,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #bahf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #bc1 #bjac ,mr4  
,m>key 7= himself1 ,ms4 ,slaught]1 ,mr4 
,clay1 & ,mr4 ,rangel7 introduc$ !      
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide = ! comp\nd+
 ( drug products4  #a4 ,%ort title ,?is 
,act may be cit$ z ! ,v]ify+ ,au?ority &
 ,legality ,9 ,drug ,comp\nd+ ,act (    
#bjac or ! ,,valid ,comp\nd+ ,act4  #b4 
,application ( ,f$]al law to practice ( 
ph>macy comp\nd+  7a7 ,am5dm5t ,section 
#ejc;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is
 am5d$ to read z foll[s3  #ejc;,a4      
,ph>macy comp\nd+  7a7 ,9 g5]al         
,sections #eja7;a77#b77;,b71            
#ejb7;f77#a71 & #eje %all n apply )     
respect to a drug product if ea* ( !    
foll[+ applies3  7#a7 ,except z provid$ 
9 subsection 7d71 ! drug product is     
comp\nd$ = an id5tifi$ individual pati5t

 bas$ on ! receipt ( a prescription     
ord]4  7#b7 ,! drug product is comp\nd$ 
by a lic5s$ ph>maci/ 9 a ,/ate-lic5s$   
ph>macy or a ,f$]al facility1 or by a   
lic5s$ physician1 pursuant to su*       
prescription ord] or notation4  7#c7 ,9 
! case ( a drug product t is comp\nd$   
us+ bulk sub/ances 7z def9$ 9 section   
#bjg4c7;a77#d7 ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulations7--  7,a7 su* bulk           
sub/ances--  7i7 are compon5ts ( "o or m
 drugs = :i* an approval ( an           
application fil$ "u subsection 7b7 or   
7j7 ( section #eje is 9 effect2  7ii7   
are compon5ts ( drugs t may be lawfully 
m>ket$ 9 ! ,unit$ ,/ates )\t su* an     
approval pursuant to ! def9ition ( a new
 drug 9 section #bja2 or  7iii7 appe> on
 ! li/ 9 effect "u subsection 7b72 &    
7,b7 su* bulk sub/ances comply ) ! /&>ds
 ( an applicable ,unit$ ,/ates          
,ph>macopeia or ,national ,=mul>y       
monograph1 if a monograph exi/s4  7#d7  
,any bulk sub/ance us$ = purposes (     

comp\nd+ ! drug product--  7,a7 is      
manufactur$ by an e/abli%m5t t is       
regi/]$ "u section #eaj 7includ+ a =eign
 e/abli%m5t t is regi/]$ "u section     
#eaj7;i772 &  7,b7 is accompani$ by     
valid c]tificates ( analysis4  7#e7 ,!  
ph>maci/ or physician comp\nd+ ! drug   
product complies ) ! /&>ds ( any        
applicable ,unit$ ,/ates ,ph>macopeia   
*apt]s on ph>macy comp\nd+4  7#f7 ,!    
drug product1 includ+ ! dosage =m & any 
+r$i5t !re(--  7,a7 is n includ$ 9 ! li/
 "u subsection 7c72 &  7,b7 is n )drawn 
or remov$ f ! m>ket because su* drug    
product or any +r$i5t !re( has be5 f\nd 
to be unsafe or n effective4  7#g7      
,subject to subsection 7e71 ! drug      
product is n a copy ( a comm]cially     
available drug4  7#h7 ,if ! drug product
 is produc$ us+ high-risk /]ile         
comp\nd+1 ! drug product is comp\nd$ 9  
accordance ) ! /&>ds1 processes1 &      
proc$ures e/abli%$ "u subsection 7f74   
7b7 ,li/ ( bulk sub/ances f :i* drug    
products may be comp\nd$  7#a7 ,9 g5]al 

,= purposes ( subsection                
7a77#c77;,a77iii71 ! ,secret>y %all1 by 
guidance--  7,a7 develop & ma9ta9 a li/ 
( bulk sub/ances f :i* drug products may
 be comp\nd$2 &  7,b7 include 9 ! li/   
only bulk sub/ances t are n describ$ 9  
clause 7i7 or 7ii7 ( subsection         
7a77#c77;,a7 & may be comp\nd$ to meet a
 m$ical ne$ t _c be fill$ by us+ a bulk 
sub/ance t is describ$ 9 su* clause 7i7 
or 7ii72  7,c7 specify = ea* bulk       
sub/ance on ! li/ "u ?is subsection any 
limitation on comp\nd+ ! bulk sub/ance2 
&  7,d7 specify = ea* bulk sub/ance on !
 li/ "u ?is subsection ! p>ticul> m$ical
 ne$ t is met by plac+ su* sub/ance on !
 li/4  7#b7 ,initial publication2       
updates ,! ,secret>y %all--  7,a7 n lat]
 ?an #a ye> aft] ! date ( ! enactm5t ( !
 ,v]ify+ ,au?ority & ,legality ,9 ,drug 
,comp\nd+ ,act ( #bjac1 publi% an       
initial li/ "u p>agraph 7#a72 &  7,b7 n 
less frequ5tly ?an e ye> !reaft]1 review
 &1 z appropriate1 update ! li/ "u      
p>agraph 7#a74  7#c7 ,availability ,!   

