,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #ahde  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #ba1 #bjai ,ms4  
,ku/] ( ,new ,hamp%ire 7= h]self & ,mr4 
,mull97 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to provide = !    
e/abli%m5t ( ! ,prescription ,safety    
,al]t ,sy/em ) respect to cov]$ drug    
products1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,analyz+
 & ,lev]ag+ ,exi/+ ,rx ,transactions    
,act ( #bjai or ! ,,al]t ,act ( #bjai4  
#b4 ,prescription ,safety ,al]t ,sy/em  
to help prev5t abuse & misuse (         
prescription drugs ,! ,f$]al ,food1     
,drug1 & ,cosmetic ,act is am5d$ by     
ins]t+ aft] section #eje-a ( su* ,act   
7#ba ,u4,s4,c4 #cee-a7 ! foll[+ new     
section3  #eje-b4 ,prescription ,safety 
,al]t ,sy/em to prev5t abuse & misuse   
7a7 ,9 g5]al ,= ! purpose ( combat+ !   
national prescription drug abuse        
epidemic1 ! ,secret>y %all1 ) respect to
 cov]$ drug products1 e/abli% & ma9ta9  

an electronic sy/em1 to be kn[n z !     
,prescription ,safety ,al]t ,sy/em1 t-- 
7#a7 reviews pati5t prescription &      
disp5s+ hi/ory ?r\gh ph>maceutical      
claims data transactions describ$ 9     
section #aagc7;a77#b7 ( ! ,social       
,security ,act & develop$ by a /&>d     
sett+ organization2  7#b7 collects1     
ma9ta9s1 & is capable ( provid+ to      
disp5s]s1 )9 a disp5s]'s ord9>y cl9ical 
workfl[1 in=mation ab\t a pati5t's      
prescription & disp5s+ hi/ory2  7#c7    
deliv]s in=mation ab\t a pati5t's       
prescription & disp5s+ hi/ory 9 summ>y  
=m1 t all[s ! disp5s] to evaluate ! risk
 ( misuse1 abuse1 addiction1 ov]dose1 & 
drug-drug int]actions associat$ ) fill+ 
! prescription s\ght by a pati5t bas$ ^u
 su* pati5t's prescription & disp5s+    
hi/ory = cov]$ drug products2  7#d7     
provides to disp5s]s ! in=mation        
describ$ 9 p>agraphs 7#b7 & 7#c7 9      
real-"t2  7#e7 all[s disp5s]s to obta9  
access to a pati5t's prescription &     
disp5s+ hi/ory2 &  7#f7 requires        

disp5s]s z a condition on us+ su* ,sy/em
 to h a writt5 use agreem5t ) su* ,sy/em
 to-- 7,a7 all[ su* ,sy/em to access    
requir$ data elem5ts ab\t ! disp5s]'s   
pati5ts to ensure t ! prescrib+ &       
disp5s+ hi/ory ( su* pati5ts is updat$  
on a real-"t basis 9 su* ,sy/em2 &  7,b7
 receive in=mation ab\t a pati5t's      
prescription & disp5s+ hi/ory 9 summ>y  
=m f su* ,sy/em4  7b7 ,implem5tation    
,beg9n+ n lat] ?an #ab mon?s aft] ! date
 ( enactm5t ( ?is ,act1 ! ,secret>y %all
 require1 pursuant to section #eje-a1 t 
cov]$ drug products be disp5s$ us+ !    
,prescription ,safety ,al]t ,sy/em to   
help combat ! national prescription drug
 abuse epidemic4  7c7 ,purposes (       
collect+ & mak+ available in=mation ,!  
,prescription ,safety ,al]t ,sy/em %all 
collect & make available in=mation only 
= ! foll[+ purposes3 7#a7 ,provid+      
disp5s]s ) in=mation to evaluate ! risk 
( misuse1 abuse1 addiction1 ov]dose1 &  
drug-drug int]actions associat$ ) a     
cov]$ drug product bas$ ^u a pati5t's   

prescription & disp5s+ hi/ory4  7#b7    
,provid+ ! ,secret>y ) aggregate        
in=mation on an annualiz$ basis reg>d+ !
 numb] ( pati5ts or prescriptions flagg$
 by su* ,sy/em or a disp5s] z pot5tially
 pres5t+ a risk ( misuse1 abuse1        
addiction1 ov]dose1 or drug-drug        
int]actions1 & o!r aggregate in=mation1 
:]e ! ,secret>y deems ! provision ( su* 
in=mation to be appropriate4  7d7 ,rule 
( con/ruction on liability ,no?+ 9 ?is  
section %all be con/ru$ to create or    
s]ve z ! basis = additional liability = 
any entity connect+ to ! ,sy/em1 beyond 
exi/+ applicable ,/ate & ,f$]al laws &  
regulations4  7e7 ,waiv]s  7#a7 ,9 g5]al
 ,! ,secret>y may waive ! requirem5ts ( 
?is section 9 :ole or 9 "p if !         
,secret>y det]m9es t compliance ) su*   
requirem5ts is n feasible due to-- 7,a7 
a public heal? em]g5cy decl>$ pursuant  
to section #cai ( ! ,public ,heal?      
,s]vice ,act2 or  7,b7 a natural disa/]1
 a p[] disruption1 or o!r ext5uat+      
circum/ances4  7#b7 ,guidance ,n lat]   

