,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #cjhi  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #ab1 #bjac  
,mr4 ,griffi? ( ,virg9ia 7= himself1    
,ms4 ,de,gette1 & ,mr4 ,g5e ,gre5 (     
,texas7 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d section   
#ejc;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act ) respect to ph>macy     
comp\nd+4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,comp\nd+ ,cl>ity ,act (   
#bjac4  #b4  ,traditional ph>macy       
comp\nd+ ,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 ,traditional ph>macy  
comp\nd+  7a7 ,9 ,g5]al ,sections       
#eja7;a77#b77;,b71 #ejb7;f77#a71 & #eje 
( ?is ,act & section #cea ( ! ,public   
,heal? ,s]vice ,act %all n apply to a   
drug product = human use if ea* ( !     
foll[+ conditions is met3  7#a7         
,id5tifi$ pati5t & receipt (            
prescription ,! drug product is comp\nd$

 9 accordance ) "o ( ! foll[+3  7,a7 ,9 
g5]al ,! 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 = an id5tifi$ individual     
pati5t bas$ on ! receipt ( a valid      
prescription4  7,b7 ,anticipatory       
comp\nd+ ,! 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 9 limit$ quantities   
be=e ! receipt ( a valid prescription = 
an id5tifi$ individual pati5t1 bas$ on--
  7i7 hi/orical dem& = ! drug product2 &
  7ii7 a hi/ory ( prescriptions = ! drug
 product g5]at$ solely )9 an e/abli%$   
relation%ip betwe5 ! lic5s$ ph>maci/ or 
lic5s$ physician :o is p]=m+ ! comp\nd+ 
&--  7,i7 ! individual pati5t2 or       
7,,ii7 ! physician or o!r lic5s$        
practition] :o writes ! prescription4   
7,c7 ,comp\nd+ = (fice use ,! 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 a non-pati5t-specific       
pur*ase ord] &--  7i7 ! drug product w  
be adm9i/]$ by a heal? c>e practition]  
)9 a physician's (fice1 a hospital1 or  
ano!r heal? c>e sett+2  7ii7 valid      
pati5t-specific prescriptions or1 :5 a  
comp\nd$ drug product is adm9i/]$ )9 !  
same heal? sy/em 9 :i* x 0 comp\nd$1    
valid pati5t names--  7,i7 are submitt$1
 electronically or o!rwise1 to !        
ph>maci/ or physician :o p]=ms !        
comp\nd+1 n lat] ?an #g bus9ess days    
aft] ! drug product is adm9i/]$2 &      
7,,ii7 w1 9 ! aggregate1 acc\nt = !     
total volume ( drug product comp\nd$    
pursuant to ! non-pati5t-specific       
pur*ase ord]2  7iii7 dur+ any #f-mon?   
p]iod1 ( ! total drug products disp5s$ f
 ! facility at :i* ! drug product 0     
comp\nd$1 n m ?an #e p]c5t are comp\nd$ 
/]ile drug products t are--  7,i7       
disp5s$ pursuant to ?is subp>agraph2 &  
7,,ii7 %ipp$ int]/ate2  7iv7 records ( !
 comp\nd+ w be kept = n less ?an #c     
ye>s2 &  7v7 ! /atem5t ,(fice ,use ,only

 & ! /atem5t ,n = resale appe> on !     
comp\nd$ drug product4  ,comp\nd+ "u ?is
 subp>agraph %all n be consid]$ to be 9 
violation ( clause 7ii7 because ( !     
failure ( a ph>maci/ or a physician to  
acc\nt = valid pati5t-specific          
prescriptions or valid pati5t names z   
requir$ by su* clause1 s long z !       
ph>maci/ or physician makes a good fai?1
 reasonable ef=t to acc\nt = !          
prescriptions or names1 z applicable1 & 
does n cont9ue to comp\nd drug products 
"u ?is subp>agraph = a heal? c>e        
practition] or facility ) a hi/ory (    
fail+ to submit su* prescriptions or    
pati5t names4  7#b7 ,quality /&>ds      
,irrespective ( :e!r a drug product is  
comp\nd$ "u subp>agraph 7,a71 7,b71 or  
7,c7 ( p>agraph 7#a71 ! drug product is 
comp\nd$1 /or$1 & dat$ 9 compliance ) ! 
,unit$ ,/ates ,ph>macopoeia *apt]s t are
 applicable to ph>maceutical comp\nd+   
7includ+ ! *apt] on /]ile prep>ations74 
7#c7 ,bulk drug sub/ances ,if ! drug    
product is comp\nd$ us+ bulk drug       

