  
,m$ic>e "p ,d ,section #ahfj;,d-#db ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aeb7 is am5d$ by add+ at ! end !
 foll[+ new subsection3  7e7            

,prohibition ( cov]age = c]ta9 g5]ic    
drugs manufactur$ outside ( ! ,unit$    
,/ates  7#a7 ,9 g5]al ,cov]age %all only
 be available "u ?is "p = a cov]$ "p ,d 
drug t is a g5]ic drug disp5s$ on or    
aft] ,janu>y #a1 #bjbe1 if x is a g5]ic 
drug manufactur$ dome/ically 7z describ$
 9 section #b7;b7 ( ! ,accel]at+        
,movem5t ( ,ess5tial ,rx ,items to      
,create ,access to ,national ,drug      
,res\rces = ,,u ,gov]nm5t ,s]vices      
,act74  7#b7 ,exceptions ,p>agraph 7#a7 
%all n apply1 ) respect to a cov]$ "p ,d
 drug1 dur+ any p]iod = :i* !           
,secret>y-- 7,a7 has notifi$ !          
,adm9i/rator ( ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices pursuant to section   
#b7;a7 ( ! ,accel]at+ ,movem5t (        
,ess5tial ,rx ,items to ,create ,access 
to ,national ,drug ,res\rces = ,,u      
,gov]nm5t ,s]vices ,act t ! circum/ances
 "u p>agraph 7#b71 7#c71 or 7#d7 ( su*  
section apply2 or  7,b7 o!rwise det]m9es
 t access to ! drug is ess5tial to !    
heal? ( b5efici>ies "u ?is "p4  4  #e4  

,prohibition ( paym5t "u ,m$icaid &     
,,*ip = c]ta9 g5]ic drugs manufactur$   
outside ( ! ,unit$ ,/ates  7a7 ,m$icaid 
,title ,,xix ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #acif et seq47 is am5d$--
 7#a7 9 section #aijc7;i77#aj7-- 7,a7 9 
subp>agraph 7,d71 by /rik+ 2 & & ins]t+ 
a semicolon2  7,b7 9 subp>agraph 7,e71  
by /rik+ 2 or & ins]t+ 2 &2 &  7,c7 by  
ins]t+ aft] subp>agraph 7,e7 ! foll[+   
new subp>agraph3  7,f7 ) respect to any 
am\nt exp5d$ = a cov]$ outpati5t drug   
:i* ! ,/ate is requir$ to exclude f     
cov]age "u section #aibg7;d77#h72 or  2 
&  7#b7 9 section #aibg7;d71 by add+ at 
! end ! foll[+ new p>agraph3  7#h7      
,re/riction on cov]age ( =eign-made     
g5]ic drugs  7,a7 ,9 g5]al ,beg9n+      
,janu>y #a1 #bjbe1 a ,/ate %all exclude 
cov]age ( a =eign-made g5]ic cov]$      
outpati5t drug if !re is a g5]ic drug t 
is manufactur$ dome/ically 7z describ$ 9
 section #b7;b7 ( ! ,accel]at+ ,movem5t 
( ,ess5tial ,rx ,items to ,create       
,access to ,national ,drug ,res\rces =  

,,u ,gov]nm5t ,s]vices ,act7 t ref]5ces 
! same li/$ drug "u section #eje7;j77#g7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act z ! =eign-made g5]ic cov]$         
outpati5t drug4  7,b7 ,def9ition (      
=eign-made g5]ic cov]$ outpati5t drug ,=
 purposes ( ?is p>agraph1 ! t]m         
=eign-made g5]ic cov]$ outpati5t drug   
means a cov]$ outpati5t drug t-- 7i7 is 
approv$ "u section #eje7;j7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act2 &  7ii7 
is n a g5]ic drug t is manufactur$      
dome/ically 7z describ$ 9 section #b7;b7
 ( ! ,accel]at+ ,movem5t ( ,ess5tial ,rx
 ,items to ,create ,access to ,national 
,drug ,res\rces = ,,u ,gov]nm5t ,s]vices
 ,act74  7,c7 ,exceptions ,subp>agraph  
7,a7 %all n apply to a =eign-made g5]ic 
cov]$ outpati5t drug dur+ any p]iod =   
:i* ! ,secret>y-- 7i7 has notifi$ !     
,adm9i/rator ( ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices pursuant to section   
#b7;a7 ( ! ,accel]at+ ,movem5t (        
,ess5tial ,rx ,items to ,create ,access 
to ,national ,drug ,res\rces = ,,u      

