,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #aajh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,febru>y #af1         
#bjag,ms4 ,de,lauro introduc$ ! foll[+  
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to       
provide = ! m&atory recall ( drugs      
regulat$ by ! ,food & ,drug             
,adm9i/ration4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,recall ,unsafe    
,drugs ,act ( #bjag4  #b4 ,notification1
 nondi/ribution1 & recall ( adult]at$ or
 misbr&$ drugs  7a7 ,prohibit$ ,acts    
,section #cja ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is 
am5d$ by add+ at ! end ! foll[+3  7eee7 
,! failure to comply )-- 7#a7 !         
notification requirem5t "u section      
#efi;,d7a72  7#b7 an ord] issu$ "u      
p>agraph 7#a7 ( section #efi;,d7c71     
foll[+ a he>+1 if reque/$1 "u p>agraph  
7#b77;,c7 ( su* section2  7#c7 an ord]  
am5d$ "u p>agraph 7#b7 or p>agraph 7#c7 
( section #efi;,d7c72 or  7#d7 an       
em]g5cy ord] issu$ "u section           

#efi;,d7d74  7fff7 ,! failure to h 9    
effect a recall plan "u section         
#efi7;g74  4  7b7 ,nondi/ribution &     
,recall ( ,adult]at$ or ,misbr&$ drugs  
,sub*apt] ,e ( *apt] ,v ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;bbb et seq47 is am5d$ by 
add+ at ! end ! foll[+3  #efi;,d4       
,notification1 nondi/ribution1 & recall 
( c]ta9 adult]at$ or misbr&$ drugs  7a7 
,notification reg>d+ c]ta9 adult]at$ or 
misbr&$ drugs  7#a7 ,9 g5]al ,any p]son 
requir$ to regi/] "u section #eaj %all1 
z soon z practicable1 notify ! ,secret>y
 ( ! id5tity & location ( a drug1 if su*
 p]son has reason to believe--  7,a7 t  
su* drug1 :5 introduc$ into or :ile 9   
int]/ate comm]ce1 or :ile held = sale   
7reg>dless ( :e!r ! fir/ sale7 aft]     
%ipm5t 9 int]/ate comm]ce1 is adult]at$ 
or misbr&$2 &  7,b7 !re is a reasonable 
probability t ! use or consumption (1 or
 exposure to1 ! drug 7or an +r$i5t or   
compon5t us$ 9 any su* drug7 w cause a  
?reat ( s]i\s adv]se heal? consequ5ces  

or dea? to humans or animals4  7#b7     
,mann] ( notification ,notification "u  
p>agraph 7#a7 %all be made 9 su* mann] &
 by su* means z ! ,secret>y may require 
by regulation or guidance4  7b7         
,volunt>y recall ,! ,secret>y may reque/
 t any p]son :o di/ributes a drug t !   
,secret>y has reason to believe is      
adult]at$1 misbr&$1 or o!rwise 9        
violation ( ?is ,act volunt>ily--  7#a7 
recall su* drug2 &  7#b7 provide =      
notice1 includ+ to individuals z        
appropriate1 to p]sons :o may be affect$
 by ! recall4  7c7 ,ord] ,to cease      
di/ribution & recall drug & relat$      
proc$ures  7#a7 ,issuance ( ord] ,if !  
,secret>y has reason to believe t ! use 
or consumption (1 or exposure to1 a drug
 7or an +r$i5t or compon5t us$ 9 any su*
 drug7 may cause s]i\s adv]se heal?     
consequ5ces or dea? to humans or        
animals1 ! ,secret>y %all h ! au?ority  
to issue an ord] requir+ any p]son :o   
di/ributes su* drug--  7,a7 to          
imm$iately cease di/ribution ( su* drug2

