,,ii ,cal5d> ,no4 #bcf #aac? ,,congress 
#a/ ,session  ,h4 ,r4 #cbjd  ,,9 ,,!    
,,s5ate ,,( ,,! ,,unit$ ,,/ates         
,septemb] #cj1 #bjac,receiv$  ,novemb]  
#d1 #bjac,read ! fir/ "t  ,novemb] #e1  
#bjac,read ! second "t & plac$ on !     
cal5d>  ,,an ,,act  ,to am5d ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act ) respect
 to human drug comp\nd+ & drug supply   
*a9 security1 & = o!r purposes4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,drug ,quality & ,security ,act4  #b4   
,ref]5ces 9 ,act2 table ( cont5ts  7a7  
,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  7b7 
,table ( cont5ts ,! table ( cont5ts (   
?is ,act is z foll[s3 ,sec4 #a4 ,%ort   
title4,sec4 #b4 ,ref]5ces 9 ,act2 table 
( cont5ts4,,title ,i--,drug             
compounding,sec4 #aja4 ,%ort title4,sec4
 #ajb4 ,volunt>y outs\rc+               

facilities4,sec4 #ajc4 ,p5alties4,sec4  
#ajd4 ,regulations4,sec4 #aje4 ,enhanc$ 
communication4,sec4 #ajf4               
,sev]ability4,sec4 #ajg4 ,,gao          
/udy4,,title ,,ii--,drug ,supply ,*a9   
,security,sec4 #bja4 ,%ort title4,sec4  
#bjb4 ,ph>maceutical di/ribution supply 
*a94,sec4 #bjc4 ,enhanc$ drug           
di/ribution security4,sec4 #bjd4        
,national /&>ds = prescription drug     
:olesale di/ributors4,sec4 #bje4        
,national /&>ds = ?ird-p>ty logi/ics    
provid]s2 uni=m national policy4,sec4   
#bjf4 ,p5alties4,sec4 #bjg4 ,con=m+     
am5dm5t4,sec4 #bjh4 ,sav+s clause4  ,i  
,drug comp\nd+  #aja4 ,%ort title ,?is  
,act may be cit$ z ! ,comp\nd+ ,quality 
,act4  #ajb4 ,volunt>y outs\rc+         
facilities  7a7 ,9 g5]al ,sub*apt] ,a ( 
*apt] ,v 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 ! foll[+ new
 section3  #ejc;,b4 ,outs\rc+ facilities
  7a7 ,9 g5]al ,sections #ejb7;f77#a71  

#eje1 & #ehb %all n apply to a drug     
comp\nd$ by or "u ! direct sup]vision ( 
a lic5s$ ph>maci/ 9 a facility t elects 
to regi/] z an outs\rc+ facility if ea* 
( ! foll[+ conditions is met3 7#a7      
,regi/ration & report+ ,! drug is       
comp\nd$ 9 an outs\rc+ facility t is 9  
compliance ) ! requirem5ts ( subsection 
7b74  7#b7 ,bulk drug sub/ances ,! drug 
is comp\nd$ 9 an outs\rc+ facility t    
does n comp\nd us+ bulk drug sub/ances  
7z def9$ 9 section #bjg4c7;a77#d7 (     
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulation771 unless--
 7,a7 7i7 ! bulk drug sub/ance appe>s on
 a li/ e/abli%$ by ! ,secret>y id5tify+ 
bulk drug sub/ances = :i* !re is a      
cl9ical ne$1 by-- 7,i7 publi%+ a notice 
9 ! ,f$]al ,regi/] propos+ bulk drug    
sub/ances to be includ$ on ! li/1       
includ+ ! rationale = su* proposal2     
7,,ii7 provid+ a p]iod ( n less ?an #fj 
cal5d> days = comm5t on ! notice2 &     
7,,iii7 publi%+ a notice 9 ! ,f$]al     
,regi/] designat+ bulk drug sub/ances = 

inclusion on ! li/2 or  7ii7 ! drug     
comp\nd$ f su* bulk drug sub/ance appe>s
 on ! drug %ortage li/ 9 effect "u      
section #ejf;,e at ! "t ( comp\nd+1     
di/ribution1 & disp5s+2  7,b7 if an     
applicable monograph exi/s "u ! ,unit$  
,/ates ,ph>macopeia1 ! ,national        
,=mul>y1 or ano!r comp5dium or          
ph>macopeia recogniz$ by ! ,secret>y =  
purposes ( ?is p>agraph1 ! bulk drug    
sub/ances ea* comply ) ! monograph2     
7,c7 ! 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,d7 ! bulk drug sub/ances
 are ea* accompani$ by a valid          
c]tificate ( analysis4  7#c7 ,+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+ ! drug1 su* +r$i5ts  
comply ) ! /&>ds ( ! applicable ,unit$  
,/ates ,ph>macopeia or ,national ,=mul>y
 monograph1 if su* monograph exi/s1 or (
 ano!r comp5dium or ph>macopeia         

recogniz$ by ! ,secret>y = purposes (   
?is p>agraph if any4  7#d7 ,drugs )drawn
 or remov$ because unsafe or n effective
 ,! drug does n appe> on a li/ publi%$  
by ! ,secret>y ( drugs t h be5 )drawn or
 remov$ f ! m>ket because su* drugs or  
compon5ts ( su* drugs h be5 f\nd to be  
unsafe or n effective4  7#e7 ,ess5tially
 a copy ( an approv$ drug ,! drug is n  
ess5tially a copy ( "o or m approv$     
drugs4  7#f7 ,drugs pres5t+ demon/rable 
difficulties = comp\nd+ ,! drug-- 7,a7  
is n id5tifi$ 7directly or z "p ( a     
category ( drugs7 on a li/ publi%$ by ! 
,secret>y1 ?r\gh ! process describ$ 9   
subsection 7c71 ( drugs or categories ( 
drugs t pres5t demon/rable difficulties 
= comp\nd+ t are reasonably likely to   
lead to an adv]se effect on ! safety or 
effectiv5ess ( ! drug or category (     
drugs1 tak+ into acc\nt ! risks &       
b5efits to pati5ts2 or  7,b7 is comp\nd$
 9 accordance ) all applicable          
conditions id5tifi$ on ! li/ describ$ 9 
subp>agraph 7,a7 z conditions t are     

necess>y to prev5t ! drug or category ( 
drugs f pres5t+ ! demon/rable           
difficulties describ$ 9 subp>agraph     
7,a74  7#g7 ,elem5ts to assure safe use 
,9 ! case ( a drug t is comp\nd$ f a    
drug t is ! subject ( a risk evaluation 
& mitigation /rategy approv$ ) elem5ts  
to assure safe use pursuant to section  
#eje-a1 or f a bulk drug sub/ance t is a
 compon5t ( su* drug1 ! outs\rc+        
facility demon/rates to ! ,secret>y     
prior to beg9n+ comp\nd+ t su* facility 
w utilize controls comp>able to !       
controls applicable "u ! relevant risk  
evaluation & mitigation /rategy4  7#h7  
,prohibition on :olesal+ ,! drug w n be 
sold or transf]r$ by an entity o!r ?an !
 outs\rc+ facility t comp\nd$ su* drug4 
,?is p>agraph does n prohibit           
adm9i/ration ( a drug 9 a heal? c>e     
sett+ or disp5s+ a drug pursuant to a   
prescription execut$ 9 accordance )     
section #ejc7;b77#a74  7#i7 ,fees ,!    
drug is comp\nd$ 9 an outs\rc+ facility 
t has paid all fees ow$ by su* facility 

pursuant to section #gdd,k4  7#aj7      
,label+ ( drugs  7,a7 ,label ,! label ( 
! drug includes-- 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$ drug2  7ii7 ! "n1    
address1 & phone numb] ( ! applicable   
outs\rc+ facility2 &  7iii7 ) respect to
 ! drug-- 7,i7 ! lot or bat* numb]2     
7,,ii7 ! e/abli%$ "n ( ! drug2  7,,iii7 
! dosage =m & /r5g?2  7,,iv7 ! /atem5t (
 quantity or volume1 z appropriate2     
7,v7 ! date t ! drug 0 comp\nd$2  7,,vi7
 ! expiration date2  7,,vii7 /orage &   
h&l+ in/ructions2  7,,viii7 ! ,national 
,drug ,code numb]1 if available2  7,,ix7
 ! /atem5t ,n = resale1 &1 if ! drug is 
disp5s$ or di/ribut$ o!r ?an pursuant to
 a prescription = an individual id5tifi$
 pati5t1 ! /atem5t ,(fice ,use ,only2 & 
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 ( ! 
drug 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$wat* &     
#a-hjj-;,,fda-#ajhh 7or any successor   
,int]net ,web site or phone numb]72 &   
7iii7 directions = use1 includ+1 z      
appropriate1 dosage & adm9i/ration4     
7,c7 ,additional in=mation ,! label &   
label+ ( ! drug %all include any o!r    
in=mation z det]m9$ necess>y & specifi$ 
9 regulations promulgat$ by ! ,secret>y4
  7#aa7 ,outs\rc+ facility requirem5t ,!
 drug is comp\nd$ 9 an outs\rc+ facility
 9 :i* ! comp\nd+ ( drugs occurs only 9 
accordance ) ?is section4  7b7          
,regi/ration ( outs\rc+ facilities &    
report+ ( drugs  7#a7 ,regi/ration (    
outs\rc+ facilities  7,a7 ,annual       
regi/ration ,^u elect+ & 9 ord] to      

become an outs\rc+ facility1 & dur+ !   
p]iod beg9n+ on ,octob] #a & end+ on    
,decemb] #ca ( ea* ye> !reaft]1 a       
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 email address2 &  7ii7 %all     
indicate :e!r ! outs\rc+ facility int5ds
 to comp\nd a drug t appe>s on ! li/ 9  
effect "u section #ejf;,e dur+ !        
subsequ5t cal5d> ye>4  7,b7             
,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 drugs4  7#b7 ,drug 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+ ! drugs comp\nd$ by su*        
outs\rc+ facility dur+ ! previ\s #f-mon?
 p]iod2 &  7ii7 ) respect to ea* drug   
id5tifi$ "u clause 7i71 provid+ ! active
 +r$i5t1 ! s\rce ( su* active +r$i5t1 ! 
,national ,drug ,code numb] ( ! s\rce   
drug or bulk active +r$i5t1 if          
available1 ! /r5g? ( ! active +r$i5t p] 
unit1 ! dosage =m & r\te ( adm9i/ration1
 ! package description1 ! numb] (       
individual units produc$1 & ! ,national 
,drug ,code numb] ( ! f9al product1 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;,b77i71 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 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 ( ! drugs 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 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 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$]al    
,regulations 7or any successor          
regulations74  7c7 ,regulations  7#a7 ,9
 g5]al ,! ,secret>y %all implem5t ! li/ 
describ$ 9 subsection 7a77#f7 ?r\gh     
regulations4  7#b7 ,advisory committee  
on comp\nd+ ,be=e issu+ regulations to  
implem5t subsection 7a77#f71 ! ,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>macopeia1 
ph>maci/s ) curr5t exp]i5ce & exp]tise 9
 comp\nd+1 physicians ) backgr\nd & k 9 
comp\nd+1 & pati5t & public heal?       
advocacy organizations4  7#c7 ,int]im   
li/  7,a7 ,9 g5]al ,be=e ! effective    
date ( ! regulations f9aliz$ to implem5t
 subsection 7a77#f71 ! ,secret>y may    
designate drugs1 categories ( drugs1 or 
conditions z describ$ su* subsection    
by-- 7i7 publi%+ a notice ( su*         
sub/ances1 drugs1 categories ( drugs1 or

 conditions propos$ = designation1      
includ+ ! rationale = su* designation1 9
 ! ,f$]al ,regi/]2  7ii7 provid+ a p]iod
 ( n less ?an #fj cal5d> days = comm5t  
on ! notice2 &  7iii7 publi%+ a notice 9
 ! ,f$]al ,regi/] designat+ su* drugs1  
categories ( drugs1 or conditions4  7,b7
 ,sunset ( ,notice ,any notice provid$  
"u subp>agraph 7,a7 %all n be effective 
aft] ! e>li] (-- 7i7 ! date t is #e ye>s
 aft] ! date ( enactm5t ( ! ,comp\nd+   
,quality ,act2 or  7ii7 ! effective date
 ( ! f9al regulations issu$ to implem5t 
subsection 7a77#f74  7#d7 ,updates ,!   
,secret>y %all review1 & update z       
necess>y1 ! regulations conta9+ ! li/s (
 drugs1 categories ( drugs1 or          
conditions describ$ 9 subsection 7a77#f7
 regul>ly1 b n less ?an once e #d ye>s4 
,no?+ 9 ! previ\s s5t5ce prohibits      
submissions to ! ,secret>y1 be=e or dur+
 any #d-ye> p]iod describ$ 9 su* s5t5ce1
 reque/+ updates to su* li/s4  7d7      
,def9itions ,9 ?is section3 7#a7 ,! t]m 
comp\nd+ includes ! comb9+1 admix+1     

mix+1 dilut+1 pool+1 recon/itut+1 or    
o!rwise alt]+ ( a drug or bulk drug     
sub/ance to create a drug4  7#b7 ,! t]m 
ess5tially a copy ( an approv$ drug     
means-- 7,a7 a drug t is id5tical or    
ne>ly id5tical to an approv$ drug1 or a 
m>ket$ drug n subject to section        
#ejc7;b7 & n subject to approval 9 an   
application submitt$ "u section #eje1   
unless1 9 ! case ( an approv$ drug1 !   
drug appe>s on ! drug %ortage li/ 9     
effect "u section #ejf;,e at ! "t (     
comp\nd+1 di/ribution1 & disp5s+2 or    
7,b7 a drug1 a compon5t ( :i* is a bulk 
drug sub/ance t is a compon5t ( an      
approv$ drug or a m>ket$ drug t is n    
subject to section #ejc7;b7 & n subject 
to approval 9 an application submitt$ "u
 section #eje1 unless !re is a *ange t  
produces = an individual pati5t a       
cl9ical diff]5ce1 z det]m9$ by !        
prescrib+ practition]1 betwe5 ! comp\nd$
 drug & ! comp>able approv$ drug4  7#c7 
,! t]m approv$ drug means a drug t is   
approv$ "u section #eje & does n appe>  

on ! li/ describ$ 9 subsection 7a77#d7 (
 drugs t h be5 )drawn or remov$ f !     
m>ket because su* drugs or compon5ts (  
su* drugs h be5 f\nd to be unsafe or n  
effective4  7#d7 7,a7 ,! t]m outs\rc+   
facility means a facility at "o         
geographic location or address t-- 7i7  
is engag$ 9 ! comp\nd+ ( /]ile drugs2   
7ii7 has elect$ to regi/] z an outs\rc+ 
facility2 &  7iii7 complies ) all ( !   
requirem5ts ( ?is section4  7,b7 ,an    
outs\rc+ facility is n requir$ to be a  
lic5s$ ph>macy4  7,c7 ,an outs\rc+      
facility may or may n obta9             
prescriptions = id5tifi$ individual     
pati5ts4  7#e7 ,! t]m /]ile drug means a
 drug t is int5d$ = p>5t]al             
adm9i/ration1 an oph?almic or oral      
inhalation drug 9 aque\s =mat1 or a drug
 t is requir$ to be /]ile "u ,f$]al or  
,/ate law4  4  7d7 ,obligation to pay   
fees ,paym5t ( ! fee "u section #gdd,k1 
z describ$ 9 subsection 7a77#i71 %all n 
relieve an outs\rc+ facility t is lic5s$
 z a ph>macy 9 any ,/ate t requires     

ph>macy lic5s+ fees ( its obligation to 
pay su* ,/ate fees4  4  7b7 ,fees       
,sub*apt] ,c ( *apt] ,,vii 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;,b7d77#d74  7#d7 ,! t]m re9spection
 means1 ) respect to an outs\rc+        
facility1 #a 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 fee & 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#b74  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$]al 
,regi/]1 = a fiscal ye> by ! am\nt equal
 to ! sum (-- 7i7 #a2  7ii7 ! av]age    
annual p]c5t *ange 9 ! co/1 p] full-"t  
equival5t position ( ! ,food & ,drug    
,adm9i/ration1 ( all p]sonnel           
comp5sation & b5efits paid ) respect to 
su* positions = ! fir/ #c ye>s ( !      
prec$+ #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$+ #d fiscal ye>s2 plus  7iii7 !   
av]age annual p]c5t *ange t occurr$ 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 describ$ 9
 ?is p>agraph %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 drugs 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> #bjad & ea* subsequ5t fiscal ye>1  
!re is au?oriz$ to be appropriat$ = fees
 "u ?is section an am\nt equival5t to ! 
total am\nt ( fees assess$ = su* fiscal 
ye> "u ?is section4  4  #ajc4 ,p5alties 
7a7 ,prohibit$ acts ,section #cja 7#ba  
,u4,s4,c4 #cca7 is am5d$ by add+ at !   
end ! foll[+3  7ccc7 7#a7 ,! resale ( a 
comp\nd$ drug t is label$ n = resale 9  

accordance ) section #ejc;,b4  7#b7 ,)  
respect to a drug to be comp\nd$        
pursuant to section #ejc;,a or #ejc;,b1 
! int5tional falsification ( a          
prescription1 z applicable4  7#c7 ,!    
failure to report drugs or adv]se ev5ts 
by an entity t is regi/]$ 9 accordance )
 subsection 7b7 ( section #ejc;,b4  4   
7b7 ,misbr&$ drugs ,section #ejb 7#ba   
,u4,s4,c4 #ceb7 is am5d$ by add+ at !   
end ! foll[+3  7bb7 ,if ! adv]tis+ or   
promotion ( a comp\nd$ drug is false or 
mislead+ 9 any p>ticul>4  4  #ajd4      
,regulations ,9 promulgat+ any          
regulations to implem5t ?is title 7& !  
am5dm5ts made by ?is title71 ! ,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 cal5d> 
days = comm5ts on ! propos$ regulation2 
&  7#c7 publi% ! f9al regulation n m ?an
 #ah mon?s foll[+ publication ( !       
propos$ rule & n less ?an #cj cal5d>    
days be=e ! effective date ( su* f9al   

regulation4  #aje4 ,enhanc$             
communication  7a7 ,submissions f ,/ate 
bo>ds ( ph>macy ,9 a mann] specifi$ by !
 ,secret>y ( ,heal? & ,human ,s]vices   
7ref]r$ to 9 ?is section z ! ,secret>y71
 ! ,secret>y %all receive submissions f 
,/ate bo>ds ( ph>macy-- 7#a7 describ+   
actions tak5 aga9/ comp\nd+ ph>macies1 z
 describ$ 9 subsection 7b72 or  7#b7    
express+ conc]ns t a comp\nd+ ph>macy   
may be act+ contr>y to section #ejc;,a (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cec;a74  7b7 ,cont5t ( 
submissions f /ate bo>ds ( ph>macy ,an  
action ref]r$ to 9 subsection 7a77#a7   
is1 ) respect to a ph>macy t comp\nds   
drugs1 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/ration =        
violations ( a ,/ate's ph>macy          
regulations p]ta9+ to comp\nd+4  7#c7 ,!

 recall ( a comp\nd$ drug due to conc]ns
 relat+ to ! quality or purity ( su*    
drug4  7c7 ,consultation ,! ,secret>y   
%all implem5t subsection 7a7 9          
consultation ) ! ,national ,association 
( ,bo>ds ( ,ph>macy4  7d7 ,notify+ /ate 
bo>ds ( ph>macy ,! ,secret>y %all       
imm$iately notify ,/ate bo>ds ( ph>macy 
:5-- 7#a7 ! ,secret>y receives a        
submission "u subsection 7a77#a72 or    
7#b7 ! ,secret>y makes a det]m9ation t a
 ph>macy is act+ contr>y to section     
#ejc;,a ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act4  #ajf4 ,sev]ability  7a7
 ,9 g5]al ,section #ejc;,a 7#ba         
,u4,s4,c4 #cec;a7 is am5d$ -- 7#a7 9    
subsection 7a71 9 ! matt] prec$+        
p>agraph 7#a71 by /rik+ unsolicit$2     
7#b7 by /rik+ subsection 7c72  7#c7 by  
r$esignat+ subsections 7d7 ?r\gh 7f7 z  
subsections 7c7 ?r\gh 7e71 respectively2
 &  7#d7 9 subsection                   
7b77#a77;,a77i77,,iii71 by /rik+        
subsection 7d7 & ins]t+ subsection 7c74 
7b7 ,sev]ability ,if any provision ( ?is

