,i  #aaeth ,,congress  #b;d ,session    
,h4 ,r4 #fggi  ,,in ,,the ,,house ,,of  
,,representatives  ,september #ab1      
#bjah,mr4 ,buck introduced the following
 bill2 which was referred to the        
,committee on ,energy and ,commerce1 and
 in addition to the ,committee on the   
,judiciary1 for a period to be          
subsequently determined by the ,speaker1
 in each case for consideration of such 
provisions as fall within the           
jurisdiction of the committee concerned 
,a ,,bill  ,to amend the ,controlled    
,substances ,act to require the ,drug   
,enforcement ,administration to report  
certain information on distribution of  
opioids1 and for other purposes4  #a4   
,short title ,this ,act may be cited as 
the ,using ,data to ,prevent ,opioid    
,diversion ,act of #bjah4  #b4 ,findings
 ,congress finds the following3  7#a7   
,in #bjaf1 there were nearly #fd1jjj    
drug overdose deaths in the ,united     
,states4 ,more than #db1jjj of these    
deaths were opioid-related4  7#b7 ,the  

regulations promulgated under the       
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hja et seq47 require drug    
manufacturers and distributors to--     
7,a7 provide effective controls against 
the diversion of controlled substances2 
7,b7 detect and disclose suspicious     
orders to the ,drug ,enforcement        
,administration2 and  7,c7 keep complete
 and accurate records relating to the   
manufacture or distribution of          
controlled substances4  7#c7 ,despite   
the requirements described in paragraph 
7#b71 it has been publicly reported that
 between #bjjf and #bjaf1 nearly        
#ba1jjj1jjj opioids were distributed to 
#b pharmacies in ,williamson1 ,west     
,virginia1 which has a population of    
approximately #c1jjj4 ,it has been      
further reported that between #bjjg and 
#bjjh1 nearly #i1jjj1jjj pills were     
distributed to a single pharmacy in     
,kermit1 ,west ,virginia1 which has a   
population of #cib4  7#d7 ,similarly1 it
 has been publicly reported that        

#ghj1jjj1jjj oxycodone and hydrocodone  
pills were distributed to pharmacies    
throughout ,west ,virginia between #bjjg
 and #bjab4 ,in the same period1 more   
than #a1gjj people in the ,state died   
from overdoses of these #b substances4  
7#e7 ,drug manufacturers and            
distributors are required to report the 
sale1 delivery or other disposal of     
narcotics to the ,drug ,enforcement     
,administration through the ,automated  
,reports and ,consolidated ,orders      
,system4  7#f7 ,notwithstanding the     
reporting requirement described in      
paragraph 7#e71 the ,drug ,enforcement  
,administration does not disclose the   
total quantity and type of opioids      
distributed to a single pharmacy or     
practitioner with those manufacturers   
and distributors who are required to    
input information into the ,automated   
,reports and ,consolidated ,orders      
,system4 ,this creates a barrier to     
identifying and stopping potentially    
suspicious orders4  7#g7 ,although      

manufacturers and distributors are      
already required to provide effective   
controls against the diversion of       
controlled substances1 this lack of data
 sharing may create a barrier to better 
identifying and stopping potentially    
suspicious orders4  7#h7 ,on an annual  
basis1 the ,attorney ,general of the    
,united ,states is statutorily required 
to share the controlled substance or    
substances in schedule ,,ii that have   
the highest rates of abuse and to       
prepare and make available reports on   
the distribution patterns of such       
substances1 with ,state regulatory1     
licensing1 and law enforcement agencies4
 ,the ,attorney ,general of the ,united 
,states has entered into data sharing   
agreements with the attorneys general of
 the vast majority of ,states1 ,puerto  
,rico1 and the ,district of ,colombia to
 share1 pursuant to ,state law and      
policy1 data obtained from ,state       
prescription drug monitoring programs   
and other sources4  7#i7 ,to further    