sub/ances 7z def9$ 9 regulations ( !    
,secret>y publi%$ at section            
#bjg4c7;a77#d7 ( title #ba ( ! ,code (  
,f$]al ,regulations 7or any successor   
regulations77--  7,a7 ! bulk drug       
sub/ances--  7i7 if an applicable       
monograph exi/s "u ! ,unit$ ,/ates      
,ph>macopoeia1 ! ,national ,=mul>y1 or  
ano!r comp5dium or ph>macopeia recogniz$
 "u ,f$]al law1 ea* comply ) !          
monograph2  7ii7 if su* a monograph does
 n exi/1 ea* are drug sub/ances t are   
compon5ts ( drug products approv$ or    
lic5s$ by ! ,secret>y = human use2 or   
7iii7 if su* a monograph does n exi/ & !
 drug sub/ance is n a compon5t ( a drug 
product s approv$ or lic5s$1 ea* appe>  
on a li/ publi%$ by ! ,secret>y 7?r\gh  
regulations issu$ "u subsection 7e772   
7,b7 ! bulk drug sub/ances are ea*      
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,c7 ! bulk drug sub/ances
 are ea* accompani$ by a valid          

c]tificate ( analysis4  7#d7 ,+r$i5ts   
7o!r ?an bulk drug sub/ances7 ,if any   
+r$i5ts 7o!r ?an bulk drug sub/ances7   
are us$ 9 comp\nd+ ! drug product1 su*  
+r$i5ts comply ) ! /&>ds ( an applicable
 ,unit$ ,/ates ,ph>macopoeia or         
,national ,=mul>y monograph4  7#e7 ,drug
 products )drawn or remov$ because      
unsafe or n effective ,! drug product   
does n appe> on a li/ publi%$ by !      
,secret>y ( drug products t h be5 )drawn
 or remov$ f ! m>ket because su* drug   
products or compon5ts ( su* drug        
products h be5 f\nd to be unsafe or n   
effective4  7#f7 ,ess5tially a copy ( a 
m>ket$ & approv$ drug product ,! lic5s$ 
ph>maci/ or lic5s$ physician does n     
comp\nd any drug product t is ess5tially
 a copy ( a m>ket$ & approv$ drug       
product4  7#g7 ,drug products pres5t+   
demon/rable difficulties = comp\nd+ ,!  
drug product is n id5tifi$ 7directly or 
z "p ( a category ( drug products7 9 a  
li/ publi%$ by ! ,secret>y 7?r\gh       
regulations issu$ "u subsection 7e77 z a

 drug product t pres5ts demon/rable     
difficulties = comp\nd+ t reasonably    
demon/rate an adv]se effect on ! safety 
or effectiv5ess ( t drug product4  7#h7 
,prohibition on :olesal+ ,! drug product
 w n be sold by an entity o!r ?an !     
ph>macy or physician t comp\nd$ su* drug
 product4  7b7 ,/ate regulation ,no?+ 9 
?is section %all prev5t a ,/ate f--     
7#a7 impos+ re/rictions on ! type (     
comp\nd+ describ$ 9 subp>agraph 7,b7 or 
7,c7 ( subsection 7a77#a7 t are 9       
addition to ! re/rictions applicable "u 
?is section2 or  7#b7 en=c+ requirem5ts 
or re/rictions conta9$ 9 ! *apt]s or    
/&>ds describ$ 9 subsection 7a77#b74    
7c7 ,notification sy/em  7#a7           
,developm5t & implem5tation ,! ,secret>y
 %all develop & implem5t a sy/em =      
receiv+ & review+ submissions f ,/ate   
bo>ds ( ph>macy--  7,a7 describ+ actions
 tak5 aga9/ comp\nd+ ph>macies2 or  7,b7
 express+ conc]ns t a comp\nd+ ph>macy  
may be act+ 9 violation ( "o or m       
requirem5ts ( ?is section4  7#b7 ,cont5t

 ( submissions f ,/ate bo>ds ( ph>macy  
,an action ref]r$ to 9 p>agraph         
7#a77;,a7 is1 ) respect to a ph>macy t  
comp\nds drug products1 any ( ! foll[+3 
7,a7 ,! issuance ( a w>n+ lett]1 or !   
imposition ( sanctions or p5alties1 by a
 ,/ate = violations ( a ,/ate's ph>macy 
regulations p]ta9+ to comp\nd+4  7,b7 ,!
 susp5sion or revocation ( a ,/ate-issu$
 ph>macy lic5se or regi/ration4  7,c7 ,!
 recall ( comp\nd$ drug products due to 
conc]ns relat+ to ! quality or purity ( 
su* products4  7#c7 ,consultation ,!    
,secret>y %all develop ! sy/em "u       
p>agraph 7#a7 9 consultation ) !        
,national ,association ( ,bo>ds (       
,ph>macy4  7#d7 ,review & det]m9ation by
 ,secret>y ,! ,secret>y %all review ea* 
submission receiv$ "u p>agraph 7#a7 &   
su* o!r in=mation z ! ,secret>y det]m9es
 necess>y 7includ+ in=mation collect$   
?r\gh an inspection or ma9ta9$ 9 !      
,adv]se ,ev5t ,report+ ,sy/em database7 
& make a det]m9ation z to :e!r ! ph>macy
 involv$ may be 9 violation ( "o or m   