 ,act 7includ+ ! am5dm5ts made by ?is   
,act7 is decl>$ uncon/itutional1 or !   
applicability ( ?is ,act 7includ+ !     
am5dm5ts made by ?is ,act7 to any p]son 
or circum/ance is held invalid1 !       
con/itutionality ( ! rema9d] ( ?is ,act 
7includ+ ! am5dm5ts made by ?is ,act7 & 
! applicability !re( to o!r p]sons &    
circum/ances %all n be affect$4  #ajg4  
,,gao /udy  7a7 ,/udy ,n lat] ?an #cf   
mon?s aft] ! date ( ! enactm5t ( ?is    
,act1 ! ,comptroll] ,g5]al ( ! ,unit$   
,/ates %all submit to ,congress a report
 on ph>macy comp\nd+ & ! adequacy (     
,/ate & ,f$]al ef=ts to assure ! safety 
( comp\nd$ drugs4  7b7 ,cont5ts ,!      
report requir$ "u ?is section %all      
include-- 7#a7 a review ( ph>macy       
comp\nd+ 9 ea* ,/ate1 & ! sett+s 9 :i*  
su* comp\nd+ occurs2  7#b7 a review ( ! 
,/ate laws & policies gov]n+ ph>macy    
comp\nd+1 includ+ en=cem5t ( ,/ate laws 
& policies2  7#c7 an assessm5t ( !      
available tools to p]mit pur*as]s (     
comp\nd$ drugs to det]m9e ! safety &    

quality ( su* drugs2  7#d7 an evaluation
 ( ! effectiv5ess ( ! communication     
among ,/ates & betwe5 ,/ates & ! ,food &
 ,drug ,adm9i/ration reg>d+ comp\nd+2 & 
7#e7 an evaluation ( ! ,food & ,drug    
,adm9i/ration's implem5tation ( sections
 #ejc;,a & #ejc;,b ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act4  ,,ii ,drug    
,supply ,*a9 ,security  #bja4 ,%ort     
title ,?is title may be cit$ z ! ,drug  
,supply ,*a9 ,security ,act4  #bjb4     
,ph>maceutical di/ribution supply *a9   
,*apt] ,v 7#ba ,u4,s4,c4 #cea et seq47  
is am5d$ by add+ at ! end ! foll[+3  ,h 
,ph>maceutical di/ribution supply *a9   
#eha4 ,def9itions ,9 ?is sub*apt]3 7#a7 
,affiliate ,! t]m affiliate means a     
bus9ess entity t has a relation%ip ) a  
second bus9ess entity if1 directly or   
indirectly-- 7,a7 "o bus9ess entity     
controls1 or has ! p[] to control1 ! o!r
 bus9ess entity2 or  7,b7 a ?ird p>ty   
controls1 or has ! p[] to control1 bo? (
 ! bus9ess entities4  7#b7 ,au?oriz$ ,! 
t]m au?oriz$ means-- 7,a7 9 ! case ( a  

manufactur] or repackag]1 hav+ a valid  
regi/ration 9 accordance ) section #eaj2
  7,b7 9 ! case ( a :olesale di/ributor1
 hav+ a valid lic5se "u ,/ate law or    
section #ehc1 9 accordance ) section    
#ehb7;a77#f71 & comply+ ) ! lic5sure    
report+ requirem5ts "u section #ejc7;e71
 z am5d$ by ! ,drug ,supply ,*a9        
,security ,act2  7,c7 9 ! case ( a      
?ird-p>ty logi/ics provid]1 hav+ a valid
 lic5se "u ,/ate law or section         
#ehd7;a77#a71 9 accordance ) section    
#ehb7;a77#g71 & comply+ ) ! lic5sure    
report+ requirem5ts "u section #ehd7;b72
 &  7,d7 9 ! case ( a disp5s]1 hav+ a   
valid lic5se "u ,/ate law4  7#c7        
,disp5s] ,! t]m disp5s]-- 7,a7 means a  
retail ph>macy1 hospital ph>macy1 a gr\p
 ( *a9 ph>macies "u common own]%ip &    
control t d n act z a :olesale          
di/ributor1 or any o!r p]son au?oriz$ by
 law to disp5se or adm9i/] prescription 
drugs1 & ! affiliat$ w>eh\ses or        
di/ribution c5t]s ( su* entities "u     
common own]%ip & control t d n act z a  

:olesale di/ributor2 &  7,b7 does n     
include a p]son :o disp5ses only        
products to be us$ 9 animals 9          
accordance ) section #eab7;a77#e74  7#d7
 ,disposition ,! t]m disposition1 )     
respect to a product )9 ! possession or 
control ( an entity1 means ! removal (  
su* product f ! ph>maceutical           
di/ribution supply *a91 :i* may include 
disposal or return ( ! product =        
disposal or o!r appropriate h&l+ & o!r  
actions1 su* z reta9+ a sample ( !      
product = fur!r additional physical     
exam9ation or laboratory analysis ( !   
product by a manufactur] or regulatory  
or law en=cem5t ag5cy4  7#e7 ,di/ribute 
or di/ribution ,! t]m di/ribute or      
di/ribution means ! sale1 pur*ase1      
trade1 deliv]y1 h&l+1 /orage1 or receipt
 ( a product1 & does n include ! disp5s+
 ( a product pursuant to a prescription 
execut$ 9 accordance ) section          
#ejc7;b77#a7 or ! disp5s+ ( a product   
approv$ "u section #eab7;b74  7#f7      
,exclusive di/ributor ,! t]m exclusive  

di/ributor means ! :olesale di/ributor t
 directly pur*as$ ! product f !         
manufactur] & is ! sole di/ributor ( t  
manufactur]'s product to a subsequ5t    
repackag]1 :olesale di/ributor1 or      
disp5s]4  7#g7 ,homog5e\s case ,! t]m   
homog5e\s case means a seal$ case       
conta9+ only product t has a s+le       
,national ,drug ,code numb] belong+ to a
 s+le lot4  7#h7 ,illegitimate product  
,! t]m illegitimate product means a     
product = :i* cr$ible evid5ce %[s t !   
product-- 7,a7 is c\nt]feit1 div]t$1 or 
/ol52  7,b7 is int5tionally adult]at$   
su* t ! product w\ld result 9 s]i\s     
adv]se heal? consequ5ces or dea? to     
humans2  7,c7 is ! subject ( a fraudul5t
 transaction2 or  7,d7 appe>s o!rwise   
unfit = di/ribution su* t ! product w\ld
 be reasonably likely to result 9 s]i\s 
adv]se heal? consequ5ces or dea? to     
humans4  7#i7 ,lic5s$ ,! t]m lic5s$     
means-- 7,a7 9 ! case ( a :olesale      
di/ributor1 hav+ a valid lic5se 9       
accordance ) section #ejc7;e7 or section

 #ehb7;a77#f71 z applicable2  7,b7 9 !  
case ( a ?ird-p>ty logi/ics provid]1    
hav+ a valid lic5se 9 accordance )      
section #ehd7;a7 or section             
#ehb7;a77#g71 z applicable2 &  7,c7 9 ! 
case ( a disp5s]1 hav+ a valid lic5se "u
 ,/ate law4  7#aj7 ,manufactur] ,! t]m  
manufactur] means1 ) respect to a       
product-- 7,a7 a p]son t holds an       
application approv$ "u section #eje or a
 lic5se issu$ "u section #cea ( !       
,public ,heal? ,s]vice ,act = su*       
product1 or if su* product is n !       
subject ( an approv$ application or     
lic5se1 ! p]son :o manufactur$ !        
product2  7,b7 a co-lic5s$ p>tn] ( !    
p]son describ$ 9 subp>agraph 7,a7 t     
obta9s ! product directly f a p]son     
describ$ 9 ?is subp>agraph or           
subp>agraph 7,a7 or 7,c72 or  7,c7 an   
affiliate ( a p]son describ$ 9          
subp>agraph 7,a7 or 7,b7 t receives !   
product directly f a p]son describ$ 9   
?is subp>agraph or subp>agraph 7,a7 or  
7,b74  7#aa7 ,package  7,a7 ,9 g5]al ,! 

t]m package means ! smalle/ individual  
saleable unit ( product = di/ribution by
 a manufactur] or repackag] t is int5d$ 
by ! manufactur] = ultimate sale to !   
disp5s] ( su* product4  7,b7 ,individual
 saleable unit ,= purposes ( ?is        
p>agraph1 an individual saleable unit is
 ! smalle/ conta9] ( product introduc$  
into comm]ce by ! manufactur] or        
repackag] t is int5d$ by ! manufactur]  
or repackag] = individual sale to a     
disp5s]4  7#ab7 ,prescription drug ,!   
t]m prescription drug means a drug =    
human use subject to section            
#ejc7;b77#a74  7#ac7 ,product ,! t]m    
product means a prescription drug 9 a   
f9i%$ dosage =m = adm9i/ration to a     
pati5t )\t sub/antial fur!r manufactur+ 
7su* z capsules1 tablets1 & lyophiliz$  
products be=e recon/itution71 b =       
purposes ( section #ehb1 does n include 
blood or blood compon5ts int5d$ =       
transfusion1 radioactive drugs or       
radioactive biological products 7z def9$
 9 section #fjj4c7;ee7 ( title #ba1     

,code ( ,f$]al ,regulations7 t are      
regulat$ by ! ,nucle> ,regulatory       
,commission or by a ,/ate pursuant to an
 agreem5t ) su* ,commission "u section  
#bgd ( ! ,atomic ,en]gy ,act ( #aied    
7#db ,u4,s4,c4 #bjba71 imag+ drugs1 an  
intrav5\s product describ$ 9 clause     
7xiv71 7xv71 or 7xvi7 ( p>agraph        
7#bd77;,b71 any m$ical gas 7z def9$ 9   
section #ege71 homeopa?ic drugs m>ket$ 9
 accordance ) applicable guidance "u ?is
 ,act1 or a drug comp\nd$ 9 compliance )
 section #ejc;,a or #ejc;,b4  7#ad7     
,product id5tifi] ,! t]m product        
id5tifi] means a /&>diz$ graphic t      
includes1 9 bo? human-readable =m & on a
 ma*9e-readable data c>ri] t con=ms to !
 /&>ds develop$ by a widely recogniz$   
int]national /&>ds developm5t           
organization1 ! /&>diz$ num]ical        
id5tifi]1 lot numb]1 & expiration date (
 ! product4  7#ae7 ,qu>ant9e ,! t]m     
qu>ant9e means ! /orage or id5tification
 ( a product1 to prev5t di/ribution or  
transf] ( ! product1 9 a physically     

sep>ate area cle>ly id5tifi$ = su* use  
or ?r\gh o!r proc$ures4  7#af7          
,repackag] ,! t]m repackag] means a     
p]son :o owns or op]ates an e/abli%m5t t
 repacks & relabels a product or package
 =-- 7,a7 fur!r sale2 or  7,b7          
di/ribution )\t a fur!r transaction4    
7#ag7 ,return ,! t]m return means       
provid+ product to ! au?oriz$ imm$iate  
trad+ p>tn] f :i* su* product 0 pur*as$ 
or receiv$1 or to a returns processor or
 rev]se logi/ics provid] = h&l+ ( su*   
product4  7#ah7 ,returns processor or   
rev]se logi/ics provid] ,! t]m returns  
processor or rev]se logi/ics provid]    
means a p]son :o owns or op]ates an     
e/abli%m5t t dispositions or o!rwise    
processes saleable or nonsaleable       
product receiv$ f an au?oriz$ trad+     
p>tn] su* t ! product may be process$ = 
cr$it to ! pur*as]1 manufactur]1 or     
sell] or dispos$ ( = no fur!r           
di/ribution4  7#ai7 ,specific pati5t ne$
 ,! t]m specific pati5t ne$ ref]s to !  
transf] ( a product f "o ph>macy to     

ano!r to fill a prescription = an       
id5tifi$ pati5t4 ,su* t]m does n include
 ! transf] ( a product f "o ph>macy to  
ano!r = ! purpose ( increas+ or repl5i%+
 /ock 9 anticipation ( a pot5tial ne$4  
7#bj7 ,/&>diz$ num]ical id5tifi] ,! t]m 
/&>diz$ num]ical id5tifi] means a set ( 
numb]s or *>act]s us$ to uniquely       
id5tify ea* package or homog5\s case t  
is compos$ ( ! ,national ,drug ,code t  
corresponds to ! specific product       
7includ+ ! p>ticul> package             
configuration7 comb9$ ) a unique        
alphanum]ic s]ial numb] ( up to #bj     
*>act]s4  7#ba7 ,suspect product ,! t]m 
suspect product means a product = :i*   
!re is reason to believe t su* product--
 7,a7 is pot5tially c\nt]feit1 div]t$1  
or /ol52  7,b7 is pot5tially            
int5tionally adult]at$ su* t ! product  
w\ld result 9 s]i\s adv]se heal?        
consequ5ces or dea? to humans2  7,c7 is 
pot5tially ! subject ( a fraudul5t      
transaction2 or  7,d7 appe>s o!rwise    
unfit = di/ribution su* t ! product w\ld

 result 9 s]i\s adv]se heal? consequ5ces
 or dea? to humans4  7#bb7 ,?ird-p>ty   
logi/ics provid] ,! t]m ?ird-p>ty       
logi/ics provid] means an entity t      
provides or coord9ates w>eh\s+1 or o!r  
logi/ics s]vices ( a product 9 int]/ate 
comm]ce on behalf ( a manufactur]1      
:olesale di/ributor1 or disp5s] ( a     
product1 b does n take own]%ip ( !      
product1 nor h responsibility to direct 
! sale or disposition ( ! product4      
7#bc7 ,trad+ p>tn] ,! t]m trad+ p>tn]   
means-- 7,a7 a manufactur]1 repackag]1  
:olesale di/ributor1 or disp5s] f :om a 
manufactur]1 repackag]1 :olesale        
di/ributor1 or disp5s] accepts direct   
own]%ip ( a product or to :om a         
manufactur]1 repackag]1 :olesale        
di/ributor1 or disp5s] transf]s direct  
own]%ip ( a product2 or  7,b7 a         
?ird-p>ty logi/ics provid] f :om a      
manufactur]1 repackag]1 :olesale        
di/ributor1 or disp5s] accepts direct   
possession ( a product or to :om a      
manufactur]1 repackag]1 :olesale        

di/ributor1 or disp5s] transf]s direct  
possession ( a product4  7#bd7          
,transaction  7,a7 ,9 g5]al ,! t]m      
transaction means ! transf] ( product   
betwe5 p]sons 9 :i* a *ange ( own]%ip   
occurs4  7,b7 ,exemptions ,! t]m        
transaction does n include-- 7i7        
intracompany di/ribution ( any product  
betwe5 memb]s ( an affiliate or )9 a    
manufactur]2  7ii7 ! di/ribution ( a    
product among hospitals or o!r heal? c>e
 entities t are "u common control2      
7iii7 ! di/ribution ( a product =       
em]g5cy m$ical reasons includ+ a public 
heal? em]g5cy decl>ation pursuant to    
section #cai ( ! ,public ,heal? ,s]vice 
,act1 except t a drug %ortage n caus$ by
 a public heal? em]g5cy %all n con/itute
 an em]g5cy m$ical reason2  7iv7 !      
disp5s+ ( a product pursuant to a       
prescription execut$ 9 accordance )     
section #ejc7;b77#a72  7v7 ! di/ribution
 ( product samples by a manufactur] or a
 lic5s$ :olesale di/ributor 9 accordance
 ) section #ejc7;d72  7vi7 ! di/ribution

 ( blood or blood compon5ts int5d$ =    
transfusion2  7vii7 ! di/ribution (     
m9imal quantities ( product by a lic5s$ 
retail ph>macy to a lic5s$ practition] =
 (fice use2  7viii7 ! sale1 pur*ase1 or 
trade ( a drug or an (f] to sell1       
pur*ase1 or trade a drug by a *>itable  
organization describ$ 9 section         
#eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code 
( #aihf to a nonpr(it affiliate ( !     
organization to ! ext5t o!rwise p]mitt$ 
by law2  7ix7 ! di/ribution ( a product 
pursuant to ! sale or m]g] ( a ph>macy  
or ph>macies or a :olesale di/ributor or
 :olesale di/ributors1 except t any     
records requir$ to be ma9ta9$ = !       
product %all be transf]r$ to ! new own] 
( ! ph>macy or ph>macies or :olesale    
di/ributor or :olesale di/ributors2  7x7
 ! disp5s+ ( a product approv$ "u       
section #eab7;c72  7xi7 products        
transf]r$ to or f any facility t is     
lic5s$ by ! ,nucle> ,regulatory         
,commission or by a ,/ate pursuant to an
 agreem5t ) su* ,commission "u section  

#bgd ( ! ,atomic ,en]gy ,act ( #aied    
7#db ,u4,s4,c4 #bjba72  7xii7 a         
comb9ation product t is n subject to    
approval "u section #eje or lic5sure "u 
section #cea ( ! ,public ,heal? ,s]vice 
,act1 & t is-- 7,i7 a product compris$ (
 a device & #a or m o!r regulat$        
compon5ts 7su* z a drug_/device1        
biologic_/device1 or                    
drug_/device_/biologic7 t are           
physically1 *emically1 or o!rwise comb9$
 or mix$ & produc$ z a s+le entity2     
7,,ii7 #b or m sep>ate products packag$ 
toge!r 9 a s+le package or z a unit &   
compris$ ( a drug & device or device &  
biological product2 or  7,,iii7 #b or m 
f9i%$ m$ical devices plus "o or m drug  
or biological products t are packag$    
toge!r 9 :at is ref]r$ to z a m$ical    
conv5i5ce kit z describ$ 9 clause       
7xiii72  7xiii7 ! di/ribution ( a       
collection ( f9i%$ m$ical devices1 :i*  
may include a product or biological     
product1 assembl$ 9 kit =m /rictly = !  
conv5i5ce ( ! pur*as] or us] 7ref]r$ to 

9 ?is clause z a m$ical conv5i5ce kit7  
if-- 7,i7 ! m$ical conv5i5ce kit is     
assembl$ 9 an e/abli%m5t t is regi/]$ ) 
! ,food & ,drug ,adm9i/ration z a device
 manufactur] 9 accordance ) section     
#eaj7;b77#b72  7,,ii7 ! m$ical conv5i5ce
 kit does n conta9 a controll$ sub/ance 
t appe>s 9 a s*$ule conta9$ 9 !         
,compreh5sive ,drug ,abuse ,prev5tion & 
,control ,act ( #aigj2  7,,iii7 9 ! case
 ( a m$ical conv5i5ce kit t includes a  
product1 ! p]son t manufactur]s ! kit-- 
7aa7 pur*as$ su* product directly f !   
ph>maceutical manufactur] or f a        
:olesale di/ributor t pur*as$ ! product 
directly f ! ph>maceutical manufactur]2 
&  7bb7 does n alt] ! prim>y conta9] or 
label ( ! product z pur*as$ f !         
manufactur] or :olesale di/ributor2 &   
7,,iv7 9 ! case ( a m$ical conv5i5ce kit
 t includes a product1 ! product is--   
7aa7 an intrav5\s solution int5d$ = !   
repl5i%m5t ( fluids & electrolytes2     
7bb7 a product int5d$ to ma9ta9 !       
equilibrium ( wat] & m9]als 9 ! body2   