,secret>y %all make ! li/ "u p>agraph   
7#a7 available on ! public ,web site ( !
 ,food & ,drug ,adm9i/ration4  7#d7     
,transmission to ,/ate regulatory       
ag5cies ,^u publication ( ! initial li/ 
"u p>agraph 7#a71 & ^u ea* update to !  
li/1 ! ,secret>y %all transmit an       
up-to-date copy ( ! li/ to ! ag5cy 9 ea*
 ,/ate ) prim>y responsibility =        
regulat+ ph>macies4  7#e7 ,petitions    
7,a7 ,9 g5]al ,9 c>ry+ out ?is          
subsection1 ! ,secret>y %all receive &  
consid] petitions f any p]son id5tify+ a
 sub/ance t %\ld be add$ to1 or remov$  
f1 ! li/ "u ?is subsection4  7,b7       
,requirem5t = petitions seek+ to add a  
bulk sub/ance ,any petition seek+ to add
 a bulk sub/ance to ! li/ "u ?is        
subsection %all specify ! reasons--  7i7
 :y ! bulk sub/ance is ne$$ = a proc$ure
 or population2 &  7ii7 :y su* ne$ is n 
met by bulk sub/ances t are describ$ 9  
clause 7i7 or 7ii7 ( subsection         
7a77#c77;,a74  7,c7 ,approval or d5ial  
,! ,secret>y %all approve or d5y any    

petition receiv$ "u ?is p>agraph1 &     
update ! li/ "u p>agraph 7#a7 accord+ly1
 n lat] ?an #ij days aft] receipt ( !   
petition1 unless an ext5sion ( "t is    
mutually agre$ ^u by ! ,secret>y & !    
petition]4  7,d7 ,f9al ag5cy action ,a  
decision ( ! ,secret>y to approve or d5y
 a petition receiv$ "u ?is p>agraph %all
 con/itute f9al ag5cy action subject to 
judicial review4  7,e7 ,public po/+ ,!  
,secret>y %all publically po/--  7i7 all
 petitions receiv$ "u ?is p>agraph )9   
#ba days ( receipt2 &  7ii7 ea*         
approval1 d5ial1 & ext5sion "u          
subp>agraph 7,c7 promptly4  7c7 ,li/ (  
drug products t %\ld n be comp\nd$  7#a7
 ,9 g5]al ,= purposes ( subsection      
7a77#f71 ! ,secret>y %all1 by guidance--
  7,a7 develop & ma9ta9 a li/ ( drug    
products t %\ld n be comp\nd$1 includ+  
any categories1 dosage =ms1 or +r$i5ts (
 su* drug products2 &  7,b7 include on  
su* li/1 at a m9imum--  7i7 drug        
products 7or categories1 dosage =ms1 or 
+r$i5ts !re(7 ^: comp\nd+ is reasonably 

likely to cause an adv]se effect on     
safety or effectiv5ess ( su* drug       
product1 includ+ ext5d$ release         
products1 met]$ dose inhal]s1 transd]mal
 pat*es1 & liposomal products2 &  7ii7  
drug products 7or categories1 dosage    
=ms1 or +r$i5ts !re(7 t h be5 )drawn or 
remov$ f ! m>ket because !y h be5 f\nd  
to be unsafe or n effective4  7#b7      
,applicability ( c]ta9 provisions ,!    
provisions ( p>agraphs 7#b71 7#c71 &    
7#d7 ( subsection 7b7 %all apply )      
respect to ! li/ "u ?is subsection to ! 
same ext5t & 9 ! same mann] z su*       
provisions apply ) respect to ! li/ "u  
subsection 7b74  7#c7 ,petitions ,9     
c>ry+ out ?is subsection1 ! ,secret>y   
%all receive & consid] petitions f any  
p]son id5tify+ a drug product t %\ld be 
add$ to1 or remov$ f1 ! li/ "u ?is      
subsection4 ,subp>agraphs 7,c7 ?r\gh    
7,e7 ( subsection 7b77#b7 %all apply )  
respect to petitions "u ?is p>agraph to 
! same ext5t & 9 ! same mann] z su*     
subp>agraphs apply ) respect to         