reduce barriers associated with         
identifying suspicious patterns and     
stopping the diversion of opioids1 the  
remaining ,states and territories of the
 ,united ,states should enter into      
similar agreements with1 and to the     
greatest extent practical share data    
obtained from ,state prescription drug  
monitoring programs with1 the ,attorney 
,general of the ,united ,states4  #c4   
,purpose  7a7 ,in general ,the purpose  
of this ,act is to provide drug         
manufacturers and distributors with     
access to anonymized information through
 the ,automated ,reports and            
,consolidated ,orders ,system to help   
drug manufacturers and distributors     
identify1 report1 and stop suspicious   
orders of opioids and reduce diversion  
rates4  7b7 ,rule of construction       
,nothing in this ,act should be         
construed to absolve a drug             
manufacturer1 drug distributor1 or other
 ,drug ,enforcement ,administration     
registrant from the responsibility of   

the manufacturer1 distributor1 or other 
registrant to--  7#a7 identify1 stop1   
and report suspicious orders2 or  7#b7  
maintain effective controls against     
diversion in accordance with section    
#cjc of the ,controlled ,substances ,act
 7#ba ,u4,s4,c4 #hbc7 or any successor  
law or associated regulation4  #d4      
,amendments  7a7 ,records and reports of
 registrants ,section #cjg of the       
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hbg7 is amended-- 7#a7 by    
redesignating subsections 7f71 7g71 and 
7h7 as subsections 7g71 7h71 and 7i71   
respectively2  7#b7 by inserting after  
subsection 7e7 the following3  7f7 7#a7 
,the ,attorney ,general shall1 not less 
frequently than quarterly1 make the     
following information available to      
manufacturer and distributor registrants
 through the ,automated ,reports and    
,consolidated ,orders ,system1 or any   
subsequent automated system developed by
 the ,drug ,enforcement ,administration 
to monitor selected controlled          

substances3  7,a7 ,the total number of  
distributor registrants that distribute 
controlled substances to a pharmacy or  
practitioner registrant1 aggregated by  
the name and address of each pharmacy   
and practitioner registrant4  7,b7 ,the 
total quantity and type of opioids      
distributed1 listed by ,administration  
,controlled ,substances ,code ,number1  
to each pharmacy and practitioner       
registrant described in subparagraph    
7,a74  7#b7 ,the information required to
 be made available under paragraph 7#a7 
shall be made available not later than  
the #aeth day of the first month        
following the quarter to which the      
information relates4  7#c7  7,a7 ,all   
registered manufacturers and            
distributors shall be responsible for   
reviewing the information made available
 by the ,attorney ,general under this   
subsection4  7,b7 ,in determining       
whether to initiate proceedings under   
this title against a registered         
manufacturer or distributor based on the

 failure of the registrant to maintain  
effective controls against diversion or 
otherwise comply with the requirements  
of this title or the regulations issued 
thereunder1 the ,attorney ,general may  
take into account that the information  
made available under this subsection was
 available to the registrant4  2 and    
7#c7 by inserting after subsection 7i71 
as so redesignated1 the following3  7j7 
,all of the reports required under this 
section shall be provided in an         
electronic format4  4  7b7 ,cooperative 
arrangements ,section #ejc of the       
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hgc7 is amended-- 7#a7 by    
striking subsection 7c7 and inserting   
the following3  7c7  7#a7 ,the ,attorney
 ,general shall1 once every #f months1  
prepare and make available to           
regulatory1 licensing1 attorneys        
general1 and law enforcement agencies of
 ,states a standardized report          
containing descriptive and analytic     
information on the actual distribution  

patterns1 as gathered through the       
,automated ,reports and ,consolidated   
,orders ,system1 or any subsequent      
automated system1 pursuant to section   
#cjg and which includes detailed        
amounts1 outliers1 and trends of        
distributor and pharmacy registrants1 in
 such ,states for the controlled        
substances contained in schedule ,,ii1  
which1 in the discretion of the         
,attorney ,general1 are determined to   
have the highest abuse4  7#b7 ,if the   
,attorney ,general publishes the report 
described in paragraph 7#a7 once every  
#f months as required under paragraph   
7#a71 nothing in this subsection shall  
be construed to bring an action in any  
court to challenge the sufficiency of   
the information or to compel the        
,attorney ,general to produce any       
documents or reports referred to in this
 subsection4  4  7c7 ,civil and criminal
 penalties ,section #djb of the         
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hdb7 is amended-- 7#a7 in    

