,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #cjai  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,augu/ #b1 #bjac ,ms4 
,de,lauro 7= h]self1 ,mrs4 ,l[ey1 ,mr4  
,cony]s1 ,mr4 ,honda1 & ,mr4 ,ellison7  
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d *apt] ,v ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act to       
enhance ! requirem5ts = ph>macies t     
comp\nd drug products4  #a4 ,%ort title 
,?is ,act may be cit$ z ! ,support+     
,access to ,=mulat$ & ,effective        
,comp\nd$ ,drugs ,act ( #bjac or !      
,s4,a4,f4,e4 ,comp\nd$ ,drugs ,act (    
#bjac4  #b4 ,enhanc$ requirem5ts =      
comp\nd$ drugs  7a7 ,9 g5]al ,section   
#ejc;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is
 am5d$--  7#a7 9 subsection             
7a77#a77;,a71 by ins]t+ t is regi/]$ ) !
 ,secret>y "u subsection 7b77#f7 7or is 
subject to ! exception "u subsection    
7b77#f77;,c77 aft] ,/ate lic5s$ ph>macy2
  7#b7 9 subsection 7b7--  7,a7 9       

p>agraph 7#a77;,a71 by ins]t+ 7mean+ n m
 ?an #e p]c5t ( ! total quantity ( drugs
 products comp\nd$ by ! ph>maci/ or     
physician 9 any #cj day p]iod7 aft]     
limit$ quantities2  7,b7 9 p>agraph     
7#a77;,c71 by /rik+ & at ! end2  7,c7 9 
p>agraph 7#a77;,d71 by /rik+ regul>ly or
 9 inord9ate am\nts 7z def9$ by !       
,secret>y72  7,d7 by add+ at ! end (    
p>agraph 7#a7 ! foll[+3  7,e7 does n    
comp\nd a drug product t appe>s on ! li/
 promulgat$ by ! ,secret>y "u subsection
 7h72 &  7,f7 does n comp\nd a drug     
product 9 violation ( ! m9imum /&>ds    
promulgat$ "u subsection 7i74  2 &  7,e7
 by add+ at ! end ( ! subsection !      
foll[+3  7#d7 ,notification  7,a7       
,prescrib] notification ,be=e provid+ a 
prescription ord] = a drug to be        
comp\nd$ "u subsection 7a71 ! physician 
or o!r lic5s$ practition] :o w write su*
 ord] %all--  7i7 in=m ! individual     
pati5t = :om su* ord] is be+ writt5 t a 
comp\nd$ drug is be+ prescrib$2 &  7ii7 
provide su* pati5t ) a writt5 docum5t   

conta9+ in=mation conc]n+ !             
availability1 safety1 & production (    
comp\nd$ drugs4  7,b7 ,confirmation by  
ph>maci/ ,except 9 ! case ( a comp\nd$  
drug product us$ 9 a proc$ure describ$ 9
 subp>agraph 7,c71 a lic5s$ ph>maci/ or 
lic5s$ physician :o disp5ses a comp\nd$ 
drug "u subsection 7a7 %all1 at ! "t su*
 drug is disp5s$--  7i7 confirm t !     
pati5t 7or ! individual to :om ! drug is
 deliv]$ on behalf ( ! pati5t7 und]/&s t
 ! drug is a comp\nd$ drug2 &  7ii7     
provide a writt5 docum5t conta9+ !      
in=mation describ$ 9 subp>agraph        
7,a77ii74  7,c7 ,provid] notification   
,prior to provid+ a heal? c>e s]vice t w
 be conduct$ by a heal? c>e provid] 9 a 
heal? c>e sett+ 7su* z a hospital or a  
physician's (fice7 & dur+ :i* s]vice a  
drug comp\nd$ "u subsection 7a7 w be    
adm9i/]$ to a pati5t = purposes ( treat+
 su* pati5t1 ! heal? c>e provid] %all-- 
7i7 in=m ! pati5t t a comp\nd$ drug w be
 us$ dur+ ! proc$ure2 &  7ii7 provide   
su* pati5t ) a writt5 docum5t conta9+ ! 