petitions "u subsection 7b77#e74  7d7   
,exception to requirem5t ( id5tifi$     
individual pati5t  7#a7 ,9 ,g5]al ,a    
ph>macy or ph>maci/ t is n requir$ to be
 regi/]$ "u section #eaj may comp\nd a  
drug product )\t reg>d to subsection    
7a77#a7 if ! ph>macy or ph>maci/--  7,a7
 regi/]s ) ! ,secret>y z specifi$       
pursuant to p>agraph 7#b72 &  7,b7      
agrees to comply ) any condition (      
op]ation or limitation ( activity       
specifi$ by ! ,secret>y1 includ+ !      
conditions & limitations specifi$       
pursuant to p>agraph 7#b74  7#b7        
,regi/ration & requirem5ts ,! ,secret>y 
%all specify by regulation = ea* type ( 
ph>macy or ph>maci/ comp\nd+ drug       
products pursuant to ! exception "u ?is 
subsection--  7,a7 ! regi/ration        
requirem5ts = su* ph>macy or ph>maci/ & 
! in=mation t mu/ be submitt$ ) !       
regi/ration1 :i* in=mation %all         
include--  7i7 ! "n & location ( !      
ph>macy2  7ii7 ! types ( drugs t are    
comp\nd$2  7iii7 ! active +r$i5ts 9 ea* 

su* drug2  7iv7 ! s\rce & /r5g? ( !     
active +r$i5t 9 ea* drug2  7v7 ! dosage 
=m & r\te ( adm9i/ration ( ea* drug2    
7vi7 ! numb] ( individual units produc$ 
( ea* drug2  7vii7 ! ,/ates to :i* drugs
 7 %ipp$2  7viii7 ! numb] ( individual  
units ( ea* drug t are %ipp$ to ea*     
,/ate2 &  7ix7 affirmation t ! ph>macy  
or ph>maci/ is 9 compliance ) ,/ate     
ph>macy lic5s+ regulations2  7,b7 !     
frequ5cy 9 :i* in=mation describ$ 9     
subp>agraph 7,a7 mu/ be submitt$2  7,c7 
! conditions ( op]ation1 includ+ good   
manufactur+ practices & requirem5ts =   
?ird-p>ty te/+1 applicable to ! comp\nd+
 ( drugs2 &  7,d7 any limitations on !  
activities ( su* ph>macy or ph>maci/4   
7#c7 ,types ( ph>macies eligible ,!     
,secret>y %all specify sep>ate          
requirem5ts = ea* type ( ph>macy &      
ph>maci/ au?oriz$ to comp\nd drug       
products pursuant to ! exception "u ?is 
subsection4 ,! ,secret>y %all include   
sep>ate requirem5ts =--  7,a7 any       
ph>macy or ph>maci/ )9 a hospital sy/em 

t is comp\nd+ drug products exclusively 
= disp5s+ to pati5ts )9 t hospital      
sy/em2 &  7,b7 any ph>macy or ph>maci/ t
 comp\nds /]ile drug products4  7#d7    
,memor&um ( und]/&+  7,a7 ,9 g5]al      
,subject to subp>agraph 7,c71 !         
,secret>y may ent] into appropriate     
memor&a ( und]/&+ ) ,/ates to address   
,/ate implem5tation ( ! exception "u ?is
 subsection--  7i7 ensur+1 to !         
,secret>y's satisfaction1 t ! ,/ate w   
implem5t ! exception "u ?is subsection 9
 accordance ) ! requirem5ts ( ?is       
section2 &  7ii7 includ+ su* o!r        
in=mation & assurances z ! ,secret>y may
 require4  7,b7 ,process2 crit]ia ,!    
,secret>y %all--  7i7 e/abli% a process 
& crit]ia = ent]+ into a memor&um (     
und]/&+ "u ?is p>agraph1 includ+ ! %>+ (
 in=mation betwe5 ,/ate & ,f$]al        
au?orities2 &  7ii7 reevaluate ea* su*  
memor&um ( und]/&+ n less ?an e #e ye>s 
to ensure1 to ! ,secret>y's             
satisfaction1 t ! ,/ate's implem5tation 
( ! memor&um ( und]/&+ cont9ues to con=m