7cc7 a product int5d$ = irrigation or   
recon/itution2  7dd7 an ane/hetic2  7ee7
 an anticoagulant2  7ff7 a vasopressor2 
or  7gg7 a sympa?omimetic2  7xiv7 !     
di/ribution ( an intrav5\s product t1 by
 its =mulation1 is int5d$ = ! repl5i%m5t
 ( fluids & electrolytes 7su* z sodium1 
*loride1 & potassium7 or calories 7su* z
 dextrose & am9o acids72  7xv7 !        
di/ribution ( an intrav5\s product us$  
to ma9ta9 ! equilibrium ( wat] & m9]als 
9 ! body1 su* z dialysis solutions2     
7xvi7 ! di/ribution ( a product t is    
int5d$ = irrigation1 or /]ile wat]1 :e!r
 int5d$ = su* purposes or = injection2  
7xvii7 ! di/ribution ( a m$ical gas 7z  
def9$ 9 section #ege72 or  7xviii7 !    
di/ribution or sale ( any lic5s$ product
 "u section #cea ( ! ,public ,heal?     
,s]vice ,act t meets ! def9ition ( a    
device "u section #bja7;h74  7#be7      
,transaction hi/ory ,! t]m transaction  
hi/ory means a /atem5t 9 pap] or        
electronic =m1 includ+ ! transaction    
in=mation = ea* prior transaction go+   

back to ! manufactur] ( ! product4      
7#bf7 ,transaction in=mation ,! t]m     
transaction in=mation means-- 7,a7 !    
propriet>y or e/abli%$ "n or names ( !  
product2  7,b7 ! /r5g? & dosage =m ( !  
product2  7,c7 ! ,national ,drug ,code  
numb] ( ! product2  7,d7 ! conta9] size2
  7,e7 ! numb] ( conta9]s2  7,f7 ! lot  
numb] ( ! product2  7,g7 ! date ( !     
transaction2  7,h7 ! date ( ! %ipm5t1 if
 m ?an #bd h\rs aft] ! date ( !         
transaction2  7,i7 ! bus9ess "n &       
address ( ! p]son f :om own]%ip is be+  
transf]r$2 &  7,j7 ! bus9ess "n &       
address ( ! p]son to :om own]%ip is be+ 
transf]r$4  7#bg7 ,transaction /atem5t  
,! transaction /atem5t is a /atem5t1 9  
pap] or electronic =m1 t ! entity       
transf]r+ own]%ip 9 a transaction-- 7,a7
 is au?oriz$ z requir$ "u ! ,drug       
,supply ,*a9 ,security ,act2  7,b7      
receiv$ ! product f a p]son t is        
au?oriz$ z requir$ "u ! ,drug ,supply   
,*a9 ,security ,act2  7,c7 receiv$      
transaction in=mation & a transaction   

/atem5t f ! prior own] ( ! product1 z   
requir$ "u section #ehb2  7,d7 did n    
kn[+ly %ip a suspect or illegitimate    
product2  7,e7 _h sy/ems & processes 9  
place to comply ) v]ification           
requirem5ts "u section #ehb2  7,f7 did n
 kn[+ly provide false transaction       
in=mation2 &  7,g7 did n kn[+ly alt] !  
transaction hi/ory4  7#bh7 ,v]ification 
or v]ify ,! t]m v]ification or v]ify    
means det]m9+ :e!r ! product id5tifi]   
affix$ to1 or impr9t$ ^u1 a package or  
homog5e\s case corresponds to ! /&>diz$ 
num]ical id5tifi] or lot numb] &        
expiration date assign$ to ! product by 
! manufactur] or ! repackag]1 z         
applicable 9 accordance ) section #ehb4 
7#bi7 ,:olesale di/ributor ,! t]m       
:olesale di/ributor means a p]son 7o!r  
?an a manufactur]1 a manufactur]'s      
co-lic5s$ p>tn]1 a ?ird-p>ty logi/ics   
provid]1 or repackag]7 engag$ 9 :olesale
 di/ribution 7z def9$ 9 section         
#ejc7;e77#d71 z am5d$ by ! ,drug ,supply
 ,*a9 ,security ,act74  #ehb4           

,requirem5ts  7a7 ,9 g5]al  7#a7 ,o!r   
activities ,ea* manufactur]1 repackag]1 
:olesale di/ributor1 & disp5s] %all     
comply ) ! requirem5ts set =? 9 ?is     
section ) respect to ! role ( su*       
manufactur]1 repackag]1 :olesale        
di/ributor1 or disp5s] 9 a transaction  
involv+ product4 ,if an entity meets !  
def9ition ( m ?an "o ( ! entities li/$ 9
 ! prec$+ s5t5ce1 su* entity %all comply
 ) all applicable requirem5ts 9 ?is     
section1 b %all n be requir$ to         
duplicate requirem5ts4  7#b7 ,initial   
/&>ds  7,a7 ,9 g5]al ,! ,secret>y %all1 
9 consultation ) o!r appropriate ,f$]al 
(ficials1 manufactur]s1 repackag]s1     
:olesale di/ributors1 disp5s]s1 & o!r   
ph>maceutical di/ribution supply *a9    
/akehold]s1 issue a draft guidance      
docum5t t e/abli%es /&>ds = !           
int]op]able ex*ange ( transaction       
in=mation1 transaction hi/ory1 &        
transaction /atem5ts1 9 pap] or         
electronic =mat1 = compliance ) ?is     
subsection & subsections 7b71 7c71 7d71 

& 7e74 ,9 e/abli%+ su* /&>ds1 !         
,secret>y %all consid] ! feasibility (  
e/abli%+ /&>diz$ docum5tation to be us$ 
by memb]s ( ! ph>maceutical di/ribution 
supply *a9 to convey ! transaction      
in=mation1 transaction hi/ory1 &        
transaction /atem5t to ! subsequ5t      
pur*as] ( a product & to facilitate !   
ex*ange ( lot level data4 ,! /&>ds      
e/abli%$ "u ?is p>agraph %all take into 
consid]ation ! /&>ds e/abli%$ "u section
 #eje;,d & %all comply ) a =m & =mat    
develop$ by a widely recogniz$          
int]national /&>ds developm5t           
organization4  7,b7 ,public input ,prior
 to issu+ ! draft guidance "u           
subp>agraph 7,a71 ! ,secret>y %all ga!r 
comm5ts & in=mation f /akehold]s &      
ma9ta9 su* comm5ts & in=mation 9 a      
public docket = at lea/ #fj days prior  
to issu+ su* guidance4  7,c7            
,publication ,! ,secret>y %all publi% ! 
/&>ds e/abli%$ "u subp>agraph 7,a7 n    
lat] ?an #a ye> aft] ! date ( enactm5t (
 ! ,drug ,supply ,*a9 ,security ,act4   

7#c7 ,waiv]s1 exceptions1 & exemptions  
7,a7 ,9 g5]al ,n lat] ?an #b ye>s aft] !
 date ( enactm5t ( ! ,drug ,supply ,*a9 
,security ,act1 ! ,secret>y %all1 by    
guidance-- 7i7 e/abli% a process by :i* 
an au?oriz$ manufactur]1 repackag]1     
:olesale di/ributor1 or disp5s] may     
reque/ a waiv] f any ( ! requirem5ts set
 =? 9 ?is section1 :i* ! ,secret>y may  
grant if ! ,secret>y det]m9es t su*     
requirem5ts w\ld result 9 an undue      
economic h>d%ip or = em]g5cy m$ical     
reasons1 includ+ a public heal? em]g5cy 
decl>ation pursuant to section #cai ( ! 
,public ,heal? ,s]vice ,act2  7ii7      
e/abli% a process by :i* ! ,secret>y    
det]m9es exceptions1 & a process ?r\gh  
:i* a manufactur] or repackag] may      
reque/ su* an exception1 to !           
requirem5ts relat+ to product id5tifi]s 
if a product is packag$ 9 a conta9] too 
small or o!rwise unable to accommodate a
 label ) suffici5t space to be> !       
in=mation requir$ = compliance ) ?is    
section2 &  7iii7 e/abli% a process by  

:i* ! ,secret>y may det]m9e o!r products
 or transactions t %all be exempt f !   
requirem5ts ( ?is section4  7,b7 ,cont5t
 ,! guidance issu$ "u subp>agraph 7,a7  
%all include a process = ! bi5nial      
review & r5ewal ( su* waiv]s1           
exceptions1 & exemptions1 z applicable4 
7,c7 ,process ,9 issu+ ! guidance "u ?is
 p>agraph1 ! ,secret>y %all provide an  
effective date t is n lat] ?an #ahj days
 prior to ! date on :i* manufactur]s are
 requir$ to affix or impr9t a product   
id5tifi] to ea* package & homog5\s case 
( product int5d$ to be introduc$ 9 a    
transaction into comm]ce consi/5t ) ?is 
section4  7#d7 ,self-execut+ requirem5ts
 ,except :]e o!rwise specifi$1 !        
requirem5ts ( ?is section may be en=c$  
)\t fur!r regulations or guidance f !   
,secret>y4  7#e7 ,gr&fa!r+ product  7,a7
 ,product id5tifi] ,n lat] ?an #b ye>s  
aft] ! date ( enactm5t ( ! ,drug ,supply
 ,*a9 ,security ,act1 ! ,secret>y %all  
f9alize guidance specify+ :e!r & "u :at 
circum/ances product t is n label$ ) a  

product id5tifi] & t is 9 !             
ph>maceutical di/ribution supply *a9 at 
! "t ( ! effective date ( ! requirem5ts 
( ?is section %all be exempt$ f !       
requirem5ts ( ?is section4  7,b7 ,trac+ 
,= a product t ent]$ ! ph>maceutical    
di/ribution supply *a9 prior to ,janu>y 
#a1 #bjae-- 7i7 au?oriz$ trad+ p>tn]s   
%all be exempt f provid+ transaction    
in=mation z requir$ "u subsections      
7b77#a77;,a77i71 7c77#a77;,a77ii71      
7d77#a77;,a77ii71 & 7e77#a77;,a77ii72   
7ii7 transaction hi/ory requir$ "u ?is  
section %all beg9 ) ! own] ( su* product
 on su* date2 &  7iii7 ! own]s ( su*    
product on su* date %all be exempt f    
ass]t+ receipt ( transaction in=mation &
 transaction /atem5t f ! prior own] z   
requir$ "u ?is section4  7#f7 ,:olesale 
di/ributor lic5ses ,not)/&+ section     
#eha7i77;,a71 until ! effective date ( !
 :olesale di/ributor lic5s+ regulations 
"u section #ehc1 ! t]m lic5s$ or        
au?oriz$1 z x relates to a :olesale     
di/ributor ) respect to prescription    

drugs1 %all mean a :olesale di/ributor )
 a valid lic5se "u ,/ate law4  7#g7     
,?ird-p>ty logi/ics provid] lic5ses     
,until ! effective date ( ! ?ird-p>ty   
logi/ics provid] lic5s+ regulations "u  
section #ehd1 a ?ird-p>ty logi/ics      
provid] %all be consid]$ lic5s$ "u      
section #eha7i77;,b7 unless ! ,secret>y 
has made a f9d+ t ! ?ird-p>ty logi/ics  
provid] does n utilize good h&l+ &      
di/ribution practices & publi%es notice 
!re(4  7#h7 ,label *anges ,*anges made  
to package labels solely to incorporate 
! product id5tifi] may be submitt$ to ! 
,secret>y 9 ! annual report ( an        
e/abli%m5t1 9 accordance ) section      
#cad4gj7;d7 ( *apt] #ba1 ,code ( ,f$]al 
,regulations 7or any successor          
regulation74  7#i7 ,product id5tifi]s ,)
 respect to any requirem5t relat+ to    
product id5tifi]s "u ?is sub*apt]-- 7,a7
 unless ! ,secret>y all[s1 ?r\gh        
guidance1 ! use ( o!r te*nologies = data
 in/ead ( or 9 addition to ! te*nologies
 describ$ 9 clauses 7i7 & 7ii71 !       

applicable data-- 7i7 %all be includ$ 9 
a #b-;dim5sional data matrix b>code :5  
affix$ to1 or impr9t$ ^u1 a package2 &  
7ii7 %all be includ$ 9 a l9e> or        
#b-;dim5sional data matrix b>code :5    
affix$ to1 or impr9t$ ^u1 a homog5e\s   
case2 &  7,b7 v]ification ( ! product   
id5tifi] may occur by us+ human-readable
 or ma*9e-readable me?ods4  7b7         
,manufactur] requirem5ts  7#a7 ,product 
trac+  7,a7 ,9 g5]al ,beg9n+ n lat] ?an 
,janu>y #a1 #bjae1 a manufactur] %all-- 
7i7 prior to1 or at ! "t (1 ea*         
transaction 9 :i* su* manufactur]       
transf]s own]%ip ( a product1 provide ! 
subsequ5t own] ) transaction hi/ory1    
transaction in=mation1 & a transaction  
/atem5t1 9 a s+le docum5t 9 an pap] or  
electronic =mat2 &  7ii7 capture !      
transaction in=mation 7includ+ lot level
 in=mation71 transaction hi/ory1 &      
transaction /atem5t = ea* transaction & 
ma9ta9 su* in=mation1 hi/ory1 & /atem5t 
= n less ?an #f ye>s aft] ! date ( !    
transaction4  7,b7 ,reque/s = in=mation 

,^u a reque/ by ! ,secret>y or o!r      
appropriate ,f$]al or ,/ate (ficial1 9 !
 ev5t ( a recall or = ! purpose (       
inve/igat+ a suspect product or an      
illegitimate product1 a manufactur]     
%all1 n lat] ?an #a bus9ess day1 & n to 
exce$ #dh h\rs1 aft] receiv+ ! reque/1  
or 9 o!r su* reasonable "t z det]m9$ by 
! ,secret>y1 bas$ on ! circum/ances ( ! 
reque/1 provide ! applicable transaction
 in=mation1 transaction hi/ory1 &       
transaction /atem5t = ! product4  7,c7  
,electronic =mat  7i7 ,9 g5]al ,beg9n+ n
 lat] ?an #d ye>s aft] ! date ( enactm5t
 ( ! ,drug ,supply ,*a9 ,security ,act1 
except z provid$ "u clause 7ii71 a      
manufactur] %all provide ! transaction  
in=mation1 transaction hi/ory1 &        
transaction /atem5t requir$ "u          
subp>agraph 7,a77i7 9 electronic =mat4  
7ii7 ,exception ,a manufactur] may      
cont9ue to provide ! transaction        
in=mation1 transaction hi/ory1 &        
transaction /atem5t requir$ "u          
subp>agraph 7,a77i7 9 a pap] =mat to a  

lic5s$ heal? c>e practition] au?oriz$ to
 prescribe m$ication "u ,/ate law or o!r
 lic5s$ individual "u ! sup]vision or   
direction ( su* a practition] :o        
disp5ses product 9 ! usual c\rse (      
pr(essional practice4  7#b7 ,product    
id5tifi]  7,a7 ,9 g5]al ,beg9n+ n lat]  
?an #d ye>s aft] ! date ( enactm5t ( !  
,drug ,supply ,*a9 ,security ,act1 a    
manufactur] %all affix or impr9t a      
product id5tifi] to ea* package &       
homog5\s case ( a product int5d$ to be  
introduc$ 9 a transaction into comm]ce4 
,su* manufactur] %all ma9ta9 ! product  
id5tifi] in=mation = su* product = n    
less ?an #f ye>s aft] ! date ( !        
transaction4  7,b7 ,exception ,a package
 t is requir$ to h a /&>diz$ num]ical   
id5tifi] is n requir$ to h a unique     
device id5tifi]4  7#c7 ,au?oriz$ trad+  
p>tn]s ,beg9n+ n lat] ?an ,janu>y #a1   
#bjae1 ! trad+ p>tn]s ( a manufactur]   
may be only au?oriz$ trad+ p>tn]s4  7#d7
 ,v]ification ,beg9n+ n lat] ?an ,janu>y
 #a1 #bjae1 a manufactur] %all h sy/ems 

9 place to enable ! manufactur] to      
comply ) ! foll[+ requirem5ts3 7,a7     
,suspect product  7i7 ,9 g5]al ,^u mak+ 
a det]m9ation t a product 9 ! possession
 or control ( ! manufactur] is a suspect
 product1 or ^u receiv+ a reque/ =      
v]ification f ! ,secret>y t has made a  
det]m9ation t a product )9 ! possession 
or control ( a manufactur] is a suspect 
product1 a manufactur] %all-- 7,i7      
qu>ant9e su* product )9 ! possession or 
control ( ! manufactur] f product int5d$
 = di/ribution until su* product is     
cle>$ or disposition$2 &  7,,ii7        
promptly conduct an inve/igation 9      
coord9ation ) trad+ p>tn]s1 z           
applicable1 to det]m9e :e!r ! product is
 an illegitimate product1 :i* %all      
include validat+ any applicable         
transaction hi/ory & transaction        
in=mation 9 ! possession ( ! manufactur]
 & o!rwise inve/igat+ to det]m9e :e!r ! 
product is an illegitimate product1 &1  
beg9n+ #d ye>s aft] ! date ( enactm5t ( 
! ,drug ,supply ,*a9 ,security ,act1    

v]ify+ ! product at ! package level1    
includ+ ! /&>diz$ num]ical id5tifi]4    
7ii7 ,cle>$ product ,if ! manufactur]   
makes ! det]m9ation t a suspect product 
is n an illegitimate product1 !         
manufactur] %all promptly notify !      
,secret>y1 if applicable1 ( su*         
det]m9ation & su* product may be fur!r  
di/ribut$4  7iii7 ,records ,a           
manufactur] %all keep records ( !       
inve/igation ( a suspect product = n    
less ?an #f ye>s aft] ! conclusion ( !  
inve/igation4  7,b7 ,illegitimate       
product  7i7 ,9 g5]al ,^u det]m9+ t a   
product 9 ! possession or control ( a   
manufactur] is an illegitimate product1 
! manufactur] %all1 9 a mann] consi/5t )
 ! sy/ems & processes ( su*             
manufactur]-- 7,i7 qu>ant9e su* product 
)9 ! possession or control ( !          
manufactur] f product int5d$ =          
di/ribution until su* product is        
disposition$2  7,,ii7 disposition !     
illegitimate product )9 ! possession or 
control ( ! manufactur]2  7,,iii7 take  

reasonable & appropriate /eps to assi/ a
 trad+ p>tn] to disposition an          
illegitimate product n 9 ! possession or
 control ( ! manufactur]2 &  7,,iv7     
reta9 a sample ( ! product = fur!r      
physical exam9ation or laboratory       
analysis ( ! product by ! manufactur] or
 ,secret>y 7or o!r appropriate ,f$]al or
 ,/ate (ficial7 ^u reque/ by ! ,secret>y
 7or o!r appropriate ,f$]al or ,/ate    
(ficial71 z necess>y & appropriate4     
7ii7 ,mak+ a notification  7,i7         
,illegitimate product ,^u det]m9+ t a   
product 9 ! possession or control ( !   
manufactur] is an illegitimate product1 
! manufactur] %all notify ! ,secret>y & 
all imm$iate trad+ p>tn]s t !           
manufactur] has reason to believe may h 
receiv$ su* illegitimate product ( su*  
det]m9ation n lat] ?an #bd h\rs aft]    
mak+ su* det]m9ation4  7,,ii7 ,high risk
 ( illegitimacy ,a manufactur] %all     
notify ! ,secret>y & imm$iate trad+     
p>tn]s t ! manufactur] has reason to    
believe may h 9 ! trad+ p>tn]'s         

possession a product manufactur$ by1 or 
purport$ to be a product manufactur$ by1
 ! manufactur] n lat] ?an #bd h\rs aft] 
det]m9+ or be+ notifi$ by ! ,secret>y or
 a trad+ p>tn] t !re is a high risk t   
su* product is an illegitimate product4 
,= purposes ( ?is subclause1 a high risk
 may include a specific high risk t c\ld
 increase ! likelihood t illegitimate   
product w ent] ! ph>maceutical          
di/ribution supply *a9 & o!r high risks 
z det]m9$ by ! ,secret>y 9 guidance     
pursuant to subsection 7h74  7iii7      
,respond+ to a notification ,^u !       
receipt ( a notification f ! ,secret>y  
or a trad+ p>tn] t a det]m9ation has be5
 made t a product is an illegitimate    
product1 a manufactur] %all id5tify all 
illegitimate product subject to su*     
notification t is 9 ! possession or     
control ( ! manufactur]1 includ+ any    
product t is subsequ5tly receiv$1 & %all
 p]=m ! activities describ$ 9           
subp>agraph 7,a74  7iv7 ,t]m9at+ a      
notification ,^u mak+ a det]m9ation1 9  

consultation ) ! ,secret>y1 t a         
notification is no long] necess>y1 a    
manufactur] %all promptly notify        
imm$iate trad+ p>tn]s t ! manufactur]   
notifi$ pursuant to clause 7ii7 t su*   
notification has be5 t]m9at$4  7v7      
,records ,a manufactur] %all keep       
records ( ! disposition ( an            
illegitimate product = n less ?an #f    
ye>s aft] ! conclusion ( ! disposition4 
7,c7 ,reque/s = v]ification ,beg9n+ #d  
ye>s aft] ! date ( enactm5t ( ! ,drug   
,supply ,*a9 ,security ,act1 ^u receiv+ 
a reque/ = v]ification f an au?oriz$    
repackag]1 :olesale di/ributor1 or      
disp5s] t is 9 possession or control ( a
 product su* p]son believes to be       
manufactur$ by su* manufactur]1 a       
manufactur] %all1 n lat] ?an #bd h\rs   
aft] receiv+ ! reque/ = v]ification or 9
 o!r su* reasonable "t z det]m9$ by !   
,secret>y1 bas$ on ! circum/ances ( !   
reque/1 notify ! p]son mak+ ! reque/    
:e!r ! product id5tifi]1 includ+ !      
/&>diz$ num]ical id5tifi]1 t is !       

