,,ii  #aac? ,,congress  #a/ ,session    
,s4 #iei  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,may #ae1 #bjac ,mr4   
,h>k9 7= himself1 ,mr4 ,alex&]1 ,mr4    
,rob]ts1 ,mr4 ,frank51 & ,ms4 ,mikulski7
 introduc$ ! foll[+ bill2 :i* 0 read    
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to    
comp\nd+ drugs4  #a4 ,%ort title2       
ref]5ces 9 ,act  7a7 ,%ort title ,?is   
,act may be cit$ z ! ,ph>maceutical     
,comp\nd+ ,quality & ,acc\ntability     
,act4  7b7 ,ref]5ces 9 ,act ,except z   
o!rwise specifi$1 am5dm5ts made by ?is  
,act to a section or o!r provision ( law
 are am5dm5ts to su* section or o!r     
provision ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq474  #b4 ,regulation ( human & animal
 drug comp\nd+  7a7 ,cl>ification ( new 
drug & new animal drug /atus ,= purposes
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cja et seq471 !    

t]ms new drug 7z def9$ 9 section #bja7p7
 ( su* ,act7 & new animal drug 7z def9$ 
9 section #bja7v7 ( su* ,act7 %all      
include a comp\nd$ human drug & a       
comp\nd$ animal drug1 respectively4  7b7
 ,regulation ( human & animal drug      
comp\nd+ ,section #ejc;,a 7#ba ,u4,s4,c4
 #cec;a7 is am5d$ to read z foll[s3     
#ejc;,a4 ,human & animal drug comp\nd+  
7a7 ,scope  7#a7 ,comp\nd+ ,9 ?is       
section1 ! t]ms comp\nd+ & comp\nd--    
7,a7 include--  7i7 ! comb9+1 admix+1   
mix+1 dilut+1 recon/itut+1 or o!rwise   
alt]+ ( a m>ket$ drug2  7ii7 comp\nd+ a 
drug f a bulk drug sub/ance2 &  7iii7   
repackag+1 z def9$ 9 subsection 7b77#e72
 &  7,b7 exclude mix+1 recon/itut+1 or  
o!r su* acts ) respect to a m>ket$ drug 
t are limit$ to & p]=m$ solely 9        
accordance ) specific directions = su*  
acts conta9$ 9 approv$ label+ provid$ by
 a drug's manufactur]1 :5 p]=m$ ^u      
receipt ( a prescription ord] = an      
id5tifi$ individual pati5t4  7#b7       
,disp5s+ n a sale ,9 ?is section1 ! t]ms

 sell or resale d n include disp5s+ to  
pati5ts1 or1 9 ! case ( animal drugs1 to
 ! individual responsible = provid+ c>e 
= ! animal = :i* ! drug is int5d$1 9    
accordance ) ,/ate law1 includ+ any fee 
associat$ ) su* disp5s+4  7#c7          
,exemptions ,?is section %all n apply   
to--  7,a7 m$ical gases2  7,b7 animal   
drugs t are subject to regulation z     
biological products by ! ,secret>y (    
,agriculture "u ! ,act commonly kn[n z !
 ,virus-,s]um-,tox9 ,act2 or  7,c7 human
 blood & blood compon5ts = transfusion4 
7b7 ,def9itions ,9 ?is section3  7#a7   
,comp\nd+ manufactur]  7,a7 ,9 g5]al ,! 
t]m comp\nd+ manufactur] means a        
facility at "o geographic location or   
address--  7i7 t comp\nds any /]ile drug
 product )\t receiv+ a prescription ord]
 = su* /]ile drug product prior to      
beg9n+ comp\nd+1 & di/ributes or (f]s to
 sell su* comp\nd$ /]ile drug product 9 
int]/ate comm]ce2 or  7ii7 t repackages 
any pres]vative-free /]ile drug product 
or pools any /]ile drug products1 except

 z provid$ 9 p>agraph 7#g77;,b74  7,b7  
,exclud$ activities ,not)/&+ subp>agraph
 7,a77ii71 a facility %all n be consid]$
 a comp\nd+ manufactur] if su*          
facility--  7i7 repackages drugs 9      
accordance ) section #ejf;,f or ! f9al  
guidance describ$ 9 section #ejf;,f7d72 
&  7ii7 does n o!rwise meet ! def9ition 
( comp\nd+ manufactur] "u subp>agraph   
7,a74  7#b7 ,pool+2 pools ,! t]ms pool+ 
& pool--  7,a7 mean tak+ a s+le drug    
approv$ "u section #eje or #eab1        
conditionally approv$ "u section #ega1  
includ$ on ! index e/abli%$ "u section  
#egb7;a77#a71 or lic5s$ "u section #cea 
( ! ,public ,heal? ,s]vice ,act f !     
conta9] 9 :i* x is di/ribut$ by !       
orig9al manufactur] & comb9+ x ) ! same 
drug f "o or m o!r conta9]s )\t or be=e 
fur!r manipulat+ ! product 7su* z by    
dilut+ x or mix+ x ) ano!r1 diff]5t drug
 or drugs72  7,b7 d n include comb9+ !  
drug f two or m sep>ate conta9]s ( !    
same drug :5 a s+le conta9] ( ! drug is 
n suffici5t to prep>e a s+le dose =     

adm9i/ration to an individual pati5t2 & 
7,c7 d n include comb9+ ! drug f two or 
m sep>ate conta9]s ( compon5t products (
 a total p>5t]al nutrition product1 if  
su* pool+1 & label+ & use ( ! f9i%$     
total p>5t]al nutrition product1 comply 
) ,/ate ph>macy law4  7#c7 ,practition] 
,! t]m practition] includes a physician1
 vet]9>ian1 or any o!r p]son t is       
au?oriz$ to prescribe m$ication "u ,/ate
 law4  7#d7 ,prescription2 prescription 
ord] ,! t]m prescription or prescription
 ord] means a prescription or           
prescription ord]1 z def9$ "u applicable
 ,/ate law1 t complies ) requirem5ts    
applicable "u su* ,/ate law4  7#e7      
,repackage or repackag+ ,! t]m repackage
 or repackag+ means tak+ a drug approv$ 
"u section #eje or #eab1 conditionally  
approv$ "u section #ega1 includ$ on !   
index e/abli%$ "u section #egb7;a77#a71 
or lic5s$ "u section #cea ( ! ,public   
,heal? ,s]vice ,act f ! conta9] 9 :i* x 
is di/ribut$ by ! orig9al manufactur] & 
plac+ x 9 a diff]5t conta9] ( ! same or 