 to ! requirem5ts ( ?is section4  7,c7  
,exclusive ,f$]al au?ority ,! ,secret>y 
%all reta9 exclusive ,f$]al au?ority to 
implem5t ! exception "u ?is subsection )
 respect to ph>macies & ph>maci/s t--   
7i7 p]=m high-risk /]ile comp\nd+2 or   
7ii7 comp\nd drug products = %ipm5t     
across ,/ate l9es4  7#e7 ,ma9t5ance (   
li/ ,! ,secret>y %all ma9ta9 a          
publically available li/--  7,a7        
id5tify+ all ph>macies & ph>maci/s      
regi/]$ "u ?is subsection2 &  7,b7      
indicat+1 = ea* su* ph>macy & ph>maci/1 
:e!r ! ph>macy or ph>maci/ is subject to
 regulation by a ,/ate pursuant to a    
memor&um ( und]/&+ 9 effect "u p>agraph 
7#d74  7e7 ,exceptions reg>d+ copies (  
comm]cially available drugs ,a drug t is
 a copy ( a comm]cially available drug  
may be comp\nd$ pursuant to ?is section 
)\t reg>d to subsection 7a77#g7 if--    
7#a7 7,a7 ! comm]cially available drug t
 is be+ comp\nd$ is at ! "t (           
di/ribution on ! drug %ortage li/ "u    
section #ejf;,e1 & ! ph>macy has provid$

 notice to ! ,secret>y t su* drug is be+
 comp\nd$ n lat] ?an #e days aft]       
di/ribut+ su* drug2 or  7,b7 ! ,secret>y
 det]m9es t comp\nd+ ! drug product is  
necess>y to protect public heal? or     
wellbe+2 &  7#b7 9 ! case ( a           
comm]cially available drug m>ket$       
pursuant to a risk evaluation &         
mitigation /rategy approv$ "u section   
#eje-a & includ+ "o or m elem5ts to     
assure safe use1 ! ph>macy or ph>maci/  
comp\nd+ ! drug t is a copy ( su*       
comm]cially available drug demon/rates  
to ! ,secret>y t controls w be us$ t are
 comp>able to su* elem5ts to assure safe
 use4  7f7 ,high-,risk /]ile comp\nd+ ,=
 purposes ( subsection 7a77#h71 !       
,secret>y %all e/abli% /&>ds1 processes1
 & proc$ures = high-risk /]ile comp\nd+4
  7g7 ,inspections ,not)/&+ section     
#gjd7;a77#b77;,a71 ! facilities ( any   
ph>macy or ph>maci/ comp\nd+ drug       
products "u ?is section--  7#a7 %all be 
subject to inspection "u section #gjd2 &
  7#b7 %all1 ^u reque/ ( an (fic] or    

employee designat$ by ! ,secret>y1 p]mit
 su* (fic] or employee at all reasonable
 times to h access to1 & to copy &      
v]ify1 records = purposes ( det]m9+     
compliance ) ! provisions ( ?is ,act    
applicable to su* comp\nd+4  7h7 ,%>+ ( 
in=mation ,if dur+ an inspection ( !    
facilities ( a ph>macy or ph>maci/ "u   
?is section ! ,secret>y discov]s a      
violation ( ?is ,act1 ! ,secret>y %all  
give notice ( ! violation--  7#a7 to !  
,/ate 9 :i* ! facilities are locat$2 &  
7#b7 to any ,/ate to :i* ! ph>macy or   
ph>maci/ has %ipp$ a drug product dur+ !
 prec$+ #cj days4  7i7 ,label+ ,! label+
 ( any drug product comp\nd$ pursuant to
 ?is section %all include--  7#a7 ! "n (
 ea* drug & +r$i5t includ$2  7#b7 ! "n1 
address1 & phone numb] ( ! lic5s$       
comp\nd+ ph>macy1 ph>maci/1 or          
physician2  7#c7 ! date on :i* ! drug 0 
comp\nd$2  7#d7 in/ructions = /orage &  
use2  7#e7 ! foll[+ /atem5t3 ,?is drug  
has n be5 te/$ = safety & effectiv5ess &
 is n approv$ by ! ,,fda4 ,?is drug 0   