requirem5ts ( ?is section4  7#e7        
,notify+ ,/ate bo>ds ( ph>macy ,! sy/em 
"u p>agraph 7#a7 %all be design$ to     
imm$iately notify ,/ate bo>ds ( ph>macy 
:5--  7,a7 ! ,secret>y receives a       
submission "u p>agraph 7#a72 or  7,b7 ! 
,secret>y makes a det]m9ation t a       
ph>macy may be 9 violation ( "o or m    
requirem5ts ( ?is section4  7#f7 ,tim+  
,n lat] ?an "o ye> aft] ! date (        
enactm5t ( ! ,comp\nd+ ,cl>ity ,act (   
#bjac1 ! ,secret>y %all beg9            
implem5tation ( ! sy/em "u p>agraph     
7#a74  7d7 ,inspection au?ority ,9      
accordance ) section #gjd7;a71 !        
,secret>y may inspect a ph>macy's       
records to det]m9e :e!r ! ph>macy is 9  
violation ( "o or m requirem5ts ( ?is   
,act if--  7#a7 ! inspection is conduct$
 9 coord9ation ) ! relevant ,/ate bo>d  
or bo>ds ( ph>macy2 or  7#b7 ! ,secret>y
 has evid5ce t ! ph>macy may be 9       
violation ( su* a requirem5t4  7e7      
,regulations  7#a7 ,9 g5]al ,! ,secret>y
 %all issue regulations to implem5t ?is 

section4  7#b7 ,advisory committee on   
comp\nd+ ,be=e issu+ regulations to     
implem5t subsections 7a77#c77;,a77iii7 &
 7a77#g71 ! ,secret>y %all conv5e &     
consult an advisory committee on        
comp\nd+4 ,! advisory committee %all    
include repres5tatives f ! ,national    
,association ( ,bo>ds ( ,ph>macy1 !     
,unit$ ,/ates ,ph>macopoeia1 ph>maci/s  
hav+ curr5t exp]i5ce & exp]tise 9       
comp\nd+1 physicians hav+ backgr\nd & k 
9 comp\nd+1 & consum] organizations ) an
 exp]tise 9 comp\nd+4  7#c7 ,int]im li/s
 ,be=e ! date on :i* f9al regulations   
are issu$ to implem5t subsections       
7a77#c77;,a77iii7 & 7a77#g71 if !       
,secret>y det]m9es x is necess>y to     
protect ! public heal?1 ! ,secret>y may 
designate drug products or sub/ances z  
describ$ 9 su* subsections1 by--  7,a7  
publi%+ a notice ( su* drug products or 
sub/ances propos$ = designation1 includ+
 ! rationale = su* designation1 9 !     
,f$]al ,regi/]2  7,b7 provid+ a p]iod ( 
n less ?an #fj cal5d> days = comm5t on !

 notice2 &  7,c7 publi%+ a notice 9 !   
,f$]al ,regi/] designat+ su* drug       
products or sub/ances4  7#d7 ,updat+    
li/s ,! ,secret>y %all update !         
regulations conta9+ ! li/s ( drug       
products & sub/ances describ$ 9         
subsections 7a77#c77;,a77iii7 & 7a77#g7 
regul>ly1 b n less ?an once e ?ree ye>s4
  7#e7 ,sunset ( notice ,any notice     
publi%$ "u p>agraph 7#c7 %all n be      
effective aft] ! e>li] (--  7,a7 ! date 
t is #c ye>s aft] ! date ( ,comp\nd+    
,cl>ity ,act ( #bjac2 &  7,b7 !         
effective date ( ! f9al regulations     
issu$ to implem5t subsections           
7a77#c77;,a77iii7 & 7a77#g74  7f7       
,def9itions ,9 ?is section3  7#a7 ,! t]m
 comp\nd+ includes--  7,a7 ! comb9+1    
admix+1 mix+1 dilut+1 recon/itut+1 or   
o!rwise alt]+ ( a m>ket$ drug product1  
except :5 p]=m$ 9 accordance ) specific 
directions = su* acts conta9$ 9 approv$ 
label+ provid$ by ! product's           
manufactur] or o!rwise provid$ by t     
manufactur] consi/5t ) t label+2  7,b7 !