small] size )\t fur!r manipulat+ ! drug 
7su* z by dilut+ x or mix+ x ) ano!r1   
diff]5t drug or drugs71 unless su*      
repackag+ is done pursuant to a         
prescription = an id5tifi$ individual   
pati5t4  7#f7 ,/]ile drug product ,! t]m
 /]ile drug product means a drug t is-- 
7,a7 int5d$ = p>5t]al adm9i/ration2     
7,b7 an oph?almic or inhalation drug2 or
  7,c7 requir$ to be /]ile "u ,f$]al or 
,/ate law4  7#g7 ,traditional comp\nd]  
7,a7 ,9 g5]al ,! t]m traditional        
comp\nd] means an entity--  7i7 :]e9 a  
drug is comp\nd$ by--  7,i7 a lic5s$    
ph>maci/1 or o!r ph>macy p]sonnel 7to ! 
ext5t p]mitt$ "u ,/ate law71 9 a        
,/ate-lic5s$ ph>macy or a ,f$]al        
facility2 or  7,,ii7 a lic5s$ physician 
or lic5s$ vet]9>ian1 to ! ext5t p]mitt$ 
"u ,/ate law2  7ii7 t--  7,i7 comp\nds a
 drug ^u receipt ( a prescription ord] =
 an id5tifi$ individual pati5t2 or      
7,,ii7 comp\nds a drug 9 limit$         
quantities be=e receipt ( a prescription
 ord] = an id5tifi$ individual pati5t1  

to ! ext5t p]mitt$ "u ,/ate law1 if su* 
comp\nd+ is bas$ on a hi/ory ( ! lic5s$ 
ph>maci/1 lic5s$ physician1 or lic5s$   
vet]9>ian receiv+ prescription ord]s = !
 comp\nd+ ( ! drug1 :i* ord]s h be5     
g5]at$ solely )9 an e/abli%$ relation%ip
 betwe5 ! lic5s$ ph>maci/1 lic5s$       
physician1 or lic5s$ vet]9>ian &--  7aa7
 su* individual pati5t = :om !          
prescription ord] w be provid$1 or1 9 ! 
case ( an animal drug1 su* individual   
responsible = provid+ c>e = ! animal =  
:i* ! drug is ord]$2 or  7bb7 ! lic5s$  
physician1 lic5s$ vet]9>ian1 or o!r     
lic5s$ practition] :o w write su*       
prescription ord]2 &  7iii7 t does n    
meet ! def9ition ( a comp\nd+           
manufactur] "u p>agraph 7#a74  7,b7     
,exceptions  7i7 ,hospitals & heal?     
sy/ems  7,i7 ,9 g5]al ,a ph>macy )9 a   
hospital1 vet]9>y hospital1 or heal?    
sy/em t comp\nds a drug & disp5ses su*  
drug 7:i* may include int]/ate %ipm5t7  
)9 su* hospital or heal? sy/em or %ips  
su* drug = disp5s+ to pati5ts ) an      

e/abli%$ relation%ip ) ! hospital or    
heal? sy/em 7:i* may include int]/ate   
%ipm5t71 or t repackages                
pres]vative-free /]ile drug product or  
pools /]ile drug products1 %all be      
consid]$ a traditional comp\nd] if su*  
ph>macy o!rwise meets ! def9ition "u    
subp>agraph 7,a74  7,,ii7 ,heal? sy/em  
def9$ ,= purposes ( ?is subp>agraph1 !  
t]m heal? sy/em means two or m hospitals
 or vet]9>y hospitals t are own$ &      
op]at$ by ! same entity & t %>e access  
to databases ) drug ord] in=mation =    
pati5ts or animals1 z applicable4 ,a    
heal? sy/em includes bo? ! inpati5t &   
outpati5t facilities ( hospitals )9 !   
heal? sy/em4  7ii7 ,,pet &              
radioph>maceuticals ,a ph>macy t        
comp\nds positron emission tomography   
drugs or radioph>maceuticals %all be    
consid]$ a traditional comp\nd] if x    
does n comp\nd o!r drugs t w\ld cause x 
to be a comp\nd+ manufactur] describ$ 9 
p>agraph 7#a77;,a74  7c7 ,exemptions f  
c]ta9 requirem5ts  7#a7 ,drugs comp\nd$ 

by traditional comp\nd]s ,sections      
#eja7;a77#b77;,b71 #ejb7;f77#a71 #eje 79
 ! case ( a human drug71 section #eab 79
 ! case ( an animal drug71 & section    
#cea ( ! ,public ,heal? ,s]vice ,act 79 
! case ( a biological product7 %all n   
apply to a comp\nd$ drug if su* drug--  
7,a7 is comp\nd$ by a traditional       
comp\nd] t is 9 compliance ) ?is        
section2 &  7,b7 meets ! requirem5ts (  
?is section applicable to drugs comp\nd$
 by traditional comp\nd]s4  7#b7 ,drugs 
comp\nd$ by comp\nd+ manufactur]s       
,sections #ejb7;f77#a71 #eje 79 ! case (
 a human drug71 section #eab 79 ! case (
 an animal drug71 & section #cea ( !    
,public ,heal? ,s]vice ,act 79 ! case ( 
a biological product7 %all n apply to a 
comp\nd$ prescription drug if su* drug--
  7,a7 is comp\nd$ by a comp\nd+        
manufactur]--  7i7 t is n lic5s$ z a    
ph>macy 9 any ,/ate2 &  7ii7 t is 9     
compliance ) ?is section2 &  7,b7 meets 
! requirem5ts ( ?is section applicable  
to drugs comp\nd$ by comp\nd+           

manufactur]s4  7d7 ,drugs t may n be    
comp\nd$  7#a7 ,9 g5]al ,! foll[+ drugs 
may n be comp\nd$1 except "u conditions 
specifi$ by ! ,secret>y3  7,a7 ,drugs t 
are demon/rably difficult to comp\nd ,a 
drug or category ( drugs t pres5ts      
demon/rable difficulties = comp\nd+1 :i*
 may include a complex dosage =m or     
biological product1 z designat$ by !    
,secret>y pursuant to p>agraph 7#b74    
7,b7 ,m>ket$ drugs ,a drug1 o!r ?an a   
biological product1 t is a copy ( a     
m>ket$ drug approv$ "u #eje or #eab1    
conditionally approv$ "u section #ega1  
or includ$ on ! index e/abli%$ "u       
section #egb7;a77#a71 except z provid$ 9
 p>agraph 7#c74  7,c7 ,biological       
products ,a drug t is a biological      
product1 except z provid$ 9 p>agraph    
7#d74  7,d7 ,drugs remov$ = safety &    
efficacy ,a drug t appe>s on a li/      
publi%$ by ! ,secret>y 9 ! ,f$]al       
,regi/] ( drugs t h be5 )drawn or remov$
 f ! m>ket because su* drug or compon5ts
 ( su* drug h be5 f\nd to be unsafe or n

 effective1 subject to p>agraph 7#e74   
7#b7 ,drugs t are demon/rably difficult 
to comp\nd  7,a7 ,9 g5]al ,! ,secret>y  
may promulgate a regulation t designates
 drugs or categories ( drugs t are      
demon/rably difficult to comp\nd t may n
 be comp\nd$1 or t may be comp\nd$ only 
"u conditions specifi$ by ! ,secret>y4  
,su* regulation--  7i7 may include !    
designation ( drugs or categories (     
drugs t are complex dosage =ms or       
biological products1 su* z ext5d$       
release products1 met]$ dose inhal]s1   
transd]mal pat*es1 & /]ile liposomal    
products2 &  7ii7 %all specify1 = ea*   
drug includ$ on ! li/1 :e!r !           
prohibition or condition applies to !   
use ( ! drug 9 humans1 animals1 or bo?4 
7,b7 ,int]im li/  7i7 ,9 g5]al ,be=e !  
effective date ( ! regulation promulgat$
 "u subp>agraph 7,a71 ! ,secret>y may   
designate drugs t are complex dosage =ms
 or biological products t _c be comp\nd$
 by--  7,i7 publi%+ a notice ( su* drugs
 propos$ = designation1 includ+ !       

