#aaeth ,,congress  #b;d ,session  ,h4   
,r4 #ebbh  ,,an ,,act  ,to strengthen   
the authorities of the ,food and ,drug  
,administration to address counterfeit  
drugs1 illegal and synthetic opioids1   
and opioid-like substances1 and for     
other purposes4  #a4 ,short title2 table
 of contents  7a7 ,short title ,this    
,act may be cited as the ,stop          
,counterfeit ,drugs by ,regulating and  
,enhancing ,enforcement ,now ,act or the
 ,,screen ,act4  7b7 ,table of contents 
,the table of contents of this ,act is  
as follows3  ,sec4 #a4 ,short title2    
table of contents4 ,sec4 #b4 ,detention1
 refusal1 and destruction of drugs      
offered for importation4 ,sec4 #c4      
,notification1 nondistribution1 and     
recall of adulterated or misbranded drug
 products4 ,sec4 #d4 ,single source     
pattern of shipments of adulterated or  
misbranded drugs4 ,sec4 #e4 ,fund to    
strengthen efforts of ,,fda to combat   
the opioid and substance use epidemic4  
,sec4 #f4 ,consideration of potential   

for misuse and abuse required for drug  
approval4  #b4 ,detention1 refusal1 and 
destruction of drugs offered for        
importation  7a7 ,increasing the maximum
 dollar amount of drugs subject to      
destruction ,the sixth sentence in      
section #hja7;a7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cha7;a77 is amended by striking except
 that the ,secretary and all that       
follows through the two periods at the  
end and inserting except that the       
,secretary of ,health and ,human        
,services may destroy1 without the      
opportunity for export1 any drug refused
 admission under this section1 if such  
drug is declared to be valued at an     
amount that is #b1ejj or less 7or such  
higher amount as the ,secretary of the  
,treasury may set by regulation pursuant
 to section #dih7;a77#a7 of the ,tariff 
,act of #aicj or such higher amount as  
the ,commissioner of ,food and ,drugs   
may set based on a finding by the       
,commissioner that the higher amount is 

in the interest of public health71 or if
 such drug is entering the ,united      
,states by mail1 and was not brought    
into compliance as described under      
subsection 7b744  7b7 ,destruction of   
articles of concern ,the sixth sentence 
of section #hja7;a7 of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cha7;a771 as amended by      
subsection 7a71 is further amended by   
inserting before the period at the end  
the following3 2 and the ,secretary of  
,health and ,human ,services may        
destroy1 without the opportunity for    
export1 any article refused admission   
under clause 7#f7 of the third sentence 
of this subsection4  7c7 ,technical     
amendments ,the seventh1 eighth1 and    
ninth sentences of section #hja7;a7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cha7;a77 are      
amended-- 7#a7 by striking a drug each  
place it appears and inserting an       
article2 and  7#b7 by striking the drug 
each place it appears and inserting the 

article4  7d7 ,rule of construction ,the
 last sentence in section #hja7;a7 of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cha7;a77 is       
amended to read as follows3 ,clauses    
7#b71 7#e71 and 7#f7 of the third       
sentence of this subsection shall not be
 construed to prohibit the admission of 
narcotic or nonnarcotic drugs or other  
substances1 the importation of which is 
permitted under the ,controlled         
,substances ,import and ,export ,act44  
#c4 ,notification1 nondistribution1 and 
recall of adulterated or misbranded drug
 products  7a7 ,prohibited ,acts        
,section #cja of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cca7 is amended by adding at the end  
the following3  7eee7 ,the failure to   
comply with any order issued under      
section #efi;,d4  4  7b7 ,notification1 
nondistribution1 and recall of          
adulterated or misbranded drugs         
,subchapter ,e of chapter ,v of the     
,federal ,food1 ,drug1 and ,cosmetic    

,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is
 amended by adding at the end the       
following3  #efi;,d4 ,notification1     
,nondistribution1 ,and ,recall ,of      
,adulterated ,or ,misbranded ,drugs  7a7
 ,order ,to cease distribution and      
recall  7#a7 ,in general ,upon a        
determination that the use or           
consumption of1 or exposure to1 a drug  
may present an imminent or substantial  
hazard to the public health1 the        
,secretary shall issue an order         
requiring any person who distributes the
 drug to immediately cease distribution 
of the drug4  7#b7 ,hearing ,an order   
under paragraph 7#a7 shall provide the  
person subject to the order with an     
opportunity for an informal hearing1 to 
be held not later than #aj days after   
the date of issuance of the order1 on-- 
7,a7 the actions required by the order2 
and  7,b7 whether the order should be   
amended to require a recall of the drug4
  7#c7 ,inadequate grounds ,if1 after   
providing an opportunity for a hearing  