made specifically = y because y\r heal? 
c>e provid] det]m9$ t no ,,fda-approv$  
product w\ld suit y\r ne$s4 ,s]i\s      
adv]se reactions to ?is drug %\ld be    
report$ to ! ,,fda at 1 to ! ph>macy :]e
 ! drug 0 receiv$1 & to y\r heal? c>e   
provid]4 7,! blank %all specify a phone 
numb] & a ,web site1 to be provid$ by ! 
,secret>y = purposes ( ?is subsection472
 &  7#f7 su* o!r in=mation z ! ,secret>y
 may require4  7j7 ,report+ by ph>maci/s
 & physicians  7#a7 ,adv]se ev5t ,if a  
ph>maci/ or physician comp\nd+ a drug   
product pursuant to ?is section becomes 
aw>e ( any adv]se ev5t associat$ ) ! use
 ( su* product1 n lat] ?an #aj cal5d>   
days aft] becom+ s aw>e1 ! ph>maci/ or  
physician %all report su* adv]se ev5t to
 ! ,secret>y4  7#b7 ,in=mation relat$ to
 risk ( injury or dea? ,if a ph>maci/ or
 physician comp\nd+ a drug product      
pursuant to ?is section becomes aw>e (  
in=mation conc]n+ any bact]iological1   
fungal1 or o!r contam9ation2 any        
significant *emical1 physical1 or o!r   

*ange2 or any det]ioration ( a comp\nd$ 
drug product t has already be5 di/ribut$
 by ! ph>maci/ or physician1 t c\ld     
cause s]i\s injury or dea?1 n lat] ?an  
#b cal5d> days aft] becom+ s aw>e1 !    
ph>maci/ or physician %all report su*   
in=mation to ! ,secret>y4  7k7 ,comp\nd+
 e/abli%m5t & re9spection fees  7#a7    
,def9itions ,9 ?is subsection--  7,a7 ! 
t]m affiliate has ! mean+ giv5 su* t]m 9
 section #gce7aa72  7,b7 ! t]m cov]$    
comp\nd+ ph>macy means a ph>macy t1     
pursuant to subsection 7d7 7! exception 
to ! requirem5t ( an id5tifi$ individual
 pati5t7--  7i7 p]=ms high-risk /]ile   
comp\nd+2  7ii7 comp\nds drug products =
 %ipm5t across ,/ate l9es2 or  7iii7    
o!rwise p]=ms comp\nd+ pursuant to      
subsection 7d7 t is n regulat$ by a     
,/ate pursuant to a memor&um ( und]/&+  
"u subsection 7d77#d72  7,c7 ! t]m gross
 annual sales means ! total worldwide   
gross annual sales1 9 ,unit$ ,/ates     
doll>s1 = a cov]$ comp\nd+ ph>macy1     
includ+ ! sales ( all ! affiliates ( !  

cov]$ comp\nd+ ph>macy2 &  7,d7 ! t]m   
re9spection means1 ) respect to a cov]$ 
comp\nd+ ph>macy1 "o or m inspections   
conduct$ "u section #gjd subsequ5t to an
 inspection conduct$ "u su* provision   
:i* id5tifi$ noncompliance mat]ially    
relat$ to an applicable requirem5t ( ?is
 ,act1 specifically to det]m9e :e!r     
compliance has be5 a*iev$ to !          
,secret>y's satisfaction4  7#b7         
,e/abli%m5t & re9spection fees  7,a7 ,9 
g5]al ,= fiscal ye> #bjae & ea*         
subsequ5t fiscal ye>1 ! ,secret>y %all1 
9 accordance ) ?is subsection1 assess & 
collect--  7i7 an annual e/abli%m5t fee 
f ea* cov]$ comp\nd+ ph>macy2 &  7ii7 a 
re9spection fee f ea* cov]$ comp\nd+    
ph>macy subject to a re9spection 9 su*  
fiscal ye>4  7,b7 ,multiple re9spections
 ,a cov]$ comp\nd+ ph>macy subject to   
multiple re9spections 9 a fiscal ye>    
%all be subject to a re9spection fee =  
ea* re9spection4  7#c7 ,e/abli%m5t &    
re9spection fee sett+ ,! ,secret>y %all 
e/abli% ! e/abli%m5t & re9spection fee  

to be collect$ "u ?is subsection = ea*  
fiscal ye>1 bas$ on ! me?odology        
describ$ 9 p>agraph 7#d7 & %all publi%  
su* fee 9 a ,f$]al ,regi/] notice n lat]
 ?an #fj days be=e ! />t ( ea* su* ye>4 
7#d7 ,am\nt ( e/abli%m5t fee &          
re9spection fee  7,a7 ,9 g5]al ,= ea*   
cov]$ comp\nd+ ph>macy 9 a fiscal ye>-- 
7i7 except z provid$ 9 subp>agraph 7,d71
 ! am\nt ( ! annual e/abli%m5t fee "u   
p>agraph 7#b7 %all be equal to ! sum (--
  7,i7 #ae1jjj1 multipli$ by ! inflation
 adju/m5t factor describ$ 9 subp>agraph 
7,b72 plus  7,,ii7 ! small bus9ess      
adju/m5t factor describ$ 9 subp>agraph  
7,c72 &  7ii7 ! am\nt ( any re9spection 
fee 7if applicable7 "u p>agraph 7#b7    
%all be equal to #ae1jjj1 multipli$ by !
 inflation adju/m5t factor describ$ 9   
subp>agraph 7,b74  7,b7 ,inflation      
adju/m5t factor  7i7 ,9 g5]al ,= fiscal 
ye> #bjae & subsequ5t fiscal ye>s1 ! fee
 am\nts e/abli%$ 9 subp>agraph 7,a7 %all
 be adju/$ by ! ,secret>y by notice1    
publi%$ 9 ! ,f$]al ,regi/]1 = a fiscal  