rationale = su* designation1 9 ! ,f$]al 
,regi/]2  7,,ii7 provid+ a p]iod ( n    
less ?an #fj days = comm5t on ! notice2 
&  7,,iii7 publi%+ a notice 9 ! ,f$]al  
,regi/] designat+ ! drugs t are complex 
dosage =ms & biological products t _c be
 comp\nd$4  7ii7 ,sunset ,any notice    
provid$ "u clause 7i7 %all cease to h   
=ce or effect on ! date t is #e ye>s    
aft] ! date ( enactm5t ( !              
,ph>maceutical ,comp\nd+ ,quality &     
,acc\ntability ,act or on ! effective   
date ( ! f9al regulation "u subp>agraph 
7,a71 :i*ev] is e>li]4  7#c7 ,exceptions
 reg>d+ m>ket$ drugs  7,a7 ,9 g5]al ,a  
drug 7o!r ?an a biological product7 t is
 a copy ( a m>ket$ drug approv$ "u #eje 
or #eab1 conditionally approv$ "u       
section #ega1 or includ$ on ! index     
e/abli%$ "u section #egb7;a77#a71       
includ+ v>iations ( su* drug comp\nd$ f 
bulk sub/ances1 may be comp\nd$ only    
if--  7i7 7,i7 ! comp\nd$ v>iation      
produces = ! pati5t a cl9ical diff]5ce  
betwe5 ! comp\nd$ drug & su* m>ket$     

drug1 z det]m9$ by ! prescrib+          
practition]1 &1 prior to beg9n+ comp\nd+
 a v>iation ( su* drug1 ! facility      
comp\nd+ ! v>iation receives a          
prescription ord] specify+ t ! v>iation 
may be comp\nd$2 or  7,,ii7 7aa7 su*    
m>ket$ drug1 at ! "t ( comp\nd+ a copy (
 su* drug & at ! "t ( di/ribution ( !   
comp\nd$ drug1 is on ! drug %ortage li/ 
"u section #ejf;,e 79 ! case ( a human  
drug71 on ! ,curr5t ,drug ,%ortages li/ 
= vet]9>y products ma9ta9$ on ! ,int]net
 ,web site ( ! ,food & ,drug            
,adm9i/ration 79 ! case ( an animal     
drug71 or 9 ! ,secret>y's sole          
discretion1 has o!rwise be5 id5tifi$ by 
! ,secret>y z 9 %ortage su* z 9 a       
specific region or on a drug %ortage li/
 ma9ta9$ by a private p>ty2 &  7bb7 !   
traditional comp\nd] or ! comp\nd+      
manufactur] notifies ! ,secret>y n lat] 
?an #c cal5d> days aft] beg9n+ !        
comp\nd+1 unless ! ,secret>y waives !   
notice requirem5t2 &  7ii7 9 ! case ( a 
m>ket$ drug approv$ "u section #eje t is

 subject to a risk evaluation &         
mitigation /rategy approv$ ) elem5ts to 
assure safe use pursuant to section     
#eje-a1 ! entity comp\nd+ ! drug        
demon/rates to ! ,secret>y t ! entity w 
utilize controls t are comp>able to !   
controls applicable "u ! relevant risk  
evaluation & mitigation /rategy4  7,b7  
,exclusion ,= purposes ( ?is p>agraph1  
repackag+ a m>ket$ drug approv$ "u      
section #eje1 #eab1 conditionally       
approv$ "u section #ega1 or includ$ on !
 index e/abli%$ "u section #egb7;a77#a71
 does n make ! repackag$ drug a copy (  
su* m>ket$ drug4  7#d7 ,exceptions      
reg>d+ biological products ,a drug t is 
a biological product may be comp\nd$    
only if--  7,a7 su* drug is comp\nd$ f a
 lic5s$ biological product & ! comp\nd+ 
does n involve comb9+ or mix+ ! lic5s$  
biological product )--  7i7 a bulk drug 
sub/ance2 or  7ii7 ano!r1 diff]5t drug  
or drugs approv$ "u #eje or #eab1       
conditionally approv$ "u section #ega1  
includ$ on ! index e/abli%$ "u section  

#egb7;a77#a71 or lic5s$ "u section #cea 
( ! ,public ,heal? ,s]vice ,act1 unless 
! comp\nd+ is limit$ to ! comb9+1 mix+1 
or dilut+ ( lic5s$ all]g5ic products2 & 
7,b7 7i7 ) respect to a traditional     
comp\nd]1 ! comp\nd$ biological product 
produces = ! pati5t a cl9ical diff]5ce  
betwe5 ! comp\nd$ drug & ! lic5s$       
biological product1 z det]m9$ by !      
prescrib+ practition]1 &1 prior to      
beg9n+ comp\nd+ su* drug1 ! facility    
comp\nd+ ! v>iation receives a          
prescription ord] specify+ t !          
biological product may be comp\nd$2     
7ii7 ) respect to a comp\nd+            
manufactur]1 ! comp\nd$ v>iation        
biological product produces = ! pati5t a
 cl9ical diff]5ce betwe5 ! comp\nd$ drug
 & ! lic5s$ biological product1 z       
det]m9$ by a lic5s$ practition]         
responsible = ! pati5t's c>e 9 a heal?  
c>e entity t provides m$ical s]vices    
?r\gh lic5s$ prescrib]s directly to     
pati5ts1 &1 prior to beg9n+ comp\nd+ su*
 drug1 ! comp\nd+ manufactur] receives a

 duly au?oriz$ m$ical ord] f a hospital 
or heal? sy/em specify+ t ! biological  
product may be comp\nd$2 or  7iii7 !    
comp\nd$ biological product is an       
all]g5ic product4  7#e7 ,requirem5t     
reg>d+ drugs remov$ = safety or efficacy
 ,! li/ publi%$ by ! ,secret>y 9 !      
,f$]al ,regi/] ( drugs t h be5 )drawn or
 remov$ f ! m>ket1 z describ$ 9 p>agraph
 7#a77;,d71 %all specify :e!r a human   
drug on su* li/ may1 not)/&+ ! inclusion
 on su* li/1 be comp\nd$ = use 9        
animals4 ,! ,secret>y %all update ! li/s
 describ$ 9 subp>agraphs 7,d7 & 7,e7 (  
subsection 7e77#b71 z appropriate1 to   
con=m ) ! li/ describ$ 9 p>agraph       
7#a77;,d74  7e7 ,quality ( drug +r$i5ts 
7#a7 ,human drugs ,a traditional        
comp\nd] or a comp\nd+ manufactur]      
%all--  7,a7 comp\nd a human drug us+   
only bulk drug sub/ances 7z def9$ 9     
regulations ( ! ,secret>y publi%$ at    
section #bjg4c7;a77#d7 ( title #ba1     
,code ( ,f$]al ,regulations 7or any     
successor regulations77--  7i7 t--  7,i7