 comb9+1 admix+1 mix+1 dilut+1          
recon/itut+1 or o!rwise alt]+ a bulk    
drug sub/ance to create a drug product2 
&  7,c7 repackag+4  7#b7 ,! t]m         
ess5tially a copy ( a m>ket$ & approv$  
drug product does n include--  7,a7 a   
drug product 9 :i* !re is a *ange1 made 
= an id5tifi$ individual pati5t1 :i*    
produces = t pati5t a cl9ical diff]5ce1 
z det]m9$ by ! prescrib+ practition]1   
betwe5 ! comp\nd$ drug product & !      
comp>able m>ket$ & approv$ drug product2
 or  7,b7 a drug product t appe>s on !  
drug %ortage li/ 9 effect "u section    
#ejf;,e4  7#c7 ,! t]m lic5s$ ph>maci/   
includes any individual :o comp\nds drug
 products "u ! sup]vision ( a           
practition] lic5s$ to comp\nd drug      
products "u ,/ate law4  7#d7 ,! t]m     
m>ket$ & approv$ drug product means a   
drug product t--  7,a7 is curr5tly      
m>ket$2 &  7,b7 is approv$ "u section   
#eje ( ?is ,act or lic5s$ "u section    
#cea ( ! ,public ,heal? ,s]vice ,act4   
7#e7 7,a7 ,! t]m repackag+ means tak+ a 

drug approv$ "u section #eje ( ?is ,act 
or lic5s$ "u section #cea ( ! ,public   
,heal? ,s]vice ,act f ! conta9] 9 :i* ! 
drug is di/ribut$ by ! orig9al          
manufactur] & plac+ su* drug 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   
drugs74  7,b7 ,su* t]m does n include   
remov+ ! drug f its orig9al conta9] =   
imm$iate adm9i/ration to an id5tifi$    
individual pati5t1 su* z )draw+ a drug  
into a syr+e = imm$iate injection or    
remov+ ! drug f its orig9al conta9] )9 a
 heal? c>e entity by a practition]1 or  
o!r lic5s$ individual "u ! sup]vision or
 direction ( su* practition]1 =         
adm9i/ration )9 ! same day )9 su* heal? 
c>e entity4  4  #c4 ,outs\rc+ facilities
  7a7 ,9 g5]al ,sub*apt] ,a ( *apt] ,v (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cea et seq47 is am5d$--
  7#a7 by r$esignat+ section #ejc;,b z  
section #ejc;,c2 &  7#b7 by ins]t+ aft] 
section #ejc;,a 7#ba ,u4,s4,c4 #cec;a7 !

 foll[+ new section3  #ejc;,b4 ,outs\rc+
 facilities  7a7 ,9 g5]al ,sections     
#ejb7;f77#a7 & #eje ( ?is ,act & section
 #cea ( ! ,public ,heal? ,s]vice ,act   
%all n apply to a drug product comp\nd$ 
= human use by a lic5s$ ph>maci/ 9 an   
outs\rc+ facility if ea* ( ! foll[+     
conditions is met3  7#a7 ,regi/ration & 
report+ ,! facility is 9 compliance ) ! 
regi/ration & report+ requirem5ts (     
subsection 7b74  7#b7 ,drug product &   
sub/ance limitations ,! facility does n 
comp\nd drug products 9 violation (     
p>agraphs 7#c7 ?r\gh 7#h7 ( section     
#ejc;,a7a74  7#c7 ,fees ,! facility has 
paid all fees ow$ by su* facility       
pursuant to section #gdd,k4  7#d7       
,/&>diz$ drug products f bulk ,!        
facility does n comp\nd1 f bulk drug    
sub/ances1 /&>diz$ dosages t are n      
o!rwise comm]cially available ( a m>ket$
 & approv$ drug product4  7#e7 ,label+ (
 drug products  7,a7 ,label ,! label ( a
 drug product comp\nd$ by an outs\rc+   
facility %all include--  7i7 ! /atem5t  