 &  7,b7 to provide = notice1 includ+ to
 individuals z appropriate1 to p]sons :o
 may be affect$ by su* cessation (      
di/ribution4  7#b7 ,action foll[+ ord]  
7,a7 ,cease di/ribution & notification  
,any p]son :o is subject to an ord] "u  
p>agraph 7#a7 %all imm$iately cease     
di/ribution ( su* drug & provide        
notification z requir$ by su* ord]4     
7,b7 ,appeal ,any p]son :o is subject to
 an ord] "u p>agraph 7#a7 may appeal )9 
#bd h\rs ( issuance su* ord] to !       
,secret>y4 ,su* appeal may include a    
reque/ = an in=mal he>+ & a description 
( any ef=ts to recall su* drug und]tak5 
volunt>ily by ! p]son1 includ+ aft] a   
reque/ "u subsection 7b74  7,c7 ,in=mal 
he>+ ,except z provid$ 9 subsection 7d71
 if an appeal made "u subp>agraph 7,b7  
conta9s a reque/ = an in=mal he>+1 su*  
he>+ %all be held z soon z practicable1 
b n lat] ?an #e cal5d> days1 or less z  
det]m9$ by ! ,secret>y1 aft] su* an     
appeal is fil$1 unless ! p>ties jo9tly  
agree to an ext5sion4  7,d7 ,det]m9ation

 ,aft] af=d+ an opportunity = an in=mal 
he>+1 ! ,secret>y %all det]m9e-- 7i7    
:e!r--  7,i7 ! ord] "u p>agraph 7#a7    
%\ld be am5d$ to require a recall ( su* 
drug2 or  7,,ii7 inadequate gr\nds exi/ 
to support ! actions requir$ by ! ord]2 
or  7ii7 t ! ord] "u p>agraph 7#a7 0    
appropriate z issu$4  7,e7 ,am5dm5t or  
vacation ( ord]  7i7 ,am5dm5t ,9 ! case 
( a det]m9ation made "u subp>agraph     
7,d77i77,i71 ! ,secret>y %all am5d !    
ord] made "u p>agraph 7#a7 accord+ly4   
7ii7 ,vacation ,9 ! case ( a det]m9ation
 made "u subp>agraph 7,d77i77,,ii71 !   
,secret>y %all vacate ! ord] made "u    
p>agraph 7#a74  7#c7 ,ord] to ,recall   
7,a7 ,am5dm5t ,except z provid$ "u      
subsection 7d71 if aft] provid+ an      
opportunity = an in=mal he>+ "u p>agraph
 7#b77;,c71 ! ,secret>y det]m9es t !    
ord] %\ld be am5d$ to include a recall (
 ! drug ) respect to :i* ! ord] 0 issu$1
 ! ,secret>y %all am5d ! ord] to require
 a recall4  7,b7 ,cont5ts ,an am5d$ ord]
 "u subp>agraph 7,a7 %all-- 7i7 specify 

a timetable 9 :i* ! recall w occur2     
7ii7 require p]iodic reports to !       
,secret>y describ+ ! progress ( !       
recall2 &  7iii7 provide = notice1      
includ+ to individuals z appropriate1 to
 p]sons :o may be affect$ by ! recall4  
,9 provid+ = su* notice1 ! ,secret>y may
 all[ = ! assi/ance ( heal?             
pr(essionals1 ,/ate or local (ficials1  
or o!r individuals designat$ by !       
,secret>y4  7,c7 ,nondelegation ,an     
am5d$ ord] "u ?is p>agraph %all be ord]$
 by ! ,secret>y or an (ficial designat$ 
by ! ,secret>y4 ,an (ficial may n be s  
designat$ unless ! (ficial is ! director
 ( ! di/rict "u ?is ,act 9 :i* ! drug   
involv$ is locat$1 or is an (ficial     
s5ior to su* director4  7d7 ,em]g5cy    
,recall ,ord]  7#a7 ,9 g5]al ,if !      
,secret>y has cr$ible evid5ce or        
in=mation t a drug subject to an ord] "u
 subsection 7c77#a7 pres5ts an imm95t   
?reat ( s]i\s adv]se heal? consequ5ces  
or dea? to humans or animals1 !         
,secret>y may issue an ord] requir+ any 