 comply ) ! /&>ds ( an applicable ,unit$
 ,/ates ,ph>macopoeia or ,national      
,=mul>y monograph1 if a monograph exi/s 
& has n be5 id5tifi$ "u p>agraph 7#f71 &
 ! ,unit$ ,/ates ,ph>macopoeia *apt]s on
 ph>macy comp\nd+2  7,,ii7 if su* a     
monograph does n exi/1 are drug         
sub/ances t are compon5ts ( drugs       
approv$ by ! ,secret>y2 or  7,,iii7 if  
su* a monograph does n exi/ & ! drug    
sub/ance is n a compon5t ( a drug       
approv$ by ! ,secret>y1 t appe> on a li/
 develop$ by ! ,secret>y ?r\gh          
regulations issu$ by ! ,secret>y2  7ii7 
t are 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 &  7iii7 t are accompani$ by 
valid c]tificates ( analysis = ea*      
specific lot ( bulk drug sub/ance2 &    
7,b7 use +r$i5ts 7o!r ?an bulk drug     
sub/ances7 t comply ) ! /&>ds ( an      
applicable ,unit$ ,/ates ,ph>macopoeia  
or ,national ,=mul>y monograph1 if a    
monograph exi/s & has n be5 id5tifi$ "u 

p>agraph 7#f71 & ) ! ,unit$ ,/ates      
,ph>macopoeia *apt] on ph>macy comp\nd+4
  7#b7 ,animal drugs ,a traditional     
comp\nd] or a comp\nd+ manufactur]      
%all--  7,a7 comp\nd an animal drug us+ 
only bulk drug sub/ances 7z def9$ 9     
regulations ( ! ,secret>y publi%$ at    
section #bjg4c7;a77#d7 ( title #ba1     
,code ( ,f$]al ,regulations 7or any     
successor regulations77 t--  7i7 are    
manufactur$ by an e/abli%m5t t is       
regi/]$ "u section #eaj 7includ+ a =eign
 e/abli%m5t t is regi/]$ "u section     
#eaj7;i772 &  7ii7 are accompani$ by    
valid c]tificates ( analysis = ea*      
specific lot ( bulk drug sub/ance2  7,b7
 use +r$i5ts 7o!r ?an bulk drug         
sub/ances7 t comply ) ! /&>ds ( an      
applicable ,unit$ ,/ates ,ph>macopoeia  
or ,national ,=mul>y monograph1 if a    
monograph exi/s & has n be5 id5tifi$ "u 
p>agraph 7#f71 & ) ! ,unit$ ,/ates      
,ph>macopoeia *apt]s on ph>macy         
comp\nd+2  7,c7 9 ! case ( a comp\nd$   
animal drug = use 9 non-food-produc+    

m9or species1 use bulk sub/ances t--    
7i7 comply ) ! /&>ds ( an applicable    
,unit$ ,/ates ,ph>macopoeia or ,national
 ,=mul>y monograph1 if a monograph exi/s
 & has n be5 id5tifi$ "u p>agraph 7#f71 
& ) ! ,unit$ ,/ates ,ph>macopoeia *apt]s
 on ph>macy comp\nd+2  7ii7 if su* a    
monograph does n exi/1 are drug         
sub/ances t are compon5ts ( drugs       
approv$ by ! ,secret>y2 or  7iii7 if su*
 a monograph does n exi/ & ! drug       
sub/ance is n a compon5t ( a drug       
approv$ by ! ,secret>y1 t appe> on a li/
 develop$ by ! ,secret>y ?r\gh          
regulations issu$ by ! ,secret>y2  7,d7 
9 ! case ( a comp\nd$ animal drug = use 
9 non-food-produc+ major species1 beg9n+
 on ! date ( publication ( ! li/        
e/abli%$ 9 accordance ) p>agraph        
7#c77;,a71 %all use bulk sub/ances t are
 includ$ on su* li/1 subject to p>agraph
 7#c77;,c72 &  7,e7 9 ! case ( a        
comp\nd$ animal drug = use 9            
food-produc+ major & m9or species1 %all 
use bulk sub/ances t are includ$ on a   

li/ e/abli%$ by ! ,secret>y ( bulk      
sub/ances acceptable = use 9 comp\nd+ a 
drug = "o or m su* species1 9 accordance
 ) p>agraph 7#d74  7#c7                 
,non-food-produc+ major species li/+    
proc$ure  7,a7 ,9 g5]al ,n lat] ?an #cj 
days aft] ! effective date ( !          
,ph>maceutical ,comp\nd+ ,quality &     
,acc\ntability ,act1 ! ,secret>y %all   
e/abli% a li/ ( bulk sub/ances          
acceptable = comp\nd+ a drug = use 9    
non-food-produc+ major species1 & any   
conditions applicable to su* use1 & may 
also id5tify bulk sub/ances t !         
,secret>y has det]m9$ n acceptable =    
comp\nd+ ) respect to a drug = use 9 su*
 species4  7,b7 ,proc$ure ,9 develop+ & 
updat+ ! li/ "u subp>agraph 7,a71 !     
,secret>y %all--  7i7 publi% a notice 9 
! ,f$]al ,regi/] id5tify+ bulk sub/ances
 propos$ z acceptable & any bulk        
sub/ance det]m9e to be unacceptable1 & !
 rationale = su* propos$ designations2  
7ii7 provide a p]iod ( n less ?an #cj   
days = comm5t on ! notice2 &  7iii7     

publi% a notice 9 ! ,f$]al ,regi/]      
designat+ ! bulk sub/ances acceptable1 &
 any bulk sub/ances det]m9$ to be       
unacceptable1 & ! rationale = su*       
designations & det]m9ations4  7,c7      
,notification ,^u initial publication ( 
! li/ "u subp>agraph 7,b77iii71 any     
traditional comp\nd] or comp\nd+        
manufactur] t has receiv$ & fill$ a     
prescription 9 ! #fj days prior to su*  
publication = a comp\nd$ drug = a       
non-food-produc+ major species f a bulk 
sub/ance n address$ 9 ! notice 7ei!r z  
acceptable or unacceptable71 & t        
reasonably expect to receive & fill     
ano!r prescription = su* a drug = su*   
species )9 #fj days aft] su*            
publication1 may notify ! ,secret>y (   
su* bulk sub/ance )9 #cj days ( su*     
publication1 9 a mann] to be det]m9$ by 
! ,secret>y & publi%$ 9 ! ,f$]al ,regi/]
 on or be=e publication ( ! li/ "u      
subp>agraph 7,b77iii74 ,a traditional   
comp\nd] or comp\nd+ manufactur] t      
provides su* notice %all n be subject to

 ! re/riction 9 p>agraph 7#b77;,d7 until
 su* "t z ! ,secret>y designates su*    
bulk sub/ance z acceptable or det]m9es x
 to be unacceptable pursuant to !       
process describ$ 9 subp>agraph          
7,b77iii74  7,d7 ,modification ( li/ ,! 
,secret>y may am5d ! li/ at any "t1 9   
accordance ) process describ$ 9         
subp>agraph 7,b74  7,e7 ,crit]ia ,9     
evaluat+ bulk sub/ances = purposes (    
subp>agraph 7,b71 ! ,secret>y %all      
consid]1 among o!r factors--  7i7 !     
safety ( ! bulk sub/ance2  7ii7         
hi/orical use ( ! sub/ance 9 ph>macy    
comp\nd+2  7iii7 evid5ce ( !            
effectiv5ess ( ! bulk sub/ance or lack (
 effectiv5ess2  7iv7 :e!r any drug      
approv$ "u section #eje or #eab1        
conditionally approv$ "u section #ega1  
or includ$ on ! index e/abli%$ "u       
section #egb7;a77#a71 c be us$ on label1
 or any drug approv$ "u section #eje or 
#eab c be us$ 9 an extralabel mann] 9   
accordance ) section p>agraphs 7#d7 &   
7#e7 ( section #eab7;a71 to treat !     