,?is is a comp\nd$ drug4 or a reasonable
 comp>able alt]native /atem5t 7z        
specifi$ by ! ,secret>y7 t prom95tly    
id5tifies ! drug z a comp\nd$ drug      
product2  7ii7 ! "n1 address1 & phone   
numb] ( ! applicable outs\rc+ facility2 
&  7iii7 ) respect to ! comp\nd$ drug   
product--  7,i7 ! lot or bat* numb]2    
7,,ii7 ! e/abli%$ "n ( ! drug product2  
7,,iii7 ! dosage =m & /r5g?2  7,,iv7 !  
/atem5t ( quantity or volume1 z         
appropriate2  7,v7 ! date t ! drug      
product 0 comp\nd$2  7,,vi7 ! expiration
 date2  7,,vii7 /orage & h&l+           
in/ructions2  7,,viii7 ! ,national ,drug
 ,code numb]1 if available2  7,,ix7 ! ,n
 = resale /atem5t requir$ "u section    
#ejc;,a7a77#a77;,c77v72 &  7,x7 subject 
to subp>agraph 7,b77i71 a li/ ( active &
 inactive +r$i5ts1 id5tifi$ by e/abli%$ 
"n & ! quantity or proportion ( ea*     
+r$i5t4  7,b7 ,conta9] ,! conta9] f :i* 
! individual units ( a drug product     
comp\nd$ by an outs\rc+ facility 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,x71 if !re is n space on !   
label = su* in=mation2  7ii7 ! foll[+   
in=mation to facilitate adv]se ev5t     
report+3 www4fda4gov_/m$wat* &          
#a-hjj-;,,fda-#ajhh2 &  7iii7 directions
 = use1 includ+1 z appropriate1 dosage &
 adm9i/ration4  7,c7 ,additional        
in=mation ,! label & label+ ( a drug    
product comp\nd$ by an outs\rc+ facility
 %all include any o!r in=mation z       
det]m9$ necess>y & specifi$ 9           
regulations promulgat$ by ! ,secret>y   
7b7 ,regi/ration ( outs\rc+ facilities &
 report+ ( drug products  7#a7          
,regi/ration ( outs\rc+ facilities  7,a7
 ,annual regi/ration ,dur+ ! p]iod      
beg9n+ on ,octob] #a & end+ on ,decemb] 
#ca ea* ye>1 ea* outs\rc+ facility--    
7i7 %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 address2 &  7ii7 %all    
indicate :e!r ! outs\rc+ facility int5ds
 to comp\nd a drug product t appe>s on !
 li/ 9 effect "u section #ejf;,e dur+ ! 
subsequ5t cal5d> ye>4  7,b7 ,new        
outs\rc+ facilities ,ea* outs\rc+       
facility1 ^u fir/ engag+ 9 comp\nd+     
pursuant to ?is section1 %all imm$iately
 regi/] ) ! ,secret>y & provide !       
in=mation describ$ 9 p>agraph 7#a77;,a74
 ,! ,secret>y %all e/abli% a timel9e =  
regi/ration = ! fir/ cal5d> ye> foll[+ !
 effective date ( ! ,comp\nd+ ,cl>ity   
,act ( #bjac4 ,9 no case may regi/ration
 be requir$ until at lea/ #fj cal5d>    
days foll[+ publication ( ! timel9e 9 ! 
,f$]al ,regi/]4  7,c7 ,availability (   
regi/ration = inspection2 li/  7i7      
,regi/rations ,! ,secret>y %all make    
available = inspection1 to any p]son s  
reque/+1 any regi/ration fil$ pursuant  
to ?is p>agraph4  7ii7 ,li/ ,! ,secret>y
 %all make available on ! public        
,int]net ,web site ( ! ,food & ,drug    

,adm9i/ration a li/ ( ! "n ( ea*        
facility regi/]$ "u ?is subsection z an 
outs\rc+ facility1 ! ,/ate 9 :i* ea* su*
 facility is locat$1 :e!r ! facility    
comp\nds f bulk drug sub/ances1 & :e!r  
any su* comp\nd+ f bulk drug sub/ances  
is = /]ile or non-/]ile drug products4  
7#b7 ,drug product report+ by outs\rc+  
facilities  7,a7 ,9 g5]al ,^u initially 
regi/]+ z an outs\rc+ facility1 once    
dur+ ! mon? ( ,june ( ea* ye>1 & once   
dur+ ! mon? ( ,decemb] ( ea* ye>1 ea*   
outs\rc+ facility t regi/]s ) !         
,secret>y "u p>agraph 7#a7 %all submit  
to ! ,secret>y a report--  7i7 id5tify+ 
! drug products comp\nd$ by su* outs\rc+
 facility dur+ ! previ\s #f-mon? p]iod2 
&  7ii7 ) respect to ea* drug product   
id5tifi$ "u clause 7i71 provid+ ! active
 +r$i5t2 ! s\rce ( su* active +r$i5t2 ! 
,national ,drug ,code numb]1 if         
available1 ( ! s\rce drug product or    
bulk active +r$i5t2 ! /r5g? ( ! active  
+r$i5t p] unit2 ! dosage =m & r\te (    
adm9i/ration2 ! package description2 !  