in=mation describ$ 9 subp>agraph        
7,a77ii74  7#e7 ,label+  7,a7 ,9 g5]al  
,a drug product comp\nd$ "u subsection  
7a7 %all be cle>ly label$ z a non-,,fda 
approv$ comp\nd$ drug product4  7,b7    
,developm5t ( requirem5ts ,9 det]m9+ !  
requirem5ts = ! label "u subp>agraph    
7,a71 ! ,secret>y--  7i7 %all e/abli%1 &
 consult )1 a tempor>y advisory         
committee on comp\nd$ drug product      
label+ requirem5ts2 &  7ii7 may e/abli% 
diff]5t label+ requirem5ts =--  7,i7 a  
comp\nd$ drug product int5d$ = use by a 
heal? c>e provid] 9 an (fice or treatm5t
 sett+2 &  7,,ii7 a comp\nd$ drug       
product int5d$ = any use n describ$ 9   
subclause 7,i74  7#f7 ,regi/ration  7,a7
 ,e/abli%m5t ( process ,! ,secret>y1 9  
consultation ) exp]ts & repres5tatives (
 /akehold]s includ+ ph>macies1 comp\nd+ 
ph>macies1 ,/ate regulators1 & heal? c>e
 provid]s1 %all e/abli% a process =     
ph>macies describ$ 9 subsection         
7a77#a77;,a7 to regi/] z a comp\nd+     
ph>macy4 ,su* regi/ration %all be       

conduct$ ?r\gh an electronic me?od4     
7,b7 ,regi/ration requirem5t ,except z  
provid$ 9 subp>agraph 7,c71 9 ord] to be
 regi/]$ ) ! ,secret>y = purposes (     
subsection 7a77#a77;,a71 e p]son :o owns
 or op]ates a ph>macy %all submit to !  
,secret>y1 9 su* "t & mann] z !         
,secret>y may require--  7i7 contact    
in=mation = ! ph>macy2  7ii7 ! ,/ate or 
,/ates t ! ph>macy is lic5s$ 92  7iii7 !
 me?ods us$ by ! facility 9 comp\nd+2 & 
7iv7 any additional in=mation requir$ by
 ! ,secret>y1 :i* may include ! quantity
 ( product comp\nd$ at su* ph>macy = !  
purpose ( det]m9+ if a drug manufactur+ 
facility is inappropriately regi/]+ z a 
comp\nd+ ph>macy4  7,c7 ,prohibition on 
dual regi/ration ,an entity regi/]$ "u  
?is subsection %all n be requir$ to     
submit a regi/ration "u section #eaj4   
7,d7 ,exception ,a ph>macy %all be      
exempt f ! requirem5t to regi/] "u      
subsection 7a77#a77;,a7 if ! ph>macy--  
7i7 employs few] ?an #bj full-"t        
employees 7or #bj full-"t equival5ts72 &

  7ii7 p]=ms traditional comp\nd+ ( drug
 products = use 9 a s+le ,/ate4  2 &    
7#c7 by add+ at ! end ( section #ejc;,a 
! foll[+3  7g7 ,database  7#a7 ,9 g5]al 
,! ,secret>y %all e/abli% & ma9ta9 a    
database ( in=mation on ph>macies       
comp\nd+ drug products "u subsection 7a7
 t are lic5s$ 9 m ?an "o ,/ate1         
includ+--  7,a7 ! m9imum /&>ds = a      
comp\nd+ ph>macy lic5se 9 ea* ,/ate2    
7,b7 relevant in=mation provid$ to !    
,secret>y by ,/ate ag5cies t regulate   
ph>macies2  7,c7 reliable1 timely1 &    
compreh5sive data relat$ to inspections 
( su* ph>macies1 includ+ !              
classification ( actions indicat$ z a   
result ( su* inspections2 &  7,d7 o!r   
in=mation det]m9$ relevant by !         
,secret>y4  7#b7 ,design ,! database "u 
p>agraph 7#a7--  7,a7 %all be           
accessible1 z det]m9$ appropriate by !  
,secret>y1 to ,/ate ag5cies t regulate  
ph>macies t comp\nd drug products2  7,b7
 %all enable ,/ates & ! ,secret>y to %>e
 in=mation to ensure appropriate        