subsection 7a7--  7,a7 in paragraph     
7#ae71 by striking or at the end2  7,b7 
in paragraph 7#af71 by striking the     
period at the end and inserting 2 or2   
and  7,c7 by inserting after paragraph  
7#af7 the following3  7#ag7 in the case 
of a registered manufacturer or         
distributor of opioids1 to fail to      
review the most recent information1     
directly related to the customers of the
 manufacturer or distributor1 made      
available by the ,attorney ,general in  
accordance with section #cjg7;f74  2 and
  7#b7 in subsection 7c7-- 7,a7 in      
paragraph 7#a71 by striking subparagraph
 7,b7 and inserting the following3  7,b7
  7i7 ,except as provided in clause     
7ii71 in the case of a violation of     
paragraph 7#e71 7#aj71 or 7#ag7 of      
subsection 7a71 the penalty shall not   
exceed #aj1jjj4  7ii7 ,in the case of a 
violation described in clause 7i7       
committed by a registered manufacturer  
or distributor of opioids and related to
 the reporting of suspicious orders for 

opioids1 failing to maintain effective  
controls against diversion of opioids1  
or failing to review the most recent    
information made available by the       
,attorney ,general in accordance with   
section #cjg7;f71 the penalty shall not 
exceed #ajj1jjj4  2 and  7,b7 in        
paragraph 7#b7-- 7i7 in subparagraph    
7,a71 by inserting or 7,d7 after        
subparagraph 7,b72 and  7ii7 by adding  
at the end the following3  7,d7 ,in the 
case of a violation described in        
subparagraph 7,a7 that was a violation  
of paragraph 7#e71 7#aj71 or 7#ag7 of   
subsection 7a7 committed by a registered
 manufacturer or distributor of opioids 
that relates to the reporting of        
suspicious orders for opioids1 failing  
to maintain effective controls against  
diversion of opioids1 or failing to     
review the most recent information made 
available by the ,attorney ,general in  
accordance with section #cjg7;f71 the   
criminal fine under title #ah1 ,united  
,states ,code1 shall not exceed         

#ejj1jjj4  4  #e4 ,report ,not later    
than #a year after the date of enactment
 of this ,act1 the ,attorney ,general   
shall submit to ,congress a report that 
provides information about how the      
,attorney ,general is using data in the 
,automation of ,reports and             
,consolidated ,orders ,system to        
identify and stop suspicious activity1  
including whether the ,attorney ,general
 is looking at aggregate orders from    
individual pharmacies to multiple       
distributors that in total are          
suspicious1 even if no individual order 
rises to the level of a suspicious order
 to a given distributor4  #f4           
,improvements to prevent drug diversion 
7a7 ,definition  7#a7 ,in general       
,section #ajb of the ,controlled        
,substances ,act 7#ba ,u4,s4,c4 #hjb7 is
 amended by adding at the end the       
following3  7#eg7 ,the term suspicious  
order includes-- 7,a7 an order of a     
controlled substance of unusual size2   
7,b7 an order of a controlled substance 

deviating substantially from a normal   
pattern2  7,c7 orders of controlled     
substances of unusual frequency2 and    
7,d7 an order or pattern of orders of a 
controlled substance that meet such     
other criteria as are established by the
 ,attorney ,general by regulation4  4   
7#b7 ,regulations ,not later than #a    
year after the date of enactment of this
 ,act1 the ,attorney ,general shall     
promulgate regulations under paragraph  
7#eg77;,d7 of section #ajb of the       
,controlled ,substances ,act1 as added  
by paragraph 7#a7 of this subsection4   
7b7 ,suspicious orders ,part ,c of the  
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hba et seq47 is amended by   
adding at the end the following3  #cab4 
,suspicious orders  7a7 ,reporting ,each
 registrant shall-- 7#a7 design and     
operate a system to identify suspicious 
orders for the registrant2  7#b7 ensure 
that the system designed and operated   
under paragraph 7#a7 by the registrant  
complies with applicable ,federal and   