numb] ( individual units produc$2 & !   
,national ,drug ,code numb] ( ! f9al    
product1 if assign$4  7,b7 ,=m ,ea*     
report "u subp>agraph 7,a7 %all be      
prep>$ 9 su* =m & mann] z ! ,secret>y   
may prescribe by regulation or guidance4
  7,c7 ,confid5tiality ,reports submitt$
 "u ?is p>agraph %all be exempt f       
inspection "u p>agraph 7#a77;,c71 unless
 ! ,secret>y f9ds t su* an exemption    
w\ld be inconsi/5t ) ! protection ( !   
public heal?4  7#c7 ,electronic         
regi/ration & report+ ,regi/rations &   
drug product report+ "u ?is subsection  
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  7,a7 ,9 g5]al ,outs\rc+       
facilities--  7i7 %all be subject to    
inspection pursuant to section #gjd2 &  
7ii7 %all n be eligible = ! exemption "u

 section #gjd7;a77#b77;,a74  7,b7       
,risk-bas$ s*$ule ,! ,secret>y1 act+    
?r\gh "o or m (fic]s or employees duly  
designat$ by ! ,secret>y1 %all inspect  
outs\rc+ facilities 9 accordance ) a    
risk-bas$ s*$ule e/abli%$ by !          
,secret>y4  7,c7 ,risk factors ,9       
e/abli%+ ! risk-bas$ s*$ule1 ! ,secret>y
 %all inspect outs\rc+ facilities       
accord+ to ! kn[n safety risks ( su*    
outs\rc+ facilities1 :i* %all be bas$ on
 ! foll[+ factors3  7i7 ,! compliance   
hi/ory ( ! outs\rc+ facility4  7ii7 ,!  
record1 hi/ory1 & nature ( recalls l9k$ 
to ! outs\rc+ facility4  7iii7 ,! inh]5t
 risk ( ! drug products comp\nd$ at !   
outs\rc+ facility4  7iv7 ,! inspection  
frequ5cy & hi/ory ( ! outs\rc+ facility1
 includ+ :e!r ! outs\rc+ facility has   
be5 inspect$ pursuant to section #gjd )9
 ! la/ #d ye>s4  7v7 ,:e!r ! outs\rc+   
facility has regi/]$ "u ?is p>agraph z  
an entity t int5ds to comp\nd a drug    
product t appe>s on ! li/ 9 effect "u   
section #ejf;,e4  7vi7 ,any o!r crit]ia 

deem$ necess>y & appropriate by !       
,secret>y = purposes ( allocat+         
inspection res\rces4  7#e7 ,adv]se ev5t 
report+ ,outs\rc+ facilities %all be    
requir$ to submit adv]se ev5t reports to
 ! ,secret>y 9 accordance ) ! cont5t &  
=mat requirem5ts e/abli%$ ?r\gh guidance
 or regulation "u section #caj4cje (    
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulations7 or       
section #fjj4hj ( title #ba1 ,code (    
,f$]al ,regulations 7or any successor   
regulations74  7c7 ,def9itions ,9 ?is   
section3  7#a7 ,outs\rc+ facility ,! t]m
 outs\rc+ facility means a facility at  
"o geographic location or address t     
comp\nds /]ile drug products = (fice use
 9 excess ( ! limitation set =? 9       
section #ejc;,a7a77#a77;,c77iii74  7#b7 
,o!r def9itions ,! t]ms comp\nd+1       
ess5tially a copy ( a m>ket$ & approv$  
drug product1 lic5s$ ph>maci/1 & m>ket$ 
& approv$ drug product h ! mean+s giv5  
su* t]ms 9 section #ejc;,a7f74  4  7b7  
,fees ,sub*apt] ,c ( *apt] ,,vii ( !    