ov]sight ( ph>macies t comp\nd drug     
products2  7,c7 %all be us$ by !        
,secret>y to in=m ! ,f$]al inspection & 
ov]sight ( ph>macies t comp\nd drug     
products to ensure t issues & ph>macies 
id5tifi$ 9 ! database receive           
appropriate ov]sight2 &  7,d7 %all be   
accessible1 z det]m9$ appropriate by !  
,secret>y1 to heal? c>e provid]s &      
consum]s4  7h7 ,active +r$i5ts & dosage 
=ms t %\ld n be comp\nd$ ,! ,secret>y   
%all1 aft] consultation ) appropriate   
/akehold]s 7includ+ ph>maci/s1 pati5t & 
public heal? advocacy gr\ps1            
manufactur]s1 & heal? c>e pr(essionals71
 promulgate a li/ ( active +r$i5ts &    
dosage =ms t %\ld n be comp\nd$1 because
 ! comp\nd+ ( su* active +r$i5t or      
dosage =m is reasonably likely to pres5t
 a risk to public heal?4  7i7 ,m9imum   
/&>ds  7#a7 ,9 g5]al ,! ,secret>y %all  
promulgate m9imum /&>ds = ! safe        
production ( comp\nd$ drug products "u  
?is section4  7#b7 ,cont5ts ,! /&>ds "u 
p>agraph 7#a7 %all ea* specify--  7,a7 !

 type ( comp\nd$ drug products to :i* !y
 apply2 &  7,b7 ! int5d$ r\te (         
adm9i/ration4  7j7 ,tra9+ ,! ,secret>y  
%all conduct a s]ies ( regional tra9+   
opportunities = ,/ate ag5cies t regulate
 ph>macies t comp\nd drug products4 ,^! 
tra9+ opportunities %all include        
in=mation on ! m9imum /&>ds "u          
subsection 7i71 sample inspection       
protocol1 & recordkeep+ to facilitate ! 
inclusion ( ,/ate f9d+s & inspections   
into ! database "u subsection 7g74  4   
7b7 ,deadl9es & advisory committees     
7#a7 ,deadl9e = issuance ( regulations  
,n lat] ?an #ah mon?s aft] ! date (     
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices %all issue     
regulations to implem5t--  7,a7         
p>agraphs 7#d7 & 7#e7 ( section         
#ejc;,a7b7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act1 z add$ by subsection    
7a72 &  7,b7 subsection 7g7 ( section   
#ejc;,a ( su* ,act4  7#b7 ,label+       
advisory committee  7,a7 ,e/abli%m5t ,! 
,secret>y ( ,heal? & ,human ,s]vices    

%all e/abli% an advisory committee on   
label+ 7z def9$ 9 section #bja ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cba77 ( comp\nd$ drug   
products & %all consult su* committee 9 
! developm5t ( ! regulations "u p>agraph
 7#a77;,a74  7,b7 ,memb]%ip ,! advisory 
committee %all include repres5tatives ( 
pati5ts or consum]s1 heal? c>e provid]s1
 comp\nd+ ph>macies1 ,/ate ag5cies t    
regulate comp\nd+ ph>macies1 & at lea/  
"o memb] ) exp]tise on cle>ly           
communicat+ in=mation 9 su* label+ (    
drugs4  7,c7 ,meet+s ,! advisory        
committee %all hold an initial meet+ n  
lat] ?an #f mon?s aft] ! date ( enactm5t
 ( ?is ,act4  7,d7 ,recomm5dations ,n   
lat] ?an #ab mon?s aft] ! date (        
enactm5t ( ?is ,act1 ! advisory         
committee %all submit to ! ,secret>y (  
,heal? & ,human ,s]vices recomm5dations 
on ! regulations "u p>agraph 7#a77;,a71 
includ+ recomm5dations on ! type (      
in=mation & language t %\ld be includ$  
on ! labels ( drug products t are       

comp\nd$ pursuant to section #ejc;,a ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 
7,e7 ,t]m9ation ,! advisory committee "u
 ?is subp>agraph %all t]m9ate ^u !      
submission ( ! recomm5dations "u        
subp>agraph 7,d74  7#c7 ,database       
advisory committee  7,a7 ,e/abli%m5t ,! 
,secret>y ( ,heal? & ,human ,s]vices    
%all e/abli% an advisory committee on ! 
database describ$ 9 section #ejc;,a7g7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic     
,act1 z add$ by subsection 7a71 & %all  
consult su* committee 9 ! developm5t ( !
 regulations "u p>agraph 7#a77;,b74     
7,b7 ,memb]%ip ,! advisory committee    
%all include repres5tatives ( pati5ts or
 consum]s1 heal? c>e provid]s1 comp\nd+ 
ph>macies1 ,/ate ag5cies t regulate     
comp\nd+ ph>macies1 & in=mation         
te*nology exp]ts4  7,c7 ,meet+s ,!      
advisory committee %all hold an initial 
meet+ n lat] ?an #f mon?s aft] ! date ( 
enactm5t ( ?is ,act4  7,d7              
,recomm5dations ,n lat] ?an #ab mon?s   
aft] ! date ( enactm5t ( ?is ,act1 !    