subject ( ! reque/ corresponds to !     
product id5tifi] affix$ or impr9t$ by ! 
manufactur]4 ,if a manufactur] respond+ 
to a reque/ = v]ification id5tifies a   
product id5tifi] t does n correspond to 
t affix$ or impr9t$ by ! manufactur]1 ! 
manufactur] %all treat su* product z    
suspect product & conduct an            
inve/igation z describ$ 9 subp>agraph   
7,a74 ,if ! manufactur] has reason to   
believe ! product is an illegitimate    
product1 ! manufactur] %all advise !    
p]son mak+ ! reque/ ( su* belief at ! "t
 su* manufactur] responds to ! reque/ = 
v]ification4  7,d7 ,electronic database 
,a manufactur] may satisfy ! requirem5ts
 ( ?is p>agraph by develop+ a secure    
electronic database or utiliz+ a secure 
electronic database develop$ or op]at$  
by ano!r entity4 ,! own] ( su* database 
%all e/abli% ! requirem5ts & processes  
to respond to reque/s & may provide =   
data access to o!r memb]s ( !           
ph>maceutical di/ribution supply *a91 z 
appropriate4 ,! developm5t & op]ation ( 

su* a database %all n relieve a         
manufactur] ( ! requirem5t "u ?is       
p>agraph to respond to a reque/ =       
v]ification submitt$ by means o!r ?an a 
secure electronic database4  7,e7       
,saleable return$ product ,beg9n+ #d    
ye>s aft] ! date ( enactm5t ( ! ,drug   
,supply ,*a9 ,security ,act 7except z   
provid$ pursuant to subsection 7a77#e771
 ^u receipt ( a return$ product t !     
manufactur] int5ds to fur!r di/ribute1  
be=e fur!r di/ribut+ su* product1 !     
manufactur] %all v]ify ! product        
id5tifi]1 includ+ ! /&>diz$ num]ical    
id5tifi]1 = ea* seal$ homog5e\s case (  
su* product or1 if su* product is n 9 a 
seal$ homog5e\s case1 v]ify ! product   
id5tifi]1 includ+ ! /&>diz$ num]ical    
id5tifi]1 on ea* package4  7,f7         
,nonsaleable return$ product ,a         
manufactur] may return a nonsaleable    
product to ! manufactur] or repackag]1  
to ! :olesale di/ributor f :om su*      
product 0 pur*as$1 or to a p]son act+ on
 behalf ( su* a p]son1 includ+ a returns

 processor1 )\t provid+ ! in=mation     
describ$ 9 p>agraph 7#a77;,a77i74  7c7  
,:olesale di/ributor requirem5ts  7#a7  
,product trac+  7,a7 ,9 g5]al ,beg9n+ n 
lat] ?an ,janu>y #a1 #bjae1 ! foll[+    
requirem5ts %all apply to :olesale      
di/ributors3 7i7 ,a :olesale di/ributor 
%all n accept own]%ip ( a product unless
 ! previ\s own] prior to1 or at ! "t (1 
! transaction provides ! transaction    
hi/ory1 transaction in=mation1 & a      
transaction /atem5t = ! product1 z      
applicable "u ?is subp>agraph4  7ii7    
7,i7 7aa7 ,if ! :olesale di/ributor     
pur*as$ a product directly f !          
manufactur]1 ! exclusive di/ributor ( ! 
manufactur]1 or a repackag] t pur*as$   
directly f ! manufactur]1 !n prior to1  
or at ! "t (1 ea* transaction 9 :i* !   
:olesale di/ributor transf]s own]%ip ( a
 product1 ! :olesale di/ributor %all    
provide to ! subsequ5t pur*as]-- 7,,aa7 
a transaction /atem5t1 :i* %all /ate t  
su* :olesale di/ributor1 or a memb] ( ! 
affiliate ( su* :olesale di/ributor1    

pur*as$ ! product directly f !          
manufactur]1 exclusive di/ributor ( !   
manufactur]1 or repackag] t pur*as$ !   
product directly f ! manufactur]2 &     
7,,bb7 subject to subclause 7,,ii71 !   
transaction hi/ory & transaction        
in=mation4  7bb7 ,! :olesale di/ributor 
%all provide ! transaction hi/ory1      
transaction in=mation1 & transaction    
/atem5t "u item 7aa7-- 7,,aa7 if provid$
 to a disp5s]1 on a s+le docum5t 9 a    
pap] or electronic =mat2 & 7,,bb7 if    
provid$ to a :olesale di/ributor1 ?r\gh 
any comb9ation ( self-g5]at$ pap]1      
electronic data1 or manufactur]-provid$ 
in=mation on ! product package4  7,,ii7 
,= purposes ( transactions describ$ 9   
subclause 7,i71 transaction hi/ory &    
transaction in=mation %all n be requir$ 
to include ! lot numb] ( ! product1 !   
initial transaction date1 or ! initial  
%ipm5t date f ! manufactur] 7z def9$ 9  
subp>agraphs 7,f71 7,g71 & 7,h7 (       
section #eha7bf774  7iii7 ,if ! :olesale
 di/ributor did n pur*ase a product     

directly f ! manufactur]1 ! exclusive   
di/ributor ( ! manufactur]1 or a        
repackag] t pur*as$ directly f !        
manufactur]1 z describ$ 9 clause 7ii71  
!n prior to1 or at ! "t (1 ea*          
transaction or subsequ5t transaction1 ! 
:olesale di/ributor %all provide to !   
subsequ5t pur*as] a transaction /atem5t1
 transaction hi/ory1 & transaction      
in=mation1 9 a pap] or electronic =mat t
 complies ) ! guidance docum5t issu$ "u 
subsection 7a77#b74  7iv7 ,= ! purposes 
( clause 7iii71 ! transaction hi/ory    
suppli$ %all beg9 only ) ! :olesale     
di/ributor describ$ 9 clause 7ii77,i71 b
 ! :olesale di/ributor describ$ 9 clause
 7iii7 %all in=m ! subsequ5t pur*as] t  
su* :olesale di/ributor receiv$ a direct
 pur*ase /atem5t f a :olesale di/ributor
 describ$ 9 clause 7ii77,i74  7v7 ,a    
:olesale di/ributor %all-- 7,i7 capture 
! transaction in=mation 7includ+ lot    
level in=mation7 consi/5t ) !           
requirem5ts ( ?is section1 transaction  
hi/ory1 & transaction /atem5t = ea*     

transaction describ$ 9 clauses 7i71     
7ii71 & 7iii7 & ma9ta9 su* in=mation1   
hi/ory1 & /atem5t = n less ?an #f ye>s  
aft] ! date ( ! transaction2 &  7,,ii7  
ma9ta9 ! confid5tiality ( ! transaction 
in=mation 7includ+ any lot level        
in=mation consi/5t ) ! requirem5ts ( ?is
 section71 transaction hi/ory1 &        
transaction /atem5t = a product 9 a     
mann] t prohibits disclosure to any     
p]son o!r ?an ! ,secret>y or o!r        
appropriate ,f$]al or ,/ate (ficial1    
except to comply ) clauses 7ii7 & 7iii71
 &1 z applicable1 pursuant to an        
agreem5t "u subp>agraph 7,d74  7,b7     
,returns  7i7 ,saleable returns ,not)/&+
 subp>agraph 7,a77i71 ! foll[+ %all     
apply3 7,i7 ,requirem5ts ,until ! date t
 is #f ye>s aft] ! date ( enactm5t ( !  
,drug ,supply ,*a9 ,security ,act       
7except z provid$ pursuant to subsection
 7a77#e771 a :olesale di/ributor may    
accept return$ product f a disp5s] or   
repackag] pursuant to ! t]ms &          
conditions ( any agreem5t betwe5 !      

p>ties1 &1 not)/&+ subp>agraph 7,a77ii71
 may di/ribute su* return$ product )\t  
provid+ ! transaction hi/ory4 ,=        
transactions subsequ5t to ! return1 !   
transaction hi/ory ( su* product %all   
beg9 ) ! :olesale di/ributor t accept$ !
 return$ product1 consi/5t ) !          
requirem5ts ( ?is subsection4  7,,ii7   
,enhanc$ requirem5ts ,beg9n+ #f ye>s    
aft] ! date ( enactm5t ( ! ,drug ,supply
 ,*a9 ,security ,act 7except z provid$  
pursuant to subsection 7a77#e771 a      
:olesale di/ributor may accept return$  
product f a disp5s] or repackag] only if
 ! :olesale di/ributor c associate      
return$ product ) ! transaction         
in=mation & transaction /atem5t         
associat$ ) t product4 ,= all           
transactions aft] su* date1 !           
transaction hi/ory1 z applicable1 ( su* 
product %all beg9 ) ! :olesale          
di/ributor t accept$ & v]ifi$ ! return$ 
product4 ,= purposes ( ?is subp>agraph1 
! transaction in=mation & transaction   
hi/ory1 z applicable1 ne$ n include     

transaction dates if x is n reasonably  
practicable to obta9 su* dates4  7ii7   
,nonsaleable returns ,a :olesale        
di/ributor may return a nonsaleable     
product to ! manufactur] or repackag]1  
to ! :olesale di/ributor f :om su*      
product 0 pur*as$1 or to a p]son act+ on
 behalf ( su* a p]son1 includ+ a returns
 processor1 )\t provid+ ! in=mation     
requir$ "u subp>agraph 7,a77i74  7,c7   
,reque/s = in=mation ,^u a reque/ by !  
,secret>y or o!r appropriate ,f$]al or  
,/ate (ficial1 9 ! ev5t ( a recall or = 
! purpose ( inve/igat+ a suspect product
 or an illegitimate product1 a :olesale 
di/ributor %all1 n lat] ?an #a bus9ess  
day1 & n to exce$ #dh h\rs1 aft] receiv+
 ! reque/ or 9 o!r su* reasonable "t z  
det]m9$ by ! ,secret>y1 bas$ on !       
circum/ances ( ! reque/1 provide !      
applicable transaction in=mation1       
transaction hi/ory1 & transaction       
/atem5t = ! product4  7,d7 ,trad+ p>tn] 
agreem5ts ,beg9n+ #f ye>s aft] ! date ( 
enactm5t ( ! ,drug ,supply ,*a9         

,security ,act1 a :olesale di/ributor   
may disclose ! transaction in=mation1   
includ+ lot level in=mation1 transaction
 hi/ory1 or transaction /atem5t ( a     
product to ! subsequ5t pur*as] ( !      
product1 pursuant to a writt5 agreem5t  
betwe5 su* :olesale di/ributor & su*    
subsequ5t pur*as]4 ,no?+ 9 ?is          
subp>agraph %all be con/ru$ to limit !  
applicability ( subp>agraphs 7,a7 ?r\gh 
7,c74  7#b7 ,product id5tifi] ,beg9n+ #f
 ye>s aft] ! date ( enactm5t ( ! ,drug  
,supply ,*a9 ,security ,act1 a :olesale 
di/ributor may engage 9 transactions    
involv+ a product only if su* product is
 encod$ ) a product id5tifi] 7except z  
provid$ pursuant to subsection 7a77#e774
  7#c7 ,au?oriz$ trad+ p>tn]s ,beg9n+ n 
lat] ?an ,janu>y #a1 #bjae1 ! trad+     
p>tn]s ( a :olesale di/ributor may be   
only au?oriz$ trad+ p>tn]s4  7#d7       
,v]ification ,beg9n+ n lat] ?an ,janu>y 
#a1 #bjae1 a :olesale di/ributor %all h 
sy/ems 9 place to enable ! :olesale     
di/ributor to comply ) ! foll[+         

requirem5ts3 7,a7 ,suspect product  7i7 
,9 g5]al ,^u mak+ a det]m9ation t a     
product 9 ! possession or control ( a   
:olesale di/ributor is a suspect        
product1 or ^u receiv+ a reque/ =       
v]ification f ! ,secret>y t has made a  
det]m9ation t a product )9 ! possession 
or control ( a :olesale di/ributor is a 
suspect product1 a :olesale di/ributor  
%all-- 7,i7 qu>ant9e su* product )9 !   
possession or control ( ! :olesale      
di/ributor f product int5d$ =           
di/ribution until su* product is cle>$  
or disposition$2 &  7,,ii7 promptly     
conduct an inve/igation 9 coord9ation ) 
trad+ p>tn]s1 z applicable1 to det]m9e  
:e!r ! product is an illegitimate       
product1 :i* %all include validat+ any  
applicable transaction hi/ory &         
transaction in=mation 9 ! possession ( !
 :olesale di/ributor & o!rwise          
inve/igat+ to det]m9e :e!r ! product is 
an illegitimate product1 &1 beg9n+ #f   
ye>s aft] ! date ( enactm5t ( ! ,drug   
,supply ,*a9 ,security ,act 7except z   

provid$ pursuant to subsection 7a77#e771
 v]ify+ ! product at ! package level1   
includ+ ! /&>diz$ num]ical id5tifi]4    
7ii7 ,cle>$ product ,if ! :olesale      
di/ributor det]m9es t a suspect product 
is n an illegitimate product1 ! :olesale
 di/ributor %all promptly notify !      
,secret>y1 if applicable1 ( su*         
det]m9ation & su* product may be fur!r  
di/ribut$4  7iii7 ,records ,a :olesale  
di/ributor %all keep records ( !        
inve/igation ( a suspect product = n    
less ?an #f ye>s aft] ! conclusion ( !  
inve/igation4  7,b7 ,illegitimate       
product  7i7 ,9 g5]al ,^u det]m9+1 9    
coord9ation ) ! manufactur]1 t a product
 9 ! possession or control ( a :olesale 
di/ributor is an illegitimate product1 !
 :olesale di/ributor %all1 9 a mann] t  
is consi/5t ) ! sy/ems & processes ( su*
 :olesale di/ributor-- 7,i7 qu>ant9e su*
 product )9 ! possession or control ( ! 
:olesale di/ributor f product int5d$ =  
di/ribution until su* product is        
disposition$2  7,,ii7 disposition !     

illegitimate product )9 ! possession or 
control ( ! :olesale di/ributor2        
7,,iii7 take reasonable & appropriate   
/eps to assi/ a trad+ p>tn] to          
disposition an illegitimate product n 9 
! possession or control ( ! :olesale    
di/ributor2 &  7,,iv7 reta9 a sample ( !
 product = fur!r physical exam9ation or 
laboratory analysis ( ! product by !    
manufactur] or ,secret>y 7or o!r        
appropriate ,f$]al or ,/ate (ficial7 ^u 
reque/ by ! manufactur] or ,secret>y 7or
 o!r appropriate ,f$]al or ,/ate        
(ficial71 z necess>y & appropriate4     
7ii7 ,mak+ a notification ,^u det]m9+ t 
a product 9 ! possession or control ( ! 
:olesale di/ributor is an illegitimate  
product1 ! :olesale di/ributor %all     
notify ! ,secret>y & all imm$iate trad+ 
p>tn]s t ! :olesale di/ributor has      
reason to believe may h receiv$ su*     
illegitimate product ( su* det]m9ation n
 lat] ?an #bd h\rs aft] mak+ su*        
det]m9ation4  7iii7 ,respond+ to a      
notification ,^u ! receipt ( a          

notification f ! ,secret>y or a trad+   
p>tn] t a det]m9ation has be5 made t a  
product is an illegitimate product1 a   
:olesale di/ributor %all id5tify all    
illegitimate product subject to su*     
notification t is 9 ! possession or     
control ( ! :olesale di/ributor1 includ+
 any product t is subsequ5tly receiv$1 &
 %all p]=m ! activities describ$ 9      
subp>agraph 7,a74  7iv7 ,t]m9at+ a      
notification ,^u mak+ a det]m9ation1 9  
consultation ) ! ,secret>y1 t a         
notification is no long] necess>y1 a    
:olesale di/ributor %all promptly notify
 imm$iate trad+ p>tn]s t ! :olesale     
di/ributor notifi$ pursuant to clause   
7ii7 t su* notification has be5 t]m9at$4
  7v7 ,records ,a :olesale di/ributor   
%all keep records ( ! disposition ( an  
illegitimate product = n less ?an #f    
ye>s aft] ! conclusion ( ! disposition4 
7,c7 ,electronic database ,a :olesale   
di/ributor may satisfy ! requirem5ts (  
?is p>agraph by develop+ a secure       
electronic database or utiliz+ a secure 

electronic database develop$ or op]at$  
by ano!r entity4 ,! own] ( su* database 
%all e/abli% ! requirem5ts & processes  
to respond to reque/s & may provide =   
data access to o!r memb]s ( !           
ph>maceutical di/ribution supply *a91 z 
appropriate4 ,! developm5t & op]ation ( 
su* a database %all n relieve a :olesale
 di/ributor ( ! requirem5t "u ?is       
p>agraph to respond to a v]ification    
reque/ submitt$ by means o!r ?an a      
secure electronic database4  7,d7       
,v]ification ( saleable return$ product 
,beg9n+ #f ye>s aft] ! date ( enactm5t (
 ! ,drug ,supply ,*a9 ,security ,act1 ^u
 receipt ( a return$ product t !        
:olesale di/ributor int5ds to fur!r     
di/ribute1 be=e fur!r di/ribut+ su*     
product1 ! :olesale di/ributor %all     
v]ify ! product id5tifi]1 includ+ !     
/&>diz$ num]ical id5tifi]1 = ea* seal$  
homog5e\s case ( su* product or1 if su* 
product is n 9 a seal$ homog5e\s case1  
v]ify ! product id5tifi]1 includ+ !     
/&>diz$ num]ical id5tifi]1 on ea*       

package4  7d7 ,disp5s] requirem5ts  7#a7
 ,product trac+  7,a7 ,9 g5]al ,beg9n+  
,july #a1 #bjae1 a disp5s]-- 7i7 %all n 
accept own]%ip ( a product1 unless !    
previ\s own] prior to1 or at ! "t (1 !  
transaction1 provides transaction       
hi/ory1 transaction in=mation1 & a      
transaction /atem5t2  7ii7 prior to1 or 
at ! "t (1 ea* transaction 9 :i* !      
disp5s] transf]s own]%ip ( a product 7b 
n includ+ disp5s+ to a pati5t or        
returns7 %all provide ! subsequ5t own] )
 transaction hi/ory1 transaction        
in=mation1 & a transaction /atem5t = !  
product1 except t ! requirem5ts ( ?is   
clause %all n apply to sales by a       
disp5s] to ano!r disp5s] to fulfill a   
specific pati5t ne$2 &  7iii7 %all      
capture transaction in=mation 7includ+  
lot level in=mation1 if provid$71       
transaction hi/ory1 & transaction       
/atem5ts1 z necess>y to inve/igate a    
suspect product1 & ma9ta9 su* in=mation1
 hi/ory1 & /atem5ts = n less ?an #f ye>s
 aft] ! transaction4  7,b7 ,agreem5ts ) 

?ird p>ties ,a disp5s] may ent] into a  
writt5 agreem5t ) a ?ird p>ty1 includ+  
an au?oriz$ :olesale di/ributor1 "u :i* 
! ?ird p>ty confid5tially ma9ta9s !     
transaction in=mation1 transaction      
hi/ory1 & transaction /atem5ts requir$  
to be ma9ta9$ "u ?is subsection on      
behalf ( ! disp5s]4 ,if a disp5s] ent]s 
into su* an agreem5t1 ! disp5s] %all    
ma9ta9 a copy ( ! writt5 agreem5t & %all
 n be reliev$ ( ! obligations ( !       
disp5s] "u ?is subsection4  7,c7        
,returns  7i7 ,saleable returns ,a      
disp5s] may return product to ! trad+   
p>tn] f :i* ! disp5s] obta9$ ! product  
)\t provid+ ! in=mation requir$ "u      
subp>agraph 7,a74  7ii7 ,nonsaleable    
returns ,a disp5s] may return a         
nonsaleable product to ! manufactur] or 
repackag]1 to ! :olesale di/ributor f   
:om su* product 0 pur*as$1 to a returns 
processor1 or to a p]son act+ on behalf 
( su* a p]son )\t provid+ ! in=mation   
requir$ "u subp>agraph 7,a74  7,d7      
,reque/s = in=mation ,^u a reque/ by !  