,gov]nm5t ,s]vices ,act t ! circum/ances
 "u p>agraph 7#b71 7#c71 or 7#d7 ( su*  
section apply ) respect to su* drug2 or 
7ii7 o!rwise det]m9es t access to !     
=eign-made g5]ic cov]$ outpati5t drug is
 ess5tial to ! heal? ( individuals      
enroll$ = m$ical assi/ance "u ?is title4
  7,d7 ,notice to ,/ates ,! ,secret>y   
%all provide notice to ,/ates if a      
=eign-made g5]ic cov]$ outpati5t drug is
 subject to exclusion f cov]age "u ?is  
p>agraph4  4  7b7 ,,*ip ,section        
#bajg7;e77#a77,m7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acig;gg7e77#a77,m77
 is am5d$ by ins]t+ 7#aj77;,f71 aft]    
7#b714  #f4 ,procurem5t by ,dep>tm5t (  
,vet]ans ,affairs ( g5]ic drugs         
manufactur$ dome/ically  7a7 ,9 g5]al   
,sub*apt] ,,ii ( *apt] #ha ( title #ch1 
,unit$ ,/ates ,code1 is am5d$ by ins]t+ 
aft] section #habf ! foll[+ new section3
  #habf;,a4 ,procurem5t ( g5]ic drugs   
manufactur$ dome/ically  7a7 ,9 g5]al   
,subject to subsection 7b71 ! ,secret>y 
may only procure a g5]ic drug if x is a 

g5]ic drug manufactur$ dome/ically1 z   
describ$ 9 section #b7;b7 ( ! ,accel]at+
 ,movem5t ( ,ess5tial ,rx ,items to     
,create ,access to ,national ,drug      
,res\rces = ,,u ,gov]nm5t ,s]vices ,act4
  7b7 ,exceptions ,subsection 7a7 %all n
 apply ) respect to a drug dur+ any     
p]iod = :i*-- 7#a7 ! ,secret>y ( ,heal? 
& ,human ,s]vices has notifi$ !         
,secret>y ( ,vet]ans ,affairs pursuant  
to section #b7;a7 ( ! ,accel]at+        
,movem5t ( ,ess5tial ,rx ,items to      
,create ,access to ,national ,drug      
,res\rces = ,,u ,gov]nm5t ,s]vices ,act 
t ! circum/ances "u p>agraph 7#b71 7#c71
 or 7#d7 ( su* section apply2 or  7#b7 !
 ,secret>y ( ,vet]ans ,affairs det]m9es 
t access to ! drug is ess5tial to !     
heal? ( b5efici>ies "u ! laws adm9i/]$  
by ! ,secret>y4  4  7b7 ,cl]ical am5dm5t
 ,! table ( sections at ! beg9n+ ( su*  
sub*apt] is am5d$ by ins]t+ aft] ! item 
relat+ to section #habf ! foll[+ new    
item3  #habf;,a4 ,procurem5t ( g5]ic    
drugs manufactur$ dome/ically4  4  7c7  

,effective date ,! am5dm5ts made by ?is 
section %all take effect on ,janu>y #a1 
#bjbe4  #g4 ,procurem5t by ,dep>tm5t (  
,def5se ( g5]ic drugs manufactur$       
dome/ically  7a7 ,9 g5]al ,*apt] #ee (  
title #aj1 ,unit$ ,/ates ,code1 is am5d$
 by ins]t+ aft] section #ajgd;g ! foll[+
 new section3  #ajgd;g-#a4 ,procurem5t (
 g5]ic drugs manufactur$ dome/ically    
7a7 ,9 g5]al ,subject to subsection 7b71
 ! ,secret>y ( ,def5se may only procure 
a g5]ic drug if x is a g5]ic drug       
manufactur$ dome/ically1 z describ$ 9   
section #b7;b7 ( ! ,accel]at+ ,movem5t (
 ,ess5tial ,rx ,items to ,create ,access
 to ,national ,drug ,res\rces = ,,u     
,gov]nm5t ,s]vices ,act4  7b7           
,exceptions ,subsection 7a7 %all n apply
 ) respect to a drug dur+ any p]iod =   
:i*-- 7#a7 ! ,secret>y ( ,heal? & ,human
 ,s]vices has notifi$ ! ,secret>y (     
,def5se pursuant to section #b7;a7 ( !  
,accel]at+ ,movem5t ( ,ess5tial ,rx     
,items to ,create ,access to ,national  
,drug ,res\rces = ,,u ,gov]nm5t ,s]vices

 ,act t ! circum/ances "u p>agraph 7#b71
 7#c71 or 7#d7 ( su* section apply2 or  
7#b7 ! ,secret>y ( ,def5se det]m9es t   
access to ! drug is ess5tial to ! heal? 
( b5efici>ies "u ! ,,tric>e program4  4 
7b7 ,cl]ical am5dm5t ,! table ( sections
 at ! beg9n+ ( su* *apt] is am5d$ by    
ins]t+ aft] ! item relat+ to section    
#ajgd;g ! foll[+ new item3  #ajgd;g-#a4 
,procurem5t ( g5]ic drugs manufactur$   
dome/ically4  4  7c7 ,effective date ,! 
am5dm5ts made by ?is section %all take  
effect on ,janu>y #a1 #bjbe4