advisory committee %all submit to !     
,secret>y ( ,heal? & ,human ,s]vices    
recomm5dations on ! regulations "u      
p>agraph 7#a77;,b74  7,e7 ,t]m9ation ,! 
advisory committee "u ?is subp>agraph   
%all t]m9ate ^u ! submission ( !        
recomm5dations "u subp>agraph 7,d74     
7#d7 ,p]man5t advisory committee on     
ph>macy comp\nd+ ,! ,secret>y %all      
conv5e ! ,advisory ,committee on        
,ph>macy ,comp\nd+ z appropriate to     
consid] issues relat$ to ! safety &     
availability ( comp\nd$ drug products4  
#c4 ,reports & /udies  7a7 ,biannual    
reports ,n lat] ?an #f mon?s aft] ! date
 ( enactm5t ( ?is ,act1 & at ! end ( ea*
 succe$+ #f-mon? p]iod t ends be=e !    
#be? mon? aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices %all submit to ! ,congress a   
report on ! /atus ( ! implem5tation ( ! 
requirem5ts ( ?is ,act1 & ! am5dm5ts    
made by ?is ,act4  7b7 ,?ird-,p>ty      
,accr$itation ,n lat] ?an #ab mon?s aft]
 ! date ( enactm5t ( ?is ,act1 !        

,secret>y %all submit to ! ,congress a  
report t conta9s--  7#a7 a review ( !   
/&>ds us$ by organizations t provide    
accr$itation to comp\nd+ ph>macies2 &   
7#b7 an evaluation ( ! effectiv5ess (   
su* /&>ds 9 ensur+ ! production ( safe &
 effective comp\nd$ drug products4  7c7 
,/ructure ( ,/ate ov]sight ,n lat] ?an  
#ah mon?s aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y %all submit to !      
,congress a report t conta9s--  7#a7 a  
review ( ! models us$ by ,/ates to      
/ructure _! ov]sight ( ph>macies t      
comp\nd drug products1 includ+ !        
/ructure ( ! ag5cy or (fice responsible 
= ov]sight & its relation%ip ) ! indu/ry
 t x regulates2 &  7#b7 consid]ation (  
h[ ! /ructure & relation%ip ( ,/ate     
regulators may impact ! developm5t &    
en=cem5t ( regulations to ensure safe   
comp\nd$ drug products4  7d7 ,,gao      
report ,! ,comptroll] ,g5]al ( ! ,unit$ 
,/ates %all review--  7#a7 ! ext5t to   
:i* ,f$]al heal? c>e programs 7z su* t]m
 is def9$ 9 section #aabh;,b7f7 ( !     

,social ,security ,act 7#db ,u4,s4,c4   
#acbj;a-#g;b77 ensure t comp\nd$ drug   
products :i* are paid = by su* programs 
are comp\nd$ 9 facilities t comply ) !  
requirem5ts ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq472  7#b7 :e!r ! reimbursem5t rates =
 comp\nd$ drug products "u su* ,f$]al   
heal? c>e programs are appropriate1 tak+
 into consid]ation ! co/ ( production ( 
su* comp\nd$ drug products2 &  7#c7 :e!r
 su* ,f$]al heal? c>e programs enc\rage 
! use ( comp\nd$ drug products 9 place (
 o!rwise available lawfully m>ket$ drug 
products4  #d4 ,prohibitions & p5alties 
7a7 ,prohibition ( violations ( section 
#ejc;,a ,section #cja7;d7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cca7;d77 is am5d$ by ins]t+  
#ejc;,a1 be=e #eje14  7b7 ,p5alties     
,section #cjc7;b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ccc7;b77 is am5d$ by add+ at ! end !   
foll[+3  7#h7 ,not)/&+ subsection 7a71  
any p]son :o violates section #cja7;d7 )

 respect to any comp\nd$ drug product-- 
7,a7 kn[+ly & int5tionally to defraud or
 mislead2 or  7,b7 ) consci\s or        
reckless disreg>d ( a risk ( dea? or    
s]i\s bodily injury1  %all be f9$ "u    
title #ah1 ,unit$ ,/ates ,code1         
imprison$ = n m ?an #aj ye>s1 or bo?4  4