ye> by ! am\nt equal to ! sum (--  7,i7 
"o2  7,,ii7 ! av]age annual p]c5t *ange 
9 ! co/1 p] full-"t equival5t position (
 ! ,food & ,drug ,adm9i/ration1 ( all   
p]sonnel comp5sation & b5efits paid )   
respect to su* positions = ! fir/ #c    
ye>s ( ! prec$+ #d fiscal ye>s1         
multipli$ by ! proportion ( p]sonnel    
comp5sation & b5efits co/s to total co/s
 ( an av]age full-"t equival5t position 
( ! ,food & ,drug ,adm9i/ration = ! fir/
 #c ye>s ( ! prec$+ #d fiscal ye>s2 &   
7,,iii7 ! av]age annual p]c5t *ange t   
occurr$ 9 ! ,consum] ,price ,index =    
urban consum]s 7,u4,s4 ,city ,av]age2 ,n
 ,seasonally ,adju/$2 ,all items2       
,annual ,index7 = ! fir/ #c ye>s ( !    
prec$+ #d ye>s ( available data         
multipli$ by ! proportion ( all co/s o!r
 ?an p]sonnel comp5sation & b5efits co/s
 to total co/s ( an av]age full-"t      
equival5t position ( ! ,food & ,drug    
,adm9i/ration = ! fir/ #c ye>s ( !      
prec$+ #d fiscal ye>s4  7ii7 ,comp\nd$  
basis ,! adju/m5t made ea* fiscal ye> "u

 clause 7i7 %all be add$ on a comp\nd$  
basis to ! sum ( all adju/m5ts made ea* 
fiscal ye> aft] fiscal ye> #bjad "u     
clause 7i74  7,c7 ,small bus9ess        
adju/m5t factor ,! small bus9ess        
adju/m5t factor ref]r$ to subp>agraph   
7,a77i77,,ii7 %all be an am\nt e/abli%$ 
by ! ,secret>y = ea* fiscal ye> bas$ on 
! ,secret>y's e/imate (--  7i7 ! numb] (
 small bus9esses t w pay a r$uc$        
e/abli%m5t fee = su* fiscal ye>2 &  7ii7
 ! adju/m5t to ! e/abli%m5t fee necess>y
 to a*ieve total fees equal+ ! total    
fees t ! ,secret>y w\ld h collect$ if no
 entity qualifi$ = ! small bus9ess      
exception 9 subp>agraph 7,d74  7,d7     
,exception = small bus9esses  7i7 ,9    
g5]al ,9 ! case ( a cov]$ comp\nd+      
ph>macy ) gross annual sales (          
#a1jjj1jjj or less 9 ! #ab mon?s end+   
,april #a ( ! fiscal ye> imm$iately     
prec$+ ! fiscal ye> 9 :i* ! fees "u ?is 
subsection are assess$1 ! am\nt ( !     
e/abli%m5t fee "u p>agraph 7#b7 = a     
fiscal ye> %all be equal to #a_/c ( !   

am\nt calculat$ "u subp>agraph          
7,a77i77,i7 9 su* fiscal ye>4  7ii7     
,application ,to qualify = ! exception  
"u ?is subp>agraph1 a small bus9ess %all
 submit to ! ,secret>y a writt5 reque/ =
 su* exception1 9 a =mat specifi$ by !  
,secret>y 9 guidance1 c]tify+ its gross 
annual sales = ! #ab mon?s end+ ,april  
#a ( ! fiscal ye> imm$iately prec$+ !   
fiscal ye> 9 :i* fees "u ?is subsection 
are assess$4 ,any su* application mu/ be
 submitt$ to ! ,secret>y n lat] ?an     
,april #cj = ! foll[+ fiscal ye>4 ,any  
/atem5t or repres5tation made to !      
,secret>y %all be subject to section    
#ajja ( title #ah1 ,unit$ ,/ates ,code4 
7,e7 ,cr$it+ ( fees ,9 e/abli%+ ! small 
bus9ess adju/m5t factor "u subp>agraph  
7,c7 = a fiscal ye>1 ! ,secret>y %all   
provide = ! cr$it+ ( fees f ! previ\s   
ye> to ! next ye> if ! ,secret>y        
ov]e/imat$ ! am\nt ( ! small bus9ess    
adju/m5t factor = su* previ\s fiscal    
ye>1 & consid] ! ne$ to acc\nt = any    
adju/m5t ( fees & su* o!r factors z !   

