,i  #aah? ,,congress  #a/ ,session  ,h4 
,r4 #afg  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,janu>y #i1 #bjbc,mr4 
,griffi? 7= himself & ,mr4 ,cuell>7     
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to ensure pati5ts h    
access to c]ta9 urg5t-use comp\nd$      
m$ications1 & = o!r purposes4  #a4 ,%ort
 title ,?is ,act may be cit$ z ! ,pati5t
 ,access to ,urg5t-,use ,ph>macy        
,comp\nd+ ,act ( #bjbc4  #b4 ,urg5t-use 
comp\nd+ = adm9i/ration 9 hospitals or  
o!r cl9ical sett+s ,section #ejc;,a7a7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cec;a7a77 is am5d$--   
7#a7 9 p>agraph 7#a71 by /rik+ or at !  
end2  7#b7 9 p>agraph                   
7#b77;,b77ii77,,ii71 by /rik+ ! p]iod at
 ! end & ins]t+ 2 or2 &  7#c7 by add+ at
 ! end ! foll[+ new p>agraph3  7#c7     
not)/&+ ! requirem5t 9 ! matt] prec$+   
p>agraph 7#a7 t ! drug product is       
comp\nd$ = an id5tifi$ individual pati5t

 bas$ on a valid prescription ord] or   
notation describ$ 9 su* matt]1 is by a  
lic5s$ ph>maci/ or lic5s$ physician & ! 
comp\nd$ drug product is comp\nd$ =     
di/ribution 9 limit$ quantities to a    
lic5s$ prescrib] = urg5t adm9i/ration to
 a pati5t 9 a hospital or o!r cl9ical   
sett+1 provid$ t all ( ! foll[+ are met3
  7,a7 ,! lic5s$ prescrib] c]tifies by  
notation on ! ord] to ! comp\nd+        
ph>maci/ or physician t ! lic5s$        
prescrib] has made reasonable attempts  
to obta91 & has n be5 able to obta91 to 
address ! urg5t m$ical ne$-- 7i7 a drug 
product t is approv$ or au?oriz$ by !   
,food & ,drug ,adm9i/ration ) ! same    
active +r$i5t & ! same r\te (           
adm9i/ration2 or  7ii7 a drug product t 
is comp\nd$ by an outs\rc+ facility 9   
accordance ) section #ejc;,b ) ! same   
active +r$i5t & ! same r\te (           
adm9i/ration4  7,b7 ,! comp\nd$ drug    
product is label$ ) a beyond-use-date 9 
accordance ) applicable ,unit$ ,/ates   
,ph>macopeia /&>ds4  7,c7 ,! lic5s$     

ph>maci/ or lic5s$ physician m>ks !     
packag+ ( ! comp\nd$ drug product )     
text-- 7i7 indicat+ t ! drug product is 
provid$ to ! hospital or o!r cl9ical    
sett+ only = urg5t adm9i/ration to a    
pati5t2 &  7ii7 reque/+ t ! hospital or 
o!r cl9ical sett+ provide to ! comp\nd+ 
ph>maci/ or physician ! records t       
id5tify ! pati5t or pati5ts to :om !    
drug products 7 adm9i/]$ )9-- 7,i7 #g   
days ( ea* su* pati5t receiv+ su*       
m$ication2 or  7,,ii7 #g days ( ea* su* 
pati5t be+ dis*>g$4  7,d7 ,^u receipt ( 
records reque/$ pursuant to subp>agraph 
7,c77ii71 ! lic5s$ ph>maci/ or lic5s$   
physician ensures t ! pati5t in=mation 9
 su* records is l9k$ ) ! respective     
ord]4  7,e7 ,! lic5s$ ph>maci/ or lic5s$
 physician reports adv]se ev5ts         
associat$ ) ! comp\nd$ drug product z   
soon z possible b no lat] ?an #ae days  
aft] becom+ aw>e ( su* ev5ts to !       
,med,watch ,adv]se ,ev5t ,report+       
program ( ! ,food & ,drug ,adm9i/ration 
7or any successor program74  4  #c4     

,comp\nd+ = %ortages = adm9i/ration 9   
hospitals or o!r cl9ical sett+s         
,p>agraph 7#b7 ( section #ejc;,a7b7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cec;a7b77#b77 is am5d$  
to read z foll[s3  7#b7 ,def9ition ,=   
purposes ( p>agraph 7#a77;,d71 ! t]m    
ess5tially a copy ( a comm]cially       
available drug product does n include-- 
7,a7 a drug product 9 :i* !re is a      
*ange1 made = an id5tifi$ individual    
pati5t1 :i* produces = t pati5t a       
significant diff]5ce1 z det]m9$ by !    
prescrib+ practition]1 betwe5 ! comp\nd$
 drug & ! comp>able comm]cially         
available drug product2 or  7,b7 a drug 
product t meets ea* ( ! foll[+          
conditions3 7i7 ,at ! "t ( comp\nd+1    
di/ribution1 or disp5s+1 ! drug product 
appe>s on--  7,i7 ! drug %ortage li/ 9  
effect "u section #ejf;,e2 or  7,,ii7 ! 
drug %ortage li/ ma9ta9$ by ! ,am]ican  
,society ( ,hospital ,ph>maci/s4  7ii7  
,if ! drug product is n comp\nd$ = an   
id5tifi$ individual pati5t bas$ on a    

valid prescription ord] or notation1    
not)/&+ su* requirem5t 9 ! matt] prec$+ 
p>agraph 7#a7 ( subsection 7a71 !n !    
drug product-- 7,i7 is label$ 9         
accordance subp>agraphs 7,b7 & 7,c7 (   
subsection 7a77#c72 &  7,,ii7 is        
docum5t$ by ! comp\nd+ ph>maci/ or      
physician 9 accordance ) subp>agraphs   
7,d7 & 7,e7 ( subsection 7a77#c74  4