p]son :o di/ributes su* drug--  7,a7 to 
imm$iately recall su* drug2 &  7,b7 to  
provide = notice1 includ+ to individuals
 z appropriate1 to p]sons :o may be     
affect$ by ! recall4  7#b7 ,action      
foll[+ ord]  7,a7 ,recall & notification
 ,any p]son :o is subject to an em]g5cy 
recall ord] "u ?is subsection %all      
imm$iately recall su* drug & provide    
notification z requir$ by su* ord]4     
7,b7 ,appeal  7i7 ,tim+ ,any p]son :o is
 subject to an em]g5cy recall ord] "u   
?is subsection may appeal )9 #bd h\rs   
aft] issuance su* ord] to ! ,secret>y4  
7ii7 ,cont9uation ( recall ,! p]son     
subject to an em]g5cy recall ord] %all  
conduct ! recall not)/&+ ! p5d5cy ( any 
appeal ( su* ord]4  7,c7 ,in=mal he>+   
,an in=mal he>+ %all be held z soon z   
practicable b n lat] ?an #e cal5d> days1
 or less z det]m9$ by ! ,secret>y1 aft] 
an appeal "u subp>agraph 7,b7 is fil$1  
unless ! p>ties jo9tly agree to an      
ext5sion4  7,d7 ,det]m9ation ,aft] af=d+
 an opportunity = an in=mal he>+1 !     

,secret>y %all det]m9e-- 7i7 :e!r--     
7,i7 ! ord] "u p>agraph 7#a7 %\ld be    
am5d$ to require a recall ( su* drug2 or
  7,,ii7 inadequate gr\nds exi/ to      
support ! actions requir$ by ! ord]2 or 
7ii7 t ! ord] "u p>agraph 7#a7 0        
appropriate z issu$4  7,e7 ,am5dm5t or  
vacation ( ord]  7i7 ,am5dm5t ,9 ! case 
( a det]m9ation made "u subp>agraph     
7,d77i77,i71 ! ,secret>y %all am5d !    
ord] made "u p>agraph 7#a7 accord+ly4   
7ii7 ,vacation ,9 ! case ( a det]m9ation
 made "u subp>agraph 7,d77i77,,ii71 !   
,secret>y %all vacate ! ord] made "u    
p>agraph 7#a74  7#c7 ,nondelegation ,an 
ord] "u ?is subsection %all be issu$ by 
! ,commission] ( ,food & ,drugs1 !      
,pr9cipal ,deputy ,commission]1 or !    
,associate ,commission] = ,regulatory   
,affairs ( ! ,food & ,drug              
,adm9i/ration4  7e7 ,notice to ,consum]s
 & ,heal? ,(ficials ,! ,secret>y %all1 z
 ! ,secret>y det]m9es to be necess>y1   
provide notice ( a recall ord] "u ?is   
section to consum]s to :om ! drug 01 or 

may h be51 di/ribut$ & to appropriate   
,/ate & local heal? (ficials4  7f7      
,sav+s ,clause ,no?+ conta9$ 9 ?is      
section %all be con/ru$ z limit+-- 7#a7 
! au?ority ( ! ,secret>y to issue an    
ord] to cease di/ribution (1 or to      
recall1 a drug "u any o!r provision (   
?is ,act or ! ,public ,heal? ,s]vice    
,act2 or  7#b7 ! ability ( ! ,secret>y  
to reque/ any p]son to p]=m a volunt>y  
activity relat$ to any drug subject to  
?is ,act or ! ,public ,heal? ,s]vice    
,act4  7g7 ,recall plan ,any p]son      
requir$ to regi/] "u section #eaj %all h
 9 effect a recall plan consi/5t ) !    
requirem5ts ( ?is section4  4  7c7      
,delay$ applicability ,! am5dm5ts made  
by ?is section apply beg9n+ on ! date t 
is "o ye> aft] ! date ( ! enactm5t ( ?is
 ,act4