,state privacy laws2 and  7#c7 upon     
discovering a suspicious order or series
 of orders1 notify the ,administrator of
 the ,drug ,enforcement ,administration 
and the ,special ,agent in ,charge of   
the ,division ,office of the ,drug      
,enforcement ,administration for the    
area in which the registrant is located 
or conducts business4  7b7 ,suspicious  
order database  7#a7 ,in general ,not   
later than #a year after the date of    
enactment of this section1 the ,attorney
 ,general shall establish a centralized 
database for collecting reports of      
suspicious orders4  7#b7 ,satisfaction  
of reporting requirements ,if a         
registrant reports a suspicious order to
 the centralized database established   
under paragraph 7#a71 the registrant    
shall be considered to have complied    
with the requirement under subsection   
7a77#c7 to notify the ,administrator of 
the ,drug ,enforcement ,administration  
and the ,special ,agent in ,charge of   
the ,division ,office of the ,drug      

,enforcement ,administration for the    
area in which the registrant is located 
or conducts business4  7c7 ,sharing     
information with the ,states  7#a7 ,in  
general ,the ,attorney ,general shall   
prepare and make available information  
regarding suspicious orders in a ,state1
 including information in the database  
established under subsection 7b77#a71 to
 the point of contact for purposes of   
administrative1 civil1 and criminal     
oversight relating to the diversion of  
controlled substances for the ,state1 as
 designated by the ,governor or chief   
executive officer of the ,state4  7#b7  
,timing ,the ,attorney ,general shall   
provide information in accordance with  
paragraph 7#a7 within a reasonable      
period of time after obtaining the      
information4  7#c7 ,coordination ,in    
establishing the process for the        
provision of information under this     
subsection1 the ,attorney ,general shall
 coordinate with ,states to ensure that 
the ,attorney ,general has access to    

information1 as permitted under ,state  
law1 possessed by the ,states relating  
to prescriptions for controlled         
substances that will assist in enforcing
 ,federal law4  4  7c7 ,reports to      
,congress  7#a7 ,definition ,in this    
subsection1 the term suspicious order   
has the meaning given that term in      
section #ajb of the ,controlled         
,substances ,act1 as amended by this    
,act4  7#b7 ,one time report ,not later 
than #a year after the date of enactment
 of this ,act1 the ,attorney ,general   
shall submit to ,congress a report on   
the reporting of suspicious orders1     
which shall include--  7,a7 a           
description of the centralized database 
established under section #cab of the   
,controlled ,substances ,act1 as added  
by this section1 to collect reports of  
suspicious orders2  7,b7 a description  
of the system and reports established   
under section #cab of the ,controlled   
,substances ,act1 as added by this      
section1 to share information with      

,states2  7,c7 information regarding how
 the ,attorney ,general used reports of 
suspicious orders before the date of    
enactment of this ,act and after the    
date of enactment of this ,act1         
including how the ,attorney ,general    
received the reports and what actions   
were taken in response to the reports2  
and  7,d7 descriptions of the data      
analyses conducted on reports of        
suspicious orders to identify1 analyze1 
and stop suspicious activity4  7#c7     
,additional reports ,not later than #a  
year after the date of enactment of this
 ,act1 and annually thereafter until the
 date that is #e years after the date of
 enactment of this ,act1 the ,attorney  
,general shall submit to ,congress a    
report providing1 for the previous      
year--  7,a7 the number of reports of   
suspicious orders2  7,b7 a summary of   
actions taken in response to reports1 in
 the aggregate1 of suspicious orders2   
and  7,c7 a description of the          
information shared with ,states based on

 reports of suspicious orders4