under paragraph 7#b71 the ,secretary    
determines that inadequate grounds exist
 to support the actions required by the 
order1 the ,secretary shall vacate the  
order4  7#d7 ,amendment to order to     
require recall ,if1 after providing an  
opportunity for an informal hearing     
under paragraph 7#b71 the ,secretary    
determines that the order should be     
amended to include a recall of the drug 
with respect to which the order was     
issued1 the ,secretary shall-- 7,a7     
amend the order to require a recall2 and
  7,b7 after consultation with the drug 
sponsor1 specify a timetable in which   
the recall will occur4  7#e7 ,notice to 
persons affected ,an order under this   
subsection shall require any person who 
distributes the drug to provide for     
notice1 including to individuals as     
appropriate1 to persons who may be      
affected by the order to cease          
distribution of or recall the drug1 as  
applicable4  7#f7 ,action following     
order ,any person who is subject to an  

order under paragraph 7#a7 or 7#d7 shall
 immediately cease distribution of or   
recall1 as applicable1 the drug and     
provide notification as required by such
 order4  7b7 ,notice to consumers and   
health officials ,the ,secretary shall1 
as the ,secretary determines to be      
necessary1 provide notice of a recall   
order under this section to--  7#a7     
consumers to whom the drug was1 or may  
have been1 distributed2 and  7#b7       
appropriate ,state and local health     
officials4  7c7 ,order ,to recall  7#a7 
,contents ,an order to recall a drug    
under subsection 7a7 shall-- 7,a7       
require periodic reports to the         
,secretary describing the progress of   
the recall2 and  7,b7 provide for       
notice1 including to individuals as     
appropriate1 to persons who may be      
affected by the recall4  7#b7           
,assistance allowed ,in providing for   
notice under paragraph 7#a77;,b71 the   
,secretary may allow for the assistance 
of health professionals1 ,state or local

 officials1 or other individuals        
designated by the ,secretary4  7#c7     
,nondelegation ,an order under this     
section shall be ordered by the         
,secretary or an official designated by 
the ,secretary4 ,an official may not be 
so designated under this section unless 
the official is the ,director of the    
,center for ,drug ,evaluation and       
,research1 is an official senior to such
 ,director1 or is so designated by such 
,director4  7d7 ,savings clause ,nothing
 contained in this section shall be     
construed as limiting--  7#a7 the       
authority of the ,secretary to issue an 
order to cease distribution of1 or to   
recall1 an drug under any other         
provision of this ,act or the ,public   
,health ,service ,act2 or  7#b7 the     
ability of the ,secretary to request any
 person to perform a voluntary activity 
related to any drug subject to this ,act
 or the ,public ,health ,service ,act4  
4  7c7 ,drugs subject to refusal ,the   
third sentence of subsection 7a7 of     

section #hja of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cha7 is amended by inserting or 7#e7  
in the case of a drug1 such drug is     
subject to an order under section #efh  
to cease distribution of or recall the  
drug1 before then such article shall be 
refused admission4  7d7 ,application    
,sections #cja7;eee7 and #efi;,d of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act1 as added by subsections 7a7 and   
7b71 shall apply with respect to a drug 
as of such date1 not later than #a year 
after the date of the enactment of this 
,act1 as the ,secretary of ,health and  
,human ,services shall specify4  #d4    
,single source pattern of shipments of  
adulterated or misbranded drugs ,section
 #hja of the ,federal ,food1 ,drug1 and 
,cosmetic ,act is amended by adding at  
the end the following3  7t7 ,single     
source pattern of shipments of          
adulterated or misbranded drugs ,if the 
,secretary identifies a pattern of      
adulterated or misbranded drugs being   

offered for import from the same        
manufacturer1 distributor1 or importer1 
the ,secretary may by order choose to   
treat all drugs being offered for import
 from such manufacturer1 distributor1 or
 importer as adulterated or misbranded  
unless otherwise demonstrated4  4  #e4  
,fund to strengthen efforts of ,,fda to 
combat the opioid and substance use     
epidemic ,chapter ,x of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cia et seq47 is amended by   
adding at the end the following3  #ajae4
 ,fund to strengthen efforts of ,,fda to
 combat the opioid and substance use    
epidemic  7a7 ,in general ,the          
,commissioner of ,food and ,drugs shall 
use any funds appropriated pursuant to  
the authorization of appropriations     
under subsection 7c7 to carry out the   
programs and activities described in    
subsection 7d7 to strengthen and        
facilitate the ,food and ,drug          
,administration's efforts to address the
 opioid and substance use epidemic4     