,secret>y or o!r appropriate ,f$]al or  
,/ate (ficial1 9 ! ev5t ( a recall or = 
! purpose ( inve/igat+ a suspect or an  
illegitimate product1 a disp5s] %all1 n 
lat] ?an #b bus9ess days aft] receiv+ ! 
reque/ or 9 ano!r su* reasonable "t z   
det]m9$ by ! ,secret>y1 bas$ on !       
circum/ances ( ! reque/1 provide !      
applicable transaction in=mation1       
transaction /atem5t1 & transaction      
hi/ory :i* ! disp5s] receiv$ f ! previ\s
 own]1 :i* %all n include ! lot numb] ( 
! product1 ! initial transaction date1  
or ! initial %ipm5t date f ! manufactur]
 unless su* in=mation 0 includ$ 9 !     
transaction in=mation1 transaction      
/atem5t1 & transaction hi/ory provid$ by
 ! manufactur] or :olesale di/ributor to
 ! disp5s]4 ,! disp5s] may respond to ! 
reque/ by provid+ ! applicable in=mation
 9 ei!r pap] or electronic =mat4 ,until 
! date t is #d ye>s aft] ! date (       
enactm5t ( ! ,drug ,supply ,*a9         
,security ,act1 ! ,secret>y or o!r      
appropriate ,f$]al or ,/ate (ficial %all

 grant a disp5s] additional "t1 z       
necess>y1 only ) respect to a reque/ to 
provide lot level in=mation describ$ 9  
subp>agraph 7,f7 ( section #eha7bf7 t 0 
provid$ to ! disp5s] 9 pap] =mat1 limit 
! reque/ "t p]iod to ! #f mon?s prec$+ !
 reque/ or o!r relevant date1 &1 9 !    
ev5t ( a recall1 ! ,secret>y1 or o!r    
appropriate ,f$]al or ,/ate (ficial may 
reque/ in=mation only if su* recall     
involves a s]i\s adv]se heal? consequ5ce
 or dea? to humans4  7#b7 ,product      
id5tifi] ,beg9n+ n lat] ?an #g ye>s aft]
 ! date ( enactm5t ( ! ,drug ,supply    
,*a9 ,security ,act1 a disp5s] may      
engage 9 transactions involv+ a product 
only if su* product is encod$ ) a       
product id5tifi] 7except z provid$      
pursuant to subsection 7a77#e774  7#c7  
,au?oriz$ trad+ p>tn]s ,beg9n+ n lat]   
?an ,janu>y #a1 #bjae1 ! trad+ p>tn]s ( 
a disp5s] may be only au?oriz$ trad+    
p>tn]s4  7#d7 ,v]ification ,beg9n+ n    
lat] ?an ,janu>y #a1 #bjae1 a disp5s]   
%all h sy/ems 9 place to enable !       

disp5s] to comply ) ! foll[+            
requirem5ts3 7,a7 ,suspect product  7i7 
,9 g5]al ,^u mak+ a det]m9ation t a     
product 9 ! possession or control ( !   
disp5s] is a suspect product1 or ^u     
receiv+ a reque/ = v]ification f !      
,secret>y t has made a det]m9ation t a  
product )9 ! possession or control ( a  
disp5s] is a suspect product1 a disp5s] 
%all-- 7,i7 qu>ant9e su* product )9 !   
possession or control ( ! disp5s] f     
product int5d$ = di/ribution until su*  
product is cle>$ or disposition$2 &     
7,,ii7 promptly conduct an inve/igation 
9 coord9ation ) trad+ p>tn]s1 z         
applicable1 to det]m9e :e!r ! product is
 an illegitimate product4  7ii7         
,inve/igation ,an inve/igation conduct$ 
"u clause 7i77,,ii7 %all include-- 7,i7 
beg9n+ #g ye>s aft] ! date ( enactm5t ( 
! ,drug ,supply ,*a9 ,security ,act1    
v]ify+ :e!r ! lot numb] ( a suspect     
product corresponds ) ! lot numb] = su* 
product2  7,,ii7 beg9n+ #g ye>s aft] !  
date ( enactm5t ( su* ,act1 v]ify+ t !  

product id5tifi]1 includ+ ! /&>diz$     
num]ical id5tifi]1 ( at lea/ #c packages
 or #aj p]c5t ( su* suspect product1    
:i*ev] is great]1 or all packages1 if   
!re are few] ?an #c1 corresponds ) !    
product id5tifi] = su* product2  7,,iii7
 validat+ any applicable transaction    
hi/ory & transaction in=mation 9 !      
possession ( ! disp5s]2 &  7,,iv7       
o!rwise inve/igat+ to det]m9e :e!r !    
product is an illegitimate product4     
7iii7 ,cle>$ product ,if ! disp5s] makes
 ! det]m9ation t a suspect product is n 
an illegitimate product1 ! disp5s] %all 
promptly notify ! ,secret>y1 if         
applicable1 ( su* det]m9ation & su*     
product may be fur!r di/ribut$ or       
disp5s$4  7iv7 ,records ,a disp5s] %all 
keep records ( ! inve/igation ( a       
suspect product = n less ?an #f ye>s    
aft] ! conclusion ( ! inve/igation4     
7,b7 ,illegitimate product  7i7 ,9 g5]al
 ,^u det]m9+1 9 coord9ation ) !         
manufactur]1 t a product 9 ! possession 
or control ( a disp5s] is an            

illegitimate product1 ! disp5s] %all--  
7,i7 disposition ! illegitimate product 
)9 ! possession or control ( ! disp5s]2 
7,,ii7 take reasonable & appropriate    
/eps to assi/ a trad+ p>tn] to          
disposition an illegitimate product n 9 
! possession or control ( ! disp5s]2 &  
7,,iii7 reta9 a sample ( ! product =    
fur!r physical exam9ation or laboratory 
analysis ( ! product by ! manufactur] or
 ,secret>y 7or o!r appropriate ,f$]al or
 ,/ate (ficial7 ^u reque/ by !          
manufactur] or ,secret>y 7or o!r        
appropriate ,f$]al or ,/ate (ficial71 z 
necess>y & appropriate4  7ii7 ,mak+ a   
notification ,^u det]m9+ t a product 9 !
 possession or control ( ! disp5s] is an
 illegitimate product1 ! disp5s] %all   
notify ! ,secret>y & all imm$iate trad+ 
p>tn]s t ! disp5s] has reason to believe
 may h receiv$ su* illegitimate product 
( su* det]m9ation n lat] ?an #bd h\rs   
aft] mak+ su* det]m9ation4  7iii7       
,respond+ to a notification ,^u !       
receipt ( a notification f ! ,secret>y  

or a trad+ p>tn] t a det]m9ation has be5
 made t a product is an illegitimate    
product1 a disp5s] %all id5tify all     
illegitimate product subject to su*     
notification t is 9 ! possession or     
control ( ! disp5s]1 includ+ any product
 t is subsequ5tly receiv$1 & %all p]=m !
 activities describ$ 9 subp>agraph 7,a74
  7iv7 ,t]m9at+ a notification ,^u mak+ 
a det]m9ation1 9 consultation ) !       
,secret>y1 t a notification is no long] 
necess>y1 a disp5s] %all promptly notify
 imm$iate trad+ p>tn]s t ! disp5s]      
notifi$ pursuant to clause 7ii7 t su*   
notification has be5 t]m9at$4  7v7      
,records ,a disp5s] %all keep records ( 
! disposition ( an illegitimate product 
= n less ?an #f ye>s aft] ! conclusion (
 ! disposition4  7,c7 ,electronic       
database ,a disp5s] may satisfy !       
requirem5ts ( ?is p>agraph by develop+ a
 secure electronic database or utiliz+ a
 secure electronic database develop$ or 
op]at$ by ano!r entity4  7#e7 ,exception
 ,not)/&+ any o!r provision ( law1 !    

requirem5ts "u p>agraphs 7#a7 & 7#d7    
%all n apply to lic5s$ heal? c>e        
practition]s au?oriz$ to prescribe or   
adm9i/] m$ication "u ,/ate law or o!r   
lic5s$ individuals "u ! sup]vision or   
direction ( su* practition]s :o disp5se 
or adm9i/] product 9 ! usual c\rse (    
pr(essional practice4  7e7 ,repackag]   
requirem5ts  7#a7 ,product trac+  7,a7  
,9 g5]al ,beg9n+ n lat] ?an ,janu>y #a1 
#bjae1 a repackag] describ$ 9 section   
#eha7af77;,a7 %all-- 7i7 n accept       
own]%ip ( a product unless ! previ\s    
own]1 prior to1 or at ! "t (1 !         
transaction1 provides transaction       
hi/ory1 transaction in=mation1 & a      
transaction /atem5t = ! product2  7ii7  
prior to1 or at ! "t (1 ea* transaction 
9 :i* ! repackag] transf]s own]%ip ( a  
product1 provide ! subsequ5t own] )     
transaction hi/ory1 transaction         
in=mation1 & a transaction /atem5t = !  
product2 &  7iii7 capture ! transaction 
in=mation 7includ+ lot level in=mation71
 transaction hi/ory1 & transaction      

/atem5t = ea* transaction describ$ 9    
clauses 7i7 & 7ii7 & ma9ta9 su*         
in=mation1 hi/ory1 & /atem5t = n less   
?an #f ye>s aft] ! transaction4  7,b7   
,returns  7i7 ,nonsaleable product ,a   
repackag] describ$ 9 section            
#eha7af77;,a7 may return a nonsaleable  
product to ! manufactur] or repackag]1  
or to ! :olesale di/ributor f :om su*   
product 0 pur*as$1 or to a p]son act+ on
 behalf ( su* a p]son1 includ+ a returns
 processor1 )\t provid+ ! in=mation     
requir$ "u subp>agraph 7,a77ii74  7ii7  
,saleable or nonsaleable product ,a     
repackag] describ$ 9 section            
#eha7af77;,b7 may return a saleable or  
nonsaleable product to ! manufactur]1   
repackag]1 or to ! :olesale di/ributor f
 :om su* product 0 receiv$ )\t provid+ !
 in=mation requir$ "u subp>agraph       
7,a77ii7 on behalf ( ! hospital or o!r  
heal? c>e entity t took own]%ip ( su*   
product pursuant to ! t]ms & conditions 
( any agreem5t betwe5 su* repackag] & ! 
entity t owns ! product4  7,c7 ,reque/s 

= in=mation ,^u a reque/ by ! ,secret>y 
or o!r appropriate ,f$]al or ,/ate      
(ficial1 9 ! ev5t ( a recall or = !     
purpose ( inve/igat+ a suspect product  
or an illegitimate product1 a repackag] 
describ$ 9 section #eha7af77;,a7 %all1 n
 lat] ?an #a bus9ess day1 & n to exce$  
#dh h\rs1 aft] receiv+ ! reque/ or 9 o!r
 su* reasonable "t z det]m9$ by !       
,secret>y1 provide ! applicable         
transaction in=mation1 transaction      
hi/ory1 & transaction /atem5t = !       
product4  7#b7 ,product id5tifi]  7,a7  
,9 g5]al ,beg9n+ n lat] ?an #e ye>s aft]
 ! date ( enactm5t ( ! ,drug ,supply    
,*a9 ,security ,act1 a repackag]        
describ$ 9 section #eha7af77;,a7-- 7i7  
%all affix or impr9t a product id5tifi] 
to ea* package & homog5\s case ( product
 int5d$ to be introduc$ 9 a transaction 
9 comm]ce2  7ii7 %all ma9ta9 ! product  
id5tifi] in=mation = su* product = n    
less ?an #f ye>s aft] ! date ( !        
transaction2  7iii7 may engage 9        
transactions involv+ a product only if  

su* product is encod$ ) a product       
id5tifi] 7except z provid$ pursuant to  
subsection 7a77#e772 &  7iv7 %all ma9ta9
 records = n less ?an #f ye>s to all[ ! 
repackag] to associate ! product        
id5tifi] ! repackag] affixes or impr9ts 
) ! product id5tifi] assign$ by !       
orig9al manufactur] ( ! product4  7,b7  
,exception ,a package t is requir$ to h 
a /&>diz$ num]ical id5tifi] is n requir$
 to h a unique device id5tifi]4  7#c7   
,au?oriz$ trad+ p>tn]s ,beg9n+ ,janu>y  
#a1 #bjae1 ! trad+ p>tn]s ( a repackag] 
describ$ 9 section #eha7af7 may be only 
au?oriz$ trad+ p>tn]s4  7#d7            
,v]ification ,beg9n+ n lat] ?an ,janu>y 
#a1 #bjae1 a repackag] describ$ 9       
section #eha7af77;,a7 %all h sy/ems 9   
place to enable ! repackag] to comply ) 
! foll[+ requirem5ts3 7,a7 ,suspect     
product  7i7 ,9 g5]al ,^u mak+ a        
det]m9ation t a product 9 ! possession  
or control ( ! repackag] is a suspect   
product1 or ^u receiv+ a reque/ =       
v]ification f ! ,secret>y t has made a  

det]m9ation t a product )9 ! possession 
or control ( a repackag] is a suspect   
product1 a repackag] %all-- 7,i7        
qu>ant9e su* product )9 ! possession or 
control ( ! repackag] f product int5d$ =
 di/ribution until su* product is cle>$ 
or disposition$2 &  7,,ii7 promptly     
conduct an inve/igation 9 coord9ation ) 
trad+ p>tn]s1 z applicable1 to det]m9e  
:e!r ! product is an illegitimate       
product1 :i* %all include validat+ any  
applicable transaction hi/ory &         
transaction in=mation 9 ! possession ( !
 repackag] & o!rwise inve/igat+ to      
det]m9e :e!r ! product is an            
illegitimate product1 &1 beg9n+ #e ye>s 
aft] ! date ( enactm5t ( ! ,drug ,supply
 ,*a9 ,security ,act 7except z provid$  
pursuant to subsection 7a77#e771 v]ify+ 
! product at ! package level1 includ+ ! 
/&>diz$ num]ical id5tifi]4  7ii7 ,cle>$ 
product ,if ! repackag] makes !         
det]m9ation t a suspect product is n an 
illegitimate product1 ! repackag] %all  
promptly notify ! ,secret>y1 if         

applicable1 ( su* det]m9ation & su*     
product may be fur!r di/ribut$4  7iii7  
,records ,a repackag] %all keep records 
( ! inve/igation ( a suspect product = n
 less ?an #f ye>s aft] ! conclusion ( ! 
inve/igation4  7,b7 ,illegitimate       
product  7i7 ,9 g5]al ,^u det]m9+1 9    
coord9ation ) ! manufactur]1 t a product
 9 ! possession or control ( a repackag]
 is an illegitimate product1 ! repackag]
 %all1 9 a mann] t is consi/5t ) !      
sy/ems & processes ( su* repackag]--    
7,i7 qu>ant9e su* product )9 !          
possession or control ( ! repackag] f   
product int5d$ = di/ribution until su*  
product is disposition$2  7,,ii7        
disposition ! illegitimate product )9 ! 
possession or control ( ! repackag]2    
7,,iii7 take reasonable & appropriate   
/eps to assi/ a trad+ p>tn] to          
disposition an illegitimate product n 9 
! possession or control ( ! repackag]2 &
  7,,iv7 reta9 a sample ( ! product =   
fur!r physical exam9ation or laboratory 
analysis ( ! product by ! manufactur] or

 ,secret>y 7or o!r appropriate ,f$]al or
 ,/ate (ficial7 ^u reque/ by !          
manufactur] or ,secret>y 7or o!r        
appropriate ,f$]al or ,/ate (ficial71 z 
necess>y & appropriate4  7ii7 ,mak+ a   
notification ,^u det]m9+ t a product 9 !
 possession or control ( ! repackag] is 
an illegitimate product1 ! repackag]    
%all notify ! ,secret>y & all imm$iate  
trad+ p>tn]s t ! repackag] has reason to
 believe may h receiv$ ! illegitimate   
product ( su* det]m9ation n lat] ?an #bd
 h\rs aft] mak+ su* det]m9ation4  7iii7 
,respond+ to a notification ,^u !       
receipt ( a notification f ! ,secret>y  
or a trad+ p>tn]1 a repackag] %all      
id5tify all illegitimate product subject
 to su* notification t is 9 ! possession
 or control ( ! repackag]1 includ+ any  
product t is subsequ5tly receiv$1 & %all
 p]=m ! activities describ$ 9           
subp>agraph 7,a74  7iv7 ,t]m9at+ a      
notification ,^u mak+ a det]m9ation1 9  
consultation ) ! ,secret>y1 t a         
notification is no long] necess>y1 a    

repackag] %all promptly notify imm$iate 
trad+ p>tn]s t ! repackag] notifi$      
pursuant to clause 7ii7 t su*           
notification has be5 t]m9at$4  7v7      
,records ,a repackag] %all keep records 
( ! disposition ( an illegitimate       
product = n less ?an #f ye>s aft] !     
conclusion ( ! disposition4  7,c7       
,reque/s = v]ification ,beg9n+ #e ye>s  
aft] ! date ( enactm5t ( ! ,drug ,supply
 ,*a9 ,security ,act1 ^u receiv+ a      
reque/ = v]ification f an au?oriz$      
manufactur]1 :olesale di/ributor1 or    
disp5s] t is 9 possession or control ( a
 product !y believe to be repackag$ by  
su* repackag]1 a repackag] %all1 n lat] 
?an #bd h\rs aft] receiv+ ! v]ification 
reque/ or 9 o!r su* reasonable "t z     
det]m9$ by ! ,secret>y1 bas$ on !       
circum/ances ( ! reque/1 notify ! p]son 
mak+ ! reque/ :e!r ! product id5tifi]1  
includ+ ! /&>diz$ num]ical id5tifi]1 t  
is ! subject ( ! reque/ corresponds to !
 product id5tifi] affix$ or impr9t$ by !
 repackag]4 ,if a repackag] respond+ to 

a v]ification reque/ id5tifies a product
 id5tifi] t does n correspond to t      
affix$ or impr9t$ by ! repackag]1 !     
repackag] %all treat su* product z      
suspect product & conduct an            
inve/igation z describ$ 9 subp>agraph   
7,a74 ,if ! repackag] has reason to     
believe ! product is an illegitimate    
product1 ! repackag] %all advise ! p]son
 mak+ ! reque/ ( su* belief at ! "t su* 
repackag] responds to ! v]ification     
reque/4  7,d7 ,electronic database ,a   
repackag] may satisfy ! requirem5ts (   
p>agraph 7#d7 by develop+ a secure      
electronic database or utiliz+ a secure 
electronic database develop$ or op]at$  
by ano!r entity4 ,! own] ( su* database 
%all e/abli% ! requirem5ts & processes  
to respond to reque/s & may provide =   
data access to o!r memb]s ( !           
ph>maceutical di/ribution supply *a91 z 
appropriate4 ,! developm5t & op]ation ( 
su* a database %all n relieve a         
repackag] ( ! requirem5t "u subp>agraph 
7,c7 to respond to a v]ification reque/ 

submitt$ by means o!r ?an a secure      
electronic database4  7,e7 ,v]ification 
( saleable return$ product ,beg9n+ #e   
ye>s aft] ! date ( enactm5t ( ! ,drug   
,supply ,*a9 ,security ,act1 ^u receipt 
( a return$ product t ! repackag] int5ds
 to fur!r di/ribute1 be=e fur!r         
di/ribut+ su* product1 ! repackag] %all 
v]ify ! product id5tifi] = ea* seal$    
homog5e\s case ( su* product or1 if su* 
product is n 9 a seal$ homog5e\s case1  
v]ify ! product id5tifi] on ea* package4
  7f7 ,drop %ipm5ts  7#a7 ,9 g5]al ,a   
:olesale di/ributor t does n physically 
h&le or /ore product %all be exempt f ! 
provisions ( ?is section1 except !      
notification requirem5ts "u clauses     
7ii71 7iii71 & 7iv7 ( subsection        
7c77#d77;,b71 provid$ t ! manufactur]1  
repackag]1 or o!r :olesale di/ributor t 
di/ributes ! product to ! disp5s] by    
means ( a drop %ipm5t = su* :olesale    
di/ributor includes on ! transaction    
in=mation & transaction hi/ory to !     
disp5s] ! contact in=mation ( su*       

