,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bhga  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #ab1 #bjag,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$]al ,food1 ,drug1 
& ,cosmetic ,act ) respect to comp\nd+  
ph>macies1 & = o!r purposes4  #a4 ,%ort 
title ,?is ,act may be cit$ z ! ,pres]v+
 ,pati5t ,access to ,comp\nd$           
,m$ications ,act ( #bjag4  #b4          
,(fice-use comp\nd+ :5 au?oriz$ by ,/ate
 law ,section #ejc;,a7a7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cec;a7a77 is am5d$--  7#a7 9 
! matt] prec$+ p>agraph 7#a71 by ins]t+ 
or drug ord] = adm9i/ration to a pati5t 
9 an (fice or cl9ical sett+ aft] is     
necess>y = ! id5tifi$ pati5t2  7#b7 9   
p>agraph 7#a71 by /rik+ or at ! end2    
7#c7 9 p>agraph 7#b71 by /rik+ ! p]iod  
at ! end & ins]t+ 2 or2 &  7#d7 by add+ 
at ! end ! foll[+ new p>agraph3  7#c7 is
 by a lic5s$ ph>maci/ or lic5s$         

physician pursuant to a valid           
prescription ord] or drug ord] & !      
comp\nd$ drug is di/ribut$ or disp5s$ to
 a lic5s$ prescrib] 9 accordance ) ,/ate
 law1 = adm9i/ration to a pati5t 9 an   
(fice or cl9ical sett+4  4  #c4 ,unit$  
,/ates ph>macopoeia or national =mul>y  
monograph requirem5t ,section           
#ejc;,a7b77#a77;,a7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cec;,a7b77#a77;,a77 is am5d$--  7#a7 9 
! matt] prec$+ subclause 7i71 by ins]t+ 
1 or diet>y supplem5ts aft]             
,regulations2 &  7#b7 9 clause 7i7--    
7,a7 by am5d+ subclause 7,i7 to read z  
foll[s3  7,i7 comply ) ! monograph /&>ds
 9 any section ( ! ( ! ,unit$ ,/ates    
,ph>macopoeia or ,national ,=mul>y1     
includ+ drug sub/ance or diet>y         
supplem5t monograph1 if a monograph     
exi/s4  2 &  7,b7 by am5d+ subclause    
7,,iii7 to read z foll[s3  7,,iii7 if   
su* monograph does n exi/ & ! drug      
sub/ance or diet>y supplem5t is n a     
compon5t ( a drug approv$ by !          

,secret>y1 b appe>s on a li/ develop$ by
 ! ,secret>y ?r\gh regulations issu$ by 
! ,secret>y "u subsection 7c7 ( ?is     
section2  4  #d4 ,def9itions ,subsection
 7e7 ( section #ejc;,a ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cec;a7 is am5d$ to read z foll[s3  7e7 
,def9itions ,9 ?is section3 7#a7        
,comp\nd+ ,! t]m comp\nd+ does n include
 mix+1 recon/itut+1 or o!r su* acts t   
are p]=m$ 9 accordance ) directions     
conta9$ 9 approv$ label+ provid$ by !   
product's manufactur] & o!r manufactur] 
directions consi/5t ) t label+4  7#b7   
,di/ribute or di/ribution ,! t]ms       
di/ribute or di/ribution d n include !  
act ( disp5s+ ( a comp\nd$ drug product 
9 accordance ) ?is section4  7#c7       
,disp5se ,! t]m disp5se means = a drug  
product comp\nd$ 9 accordance ) ?is     
section1 ! act ( ! drug product leav+ ! 
facility 9 :i* x 0 comp\nd$ = deliv]y to
 a pati5t1 pati5t's ag5t1 or heal? c>e  
facility 7includ+ a hospital1           
physician's (fice1 or o!r heal? c>e     

sett+7 pursuant to a valid prescription 
ord] = an id5tifi$ pati5t4  4  #e4      
,applicability ( records exemption =    
comp\nd+ ph>macies  7a7 ,9 g5]al        
,section #gjd7;a77#b77;,a7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgd7;a77#b77;,a77 is am5d$ to
 read z foll[s3  7,a7 ph>macies :i*     
ma9ta9 e/abli%m5ts 9 con=mance ) any    
applicable local laws regulat+ !        
practice ( ph>macy & m$ic9e &1 =        
comp\nd+ ph>macies1 ! provisions (      
section #ejc;,a1 & :i* are regul>ly     
engag$ 9 disp5s+ or di/ribut+           
prescription drugs or devices1 ^u       
prescriptions or drug ord]s (           
practition]s lic5s$ to adm9i/] su* drugs
 or devices to pati5ts "u ! c>e ( su*   
practition]s 9 ! c\rse ( _! pr(essional 
practice1 & :i* d n1 ei!r ?r\gh a       
subsidi>y or o!rwise1 manufacture1      
prep>e1 propagate1 comp\nd1 or process  
drugs or devices = sale o!r ?an 9 !     
regul> c\rse ( _! bus9ess2  4  7b7      
,regi/ration exemption ,section         

#eaj7;g77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj7;g77#a77 is am5d$ to read z foll[s3
  7#a7 ph>macies :i* ma9ta9 e/abli%m5ts 
9 con=mance ) any applicable local laws 
regulat+ ! practice ( ph>macy & m$ic9e  
&1 = comp\nd+ ph>macies1 ! provisions ( 
section #ejc;,a1 & :i* are regul>ly     
engag$ 9 disp5s+ or di/ribut+           
prescription drugs or devices1 ^u       
prescriptions or drug ord]s (           
practition]s lic5s$ to adm9i/] su* drugs
 or devices to pati5ts "u ! c>e ( su*   
practition]s 9 ! c\rse ( _! pr(essional 
practice1 & :i* d n manufacture1 prep>e1
 propagate1 comp\nd1 or process drugs or
 devices = sale o!r ?an 9 ! regul> c\rse
 ( _! bus9ess2  4  #f4 ,regulations  7a7
 ,rules implem5t+ new requirem5ts ,n    
lat] ?an #ij days aft] ! date ( enactm5t
 ( ?is ,act1 ! ,secret>y ( ,heal? &     
,human ,s]vices %all promulgate rules on
 ! record to c>ry out ! am5dm5ts made by
 ?is ,act1 9 accordance ) *apt] #e (    
title #e1 ,unit$ ,/ates ,code4  7b7 ,o!r

 rules ,! ,secret>y ( ,heal? & ,human   
,s]vices %all promulgate rules on !     
record to c>ry out any ( ! provisions ( 
section #ejc;,a ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7
 o!r ?an ^? am5d$ by ?is ,act1 9        
accordance ) *apt] #e ( title #e1 ,unit$
 ,/ates ,code4