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;f et seq47 is am5d$ 
by add+ at ! end ! foll[+3  #i ,fees    
relat+ to outs\rc+ facilities  #gdd;,j4 
,def9itions ,9 ?is "p3  7#a7 ,! t]m     
affiliate has ! mean+ giv5 su* t]m 9    
section #gce7aa74  7#b7 ,! t]m gross    
annual sales means ! total worldwide    
gross annual sales1 9 ,unit$ ,/ates     
doll>s1 = an outs\rc+ facility1 includ+ 
! sales ( all ! affiliates ( ! outs\rc+ 
facility4  7#c7 ,! t]m outs\rc+ facility
 has ! mean+ giv5 to su* t]m 9 section  
#ejc;,b7c74  7#d7 ,! t]m re9spection    
means1 ) respect to an outs\rc+         
facility1 "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  #gdd,k4 ,au?ority to     
assess & use outs\rc+ facility fees  7a7
 ,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--  7,a7 an annual e/abli%m5t fee
 f ea* outs\rc+ facility2 &  7,b7 a     
re9spection fee f ea* outs\rc+ facility 
subject to a re9spection 9 su* fiscal   
ye>4  7#b7 ,multiple re9spections ,an   
outs\rc+ facility subject to multiple   
re9spections 9 a fiscal ye> %all be     
subject to a re9spection fee = ea*      
re9spection4  7b7 ,e/abli%m5t &         
re9spection fee sett+ ,! ,secret>y      
%all--  7#a7 e/abli% ! am\nt ( !        
e/abli%m5t & re9spection fee to be      
collect$ "u ?is section = ea* fiscal ye>
 bas$ on ! me?odology describ$ 9        
subsection 7c72 &  7#b7 publi% su* fee  
am\nts 9 a ,f$]al ,regi/] notice n lat] 
?an #fj cal5d> days be=e ! />t ( ea* su*
 ye>4  7c7 ,am\nt ( e/abli%m5t fee &    
re9spection fee  7#a7 ,9 g5]al ,= ea*   
outs\rc+ facility 9 a fiscal ye>--  7,a7
 except z provid$ 9 p>agraph 7#d71 !    
am\nt ( ! annual e/abli%m5t fee "u      

subsection 7b7 %all be equal to ! sum   
(--  7i7 #ae1jjj1 multipli$ by !        
inflation adju/m5t factor describ$ 9    
p>agraph 7#b72 plus  7ii7 ! small       
bus9ess adju/m5t factor describ$ 9      
p>agraph 7#c72 &  7,b7 ! am\nt ( any    
re9spection fee 7if applicable7 "u      
subsection 7b7 %all be equal to #ae1jjj1
 multipli$ by ! inflation adju/m5t      
factor describ$ 9 p>agraph 7#c74  7#b7  
,inflation adju/m5t factor  7,a7 ,9     
g5]al ,= fiscal ye> #bjae & subsequ5t   
fiscal ye>s1 ! fee am\nts e/abli%$ 9    
p>agraph 7#a7 %all be adju/$ by !       
,secret>y by notice1 publi%$ 9 ! ,f$]al 
,regi/]1 = a fiscal ye> by ! am\nt equal
 to ! sum (--  7i7 "o2  7ii7 ! av]age   
annual p]c5t *ange 9 ! co/1 p] full-"t  
equival5t position ( ! ,food & ,drug    
,adm9i/ration1 ( all p]sonnel           
comp5sation & b5efits paid ) respect to 
su* positions = ! fir/ #c ye>s ( !      
prec$+ #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$+ #d fiscal ye>s2 &  7iii7 !      
av]age annual p]c5t *ange t occurr$ 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$+ #d fiscal ye>s4  7,b7   
,comp\nd$ basis ,! adju/m5t made ea*    
fiscal ye> "u subp>agraph 7,a7 %all be  
add$ on a comp\nd$ basis to ! sum ( all 
adju/m5ts made ea* fiscal ye> aft]      
fiscal ye> #bjad "u subp>agraph 7,a74   
7#c7 ,small bus9ess adju/m5t factor ,!  
small bus9ess adju/m5t factor ref]r$ to 
9 p>agraph 7#a77;,a77ii7 %all be an     
am\nt e/abli%$ by ! ,secret>y = ea*     
fiscal ye> bas$ on ! ,secret>y's e/imate
 (--  7,a7 ! numb] ( small bus9esses t w