:olesale di/ributor & provides !        
transaction in=mation1 transaction      
hi/ory1 & transaction /atem5t directly  
to ! disp5s]4  7#b7 ,cl>ification ,=    
purposes ( ?is subsection1 provid+      
adm9i/rative s]vices1 includ+ process+ (
 ord]s & paym5ts1 %all n by itself1 be  
con/ru$ z be+ involv$ 9 ! h&l+1         
di/ribution1 or /orage ( a product4  4  
#bjc4 ,enhanc$ drug di/ribution security
 ,section #ehb1 z add$ by section #bjb1 
is am5d$ by add+ at ! end ! foll[+3  7g7
 ,enhanc$ drug di/ribution security     
7#a7 ,9 g5]al ,on ! date t is #aj ye>s  
aft] ! date ( enactm5t ( ! ,drug ,supply
 ,*a9 ,security ,act1 ! foll[+          
int]op]able1 electronic trac+ ( product 
at ! package level requirem5ts %all g   
into effect3 7,a7 ,! transaction        
in=mation & ! transaction /atem5ts z    
requir$ "u ?is section %all be ex*ang$ 9
 a secure1 int]op]able1 electronic mann]
 9 accordance ) ! /&>ds e/abli%$ "u !   
guidance issu$ pursuant to p>agraphs    
7#c7 & 7#d7 ( subsection 7h71 includ+   

any revision ( su* guidance issu$ 9     
accordance ) p>agraph 7#e7 ( su*        
subsection4  7,b7 ,! transaction        
in=mation requir$ "u ?is section %all   
include ! product id5tifi] at ! package 
level = ea* package includ$ 9 !         
transaction4  7,c7 ,sy/ems & processes =
 v]ification ( product at ! package     
level1 includ+ ! /&>diz$ num]ical       
id5tifi]1 %all be requir$ 9 accordance )
 ! /&>ds e/abli%$ "u ! guidance issu$   
pursuant to subsection 7a77#b7 & !      
guidances issu$ pursuant to p>agraphs   
7#b71 7#c71 & 7#d7 ( subsection 7h71    
includ+ any revision ( su* guidances    
issu$ 9 accordance ) p>agraph 7#e7 ( su*
 subsection1 :i* may include ! use (    
aggregation & inf]5ce z necess>y4  7,d7 
,! sy/ems & processes necess>y to       
promptly respond ) ! transaction        
in=mation & transaction /atem5t = a     
product ^u a reque/ by ! ,secret>y 7or  
o!r appropriate ,f$]al or ,/ate (ficial7
 9 ! ev5t ( a recall or = ! purposes (  
inve/igat+ a suspect product or an      

illegitimate product %all be requir$4   
7,e7 ,! sy/ems & processes necess>y to  
promptly facilitate ga!r+ ! in=mation   
necess>y to produce ! transaction       
in=mation = ea* transaction go+ back to 
! manufactur]1 z applicable1 %all be    
requir$-- 7i7 9 ! ev5t ( a reque/ by !  
,secret>y 7or o!r appropriate ,f$]al or 
,/ate (ficial71 on acc\nt ( a recall or 
= ! purposes ( inve/igat+ a suspect     
product or an illegitimate product2 or  
7ii7 9 ! ev5t ( a reque/ by an au?oriz$ 
trad+ p>tn]1 9 a secure mann] t ensures 
! protection ( confid5tial comm]cial    
in=mation & trade secrets1 = purposes ( 
inve/igat+ a suspect product or assi/+ !
 ,secret>y 7or o!r appropriate ,f$]al or
 ,/ate (ficial7 ) a reque/ describ$ 9   
clause 7i74  7,f7 ,ea* p]son accept+ a  
saleable return %all h sy/ems &         
processes 9 place to all[ acceptance (  
su* product & may accept saleable       
returns only if su* p]son c associate ! 
saleable return product ) ! transaction 
in=mation & transaction /atem5t         

associat$ ) t product4  7#b7 ,compliance
  7,a7 ,in=mation ma9t5ance agreem5t ,a 
disp5s] may ent] into a writt5 agreem5t 
) a ?ird p>ty1 includ+ an au?oriz$      
:olesale di/ributor1 "u :i* ! ?ird p>ty 
%all confid5tially ma9ta9 any in=mation 
& /atem5ts requir$ to be ma9ta9$ "u ?is 
section4 ,if a disp5s] ent]s into su* an
 agreem5t1 ! disp5s] %all ma9ta9 a copy 
( ! writt5 agreem5t & %all n be reliev$ 
( ! obligations ( ! disp5s] "u ?is      
subsection4  7,b7 ,alt]native me?ods ,! 
,secret>y1 tak+ into consid]ation !     
assessm5t conduct$ "u p>agraph 7#c71    
%all provide = alt]native me?ods (      
compliance ) any ( ! requirem5ts set =? 
9 p>agraph 7#a71 includ+-- 7i7 e/abli%+ 
timel9es = compliance by small bus9esses
 7includ+ small bus9ess disp5s]s ) #be  
or few] full-"t employees7 ) su*        
requirem5ts1 9 ord] to ensure t su*     
requirem5ts d n impose undue economic   
h>d%ip = small bus9esses1 includ+ small 
bus9ess disp5s]s = :om ! crit]ia set =? 
9 ! assessm5t "u p>agraph 7#c7 is n met1

 if ! ,secret>y det]m9es t su*          
requirem5ts "u p>agraph 7#a7 w\ld result
 9 undue economic h>d%ip2 &  7ii7       
e/abli%+ a process by :i* a disp5s] may 
reque/ a waiv] f any ( ! requirem5ts set
 =? 9 p>agraph 7#a7 if ! ,secret>y      
det]m9es t su* requirem5ts w\ld result 9
 an undue economic h>d%ip1 :i* %all     
include a process = ! bi5nial review &  
r5ewal ( any su* waiv]4  7#c7 ,assessm5t
  7,a7 ,9 g5]al ,n lat] ?an ! date t is 
#ah mon?s aft] ! ,secret>y issues ! f9al
 guidance requir$ "u subsection 7h71 !  
,secret>y %all ent] into a contract ) a 
private1 indep5d5t consult+ firm )      
exp]tise to conduct a te*nology & s(tw>e
 assessm5t t looks at ! feasibility (   
disp5s]s ) #be or few] full-"t employees
 conduct+ int]op]able1 electronic trac+ 
( products at ! package level4 ,su*     
assessm5t %all be complet$ n lat] ?an #h
 ye>s aft] ! date ( enactm5t ( ! ,drug  
,supply ,*a9 ,security ,act4  7,b7      
,condition ,z a condition ( ! aw>d ( !  
contract "u subp>agraph 7,a71 ! private1

 indep5d5t consult+ firm %all agree to  
consult ) disp5s]s ) #be or few] full-"t
 employees :5 conduct+ ! assessm5t "u   
su* subp>agraph4  7,c7 ,cont5t ,!       
assessm5t "u subp>agraph 7,a7 %all      
assess :e!r-- 7i7 ! necess>y s(tw>e &   
h>dw>e is readily accessible to su*     
disp5s]s2  7ii7 ! necess>y s(tw>e &     
h>dw>e is prohibitively exp5sive to     
obta91 in/all1 & ma9ta9 = su* disp5s]s2 
&  7iii7 ! necess>y h>dw>e & s(tw>e c be
 integrat$ into bus9ess practices1 su* z
 int]op]ability ) :olesale di/ributors1 
= su* disp5s]s4  7,d7 ,publication ,!   
,secret>y %all-- 7i7 publi% ! /atem5t ( 
"w = ! assessm5t "u subp>agraph 7,a7 =  
public comm5t prior to beg9n+ !         
assessm5t2  7ii7 publi% ! f9al assessm5t
 = public comm5t n lat] ?an #cj cal5d>  
days aft] receiv+ su* assessm5t2 &      
7iii7 hold a public meet+ n lat] ?an    
#ahj cal5d> days aft] receiv+ ! f9al    
assessm5t at :i* public /akehold]s may  
pres5t _! views on ! assessm5t4  7#d7   
,proc$ure ,not)/&+ section #eec ( title 

#e1 ,unit$ ,/ates ,code1 ! ,secret>y1 9 
promulgat+ any regulation pursuant to   
?is section1 %all-- 7,a7 provide        
appropriate flexibility by-- 7i7 n      
requir+ ! adoption ( specific bus9ess   
sy/ems = ! ma9t5ance & transmission (   
data2  7ii7 prescrib+ alt]native me?ods 
( compliance = any ( ! requirem5ts set  
=? 9 p>agraph 7#a7 or set =? 9          
regulations implem5t+ su* requirem5ts1  
includ+-- 7,i7 timel9es = small         
bus9esses to comply ) ! requirem5ts set 
=? 9 ! regulations 9 ord] to ensure t   
su* requirem5ts d n impose undue        
economic h>d%ip = small bus9esses       
7includ+ small bus9ess disp5s]s = :om ! 
crit]ia set =? 9 ! assessm5t "u p>agraph
 7#c7 is n met71 if ! ,secret>y det]m9es
 t su* requirem5ts w\ld result 9 undue  
economic h>d%ip2 &  7,,ii7 ! e/abli%m5t 
( a process by :i* a disp5s] may reque/ 
a waiv] f any ( ! requirem5ts set =? 9  
su* regulations if ! ,secret>y det]m9es 
t su* requirem5ts w\ld result 9 an undue
 economic h>d%ip2 &  7iii7 tak+ into    

consid]ation-- 7,i7 ! results ( pilot   
projects1 includ+ pilot projects        
pursuant to ?is section & private sector
 pilot projects1 includ+ ^? involv+ !   
use ( aggregation & inf]5ce2  7,,ii7 !  
public meet+s held & relat$ guidance    
docum5ts issu$ "u ?is section2  7,,iii7 
! public heal? b5efits ( any additional 
regulations 9 comp>ison to ! co/ (      
compliance ) su* requirem5ts1 includ+ on
 entities ( v>y+ sizes & capabilities2  
7,,iv7 ! div]sity ( ! ph>maceutical     
di/ribution supply *a9 by provid+       
appropriate flexibility = ea* sector1   
includ+ bo? l>ge & small bus9esses2 &   
7,v7 ! assessm5t pursuant to p>agraph   
7#c7 ) respect to small bus9ess         
disp5s]s1 includ+ relat$ public comm5t &
 ! public meet+1 & requirem5ts "u ?is   
section2  7,b7 issue a notice ( propos$ 
rulemak+ t includes a copy ( ! propos$  
regulation2  7,c7 provide a p]iod ( n   
less ?an #fj days = comm5ts on ! propos$
 regulation2 &  7,d7 publi% 9 ! ,f$]al  
,regi/] ! f9al regulation n less ?an #b 

ye>s prior to ! effective date ( !      
regulation4  7h7 ,guidance docum5ts     
7#a7 ,9 g5]al ,= ! purposes ( facilitat+
 ! successful & effici5t adoption (     
secure1 int]op]able product trac+ at !  
package level 9 ord] to enhance drug    
di/ribution security & fur!r protect !  
public heal?1 ! ,secret>y %all issue !  
guidance docum5ts z provid$ = 9 ?is     
subsection4  7#b7 ,suspect &            
illegitimate product  7,a7 ,9 g5]al ,n  
lat] ?an #ahj days aft] ! date (        
enactm5t ( ! ,drug ,supply ,*a9         
,security ,act1 ! ,secret>y %all issue a
 guidance docum5t to aid trad+ p>tn]s 9 
! id5tification ( a suspect product &   
notification t]m9ation4 ,su* guidance   
docum5t %all-- 7i7 id5tify specific     
sc5>ios t c\ld significantly increase ! 
risk ( a suspect product ent]+ !        
ph>maceutical di/ribution supply *a92   
7ii7 provide recomm5dation on h[ trad+  
p>tn]s may id5tify su* product & make a 
det]m9ation on :e!r ! product is a      
suspect product z soon z practicable2 & 

7iii7 set =? ! process by :i*           
manufactur]s1 repackag]s1 :olesale      
di/ributors1 & disp5s]s %all t]m9ate    
notifications 9 consultation ) !        
,secret>y reg>d+ illegitimate product   
pursuant to subsections 7b77#d77;,b71   
7c77#d77;,b71 7d77#d77;,b71 &           
7e77#d77;,b74  7,b7 ,revis$ guidance ,if
 ! ,secret>y revises ! guidance issu$ "u
 subp>agraph 7,a71 ! ,secret>y %all     
foll[ ! proc$ure set =? 9 p>agraph 7#e74
  7#c7 ,unit level trac+  7,a7 ,9 g5]al 
,9 ord] to enhance drug di/ribution     
security at ! package level1 n lat] ?an 
#ah mon?s aft] conduct+ a public meet+  
on ! sy/em attributes necess>y to enable
 secure trac+ ( product at ! package    
level1 includ+ all[+ = ! use (          
v]ification1 inf]5ce1 & aggregation1 z  
necess>y1 ! ,secret>y %all issue a f9al 
guidance docum5t t outl9es & makes      
recomm5dations ) respect to ! sy/em     
attributes necess>y to enable secure    
trac+ at ! package level z requir$ "u ! 
requirem5ts e/abli%$ "u subsection 7g74 

,su* guidance docum5t %all-- 7i7 def9e !
 circum/ances "u :i* ! sectors )9 !     
ph>maceutical di/ribution supply *a9    
may1 9 ! mo/ effici5t mann] practicable1
 inf] ! cont5ts ( a case1 pallet1 tote1 
or o!r aggregate ( individual packages  
or conta9]s ( product1 f a product      
id5tifi] associat$ ) ! case1 pallet1    
tote1 or o!r aggregate1 )\t op5+ ea*    
case1 pallet1 tote1 or o!r aggregate or 
o!rwise individually scann+ ea* package2
  7ii7 id5tify me?ods & processes to    
enhance secure trac+ ( product at !     
package level1 su* z secure processes to
 facilitate ! use ( inf]5ce1 enhanc$    
v]ification activities1 ! use (         
aggregation & inf]5ce1 processes t      
utilize ! product id5tifi]s to enhance  
trac+ ( product at ! package level1     
includ+ ! /&>diz$ num]ical id5tifi]1 or 
package security features2 &  7iii7     
ensure ! protection ( confid5tial       
comm]cial in=mation & trade secrets4    
7,b7 ,proc$ure ,9 issu+ ! guidance "u   
subp>agraph 7,a71 & 9 revis+ su*        

guidance1 if applicable1 ! ,secret>y    
%all foll[ ! proc$ure set =? 9 p>agraph 
7#e74  7#d7 ,/&>ds = int]op]able data   
ex*ange  7,a7 ,9 g5]al ,9 ord] to       
enhance secure trac+ ( a product at !   
package level1 ! ,secret>y1 n lat] ?an  
#ah mon?s aft] conduct+ a public meet+  
on ! int]op]able /&>ds necess>y to      
enhance ! security ( ! ph>maceutical    
di/ribution supply *a91 %all update !   
guidance issu$ pursuant to subsection   
7a77#b71 z necess>y & appropriate1 &    
f9alize su* guidance docum5t s t !      
guidance docum5t-- 7i7 id5tifies & makes
 recomm5dations ) respect to ! /&>ds    
necess>y = adoption 9 ord] to support ! 
secure1 int]op]able electronic data     
ex*ange among ! ph>maceutical           
di/ribution supply *a9 t comply ) a =m &
 =mat develop$ by a widely recogniz$    
int]national /&>ds developm5t           
organization2  7ii7 takes into          
consid]ation /&>ds e/abli%$ pursuant to 
subsection 7a77#b7 & section #eje;,d2   
7iii7 facilitates ! creation ( a uni=m  

process or me?odology = product trac+2 &
  7iv7 ensures ! protection (           
confid5tial comm]cial in=mation & trade 
secrets4  7,b7 ,proc$ure ,9 issu+ !     
guidance "u subp>agraph 7,a71 & 9 revis+
 su* guidance1 if applicable1 !         
,secret>y %all foll[ ! proc$ure set =? 9
 p>agraph 7#e74  7#e7 ,proc$ure ,9 issu+
 or revis+ any guidance issu$ pursuant  
to ?is subsection or subsection 7g71    
except ! initial guidance issu$ "u      
p>agraph 7#b77;,a71 ! ,secret>y %all--  
7,a7 publi% a notice 9 ! ,f$]al ,regi/] 
= a p]iod n less ?an #cj days ann\nc+ t 
! draft or revis$ draft guidance is     
available2  7,b7 po/ ! draft guidance   
docum5t on ! ,int]net ,web site ( !     
,food & ,drug ,adm9i/ration & make su*  
draft guidance docum5t available 9 h>d  
copy2  7,c7 provide an opportunity =    
comm5t & review & take into consid]ation
 any comm5ts receiv$2  7,d7 revise !    
draft guidance1 z appropriate2  7,e7    
publi% a notice 9 ! ,f$]al ,regi/] = a  
p]iod n less ?an #cj days ann\nc+ t !   