,such funds shall be in addition to any 
funds which are otherwise available to  
carry out such programs and activities4 
7b7 ,,fda ,opioid and ,substance ,use   
,epidemic ,response ,fund  7#a7         
,establishment of fund ,there is        
established in the ,treasury a fund1 to 
be known as the ,,fda ,opioid and       
,substance ,use ,epidemic ,response     
,fund 7referred to in this subsection as
 the ,fund71 for purposes of funding the
 programs and activities described in   
subsection 7d74  7#b7 ,transfer ,for the
 period of fiscal years #bjai through   
#bjbc1 #aaj1jjj1jjj shall be transferred
 to the ,fund from the general fund of  
the ,treasury4  7#c7 ,amounts deposited 
,any amounts transferred under paragraph
 7#b7 shall remain unavailable in the   
,fund until such amounts are            
appropriated pursuant to subsection 7c74
  7c7 ,appropriations  7#a7             
,authorization of appropriations ,for   
the period of fiscal years #bjai through
 #bjbc1 there is authorized to be       

appropriated from the ,fund to the ,food
 and ,drug ,administration1 for the     
purpose of carrying out the programs and
 activities described in subsection 7d71
 an amount not to exceed the total      
amount transferred to the ,fund under   
subsection 7b77#b74 ,notwithstanding    
subsection 7g71 such funds shall remain 
available until expended4  7#b7         
,offsetting future appropriations ,for  
any of fiscal years #bjai through #bjbc1
 for any discretionary appropriation out
 of the ,fund to the ,food and ,drug    
,administration pursuant to the         
authorization of appropriations under   
paragraph 7#a7 for the purpose of       
carrying out the programs and activities
 described in subsection 7d71 the total 
amount of such appropriations for the   
applicable fiscal year 7not to exceed   
the total amount remaining in the ,fund7
 shall be subtracted from the estimate  
of discretionary budget authority and   
the resulting outlays for any estimate  
under the ,congressional ,budget and    

,impoundment ,control ,act of #aigd or  
the ,balanced ,budget and ,emergency    
,deficit ,control ,act of #aihe1 and the
 amount transferred to the ,fund shall  
be reduced by the same amount4  7d7     
,food and ,drug ,administration ,the    
entirety of the funds made available    
pursuant to subsection 7c77#a7 shall be 
for the ,commissioner of ,food and      
,drugs1 pursuant to applicable          
authorities in the ,public ,health      
,service ,act 7#db ,u4,s4,c4 #bja et    
seq47 or this ,act and other applicable 
,federal law1 to support widespread     
innovation in non-opioid and            
non-addictive medical products for pain 
treatment1 access to opioid addiction   
treatments1 appropriate use of approved 
opioids1 and efforts to reduce illicit  
importation of opioids4 ,such support   
may include the following programs and  
activities3  7#a7 ,obligating contract  
funds beginning in fiscal year #bjai for
 an educational campaign that will--    
7,a7 educate patients and their families

 to differentiate opioid medications2   
7,b7 raise awareness about preferred    
storage and disposal methods2 and  7,c7 
inform patients1 families1 and          
communities about medication-assisted   
treatment options4  7#b7 ,building the  
,food and ,drug ,administration's       
presence in international mail          
facilities1 including through-- 7,a7    
improvements in equipment and           
information technology enhancements to  
identify unapproved1 counterfeit1 or    
other unlawful pharmaceuticals for      
destruction2  7,b7 increased and        
improved surveillance2  7,c7 renovations
 at international mail facility         
locations2 and  7,d7 the purchase of    
laboratory equipment4  7#c7 ,enhancing  
the identification and targeting of     
entities offering products and products 
being offered by such entities for      
import into the ,united ,states through 
review and analysis of ,internet        
websites1 import data1 and other sources
 of intelligence for purposes of making 

the best use of the ,food and ,drug     
,administration's inspection and        
analytical resources4  7#d7 ,increasing 
the number of staff of the ,food and    
,drug ,administration to increase the   
number of packages being examined1      
ensuring the safety of the staff        
undertaking such examinations1 and      
ensuring that packages identified as    
illegal1 counterfeit1 misbranded1 or    
adulterated are removed from commerce   
through available authorities1 including
 administrative destruction4  7#e7      
,enhancing the ,food and ,drug          
,administration's criminal              
investigations resources 7including     
full-time equivalent employees and      
equipment71 imports surveillance1 and   
international work4  7#f7 ,obtaining for
 the ,food and ,drug ,administration    
equipment and full-time equivalent      
employees needed to efficiently screen  
and analyze products offered for import1
 including by building data libraries of
 new substances and analogues to        

facilitate identification and evaluation
 of pharmaceutical-based agents and by  
purchasing screening technologies for   
use at international mail facilities4   
7#g7 ,operating the ,food and ,drug     
,administration's forensic laboratory   
facility to ensure adequate laboratory  
space and functionality for additional  
work and full-time equivalent employees4
  7e7 ,accountability and oversight     
7#a7 ,work plan  7,a7 ,in general ,not  
later than #ahj days after the date of  
enactment of this ,act1 the             
,commissioner of ,food and ,drugs shall 
submit to the ,committee on ,health1    
,education1 ,labor and ,pensions of the 
,senate and the ,committee on ,energy   
and ,commerce of the ,house of          
,representatives1 a work plan including 
the proposed allocation of funds        
appropriated pursuant to the            
authorization of appropriations under   
subsection 7c7 for each of fiscal years 
#bjai through #bjbc and the contents    
described in subparagraph 7,b74  7,b7   