applicable condition 9 ! id5tifi$       
species2 &  7v7 :e!r a comp\nd$ drug    
appropriate to treat ! applicable       
condition 9 ! id5tifi$ species c\ld be  
obta9$ by manipulat+ a drug approv$ "u  
#eje or #eab1 conditionally approv$ "u  
section #ega1 or includ$ on ! index     
e/abli%$ "u section #egb7;a77#a74  7#d7 
,food-produc+ animals li/+ proc$ure ,9  
e/abli%+ a li/ ( designat$ bulk         
sub/ances acceptable = use 9 comp\nd+ a 
drug = use 9 food-produc+ major & m9or  
species "u p>agraph 7#b71 & any         
conditions applicable to su* use1 !     
,secret>y %all--  7,a7 publi% a notice 9
 ! ,f$]al ,regi/] id5tify+ bulk         
sub/ances propos$ z acceptable & any    
bulk sub/ance det]m9e to be             
unacceptable1 & ! rationale = su*       
designations2  7,b7 provide a p]iod ( n 
less ?an #cj days = comm5t on ! notice2 
&  7,c7 publi% a notice 9 ! ,f$]al      
,regi/] designat+ ! bulk sub/ances      
acceptable = use 9 comp\nd+ a drug = use
 9 food-produc+ major & m9or species1 & 

! rationale = su* designations4  7#e7   
,)drawal p]iods ,! requirem5ts =        
e/abli%+ sub/antially ext5d$ )drawal    
p]iods 9 accordance ) section #ecj4bj ( 
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulations7 %all     
apply to comp\nd$ animal drugs = use 9  
food-produc+ animals t are comp\nd$ us+ 
bulk sub/ances4  7#f7 ,id5tification by 
,secret>y  7,a7 ,9 g5]al ,not)/&+ !     
exi/5ce ( an applicable monograph "u    
subp>agraph 7,a77i77,i7 or 7,b7 (       
p>agraph 7#a7 or subp>agraph 7,b7 or    
7,c77i7 ( p>agraph 7#b71 ! ,secret>y may
 id5tify bulk sub/ances t ! ,secret>y   
det]m9es1 bas$ on public heal? conc]ns1 
may n be us$ 9 comp\nd+ a drug4  7,b7   
,proc$ure ,9 id5tify+ ! bulk sub/ances t
 may n be us$ 9 comp\nd+1 ! ,secret>y   
%all--  7i7 publi% a notice ( su* bulk  
sub/ances propos$ = id5tification 9 !   
,f$]al ,regi/]2  7ii7 provide a p]iod ( 
n less ?an #fj days = comm5t on !       
notice2  7iii7 publi% a notice 9 !      
,f$]al ,regi/] id5tify+ ! bulk sub/ances

 t may n be us$ 9 comp\nd+ a drug2 &    
7iv7 /ate :e!r ! bulk is n suitable =   
comp\nd+ ( human drugs1 animal drugs1 or
 bo?4  7f7 ,requirem5ts reg>d+ :olesal+ 
& label+ applicable to traditional      
comp\nd]s & comp\nd+ manufactur]s  7#a7 
,9 g5]al ,a comp\nd$ drug--  7,a7 may n 
be sold by an entity o!r ?an ! comp\nd+ 
manufactur] or traditional comp\nd] t   
comp\nd$ ! drug2  7,b7 comp\nd$ by a    
comp\nd+ manufactur] may n be sold to an
 entity o!r ?an a heal? c>e entity t    
provides m$ical s]vices ?r\gh lic5s$    
prescrib]s directly to pati5ts or       
animals1 or a network ( su* provid]s1   
except t a comp\nd+ manufactur] may     
transf] )\t pr(it a comp\nd$ /]ile drug 
to a lic5s$ ph>macy if--  7i7 ! lic5s$  
ph>macy falls "u ! same corporate       
own]%ip z ! comp\nd+ manufactur]2  7ii7 
! transf] ( su* comp\nd$ /]ile drug is  
solely = ! purpose ( disp5s+ ! comp\nd$ 
/]ile drug to ! end us]1 :o has be5     
in/ruct$ by ! prescrib+ physician to    
self-adm9i/] su* comp\nd$ /]ile drug2   

7iii7 z ( ! date ( enactm5t ( !         
,ph>maceutical ,comp\nd+ ,quality &     
,acc\ntability ,act1 ! comp\nd+         
manufactur] is an entity t provides     
ph>macy b5efits managem5t s]vices on    
behalf ( a heal? b5efits plan2  7iv7 !  
comp\nd+ manufactur] id5tifies itself to
 ! ,secret>y ^u regi/]+ "u subsection   
7g77#b7 z an entity t qualifies = !     
exemption "u ?is subp>agraph1 & provides
 docum5tation ( ! comp\nd+ ( su* drugs z
 ( ! date ( enactm5t ( ! ,ph>maceutical 
,comp\nd+ ,quality & ,acc\ntability     
,act1 9 a mann] describ$ by ! ,secret>y2
 &  7v7 ! comp\nd+ manufactur] receives 
confirmation f ! ,secret>y t ! comp\nd+ 
manufactur] qualifies = ! exemption "u  
?is subp>agraph & ! /]ile drug or drugs 
= :i* ! exemption applies2 &  7,c7 9 !  
case ( a comp\nd$ drug sold to a heal?  
c>e entity describ$ 9 subp>agraph 7,b71 
%all be label$ n = resale4  7#b7        
,adv]tis+ & promotion ,! adv]tis+ &     
promotion ( comp\nd$ drugs %all n be    
false or mislead+ 9 any p>ticul>4  7g7  

,o!r requirem5ts applicable to comp\nd+ 
manufactur]s  7#a7 ,lic5s$ ph>maci/     
ov]sight ,a comp\nd+ manufactur] %all   
ensure t a ph>maci/ lic5s$ 9 ! ,/ate :]e
 ! comp\nd+ manufactur] is locat$       
ex]cises direct sup]vision ov] !        
op]ations ( ! comp\nd+ manufactur]4     
7#b7 ,regi/ration ( comp\nd+            
manufactur]s & report+ ( drugs  7,a7    
,regi/ration ( comp\nd+ manufactur]s    
7i7 ,annual regi/ration ,dur+ ! p]iod   
beg9n+ on ,octob] #a & end+ on ,decemb] 
#ca ea* ye>1 ea* comp\nd+ manufactur]   
%all regi/] ) ! ,secret>y its "n1 place 
( bus9ess1 & unique facility id5tifi]   
7:i* %all con=m to ! requirem5ts = !    
unique facility id5tifi] e/abli%$ "u    
section #eaj71 & a po9t ( contact e-mail
 address4  7ii7 ,new comp\nd+           
manufactur]s ,ea* comp\nd+ manufactur]1 
^u fir/ engag+ 9 ! op]ations describ$ 9 
subsection 7b77#a71 %all imm$iately     
regi/] ) ! ,secret>y & provide !        
in=mation describ$ "u clause 7i74 ,!    
,secret>y %all e/abli% a timel9e =      

