#aacth ,,congress  #b;d ,session  ,h4   
,r4 #dgji  ,,an ,,act  ,to improve      
enforcement efforts related to          
prescription drug diversion and abuse1  
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,ensuring ,patient ,access and          
,effective ,drug ,enforcement ,act of   
#bjad4  #b4 ,registration process under 
,controlled ,substances ,act  7a7       
,definitions  7#a7 ,factors as may be   
relevant to and consistent with the     
public health and safety ,section #cjc  
of the ,controlled ,substances ,act 7#ba
 ,u4,s4,c4 #hbc7 is amended by adding at
 the end the following3  7i7 ,in this   
section1 the phrase factors as may be   
relevant to and consistent with the     
public health and safety means factors  
that are relevant to and consistent with
 the findings contained in section #aja4
  4  7#b7 ,imminent danger to the public
 health or safety ,section #cjd7;d7 of  
the ,controlled ,substances ,act 7#ba   
,u4,s4,c4 #hbd7;d77 is amended--  7,a7  

by striking 7d7 ,the ,attorney ,general 
and inserting 7d77#a7 ,the ,attorney    
,general2 and  7,b7 by adding at the end
 the following3  7#b7 ,in this          
subsection1 the phrase imminent danger  
to the public health or safety means    
that1 in the absence of an immediate    
suspension order1 controlled            
substances--  7,a7 will continue to be  
intentionally distributed or dispensed--
  7i7 outside the usual course of       
professional practice2 or  7ii7 in a    
manner that poses a present or          
foreseeable risk of serious adverse     
health consequences or death2 or  7,b7  
will continue to be intentionally       
diverted outside of legitimate          
distribution channels4  4  7b7          
,opportunity ,to submit corrective      
action plan prior to revocation or      
suspension ,subsection 7c7 of section   
#cjd of the ,controlled ,substances ,act
 7#ba ,u4,s4,c4 #hbd7 is amended--  7#a7
 by striking the last two sentences in  
such subsection2  7#b7 by striking 7c7  

,before and inserting 7c77#a7 ,before2  
and  7#c7 by adding at the end the      
following3  7#b7 ,an order to show cause
 under paragraph 7#a7 shall--  7,a7     
contain a statement of the basis for the
 denial1 revocation1 or suspension1     
including specific citations to any laws
 or regulations alleged to be violated  
by the applicant or registrant2  7,b7   
direct the applicant or registrant to   
appear before the ,attorney ,general at 
a time and place stated in the order1   
but no less than thirty days after the  
date of receipt of the order2 and  7,c7 
notify the applicant or registrant of   
the opportunity to submit a corrective  
action plan on or before the date of    
appearance4  7#c7 ,upon review of any   
corrective action plan submitted by an  
applicant or registrant pursuant to     
paragraph 7#b71 the ,attorney ,general  
shall determine whether denial1         
revocation or suspension proceedings    
should be discontinued1 or deferred for 
the purposes of modification1 amendment1

 or clarification to such plan4  7#d7   
,proceedings to deny1 revoke1 or suspend
 shall be conducted pursuant to this    
section in accordance with subchapter   
,,ii of chapter #e of title #e4 ,such   
proceedings shall be independent of1 and
 not in lieu of1 criminal prosecutions  
or other proceedings under this title or
 any other law of the ,united ,states4  
7#e7 ,the requirements of this          
subsection shall not apply to the       
issuance of an immediate suspension     
order under subsection 7d74  4  #c4     
,report to ,congress on effects of law  
enforcement activities on patient access
 to medications  7a7 ,in general ,not   
later than one year after the date of   
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services1 acting 
through the ,commissioner of ,food and  
,drugs and the ,director of the ,centers
 for ,disease ,control and ,prevention1 
and in consultation with the            
,administrator of the ,drug ,enforcement
 ,administration and the ,director of   

,national ,drug ,control ,policy1 shall 
submit a report to the ,committees on   
the ,judiciary of the ,house of         
,representatives1 the ,committee on     
,energy and ,commerce of the ,house of  
,representatives1 the ,committee on the 
,judiciary of the ,senate1 and the      
,committee on ,health1 ,education1      
,labor and ,pensions of the ,senate     
identifying--  7#a7 obstacles to        
legitimate patient access to controlled 
substances2  7#b7 issues with diversion 
of controlled substances2 and  7#c7 how 
collaboration between ,federal1 ,state1 
local1 and tribal law enforcement       
agencies and the pharmaceutical industry
 can benefit patients and prevent       
diversion and abuse of controlled       
substances4  7b7 ,consultation ,the     
report under subsection 7a7 shall       
incorporate feedback and recommendations
 from the following3  7#a7 ,patient     
groups4  7#b7 ,pharmacies4  7#c7 ,drug  
manufacturers4  7#d7 ,common or contract
 carriers and warehousemen4  7#e7       

,hospitals1 physicians1 and other health
 care providers4  7#f7 ,state attorneys 
general4  7#g7 ,federal1 ,state1 local1 
and tribal law enforcement agencies4    
7#h7 ,health insurance providers and    
entities that provide pharmacy benefit  
management services on behalf of a      
health insurance provider4  7#i7        
,wholesale drug distributors4  ,passed  
the ,house of ,representatives ,july    
#bi1 #bjad4;,clerk4