,secret>y det]m9es appropriate4  7#e7   
,use ( fees ,! ,secret>y %all make all (
 ! fees collect$ pursuant to clauses 7i7
 & 7ii7 ( p>agraph 7#b77;,a7 available  
solely to pay = ! co/s ( ov]sight (     
cov]$ comp\nd+ ph>macies4  7#f7         
,supplem5t n supplant ,funds receiv$ by 
! ,secret>y pursuant to ?is subsection  
%all be us$ to supplem5t & n supplant   
any o!r ,f$]al funds available to c>ry  
out ! activities describ$ 9 ?is section4
  7#g7 ,cr$it+ & availability ( fees    
,fees au?oriz$ "u ?is subsection %all be
 collect$ & available = obligation only 
to ! ext5t & 9 ! am\nt provid$ 9 advance
 9 appropriations ,acts4 ,su* fees are  
au?oriz$ to rema9 available until       
exp5d$4 ,su* sums z may be necess>y may 
be transf]r$ f ! ,food & ,drug          
,adm9i/ration sal>ies & exp5ses         
appropriation acc\nt )\t fiscal ye>     
limitation to su* appropriation acc\nt =
 sal>ies & exp5ses ) su* fiscal ye>     
limitation4 ,! sums transf]r$ %all be   
available solely = ! purpose ( pay+ !   

co/s ( ov]sight ( cov]$ comp\nd+        
ph>macies4  7#h7 ,collection ( fees     
7,a7 ,e/abli%m5t fee ,a cov]$ comp\nd+  
ph>macy %all remit ! e/abli%m5t fee due 
"u ?is subsection 9 a fiscal ye> :5     
submitt+ a regi/ration pursuant to      
subsection 7d7 = su* fiscal ye>4  7,b7  
,re9spection fee ,! ,secret>y %all      
specify 9 ! ,f$]al ,regi/] notice       
describ$ 9 p>agraph 7#c7 ! mann] 9 :i*  
re9spection fees assess$ "u ?is         
subsection %all be collect$ & ! timel9e 
= paym5t ( su* fees4 ,su* a fee %all be 
collect$ aft] ! ,secret>y has conduct$ a
 re9spection ( ! cov]$ comp\nd+ ph>macy 
involv$4  7,c7 ,effect ( failure to pay 
fees  7i7 ,regi/ration ,a cov]$ comp\nd+
 ph>macy %all n be consid]$ regi/]$ "u  
subsection 7d7 9 a fiscal ye> until !   
date t ! cov]$ comp\nd+ ph>macy remits !
 e/abli%m5t fee "u ?is subsection = su* 
fiscal ye>4  7ii7 ,misbr&+ ,all drugs   
manufactur$1 prep>$1 propagat$1         
comp\nd$1 or process$ by a cov]$        
comp\nd+ ph>macy = :i* any e/abli%m5t   

fee or re9spection fee has n be5 paid z 
requir$ by ?is subsection %all be deem$ 
misbr&$ "u section #ejb7;cc7 until !    
fees ow$ = su* cov]$ comp\nd+ ph>macy "u
 ?is subsection h be5 paid4  7,d7       
,collection ( unpaid fees ,9 any case   
:]e ! ,secret>y does n receive paym5t ( 
a fee assess$ "u ?is subsection )9 #cj  
days aft] x is due1 su* fee %all be     
treat$ z a claim ( ! ,unit$ ,/ates      
,gov]nm5t subject to provisions (       
sub*apt] ,,ii ( *apt] #cg ( title #ca1  
,unit$ ,/ates ,code4  7#i7 ,annual      
report to congress ,n lat] ?an #abj days
 aft] ea* fiscal ye> 9 :i* fees are     
assess$ & collect$ "u ?is subsection1 ! 
,secret>y %all submit a report to !     
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate1 to include a       
description ( fees assess$ & collect$ = 
ea* ye>1 a summ>y description ( entities
 pay+ ! fees1 & ! numb] ( inspections & 
re9spections ( su* entities p]=m$ ea*   