regi/ration = ! fir/ ye> foll[+ !       
effective date ( ! ,ph>maceutical       
,comp\nd+ ,quality & ,acc\ntability     
,act4 ,9 no case may regi/ration be     
requir$ until at lea/ #fj days foll[+   
publication ( ! timel9e 9 ! ,f$]al      
,regi/]4  7iii7 ,additional facilities  
,ea* comp\nd+ manufactur] duly regi/]$ 9
 accordance ) clauses 7i7 & 7ii7 %all   
imm$iately id5tify to ! ,secret>y any   
additional facility t engages 9 !       
activities describ$ 9 subsection 7b77#a7
 & t is own$ or op]at$ 9 any ,/ate by ! 
p]son t owns or op]ates ! comp\nd+      
manufactur]4  7iv7 ,availability (      
regi/ration = inspection ,! ,secret>y   
%all make available = inspection1 to any
 p]son s reque/+1 any regi/ration fil$  
pursuant to ?is subp>agraph1 except t   
any drug report+ in=mation submitt$     
pursuant to ?is subp>agraph & !         
in=mation accompany+ su* report+ %all be
 exempt f su* inspection1 unless !      
,secret>y f9ds t su* an exemption w\ld  
be inconsi/5t ) ! protection ( ! public 

heal?4  7,b7 ,drug report+ by comp\nd+  
manufactur]s  7i7 ,9 g5]al ,ea* comp\nd+
 manufactur] :o regi/]s ) ! ,secret>y "u
 subp>agraph 7,a7 %all submit to !      
,secret>y1 once dur+ ! mon? ( ,june (   
ea* ye> & once dur+ ! mon? ( ,decemb] ( 
ea* ye>1 a report--  7,i7 id5tify+ !    
drugs comp\nd$ by su* comp\nd+          
manufactur] dur+ ! previ\s #f-mon?      
p]iod2 &  7,,ii7 ) respect to ea* drug  
id5tifi$ "u subclause 7,i71 provid+ !   
active +r$i5t1 ! s\rce ( su* active     
+r$i5t1 ! ,national ,drug ,code numb] ( 
! s\rce drug or bulk active +r$i5t1 !   
/r5g? ( ! active +r$i5t p] unit1 !      
dosage =m & r\te ( adm9i/ration1 !      
package description1 ! numb] (          
individual units produc$1 ! ,national   
,drug ,code numb] ( ! f9al product1 &   
:i* con=ms to o!r applicable requirem5ts
 id5tifi$ by ! ,secret>y 9 accordance ) 
clause 7ii74  7ii7 ,=m ,ea* report "u   
clause 7i7 %all be prep>$ 9 su* =m &    
mann] z ! ,secret>y may prescribe by    
regulation or guidance4  7,c7           

,electronic regi/ration & report+       
,regi/rations & drug report+ "u ?is     
p>agraph 7includ+ ! submission ( updat$ 
in=mation7 %all be submitt$ to !        
,secret>y by electronic means unless !  
,secret>y grants a reque/ = waiv] ( su* 
requirem5t because use ( electronic     
means is n reasonable = ! p]son reque/+ 
waiv]4  7,d7 ,risk-bas$ inspection      
frequ5cy  7i7 ,9 g5]al ,comp\nd+        
manufactur]s %all be subject to         
inspection pursuant to section #gjd4    
7ii7 ,risk-bas$ s*$ule ,! ,secret>y1    
act+ ?r\gh "o or m (fic]s or employees  
duly designat$ by ! ,secret>y1 %all     
inspect comp\nd+ manufactur]s describ$ 9
 clause 7i7 9 accordance ) a risk-bas$  
s*$ule e/abli%$ by ! ,secret>y4  7iii7  
,risk factors ,9 e/abli%+ ! risk-bas$   
s*$ule "u clause 7ii71 ! ,secret>y %all 
inspect comp\nd+ manufactur]s accord+ to
 ! kn[n safety risks ( su* comp\nd+     
manufactur]s1 :i* %all be bas$ on !     
foll[+ factors3  7,i7 ,! compliance     
hi/ory ( ! comp\nd+ manufactur]4  7,,ii7

 ,! record1 hi/ory1 & nature ( recalls  
l9k$ to ! comp\nd+ manufactur]4  7,,iii7
 ,! inh]5t risk ( ! drug comp\nd$ at !  
comp\nd+ manufactur]4  7,,iv7 ,!        
inspection frequ5cy & hi/ory ( !        
comp\nd+ manufactur]1 includ+ :e!r !    
comp\nd+ manufactur] has be5 inspect$   
pursuant to section #gjd )9 ! la/ #d    
ye>s4  7,v7 ,any o!r crit]ia deem$      
necess>y & appropriate by ! ,secret>y = 
purposes ( allocat+ inspection res\rces4
  7#c7 ,adv]se ev5t report+  7,a7       
,def9itions ,9 ?is p>agraph3  7i7       
,adv]se ev5t ,! t]m adv]se ev5t means   
any heal?-relat$ ev5t associat$ ) ! use 
( a comp\nd$ drug t is adv]se1 includ+--
  7,i7 an ev5t occurr+ 9 ! c\rse ( ! use
 ( ! drug 9 pr(essional practice2       
7,,ii7 an ev5t occurr+ f an ov]dose ( ! 
drug1 :e!r accid5tal or int5tional2     
7,,iii7 an ev5t occurr+ f abuse ( !     
drug2  7,,iv7 an ev5t occurr+ f )drawal 
( ! drug2 &  7,v7 any failure ( expect$ 
ph>macological action ( ! drug4  7ii7   
,s]i\s adv]se ev5t ,! t]m s]i\s adv]se  

ev5t means an adv]se ev5t t--  7,i7     
results 9--  7aa7 dea?2  7bb7 an adv]se 
drug ev5t t places ! pati5t at imm$iate 
risk ( dea? f ! adv]se drug ev5t z x    
occurr$ 7n includ+ an adv]se drug ev5t t
 might h caus$ dea? _h x occurr$ 9 a m  
sev]e =m72  7cc7 inpati5t               
hospitalization or prolongation ( exi/+ 
hospitalization2  7dd7 a p]si/5t or     
significant incapacity or sub/antial    
disruption ( ! ability to conduct normal
 life functions2 or  7ee7 a cong5ital   
anomaly or bir? defect2 or  7,,ii7 bas$ 
on appropriate m$ical judgm5t1 may      
jeop>dize ! pati5t & may require a      
m$ical or surgical int]v5tion to prev5t 
an outcome describ$ 9 subclause 7,i74   
7,b7 ,reports  7i7 ,adv]se ev5t report+ 
requirem5t  7,i7 #ae-;day report ,if a  
comp\nd+ manufactur] becomes aw>e ( any 
s]i\s adv]se ev5t1 su* manufactur] %all 
submit reports ( ea* in/ance to !       
,secret>y z soon z practicable1 b 9 no  
case lat] ?an #ae cal5d> days aft] !    
initial receipt ( ! applicable          