f9al guidance or f9al revis$ guidance is
 available2  7,f7 po/ ! f9al guidance   
docum5t on ! ,int]net ,web site ( !     
,food & ,drug ,adm9i/ration & make su*  
f9al guidance docum5t available 9 h>d   
copy2 &  7,g7 provide = an effective    
date ( n e>li] ?an #a ye> aft] su*      
guidance becomes f9al4  7i7 ,public     
meet+s  7#a7 ,9 g5]al ,! ,secret>y %all 
hold n less ?an #e public meet+s to     
enhance ! safety & security ( !         
ph>maceutical di/ribution supply *a9 &  
provide = comm5t4 ,! ,secret>y may hold 
! fir/ su* public meet+ n e>li] ?an #a  
ye> aft] ! date ( enactm5t ( ! ,drug    
,supply ,*a9 ,security ,act4 ,9 c>ry+   
out ! public meet+s describ$ 9 ?is      
p>agraph1 ! ,secret>y %all-- 7,a7       
prioritize topics necess>y to in=m !    
issuance ( ! guidance describ$ 9        
p>agraphs 7#c7 & 7#d7 ( subsection 7h72 
&  7,b7 take all measures reasonable &  
practicable to ensure ! protection (    
confid5tial comm]cial in=mation & trade 
secrets4  7#b7 ,cont5t ,ea* ( ! foll[+  

topics %all be address$ 9 at lea/ "o ( !
 public meet+s describ$ 9 p>agraph 7#a73
 7,a7 ,an assessm5t ( ! /eps tak5 "u    
subsections 7b7 ?r\gh 7e7 to build      
capacity = a unit-level sy/em1 includ+ !
 impact ( ! requirem5ts ( su*           
subsections on-- 7i7 ! ability ( ! heal?
 c>e sy/em collectively to ma9ta9 pati5t
 access to m$ic9es2  7ii7 ! scalability 
( su* requirem5ts1 includ+ z x relates  
to product l9es2 &  7iii7 ! capability (
 diff]5t sectors & subsectors1 includ+  
bo? l>ge & small bus9esses1 to affix &  
utilize ! product id5tifi]4  7,b7 ,!    
sy/em attributes necess>y to support !  
requirem5ts set =? "u subsection 7g71   
includ+ ! /&>ds necess>y = adoption 9   
ord] to support ! secure1 int]op]able   
electronic data ex*ange among sectors )9
 ! ph>maceutical di/ribution supply *a94
  7,c7 ,be/ practices 9 ea* ( ! diff]5t 
sectors )9 ! ph>maceutical di/ribution  
supply *a9 to implem5t ! requirem5ts (  
?is section4  7,d7 ,! co/s & b5efits ( !
 implem5tation ( ?is section1 includ+ ! 

impact on ea* ph>maceutical di/ribution 
supply *a9 sector & on public heal?4    
7,e7 ,:e!r electronic trac+ requirem5ts1
 includ+ trac+ ( product at ! package   
level1 are feasible1 co/ effective1 &   
ne$$ to protect ! public heal?4  7,f7 ,!
 sy/ems & processes ne$$ to utilize !   
product id5tifi]s to enhance trac+ (    
product at ! package level1 includ+     
all[+ = v]ification1 aggregation1 &     
inf]5ce1 z necess>y4  7,g7 ,! te*nical  
capabilities & legal au?orities1 if any1
 ne$$ to e/abli% an int]op]able1        
electronic sy/em t provides = trac+ (   
product at ! package level4  7,h7 ,!    
impact t su* additional requirem5ts w\ld
 h on pati5t safety1 ! drug supply1 co/ 
& regulatory burd51 & timely pati5t     
access to prescription drugs4  7,i7 ,o!r
 topics1 z det]m9$ appropriate by !     
,secret>y4  7j7 ,pilot projects  7#a7 ,9
 g5]al ,! ,secret>y %all e/abli% #a or m
 pilot projects1 9 coord9ation )        
au?oriz$ manufactur]s1 repackag]s1      
:olesale di/ributors1 & disp5s]s1 to    

explore & evaluate me?ods to enhance !  
safety & security ( ! ph>maceutical     
di/ribution supply *a94 ,su* projects   
%all build ^u ef=ts1 9 exi/5ce z ( !    
date ( enactm5t ( ! ,drug ,supply ,*a9  
,security ,act1 to enhance ! safety &   
security ( ! ph>maceutical di/ribution  
supply *a91 take into consid]ation any  
pilot projects conduct$ prior to su*    
date ( enactm5t1 includ+ any pilot      
projects t use aggregation & inf]5ce1 & 
in=m ! draft & f9al guidance "u         
p>agraphs 7#c7 & 7#d7 ( subsection 7h74 
7#b7 ,cont5t  7,a7 ,9 g5]al ,! ,secret>y
 %all ensure t ! pilot projects "u      
p>agraph 7#a7 reflect ! div]sity ( !    
ph>maceutical di/ribution supply *a9 & t
 ! pilot projects1 :5 tak5 z a :ole1    
include p>ticipants repres5tative ( e   
sector1 includ+ bo? l>ge & small        
bus9esses4  7,b7 ,project design ,!     
pilot projects "u p>agraph 7#a7 %all be 
design$ to-- 7i7 utilize ! product      
id5tifi] = trac+ ( a product1 :i* may   
include v]ification ( ! product id5tifi]

 ( a product1 includ+ ! use (           
aggregation & inf]5ce2  7ii7 improve !  
te*nical capabilities ( ea* sector &    
subsector to comply ) sy/ems & processes
 ne$$ to utilize ! product id5tifi]s to 
enhance trac+ ( a product2  7iii7       
id5tify sy/em attributes t are necess>y 
to implem5t ! requirem5ts e/abli%$ "u   
?is section2 &  7iv7 complete o!r       
activities z det]m9$ by ! ,secret>y4    
7k7 ,sunset ,! foll[+ requirem5ts %all h
 no =ce or effect beg9n+ on ! date t is 
#aj ye>s aft] ! date ( enactm5t ( !     
,drug ,supply ,*a9 ,security ,act3 7#a7 
,! provision & receipt ( transaction    
hi/ory "u ?is section4  7#b7 ,!         
requirem5ts set =? = returns "u         
subsections 7b77#d77;,e71               
7c77#a77;,b77i71 7d77#a77;,c77i71 &     
7e77#d77;,e74  7#c7 ,! requirem5ts set  
=? "u subp>agraphs 7,a77v77,,ii7 & 7,d7 
( subsection 7c77#a71 z appli$ to lot   
level in=mation only4  7l7 ,rule (      
con/ruction ,! requirem5ts set =? 9     
subsections 7g77#d71 7i71 & 7j7 %all n  

be con/ru$ z a condition1 prohibition1  
or prec$5t = preclud+ or delay+ !       
provisions becom+ effective pursuant to 
subsection 7g74  7m7 ,reque/s =         
in=mation ,on ! date t is #aj ye>s aft] 
! date ( enactm5t ( ! ,drug ,supply ,*a9
 ,security ,act1 ! timel9e = responses  
to reque/s = in=mation f ! ,secret>y1 or
 o!r appropriate ,f$]al or ,/ate        
(ficial1 z applicable1 "u subsections   
7b77#a77;,b71 7c77#a77;,c71 &           
7e77#a77;,c7 %all be n lat] ?an #bd h\rs
 aft] receiv+ ! reque/ f ! ,secret>y or 
o!r appropriate ,f$]al or ,/ate (ficial1
 z applicable1 or 9 su* o!r reasonable  
"t z det]m9$ by ! ,secret>y bas$ on !   
circum/ances ( ! reque/4  4  #bjd4      
,national /&>ds = prescription drug     
:olesale di/ributors  7a7 ,am5dm5ts     
7#a7 ,requirem5t ,section #ejc7;e7 7#ba 
,u4,s4,c4 #cec7;e77 is am5d$ by /rik+   
p>agraphs 7#a71 7#b71 & 7#c7 & ins]t+ ! 
foll[+3  7#a7 ,requirem5t ,subject to   
section #ehc3 7,a7 ,9 g5]al ,no p]son   
may engage 9 :olesale di/ribution ( a   

drug subject to subsection 7b77#a7 9 any
 ,/ate unless su* p]son-- 7i7 7,i7 is   
lic5s$ by ! ,/ate f :i* ! drug is       
di/ribut$2 or  7,,ii7 if ! ,/ate f :i* !
 drug is di/ribut$ has n e/abli%$ a     
lic5sure requirem5t1 is lic5s$ by !     
,secret>y2 &  7ii7 if ! drug is         
di/ribut$ int]/ate1 is lic5s$ by ! ,/ate
 into :i* ! drug is di/ribut$ if ! ,/ate
 into :i* ! drug is di/ribut$ requires !
 lic5sure ( a p]son t di/ributes drugs  
into ! ,/ate4  7,b7 ,/&>ds ,ea* ,f$]al &
 ,/ate lic5se describ$ 9 subp>agraph    
7,a7 %all meet ! /&>ds1 t]ms1 &         
conditions e/abli%$ by ! ,secret>y "u   
section #ehc4  7#b7 ,report+ & database 
7,a7 ,report+ ,beg9n+ ,janu>y #a1 #bjae1
 any p]son :o owns or op]ates an        
e/abli%m5t t engages 9 :olesale         
di/ribution %all-- 7i7 report to !      
,secret>y1 on an annual basis pursuant  
to a s*$ule det]m9$ by ! ,secret>y--    
7,i7 ea* ,/ate by :i* ! p]son is lic5s$ 
& ! appropriate id5tification numb] (   
ea* su* lic5se2 &  7,,ii7 ! "n1 address1

 & contact in=mation ( ea* facility at  
:i*1 & all trade names "u :i*1 ! p]son  
conducts bus9ess2 &  7ii7 report to !   
,secret>y )9 a reasonable p]iod ( "t & 9
 a reasonable mann]1 z det]m9$ by !     
,secret>y1 any significant discipl9>y   
actions1 su* z ! revocation or susp5sion
 ( a :olesale di/ributor lic5se1 tak5 by
 a ,/ate or ! ,f$]al ,gov]nm5t dur+ !   
report+ p]iod aga9/ ! :olesale          
di/ributor4  7,b7 ,database ,n lat] ?an 
,janu>y #a1 #bjae1 ! ,secret>y %all     
e/abli% a database ( au?oriz$ :olesale  
di/ributors4 ,su* database %all-- 7i7   
id5tify ea* au?oriz$ :olesale di/ributor
 by "n1 contact in=mation1 & ea* ,/ate  
:]e su* :olesale di/ributor is          
appropriately lic5s$ to engage 9        
:olesale di/ribution2  7ii7 be available
 to ! public on ! ,int]net ,web site ( !
 ,food & ,drug ,adm9i/ration2 &  7iii7  
be regul>ly updat$ on a s*$ule det]m9$  
by ! ,secret>y4  7,c7 ,coord9ation ,!   
,secret>y %all e/abli% a =mat & proc$ure
 = appropriate ,/ate (ficials to access 

! in=mation provid$ pursuant to         
subp>agraph 7,a7 9 a prompt & secure    
mann]4  7,d7 ,confid5tiality ,no?+ 9 ?is
 p>agraph %all be con/ru$ z au?oriz+ !  
,secret>y to disclose any in=mation t is
 a trade secret or confid5tial in=mation
 subject to section #eeb7;b77#d7 ( title
 #e1 ,unit$ ,/ates ,code1 or section    
#aije ( title #ah1 ,unit$ ,/ates ,code4 
7#c7 ,co/s  7,a7 ,au?oriz$ fees (       
secret>y ,if a ,/ate does n e/abli% a   
lic5s+ program = p]sons engag$ 9 !      
:olesale di/ribution ( a drug subject to
 subsection 7b71 ! ,secret>y %all lic5se
 a p]son engag$ 9 :olesale di/ribution  
locat$ 9 su* ,/ate & may collect a      
reasonable fee 9 su* am\nt necess>y to  
reimburse ! ,secret>y = co/s associat$ )
 e/abli%+ & adm9i/]+ ! lic5sure program 
& conduct+ p]iodic inspections "u ?is   
section4 ,! ,secret>y %all adju/ fee    
rates z ne$$ on an annual basis to      
g5]ate only ! am\nt ( rev5ue ne$$ to    
p]=m ?is s]vice4 ,fees au?oriz$ "u ?is  
p>agraph %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  7,b7 ,/ate lic5s+ fees     
,no?+ 9 ?is ,act %all prohibit ,/ates f 
collect+ fees f :olesale di/ributors 9  
connection ) ,/ate lic5s+ ( su*         
di/ributors4  4  7#b7 ,:olesale         
di/ribution ,section #ejc7;e7 7#ba      
,u4,s4,c4 #cec7;e771 z am5d$ by p>agraph
 7#a71 is fur!r am5d$ by add+ at ! end !
 foll[+3  7#d7 ,= ! purposes ( ?is      
subsection & subsection 7d71 ! t]m      
:olesale di/ribution means ! di/ribution
 ( a drug subject to subsection 7b7 to a
 p]son o!r ?an a consum] or pati5t1 or  
receipt ( a drug subject to subsection  
7b7 by a p]son o!r ?an ! consum] or     
pati5t1 b does n include-- 7,a7         

intracompany di/ribution ( any drug     
betwe5 memb]s ( an affiliate or )9 a    
manufactur]2  7,b7 ! di/ribution ( a    
drug1 or an (f] to di/ribute a drug     
among hospitals or o!r heal? c>e        
entities :i* are "u common control2     
7,c7 ! di/ribution ( a drug or an (f] to
 di/ribute a drug = em]g5cy m$ical      
reasons1 includ+ a public heal? em]g5cy 
decl>ation pursuant to section #cai ( ! 
,public ,heal? ,s]vice ,act1 except t1 =
 purposes ( ?is p>agraph1 a drug %ortage
 n caus$ by a public heal? em]g5cy %all 
n con/itute an em]g5cy m$ical reason2   
7,d7 ! disp5s+ ( a drug pursuant to a   
prescription execut$ 9 accordance )     
subsection 7b77#a72  7,e7 ! di/ribution 
( m9imal quantities ( drug by a lic5s$  
retail ph>macy to a lic5s$ practition] =
 (fice use2  7,f7 ! di/ribution ( a drug
 or an (f] to di/ribute a drug by a     
*>itable organization to a nonpr(it     
affiliate ( ! organization to ! ext5t   
o!rwise p]mitt$ by law2  7,g7 ! pur*ase 
or o!r acquisition by a disp5s]1        

hospital1 or o!r heal? c>e entity ( a   
drug = use by su* disp5s]1 hospital1 or 
o!r heal? c>e entity2  7,h7 !           
di/ribution ( a drug by ! manufactur] ( 
su* drug2  7,i7 ! receipt or transf] ( a
 drug by an au?oriz$ ?ird-p>ty logi/ics 
provid] provid$ t su* ?ird-p>ty logi/ics
 provid] does n take own]%ip ( ! drug2  
7,j7 a common c>ri] t transports a drug1
 provid$ t ! common c>ri] does n take   
own]%ip ( ! drug2  7,k7 ! di/ribution ( 
a drug1 or an (f] to di/ribute a drug by
 an au?oriz$ repackag] t has tak5       
own]%ip or possession ( ! drug & repacks
 x 9 accordance ) section #ehb7;e72     
7,l7 salable drug returns :5 conduct$ by
 a disp5s]2  7,m7 ! di/ribution ( a     
collection ( f9i%$ m$ical devices1 :i*  
may include a product or biological     
product1 assembl$ 9 kit =m /rictly = !  
conv5i5ce ( ! pur*as] or us] 7ref]r$ to 
9 ?is subp>agraph z a m$ical conv5i5ce  
kit7 if-- 7i7 ! m$ical conv5i5ce kit is 
assembl$ 9 an e/abli%m5t t is regi/]$ ) 
! ,food & ,drug ,adm9i/ration z a device

 manufactur] 9 accordance ) section     
#eaj7;b77#b72  7ii7 ! m$ical conv5i5ce  
kit does n conta9 a controll$ sub/ance t
 appe>s 9 a s*$ule conta9$ 9 !          
,compreh5sive ,drug ,abuse ,prev5tion & 
,control ,act ( #aigj2  7iii7 9 ! case (
 a m$ical conv5i5ce kit t includes a    
product1 ! p]son t manufactur]s ! kit-- 
7,i7 pur*as$ su* product directly f !   
ph>maceutical manufactur] or f a        
:olesale di/ributor t pur*as$ ! product 
directly f ! ph>maceutical manufactur]2 
&  7,,ii7 does n alt] ! prim>y conta9]  
or label ( ! product z pur*as$ f !      
manufactur] or :olesale di/ributor2 &   
7iv7 9 ! case ( a m$ical conv5i5ce kit t
 includes a product1 ! product is-- 7,i7
 an intrav5\s solution int5d$ = !       
repl5i%m5t ( fluids & electrolytes2     
7,,ii7 a product int5d$ to ma9ta9 !     
equilibrium ( wat] & m9]als 9 ! body2   
7,,iii7 a product int5d$ = irrigation or
 recon/itution2  7,,iv7 an ane/hetic2   
7,v7 an anticoagulant2  7,,vi7 a        
vasopressor2 or  7,,vii7 a              

sympa?omimetic2  7,n7 ! di/ribution ( an
 intrav5\s drug t1 by its =mulation1 is 
int5d$ = ! repl5i%m5t ( fluids &        
electrolytes 7su* z sodium1 *loride1 &  
potassium7 or calories 7su* z dextrose &
 am9o acids72  7,o7 ! di/ribution ( an  
intrav5\s drug us$ to ma9ta9 !          
equilibrium ( wat] & m9]als 9 ! body1   
su* z dialysis solutions2  7,p7 !       
di/ribution ( a drug t is int5d$ =      
irrigation1 or /]ile wat]1 :e!r int5d$ =
 su* purposes or = injection2  7,q7 !   
di/ribution ( m$ical gas1 z def9$ 9     
section #ege2  7,r7 facilitat+ !        
di/ribution ( a product by provid+      
solely adm9i/rative s]vices1 includ+    
process+ ( ord]s & paym5ts2 or  7,s7 !  
transf] ( a product by a hospital or o!r
 heal? c>e entity1 or by a :olesale     
di/ributor or manufactur] op]at+ at !   
direction ( ! hospital or o!r heal? c>e 
entity1 to a repackag] describ$ 9       
section #eha7af77;,b7 & regi/]$ "u      
section #eaj = ! purpose ( repackag+ !  
drug = use by t hospital1 or o!r heal?  

c>e entity & o!r heal? c>e entities t   
are "u common control1 if own]%ip ( !   
drug rema9s ) ! hospital or o!r heal?   
c>e entity at all times4  4  7#c7       
,?ird-p>ty logi/ics provid]s ,section   
#ejc7;e7 7#ba ,u4,s4,c4 #cec7;e771 z    
am5d$ by p>agraph 7#b71 is fur!r am5d$  
by add+ at ! end ! foll[+3  7#e7        
,?ird-p>ty logi/ics provid]s ,not)/&+   
p>agraphs 7#a7 ?r\gh 7#d71 ea* entity t 
meets ! def9ition ( a ?ird-p>ty logi/ics
 provid] "u section #eha7bb7 %all obta9 
a lic5se z a ?ird-p>ty logi/ics provid] 
z describ$ 9 section #ehd7;a7 & is n    
requir$ to obta9 a lic5se z a :olesale  
di/ributor if ! entity nev] assumes an  
own]%ip int]e/ 9 ! product x h&les4  4  
7#d7 ,affiliate ,section #ejc7;e7 7#ba  
,u4,s4,c4 #cec7;e771 z am5d$ by p>agraph
 7#c71 is fur!r am5d$ by add+ at ! end !
 foll[+3  7#f7 ,affiliate ,= purposes ( 
?is subsection1 ! t]m affiliate means a 
bus9ess entity t has a relation%ip ) a  
second bus9ess entity if1 directly or   
indirectly-- 7,a7 "o bus9ess entity     

controls1 or has ! p[] to control1 ! o!r
 bus9ess entity2 or  7,b7 a ?ird p>ty   
controls1 or has ! p[] to control1 bo? (
 ! bus9ess entities4  4  7#e7 ,/&>ds    
,sub*apt] ,h ( *apt] ,v1 z add$ by      
section #bjb1 is am5d$ by add+ at ! end 
! foll[+3  #ehc4 ,national /&>ds =      
prescription drug :olesale di/ributors  
7a7 ,9 g5]al ,! ,secret>y %all1 n lat]  
?an #b ye>s aft] ! date ( enactm5t ( !  
,drug ,supply ,*a9 ,security ,act1      
e/abli% by regulation /&>ds = ! lic5s+ (
 p]sons "u section #ejc7;e77#a7 7z am5d$
 by ! ,drug ,supply ,*a9 ,security      
,act71 includ+ ! revocation1 reissuance1
 & r5ewal ( su* lic5se4  7b7 ,cont5t ,= 
! purpose ( ensur+ uni=mity ) respect to
 /&>ds set =? 9 ?is section1 ! /&>ds    
e/abli%$ "u subsection 7a7 %all apply to
 all ,/ate & ,f$]al lic5ses describ$ "u 
section #ejc7;e77#a7 7z am5d$ by ! ,drug
 ,supply ,*a9 ,security ,act7 & %all    
include /&>ds = ! foll[+3 7#a7 ,! /orage
 & h&l+ ( prescription drugs1 includ+   
facility requirem5ts4  7#b7 ,!          