 pay a r$uc$ e/abli%m5t fee = su* fiscal
 ye>2 &  7,b7 ! 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 p>agraph 7#d74
  7#d7 ,exception = small bus9esses     
7,a7 ,9 g5]al ,9 ! case ( an outs\rc+   
facility ) 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 
section are assess$1 ! am\nt ( !        
e/abli%m5t fee "u subsection 7b7 = a    
fiscal ye> %all be equal to #a_/c ( !   
am\nt calculat$ "u p>agraph 7#a77;,a77i7
 = su* fiscal ye>4  7,b7 ,application   
,to qualify = ! exception "u ?is        
p>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$4 ,any su* application %all  
be submitt$ to ! ,secret>y n lat] ?an   
,april #cj ( su* imm$iately prec$+      
fiscal ye>4  7#e7 ,cr$it+ ( fees ,9     
e/abli%+ ! small bus9ess adju/m5t factor
 "u p>agraph 7#c7 = a fiscal ye>1 !     
,secret>y %all--  7,a7 provide = !      
cr$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>2 &  7,b7 consid] !   
ne$ to acc\nt = any adju/m5t ( fees &   
su* o!r factors z ! ,secret>y det]m9es  
appropriate4  7d7 ,use ( fees ,!        
,secret>y %all make all ( ! fees        
collect$ pursuant to subp>agraphs 7,a7 &
 7,b7 ( subsection 7a77#a7 available    
solely to pay = ! co/s ( ov]sight (     
outs\rc+ facilities4  7e7 ,supplem5t n  
supplant ,funds receiv$ by ! ,secret>y  
pursuant to ?is section %all be us$ to  
supplem5t & n supplant any o!r ,f$]al   
funds available to c>ry out ! activities
 describ$ 9 ?is section4  7f7 ,cr$it+ & 
availability ( fees ,fees au?oriz$ "u   

?is section %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 ( outs\rc+ facilities4  
7g7 ,collection ( fees  7#a7 ,e/abli%m5t
 fee ,an outs\rc+ facility %all remit ! 
e/abli%m5t fee due "u ?is section 9 a   
fiscal ye> :5 submitt+ a regi/ration    
pursuant to section #ejc;,b7b7 = su*    
fiscal ye>4  7#b7 ,re9spection fee ,!   
,secret>y %all specify 9 ! ,f$]al       
,regi/] notice describ$ 9 subsection    
7b77#b7 ! mann] 9 :i* re9spection fees  
assess$ "u ?is section %all be collect$ 
& ! timel9e = paym5t ( su* fees4 ,su* a 
fee %all be collect$ aft] ! ,secret>y   

has conduct$ a re9spection ( ! outs\rc+ 
facility involv$4  7#c7 ,effect (       
failure to pay fees  7,a7 ,regi/ration  
,an outs\rc+ facility %all n be consid]$
 regi/]$ "u section #ejc;,b7b7 9 a      
fiscal ye> until ! date t ! outs\rc+    
facility remits ! e/abli%m5t fee "u ?is 
subsection = su* fiscal ye>4  7,b7      
,misbr&+ ,all drug products manufactur$1
 prep>$1 propagat$1 comp\nd$1 or        
process$ by an outs\rc+ facility = :i*  
any e/abli%m5t fee or re9spection fee   
has n be5 paid1 z requir$ by ?is        
section1 %all be deem$ misbr&$ "u       
section #ejb until ! fees ow$ = su*     
outs\rc+ facility "u ?is section h be5  
paid4  7#d7 ,collection ( unpaid fees ,9
 any case :]e ! ,secret>y does n receive
 paym5t ( a fee assess$ "u ?is section  
)9 #cj cal5d> 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  7h7 ,annual report
 to ,congress ,n lat] ?an #abj cal5d>   

days aft] ea* fiscal ye> 9 :i* fees are 
assess$ & collect$ "u ?is section1 !    
,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$ = 
su* ye>1 a summ>y description ( entities
 pay+ ! fees1 a description ( ! hir+ &  
placem5t ( new /aff1 a description ( !  
use ( fee res\rces to support inspect+  
outs\rc+ facilities1 & ! numb] (        
inspections & re9spections ( su*        
facilities p]=m$ ea* ye>4  7i7          
,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 section4  4  #d4      
,prohibit$ acts  7a7 ,int5tional        
falsification ( prescription ord] =     
comp\nd$ drug product ,section #cja ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   

7#ba ,u4,s4,c4 #cca7 is am5d$ by ins]t+ 
aft] p>agraph 7bbb7 ! foll[+3  7ccc7 ,) 
respect to a drug product to be comp\nd$
 "u section #ejc;,a or #ejc;,b1 !       
int5tional falsification ( a            
prescription1 a pur*ase ord]1 or pati5t 
"n requir$ "u section #ejc;,a or        
#ejc;,b4  4  7b7 ,int5tional failure (  
outs\rc+ facility ,to regi/] ,section   
#cja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 z  
am5d$ by subsection 7a71 is fur!r am5d$ 
by ins]t+ aft] p>agraph 7ccc7 7z add$ by
 su* subsection71 ! foll[+3  7ddd7 ,)   
respect to any ye> 9 :i* an outs\rc+    
facility is requir$ to regi/] ) !       
,secret>y "u section #ejc;,b7b71 !      
int5tional failure ( ! outs\rc+ facility
 to s regi/]4  4