in=mation4 ,su* manufactur] %all        
inve/igate & submit to ! ,secret>y      
foll[up reports = ea* su* in/ance n lat]
 ?an #ae cal5d> days aft] receipt ( new 
in=mation or z reque/$ by ! ,secret>y4  
,unless & until ! ,secret>y e/abli%es ! 
cont5t & =mat ( adv]se ev5t reports by  
guidance or regulation1 reports %all be 
submitt$ 9 accordance ) ! cont5t & =mat 
requirem5ts "u section #caj4cje ( title 
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulations7 79 ! case (     
human drugs71 section #fjj4hj ( title   
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulations7 79 ! case (     
biological products71 or section #ead4hj
 ( title #ba1 ,code ( ,f$]al            
,regulations 7or any successor          
regulations7 79 ! case ( animal drugs74 
7,,ii7 ,annual report ,comp\nd+         
manufactur]s t report s]i\s adv]se ev5ts
 %all submit 9 ,decemb] ( ea* ye> a     
n>rative summ>y ( any analysis ( ea*    
report submitt$ "u subclause 7,i71      
includ+ a hi/ory ( actions tak5 dur+ !  

ye> because ( ea* report1 us+ ! cont5t1 
=mat1 & mann] e/abli%$ by ! ,secret>y by
 guidance or regulation4 ,until su* "t z
 ! ,secret>y publi%es su* guidance or   
regulation1 ea* comp\nd+ manufactur]    
%all reta9 su* summ>ies z "p ( ! records
 to be ma9ta9$ 9 accordance )           
subp>agraph 7,c74  7ii7 ,product quality
 report+ requirem5t ,n lat] ?an #c      
cal5d> days aft] ! comp\nd+ manufactur] 
becomes aw>e ( in=mation p]ta9+ to      
/]ility1 /ability1 or o!r product       
quality conc]ns t c\ld result 9 s]i\s   
adv]se ev5ts1 ! comp\nd+ manufactur]    
%all submit to ! ,secret>y a product    
quality report1 9 a =m & mann] e/abli%$ 
by ! ,secret>y by guidance or           
regulation4  7,c7 ,ma9t5ance ( records  
,a comp\nd+ manufactur] %all ma9ta9 = a 
p]iod ( #aj ye>s records ( all s]i\s    
adv]se drug ev5ts kn[n to ! comp\nd     
manufactur] 9 accordance ) section      
#cad4hj7;i7 ( title #ba1 ,code ( ,f$]al 
,regulations 7or any successor          
regulation71 or z o!rwise direct$ by !  

,secret>y 9 regulations4  7#d7 ,label+ (
 drugs  7,a7 ,label ,! label ( a drug   
comp\nd$ by a comp\nd+ manufactur] %all 
include--  7i7 ! /atem5t ,?is is a      
comp\nd$ drug4 or a reasonable comp>able
 alt]native /atem5t 7z specifi$ by !    
,secret>y7 t id5tifies ! drug z a       
comp\nd$ drug2  7ii7 ! "n1 address1 &   
phone numb] ( ! applicable comp\nd+     
manufactur]2 &  7iii7 ) respect to !    
comp\nd$ drug--  7,i7 ! lot or bat*     
numb]2  7,,ii7 ! e/abli%$ "n ( !        
m$ication2  7,,iii7 ! dosage =m & /r5g?2
  7,,iv7 ! /atem5t ( quantity or volume1
 z appropriate2  7,v7 9 ! case ( a drug 
int5d$ = use 9 a food-produc+ animal1 ! 
)drawal p]iod e/abli%$ pursuant to      
subsection 7e77#e7 to ensure t no       
residues f ! comp\nd$ drug c be detect$ 
9 edible tissues ( ! treat$ animal2     
7,,vi7 ! date t ! drug 0 comp\nd$2      
7,,vii7 ! expiration date2  7,,viii7    
/orage & h&l+ in/ructions2  7,,ix7 !    
,national ,drug ,code numb]1 if         
available2  7,x7 ! n = resale /atem5t   

requir$ z requir$ by subsection         
7f77#a77;,c72 &  7,,xi7 subject to      
subp>agraph 7,b77i71 a li/ ( active &   
inactive +r$i5ts1 id5tifi$ by e/abli%$  
"n & ! quantity or proportion ( ea*     
+r$i5t4  7,b7 ,conta9] ,! conta9] f :i* 
! individual units ( a drug comp\nd$ by 
a comp\nd+ manufactur] are remov$ =     
disp5s+ or = adm9i/ration 7su* z a      
pla/ic bag conta9+ individual product   
syr+es7 %all include--  7i7 ! in=mation 
describ$ "u subp>agraph 7,a77iii77,,xi71
 if !re is n space on ! label = su*     
in=mation2  7ii7 ! foll[+ in=mation to  
facilitate adv]se ev5t report+3         
www4fda4gov_/m$wat* &                   
#a-hjj-;,,fda-#ajhh2 &  7iii7 !         
directions = use1 includ+ dosage &      
adm9i/ration1 z appropriate4  7,c7      
,additional in=mation ,! label & label+ 
( a drug comp\nd$ by a comp\nd+         
manufactur] %all include any o!r        
in=mation z det]m9$ necess>y & specifi$ 
9 regulations promulgat$ by ! ,secret>y4
  7h7 ,comp\nd+ manufactur] 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 gross annual sales
 means ! total worldwide gross annual   
sales1 9 ,unit$ ,/ates doll>s1 = a      
comp\nd+ manufactur]1 includ+ ! sales ( 
all ! affiliates ( ! comp\nd+           
manufactur]2 &  7,c7 ! t]m re9spection  
means1 ) respect to a comp\nd+          
manufactur]1 "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 ,= fiscal
 ye> #bjae & ea* subsequ5t fiscal ye>1 !
 ,secret>y %all1 9 accordance ) ?is     
subsection1 assess & collect--  7,a7 an 
annual e/abli%m5t fee f ea* comp\nd+    
manufactur] to cov] inspection-relat$   
co/s relat+ to inspections ( drug       

comp\nd]s = su* ye>2 &  7,b7 a          
re9spection fee f ea* comp\nd+          
manufactur] subject to a re9spection 9  
su* fiscal ye>4  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$]al ,regi/] notice n lat]
 ?an #fj days be=e ! />t ( ea* su* ye>4 
7#d7 ,am\nt ( e/abli%m5t & re9spection  
fee  7,a7 ,9 g5]al ,except z provid$ 9  
subp>agraph 7,d71 ! am\nt ( ! annual    
e/abli%m5t fee & ! re9spection fee 7if  
applicable7 "u p>agraph 7#b7 = ea*      
comp\nd+ manufactur] 9 a fiscal ye> %all
 be equal to ! sum (--  7i7 7,i7 #ae1jjj
 p] comp\nd+ manufactur]1 multipli$ by  
7,,ii7 ! inflation adju/m5t factor      
describ$ 9 subp>agraph 7,b72 plus  7ii7 
! small bus9ess adju/m5t factor describ$
 9 subp>agraph 7,c74  7,b7 ,inflation   
adju/m5t factor  7i7 ,9 g5]al ,= fiscal 
ye> #bjae & subsequ5t fiscal ye>s1 !    