e/abli%m5t & ma9t5ance ( records ( !    
di/ributions ( su* drugs4  7#c7 ,!      
furni%+ ( a bond or o!r equival5t means 
( security1 z foll[s3 7,a7 7i7 ,= !     
issuance or r5ewal ( a :olesale         
di/ributor lic5se1 an applicant t is n a
 gov]nm5t own$ & op]at$ :olesale        
di/ributor %all submit a surety bond (  
#ajj1jjj or o!r equival5t means (       
security acceptable to ! ,/ate4  7ii7 ,=
 purposes ( clause 7i71 ! ,/ate or o!r  
applicable au?ority may accept a surety 
bond 9 ! am\nt ( #be1jjj if ! annual    
gross receipts ( ! previ\s tax ye> = !  
:olesal] is #aj1jjj1jjj or less4  7,b7  
,if a :olesale di/ributor c provide     
evid5ce t x possesses ! requir$ bond 9 a
 ,/ate1 ! requirem5t = a bond 9 ano!r   
,/ate %all be waiv$4  7#d7 ,m&atory     
backgr\nd *ecks & f+]pr9t+ ( facility   
manag]s or designat$ repres5tatives4    
7#e7 ,! e/abli%m5t & implem5tation (    
qualifications = key p]sonnel4  7#f7 ,! 
m&atory physical inspection ( any       
facility to be us$ 9 :olesale           

di/ribution )9 a reasonable "t frame f !
 initial application ( ! facility & to  
be conduct$ by ! lic5s+ au?ority or by !
 ,/ate1 consi/5t ) subsection 7c74  7#g7
 ,9 accordance ) subsection 7d71 !      
prohibition ( c]ta9 p]sons f receiv+ or 
ma9ta9+ lic5sure = :olesale di/ribution4
  7c7 ,inspections ,to satisfy !        
inspection requirem5t "u subsection     
7b77#f71 ! ,f$]al or ,/ate lic5s+       
au?ority may conduct ! inspection or may
 accept an inspection by ! ,/ate 9 :i* !
 facility is locat$1 or by a ?ird-p>ty  
accr$itation or inspection s]vice       
approv$ by ! ,secret>y or ! ,/ate lic5s+
 su* :olesale di/ributor4  7d7          
,prohibit$ p]sons ,! /&>ds e/abli%$ "u  
subsection 7a7 %all include requirem5ts 
to prohibit a p]son f receiv+ or ma9ta9+
 lic5sure = :olesale di/ribution if !   
p]son-- 7#a7 has be5 convict$ ( any     
felony = conduct relat+ to :olesale     
di/ribution1 any felony violation (     
subsection 7i7 or 7k7 ( section #cja1 or
 any felony violation ( section #acfe ( 

title #ah1 ,unit$ ,/ates ,code1 relat+  
to product tamp]+2 or  7#b7 has engag$ 9
 a patt]n ( violat+ ! requirem5ts ( ?is 
section1 or ,/ate requirem5ts =         
lic5sure1 t pres5ts a ?reat ( s]i\s     
adv]se heal? consequ5ces or dea? to     
humans4  7e7 ,requirem5ts ,! ,secret>y1 
9 promulgat+ any regulation pursuant to 
?is section1 %all1 not)/&+ section #eec 
( title #e1 ,unit$ ,/ates ,code-- 7#a7  
issue a notice ( propos$ rulemak+ t     
includes a copy ( ! propos$ regulation2 
7#b7 provide a p]iod ( n less ?an #fj   
days = comm5ts on ! propos$ regulation2 
&  7#c7 provide t ! f9al regulation take
 effect on ! date t is #b ye>s aft] !   
date su* f9al regulation is publi%$4  4 
7b7 ,au?oriz$ di/ributors ( record      
,section #ejc7;d7 7#ba ,u4,s4,c4        
#cec7;d77 is am5d$ by add+ at ! end !   
foll[+3  7#d7 ,9 ?is subsection1 ! t]m  
au?oriz$ di/ributors ( record means ^?  
di/ributors ) :om a manufactur] has     
e/abli%$ an ongo+ relation%ip to        
di/ribute su* manufactur]'s products4  4

  7c7 ,effective date ,! am5dm5ts made  
by subsections 7a7 & 7b7 %all take      
effect on ,janu>y #a1 #bjae4  #bje4     
,national /&>ds = ?ird-p>ty logi/ics    
provid]s2 uni=m national policy         
,sub*apt] ,h ( *apt] ,v1 z am5d$ by     
section #bjd1 is fur!r am5d$ by add+ at 
! end ! foll[+3  #ehd4 ,national /&>ds =
 ?ird-p>ty logi/ics provid]s  7a7       
,requirem5ts ,no ?ird-p>ty logi/ics     
provid] 9 any ,/ate may conduct         
activities 9 any ,/ate unless ea*       
facility ( su* ?ird-p>ty logi/ics       
provid]-- 7#a7 7,a7 is lic5s$ by ! ,/ate
 f :i* ! drug is di/ribut$ by !         
?ird-p>ty logi/ics provid]1 9 accordance
 ) ! regulations promulgat$ "u          
subsection 7d72 or  7,b7 if ! ,/ate f   
:i* ! drug di/ribut$ by ! ?ird-p>ty     
logi/ics provid] has n e/abli%$ a       
lic5sure requirem5t1 is lic5s$ by !     
,secret>y1 9 accordance ) ! regulations 
promulgat$ "u subsection 7d72 &  7#b7 if
 ! drug is di/ribut$ int]/ate1 is lic5s$
 by ! ,/ate into :i* ! drug is di/ribut$

 by ! ?ird-p>ty logi/ics provid] if su* 
,/ate lic5ses ?ird-p>ty logi/ics        
provid]s t di/ribute drugs into ! ,/ate 
& ! ?ird-p>ty logi/ics provid] is n     
lic5s$ by ! ,secret>y z describ$ 9      
p>agraph 7#a77;,b74  7b7 ,report+       
,beg9n+ #a ye> aft] ! date ( enactm5t ( 
! ,drug ,supply ,*a9 ,security ,act1 a  
facility ( a ?ird-p>ty logi/ics provid] 
%all report to ! ,secret>y1 on an annual
 basis pursuant to a s*$ule det]m9$ by !
 ,secret>y-- 7#a7 ! ,/ate by :i* !      
facility is lic5s$ & ! appropriate      
id5tification numb] ( su* lic5se2 &     
7#b7 ! "n & address ( ! facility & all  
trade names "u :i* su* facility conducts
 bus9ess4  7c7 ,co/s  7#a7 ,au?oriz$    
fees ( secret>y ,if a ,/ate does n      
e/abli% a lic5s+ program = a ?ird-p>ty  
logi/ics provid]1 ! ,secret>y %all      
lic5se ! ?ird-p>ty logi/ics provid]     
locat$ 9 su* ,/ate & may collect a      
reasonable fee 9 su* am\nt necess>y to  
reimburse ! ,secret>y = co/s associat$ )
 e/abli%+ & adm9i/]+ ! lic5sure program 

& conduct+ p]iodic inspections "u ?is   
section4 ,! ,secret>y %all adju/ fee    
rates z ne$$ on an annual basis to      
g5]ate only ! am\nt ( rev5ue ne$$ to    
p]=m ?is s]vice4 ,fees au?oriz$ "u ?is  
p>agraph %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  7#b7 ,/ate lic5s+ fees     
7,a7 ,/ate e/abli%$ program ,no?+ 9 ?is 
,act %all prohibit a ,/ate t has        
e/abli%$ a program to lic5se a ?ird-p>ty
 logi/ics provid] f collect+ fees f a   
?ird-p>ty logi/ics provid] = su* a      
lic5se4  7,b7 ,no ,/ate e/abli%$ program
 ,a ,/ate t does n e/abli% a program to 
lic5se a ?ird-p>ty logi/ics provid] 9   
accordance ) ?is section %all be        

prohibit$ f collect+ a ,/ate lic5s+ fee 
f a ?ird-p>ty logi/ics provid]4  7d7    
,regulations  7#a7 ,9 g5]al ,n lat] ?an 
#b ye>s aft] ! date ( enactm5t ( ! ,drug
 ,supply ,*a9 ,security ,act1 !         
,secret>y %all issue regulations reg>d+ 
! /&>ds = lic5s+ "u subsection 7a71     
includ+ ! revocation & reissuance ( su* 
lic5se1 to ?ird-p>ty logi/ics provid]s  
"u ?is section4  7#b7 ,cont5t ,su*      
regulations %all-- 7,a7 e/abli% a       
process by :i* a ?ird-p>ty accr$itation 
program approv$ by ! ,secret>y %all1 ^u 
reque/ by a ?ird-p>ty logi/ics provid]1 
issue a lic5se to ea* ?ird-p>ty logi/ics
 provid] t meets ! requirem5ts set =? 9 
?is section2  7,b7 e/abli% a process by 
:i* ! ,secret>y %all issue a lic5se to  
ea* ?ird-p>ty logi/ics provid] t meets !
 requirem5ts set =? 9 ?is section if !  
,secret>y is n able to approve a        
?ird-p>ty accr$itation program because  
no su* program meets ! ,secret>y's      
requirem5ts necess>y = approval ( su* a 
?ird-p>ty accr$itation program2  7,c7   

require t ! entity complies ) /orage    
practices1 z det]m9$ by ! ,secret>y =   
su* facility1 includ+-- 7i7 ma9ta9+     
access to w>eh\se space ( suitable size 
to facilitate safe op]ations1 includ+ a 
suitable area to qu>ant9e suspect       
product2  7ii7 ma9ta9+ adequate         
security2 &  7iii7 hav+ writt5 policies 
& proc$ures to-- 7,i7 address receipt1  
security1 /orage1 inv5tory1 %ipm5t1 &   
di/ribution ( a product2  7,,ii7        
id5tify1 record1 & report confirm$      
losses or !fts 9 ! ,unit$ ,/ates2       
7,,iii7 correct errors & inaccuracies 9 
inv5tories2  7,,iv7 provide support =   
manufactur] recalls2  7,v7 prep>e =1    
protect aga9/1 & address any reasonably 
=eseeable crisis t affects security or  
op]ation at ! facility1 su* z a /rike1  
fire1 or flood2  7,,vi7 ensure t any    
expir$ product is segregat$ f o!r       
products & return$ to ! manufactur] or  
repackag] or de/roy$2  7,,vii7 ma9ta9 ! 
capability to trace ! receipt & outb\nd 
di/ribution ( a product1 & supplies &   

records ( inv5tory2 &  7,,viii7 qu>ant9e
 or de/roy a suspect product if direct$ 
to d s by ! respective manufactur]1     
:olesale di/ributor1 disp5s]1 or an     
au?oriz$ gov]nm5t ag5cy2  7,d7 provide =
 p]iodic inspection by ! lic5s+         
au?ority1 z det]m9$ by ! ,secret>y1 (   
su* facility w>eh\se space to ensure    
compliance ) ?is section2  7,e7 prohibit
 a facility f hav+ z a manag] or        
designat$ repres5tative anyone convict$ 
( any felony violation ( subsection 7i7 
or 7k7 ( section #cja or any violation (
 section #acfe ( title #ah1 ,unit$      
,/ates ,code relat+ to product tamp]+2  
7,f7 provide = m&atory backgr\nd *ecks (
 a facility manag] or a designat$       
repres5tative ( su* manag]2  7,g7       
require a ?ird-p>ty logi/ics provid] to 
provide ! applicable lic5s+ au?ority1 ^u
 a reque/ by su* au?ority1 a li/ ( all  
product manufactur]s1 :olesale          
di/ributors1 & disp5s]s = :om !         
?ird-p>ty logi/ics provid] provides     
s]vices at su* facility2 &  7,h7 include

 proc$ures "u :i* any ?ird-p>ty logi/ics
 provid] lic5se-- 7i7 expires on ! date 
t is #c ye>s aft] issuance ( ! lic5se2 &
  7ii7 may be r5ew$ = additional #c-ye> 
p]iods4  7#c7 ,proc$ure ,9 promulgat+ ! 
regulations "u ?is subsection1 !        
,secret>y %all1 not)/&+ section #eec (  
title #e1 ,unit$ ,/ates ,code-- 7,a7    
issue a notice ( propos$ rulemak+ t     
includes a copy ( ! propos$ regulation2 
7,b7 provide a p]iod ( n less ?an #fj   
days = comm5ts on ! propos$ regulation2 
&  7,c7 provide t ! f9al regulation     
takes effect ^u ! expiration ( #a ye>   
aft] ! date t su* f9al regulation is    
issu$4  7e7 ,validity ,a lic5se issu$ "u
 ?is section %all rema9 valid z long z  
su* ?ird-p>ty logi/ics provid] rema9s   
lic5s$ consi/5t ) ?is section4 ,if !    
,secret>y f9ds t ! ?ird-p>ty            
accr$itation program demon/rates t all  
applicable requirem5ts = lic5sure "u ?is
 section are met1 ! ,secret>y %all issue
 a lic5se "u ?is section to a ?ird-p>ty 
logi/ics provid] receiv+ accr$itation1  

pursuant to subsection 7d77#b77;,a74    
#ehe4 ,uni=m national policy  7a7       
,product trac+ & o!r requirem5ts ,beg9n+
 on ! date ( enactm5t ( ! ,drug ,supply 
,*a9 ,security ,act1 no ,/ate or        
political subdivision ( a ,/ate may     
e/abli% or cont9ue 9 effect any         
requirem5ts = trac+ products ?r\gh !    
di/ribution sy/em 7includ+ any          
requirem5ts ) respect to /atem5ts (     
di/ribution hi/ory1 transaction hi/ory1 
transaction in=mation1 or transaction   
/atem5t ( a product z su* product *anges
 own]%ip 9 ! supply *a91 or v]ification1
 inve/igation1 disposition1             
notification1 or recordkeep+ relat+ to  
su* sy/ems1 includ+ pap] or electronic  
p$igree sy/ems or = track+ & trac+ drugs
 ?r\gh\t ! di/ribution sy/em7 :i* are   
inconsi/5t )1 m /r+5t ?an1 or 9 addition
 to1 any requirem5ts applicable "u      
section #ejc7;e7 7z am5d$ by su* ,act7  
or ?is sub*apt] 7or regulations issu$   
!reund]71 or :i* are inconsi/5t )-- 7#a7
 any waiv]1 exception1 or exemption     

pursuant to section #eha or #ehb2 or    
7#b7 any re/rictions specifi$ 9 section 
#ehb4  7b7 ,:olesale ,di/ributor &      
,?ird-,p>ty ,logi/ics ,provid] /&>ds    
7#a7 ,9 g5]al ,beg9n+ on ! date (       
enactm5t ( ! ,drug ,supply ,*a9         
,security ,act1 no ,/ate or political   
subdivision ( a ,/ate may e/abli% or    
cont9ue any /&>ds1 requirem5ts1 or      
regulations ) respect to :olesale       
prescription drug di/ributor or         
?ird-p>ty logi/ics provid] lic5sure t   
are inconsi/5t )1 less /r+5t ?an1       
directly relat$ to1 or cov]$ by ! /&>ds 
& requirem5ts applicable "u section     
#ejc7;e7 7z am5d$ by su* ,act71 9 ! case
 ( a :olesale di/ributor1 or section    
#ehd1 9 ! case ( a ?ird-p>ty logi/ics   
provid]4  7#b7 ,/ate regulation (       
?ird-p>ty logi/ics provid]s ,no ,/ate   
%all regulate ?ird-p>ty logi/ics        
provid]s z :olesale di/ributors4  7#c7  
,adm9i/ration fees ,not)/&+ p>agraph    
7#a71 a ,/ate may adm9i/] fee           
collections = effectuat+ ! :olesale drug

 di/ributor & ?ird-p>ty logi/ics provid]
 lic5sure requirem5ts "u sections       
#ejc7;e7 7z am5d$ by ! ,drug ,supply    
,*a9 ,security ,act71 #ehc1 & #ehd4     
7#d7 ,en=cem5t1 susp5sion1 & revocation 
,not)/&+ p>agraph 7#a71 a ,/ate-- 7,a7  
may take adm9i/rative action1 includ+   
f9es1 to en=ce a requirem5t promulgat$  
by ! ,/ate 9 accordance ) section       
#ejc7;e7 7z am5d$ by ! ,drug ,supply    
,*a9 ,security ,act7 or ?is sub*apt]2   
7,b7 may provide = ! susp5sion or       
revocation ( lic5ses issu$ by ! ,/ate = 
violations ( ! laws ( su* ,/ate2  7,c7  
^u conviction ( violations ( ,f$]al1    
,/ate1 or local drug laws or            
regulations1 may provide = f9es1        
imprisonm5t1 or civil p5alties2 &  7,d7 
may regulate activities ( lic5s$        
entities 9 a mann] t is consi/5t )      
product trac+ requirem5ts "u section    
#ehb4  7c7 ,exception ,no?+ 9 ?is       
section %all be con/ru$ to preempt ,/ate
 requirem5ts relat$ to ! di/ribution (  
prescription drugs if su* requirem5ts   

are n relat$ to product trac+ z describ$
 9 subsection 7a7 or :olesale di/ributor
 & ?ird-p>ty logi/ics provid] lic5sure z
 describ$ 9 subsection 7b7 applicable "u
 section #ejc7;e7 7z am5d$ by ! ,drug   
,supply ,*a9 ,security ,act7 or ?is     
sub*apt] 7or regulations issu$ !reund]74
  4  #bjf4 ,p5alties  7a7 ,prohibit$ act
 ,section #cja7t7 7#ba ,u4,s4,c4        
#cca7t771 is am5d$-- 7#a7 by /rik+ or   
aft] ! requirem5ts ( section #ejc7;d712 
&  7#b7 by ins]t+ 1 failure to comply ) 
! requirem5ts "u section #ehb1 ! failure
 to comply ) ! requirem5ts "u section   
#ehd1 z applicable1 aft] 9 violation (  
section #ejc7;e74  7b7 ,misbr&+ ,section
 #ejb 7#ba ,u4,s4,c4 #ceb71 z am5d$ by  
section #ajc1 is fur!r am5d$ by add+ at 
! end ! foll[+3  7cc7 ,if x is a drug & 
x fails to be> ! product id5tifi] z     
requir$ by section #ehb4  4  #bjg4      
,con=m+ am5dm5t  7a7 ,9 g5]al ,section  
#cjc7;b77#a77;,d7 7#ba ,u4,s4,c4        
#ccc7;b77#a77;,d77 is am5d$ by /rik+    
#ejc7;e77#b77;,a7 & ins]t+ #ejc7;e77#a74

  7b7 ,effective date ,! am5dm5t made by
 subsection 7a7 %all take effect on     
,janu>y #a1 #bjae4  #bjh4 ,sav+s clause 
,except z provid$ 9 ! am5dm5ts made by  
p>agraphs 7#a71 7#b71 & 7#c7 ( section  
#bjd7;a7 & by section #bjf7;a71 no?+ 9  
?is title 7includ+ ! am5dm5ts made by   
?is title7 %all be con/ru$ z alt]+ any  
au?ority ( ! ,secret>y ( ,heal? & ,human
 ,s]vices ) respect to a drug subject to
 section #ejc7;b77#a7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cec7;b77#a77 "u any o!r provision ( su*
 ,act or ! ,public ,heal? ,s]vice ,act  
7#db ,u4,s4,c4 #bja et seq474  ,pass$ ! 
,h\se ( ,repres5tatives ,septemb] #bh1  
#bjac4,k>5 ,l4 ,haas1,cl]k4  ,novemb]   
#e1 #bjac,read ! second "t & plac$ on ! 
cal5d>