?an #ab mon?s aft] ! date ( enactm5t (  
?is section1 ! ,secret>y %all issue     
guidance to cl>ify ! circum/ances "u :i*
 waiv]s w be grant$ "u p>agraph 7#a74   
7f7 ,relation to privacy law  7#a7      
,appropriate safegu>ds ,! ,secret>y %all
 take appropriate measures to safegu>d !
 privacy & cyb]security ( ! data 9 !    
,prescription ,safety ,al]t ,sy/em4     
7#b7 ,disp5s]s ,! use ( protect$ heal?  
in=mation1 or ! disclosure to !         
,prescription ,safety ,al]t ,sy/em (    
protect$ heal? in=mation1 by a disp5s]  
pursuant to requirem5ts prescrib$ "u ?is
 section is deem$ to be a use or        
disclosure1 z applicable1 requir$ by law
 & !re=e p]mitt$1 )\t ! au?orization ( !
 individual1 "u section #afd4eab7;a7 (  
title #de1 ,code ( ,f$]al ,regulations  
7or any successor regulations74  7#c7   
,disclosure by ,prescription ,safety    
,al]t ,sy/em ,! use ( protect$ heal?    
in=mation1 or ! disclosure to a disp5s] 
( protect$ heal? in=mation1 by !        
,prescription ,safety ,al]t ,sy/em      

pursuant to requirem5ts prescrib$ "u ?is
 section is deem$ to be a use or        
disclosure1 z applicable1 requir$ by law
 & !re=e p]mitt$1 )\t au?orization ( !  
individual1 "u section #afd4eab7;a7 (   
title #de ( ! ,code ( ,f$]al            
,regulations 7or any successor          
regulations74  7#d7 ,def9itions ,9 ?is  
subsection3  7,a7 ,! t]m protect$ heal? 
in=mation has ! mean+ giv5 to t t]m 9   
section #afj4ajc ( title #de1 ,code (   
,f$]al ,regulations 7or any successor   
regulations74  7,b7 ,! t]m requir$ by   
law has ! mean+ giv5 to t t]m 9 section 
#afd4ajc ( title #de ( ! ,code ( ,f$]al 
,regulations 7or any successor          
regulations74  7g7 ,def9itions ,9 ?is   
section3 7#a7 ,! t]m cov]$ drug product 
means any drug product t--  7,a7 has be5
 approv$ = any use "u section #eje ( ?is
 ,act or section #cea ( ! ,public ,heal?
 ,s]vice ,act2 &  7,b7 has be5 includ$ 9
 a li/ ( drugs publi%$ by ! ,secret>y 9 
! ,f$]al ,regi/] z pres5t+ a risk (     
misuse1 abuse1 addiction1 ov]dose1 or   

drug-drug int]actions necessitat+       
inclusion 9 ! ,prescription ,safety     
,al]t ,sy/em1 s long z ! ,secret>y      
provid$ no less ?an #cj days = public   
comm5t be=e f9aliz+ ! inclusion ( su*   
drug product 9 su* li/4  7#b7 ,! t]m    
disp5s] means a p]son :o is lic5s$ 9    
accordance ) ,/ate law to engage 9 !    
practice ( ph>macy to disp5se cov]$ drug
 products directly to pati5ts or _!     
c>egiv]s1 except su* t]m does n include 
a clos$-sy/em ph>macy4  7#c7 ,! t]m     
clos$-sy/em ph>macy means any facility1 
includ+ a nurs+ home1 correctional      
facility1 adult congregate liv+         
facility1 or o!r cu/odial c>e facility1 
t is lic5s$ by law to engage 9 !        
practice ( ph>macy t di/ributes or      
disp5ses cov]$ drug products utiliz+ a  
clos$ deliv]y sy/em :]e prescriptions   
are individually prep>$ = a cu/odial    
consum]4  7#d7 ,! t]m prescription &    
disp5s+ hi/ory means a pati5t's hi/ory1 
dat+ back a m9imum ( #ab mon?s1 or su*  
p]iod z ! ,secret>y deems appropriate1 (

 receiv+1 fill+1 or attempt+ to receive 
or fill1 prescriptions = cov]$ drug     
products1 includ+ specific data elem5ts1
 z applicable to any p>ticul> pati5t or 
prescription1 includ+-- 7,a7 a          
description ( ! drug disp5s$ or attempt$
 to be fill$2  7,b7 ph>macy national    
provid] id5tifi] 7,,npi72  7,c7         
prescription 7,rx7 numb]2  7,d7 fill    
numb]2  7,e7 o!r applicable cov]age     
code2  7,f7 date or dates ( s]vice2     
7,g7 prescrib] id5tifi]s2  7,h7 pati5t  
in=mation2  7,i7 ?ird p>ty id5tifi]s2 & 
7,j7 su* o!r in=mation ! ,secret>y deems
 appropriate by guidance4  7#e7 ,! t]m  
/&>d sett+ organization has ! mean+ giv5
 to su* t]m 9 section #aaga7h7 ( !      
,social ,security ,act4  4