ye>4  7#aj7 ,au?orization (             
appropriations ,= fiscal ye> #bjae & ea*
 subsequ5t fiscal ye>1 !re is au?oriz$  
to be appropriat$ = fees "u ?is         
subsection an am\nt equival5t to ! total
 am\nt ( fees assess$ = su* fiscal ye>  
"u ?is subsection4  7l7 ,def9itions ,9  
?is section3  7#a7 ,! t]ms comp\nd &    
comp\nd+--  7,a7 d 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+2 &  7,b7 9 ! case (
 a radioactive drug 7z def9$ 9 section  
#caj4c7n7 ( title #ba1 ,code ( ,f$]al   
,regulations 7or any successor          
regulations771 also d n include a m9or  
deviation f su* directions ) reg>d to   
radioactivity1 volume1 or /ability1 t is
 made by or "u ! direct sup]vision ( an 
au?oriz$ nucle> ph>maci/ or a physician 
:o is an au?oriz$ us] 7z su* t]ms are   
def9$ 9 section #ce4b ( title #aj1 ,code
 ( ,f$]al ,regulations1 7or any         

successor regulations774  7#b7 ,! t]m   
copy ( a comm]cially available drug     
product does n include 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 product1 provid$ t 9 !   
case ( a radioactive drug 7z def9$ 9    
section #caj4c7n7 ( title #ba1 ,code (  
,f$]al ,regulations 7or any successor   
regulations771 ! reasons = ! det]m9ation
 by ! prescrib+ practition] h be5       
docum5t$ & su* docum5tation is ma9ta9$  
by ! ph>macy4  7#c7 ,! t]m high-risk    
/]ile comp\nd+ means comp\nd+ /]ile drug
 products us+ non/]ile +r$i5ts1 non/]ile
 devices1 or non/]ile compon5ts4  4  7b7
 ,misbr&+ ,section #ejb ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #ceb7 is am5d$ by add+ at !   
end ! foll[+3  7bb7 ,if x is a drug     
product comp\nd$ pursuant to section    
#ejc;,a & its label+ does n include !   

in=mation requir$ by section #ejc;,a7i74
  7cc7 ,if x is a drug1 & x 0           
manufactur$1 prep>$1 propagat$1         
comp\nd$1 or process$ by a comp\nd+     
manufactur] = :i* fees h n be5 paid z   
requir$ by section #ejc;,a7k74  4  7c7  
,con=m+ am5dm5t ,section                
#gjd7;a77#b77;,a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cgd7;a77#b77;,a77 is am5d$ by ins]t+   
subject to section #ejc;,a1 be=e        
ph>macies :i* ma9ta9 e/abli%m5ts4  7d7  
,regulations ,n lat] ?an #a ye> aft] !  
date ( ! enactm5t ( ?is ,act1 !         
,secret>y %all promulgate f9al          
regulations = c>ry+ out ! am5dm5ts made 
by subsections 7a71 7b71 & 7c74  7e7    
,effective date ,! am5dm5ts made by     
subsections 7a71 7b71 & 7c7 %all take   
effect on ! date t is #a ye> aft] ! date
 ( ! enactm5t ( ?is ,act4  #c4          
,regi/ration ( manufactur]s comp\nd+    
drug products  7a7 ,regi/ration ,section
 #eaj7;g7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;g77 

is am5d$ by add+ at ! end ! foll[+3 ,)  
respect to comp\nd+ drugs1 ! exemption 9
 p>agraph 7#a7 does n apply ) respect to
 any ph>macy to ! ext5t to :i* ! ph>macy
 is1 9 effect1 manufactur+ su* drugs1 z 
det]m9$ by ! ,secret>y1 tak+ into       
consid]ation ! ext5t to :i* su* ph>macy 
sells ! drugs across ,/ate l9es1 !      
quantity ( ! drugs sold1 & any o!r      
factors det]m9$ appropriate by !        
,secret>y44  7b7 ,regulations ,n lat]   
?an #a ye> aft] ! date ( ! enactm5t (   
?is ,act1 ! ,secret>y ( ,heal? & ,human 
,s]vices %all promulgate regulations =  
c>ry+ out ! am5dm5t made by subsection  
7a74  7c7 ,effective date ,! am5dm5t    
made by subsection 7a7 %all take effect 
on ! date t is #a ye> aft] ! date ( !   
enactm5t ( ?is ,act4  #d4 ,no preemption
 ( additional non-,f$]al requirem5ts ,! 
requirem5ts ( ?is ,act 7includ+ !       
requirem5ts ( ! am5dm5ts made by ?is    
,act7 d n preempt any non-,f$]al        
requirem5t t is 9 addition to1 &        
compatible )1 su* requirem5ts4