rev5ues 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$+ #d fiscal ye>s1 &   
7,,iii7 ! av]age annual p]c5t *ange t   
occurr$ 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 describ$ 9 subp>agraph  
7,a77ii7 %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 comp\nd+ manufactur]
 ) gross annual sales ( #a1jjj1jjj or   
less 9 ! #ab mon?s end+ ,june #a ( !    
fiscal ye> imm$iately prec$+ ! fiscal   
ye> 9 :i* ! fees "u ?is subsection are  

assess$1 ! am\nt ( ! e/abli%m5t fee &   
re9spection fee "u p>agraph 7#b7 = a    
fiscal ye> %all be equal to #a_/c ( !   
am\nt calculat$ "u subp>agraph 7,a77i7 9
 su* fiscal ye>4  7ii7 ,application ,!  
,secret>y may require a small bus9ess to
 apply = ! exception "u ?is subp>agraph 
by c]tify+ its gross annual sales = !   
#ab mon?s end+ ,june #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 prior to ,augu/ #a = ! 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 subp>agraph 7,a7 & 
7,b7 ( p>agraph 7#b7 available solely to
 pay = ! inspection-relat$ co/s 7includ+
 re-inspection7 = ! ov]sight ( drug     
comp\nd+4  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 subsection4  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+ !   
inspection-relat$ co/s 7includ+         
re9spection7 = ! ov]sight ( drug        
comp\nd+4  7#h7 ,collection ( fees  7,a7
 ,e/abli%m5t fee ,a comp\nd+ manufactur]
 %all remit ! e/abli%m5t fee due "u ?is 
subsection 9 a fiscal ye> :5 submitt+ a 
regi/ration pursuant to subsection 7g7 =
 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 ( ! comp\nd+     
manufactur] involv$4  7,c7 ,effect (    
failure to pay fees  7i7 ,regi/ration ,a
 comp\nd+ manufactur] %all n be consid]$
 regi/]$ "u subsection 7g7 9 a fiscal   
ye> until ! date t ! comp\nd+           
manufactur] remits ! e/abli%m5t fee "u  
?is subsection = su* fiscal ye>4  7ii7  
,misbr&+ ,all drugs comp\nd$ by a       

comp\nd+ manufactur] = :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*        
comp\nd+ manufactur] "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 ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 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  7i7      
,action by ,secret>y reg>d+ compla9ts f 
,/ate bo>ds ( ph>macy  7#a7 ,designation
 ,! ,secret>y %all designate a po9t (   
contact & e/abli% a =mat & proc$ure = a 
,/ate ,bo>d ( ,ph>macy to notify !      
,secret>y if x appe>s to a ,/ate ,bo>d (
 ,ph>macy t an entity lic5s$ by a ,/ate 
z a ph>macy is requir$ to be regi/]$ ) !
 ,secret>y z a comp\nd+ manufactur]4    
7#b7 ,det]m9ation ,if ! ,secret>y       
det]m9es t su* an entity describ$ 9     
p>agraph 7#a7 is requir$ to be regi/]$ )
 ! ,secret>y z a comp\nd+ manufactur]1 !
 ,secret>y %all transmit su* det]m9ation
 to ! ,/ate ,bo>d ( ,ph>macy 9 ! ,/ate 9
 :i* ! entity is locat$1 & to ! ,/ate   
,bo>d ( ,ph>macy 9 ! notify+ ,/ate1 if  

diff]5t1 )9 #ae days ( su* det]m9ation4 
7#c7 ,effect ,! ,secret>y %all enc\rage 
direct communications betwe5 ,/ates     
reg>d+ traditional comp\nd]s4 ,no?+ 9   
?is subsection %all exp& ! ,secret>y's  
au?ority ov] or responsibility =        
traditional comp\nd+4  7j7 ,prescription
 ord] ref]5ce ,= purposes ( ?is section1
 ref]5ce to a prescription ord] = an    
id5tifi$ individual pati5t includes1 9 !
 case ( animal drugs1 a prescription    
ord] = a specific h]d or flock 7or o!r  
id5tifi$ gr\p7 ( animals4  4  7c7       
,prohibit$ act ,section #cja 7#ba       
,u4,s4,c4 #cca7 is am5d$--  7#a7 9      
subsection 7e71 by /rik+ #dag1 #daf1    
#ejd & ins]t+ #dag1 #daf1 #ejc;,a7g71   
#ejd2 &  7#b7 by add+ at ! end ! foll[+3
  7ccc7 ,! resale ( a comp\nd$ drug t is
 label$ n = resale z requir$ by section 
#ejc;,a4  4  7d7 ,report by ,,gao ,n    
lat] ?an ,novemb] #a1 #bjaf1 !          
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all conduct /udy & submit to ,congress 
a report reg>d+ ! impact ( ?is ,act 7& !

 am5dm5ts made by ?is ,act7 on ! safety 
( animal drug comp\nd+ & ! availability 
( safe & effective drugs = animals4  #c4
 ,o!r requirem5ts relat+ to comp\nd+    
manufactur]s  7a7 ,label+ ,section #ejb 
7#ba ,u4,s4,c4 #ceb7 is am5d$ by add+ at
 ! end ! foll[+3  7bb7 ,if x is a       
comp\nd$ drug & ! label+ does n include 
! in=mation z requir$ by subsections    
7f77#a77;,c7 & 7g77#d7 ( section        
#ejc;,a1 z applicable4  7cc7 ,if x is a 
drug1 & x 0 comp\nd$ by a comp\nd+      
manufactur] = :i* fees h n be5 paid z   
requir$ by section #ejc;,a7g74  4  7b7  
,application ( inspection requirem5ts to
 comp\nd+ manufactur]s ,section         
#gjd7;a77#b7 7#ba ,u4,s4,c4             
#cgd7;a77#b77 is am5d$ by add+ at ! end 
! foll[+ flu% text3  ,! exemption 9     
subp>agraph 7,a7 does n apply ) respect 
to comp\nd+ manufactur]s 7z su* t]m is  
def9$ 9 section #ejc;,a74 4  7c7        
,adult]ation ( comp\nd$ animal drugs    
conta9+ drug residues ,section          
#djb7;a77#b77;,c7 is am5d$ by /rik+     

#eab2 & ins]t+ #eab2 or 7iii7 any       
residue f a comp\nd$ animal drug24  #d4 
,implem5tation ,9 promulgat+ any        
regulations to implem5t ?is ,act 7& !   
am5dm5ts made by ?is ,act71 ! ,secret>y 
( ,heal? & ,human ,s]vices %all--  7#a7 
issue a notice ( propos$ rulemak+ t     
includes ! propos$ regulation2  7#b7    
provide a p]iod ( n less ?an #fj days = 
comm5ts on ! propos$ regulation2 &  7#c7
 publi% ! f9al regulation n m ?an #ah   
mon?s foll[+ publication ( ! propos$    
rule & n less ?an #cj days be=e !       
effective date ( su* f9al regulation4   
#e4 ,effective date ,?is ,act 7& !      
am5dm5ts made by ?is ,act7 %all take    
effect on ! date t is #a ye> aft] ! date
 ( enactm5t ( ?is ,act4