,contents ,the work plan submitted under
 subparagraph 7,a7 shall include--  7i7 
the amount of money to be obligated or  
expended out of the ,fund in each fiscal
 year for each program and activity     
described in subsection 7d72 and  7ii7 a
 description and justification of each  
such program and activity4  7#b7        
,reports  7,a7 ,annual reports ,not     
later than ,october #a of each of fiscal
 years #bjbj through #bjbd1 the         
,secretary of ,health and ,human        
,services shall submit to the ,committee
 on ,health1 ,education1 ,labor and     
,pensions of the ,senate and the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives a report 
that includes-- 7i7 the amount of money 
obligated or expended out of the ,fund  
in the prior fiscal year for each       
program and activity described in       
subsection 7d72  7ii7 a description of  
all programs and activities using funds 
provided pursuant to the authorization  
of appropriations under subsection 7c72 

and  7iii7 how the programs and         
activities are advancing public health4 
7,b7 ,additional reports ,at the request
 of the ,committee on ,health1          
,education1 ,labor and ,pensions of the 
,senate or the ,committee on ,energy and
 ,commerce of the ,house of             
,representatives1 the ,commissioner     
shall provide an update in the form of  
testimony and any additional reports to 
the respective congressional committee  
regarding the allocation of funding     
under this section or the description of
 the programs and activities undertaken 
with such funding4  7f7 ,limitations    
,notwithstanding any transfer authority 
authorized by this section or any       
appropriations ,act1 any funds made     
available pursuant to the authorization 
of appropriations under subsection 7c7  
may not be used for any purpose other   
than the programs and activities        
described in subsection 7d7 to          
strengthen and facilitate the ,food and 
,drug ,administration's efforts to      

address the opioid and substance use    
epidemic4  7g7 ,sunset ,this section    
shall expire on ,september #cj1 #bjbb1  
except that-- 7#a7 this subsection does 
not apply to reporting under subsection 
7e77#b72 and  7#b7 this section shall   
remain in effect until such time1 and to
 such extent1 as may be necessary for   
the funds transferred by subsection     
7b77#b7 to be fully expended4  4  #f4   
,consideration of potential for misuse  
and abuse required for drug approval    
7a7 ,in general ,section #eje7;d7 of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;d77 is        
amended--  7#a7 in the first sentence-- 
7,a7 by striking or 7#g7 and inserting  
7#g72 and  7,b7 by inserting or 7#h7 if 
the drug is or contains a controlled    
substance for which a listing in any    
schedule is in effect under the         
,controlled ,substances ,act or that is 
permanently scheduled pursuant to       
section #bja of such ,act1 on the basis 
of information submitted to him as part 

of the application1 or upon the basis of
 any other information before him with  
respect to such drug1 the drug is unsafe
 for use due to the risks of abuse or   
misuse or there is insufficient         
information to show that the drug is    
safe for use considering such risks2    
before he shall issue an order refusing 
to approve the application2 and  7#b7 in
 the second sentence1 by striking 7#f7  
and inserting 7#h74  7b7 ,withdrawal    
authority ,section #eje7;e7 of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;e77 is amended
 in the first sentence-- 7#a7 by        
striking or 7#e7 and inserting 7#e72 and
  7#b7 by inserting the following3 2 or 
7#f7 that1 in the case of a drug that is
 or contains a controlled substance for 
which a listing in any schedule is in   
effect under the ,controlled ,substances
 ,act or that is permanently scheduled  
pursuant to section #bja of such ,act1  
on the basis of new information before  
him with respect to such drug1 evaluated

 together with the information available
 to him when the application was        
approved1 that the drug is unsafe for   
use due to the risks of abuse or misuse 
after of a material fact4  7c7 ,rule of 
construction ,nothing in the amendments 
made by this section shall be construed 
to limit or narrow1 in any manner1 the  
meaning or application of the provisions
 of paragraphs 7#a71 7#b71 7#c71 7#d71  
7#e71 and 7#g7 of section #eje7;d7 of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7;d77 or       
paragraphs 7#a7 and 7#b7 of section     
#eje7;e7 of such ,act 7#ba ,u4,s4,c4    
#cee7;e774  ,passed the ,house of       
,representatives ,june #ab1             
#bjah4;,clerk4