,in the ,senate of the ,united ,states1 
,december #h1 #bjbj4  ,amendment3  ,that
 the bill from the ,house of            
,representatives 7,h4,r4 #effc7 entitled
 ,an ,act to amend the ,federal ,food1  
,drug1 and ,cosmetic ,act to give       
authority to the ,secretary of ,health  
and ,human ,services1 acting through the
 ,commissioner of ,food and ,drugs1 to  
destroy counterfeit devices41 do pass   
with the following ,strike all after the
 enacting clause and insert the         
following3 #a4 ,short title ,this ,act  
may be cited as the ,safeguarding       
,therapeutics ,act4  #b4 ,authority to  
destroy counterfeit devices  7a7 ,in    
general ,section #hja7;a7 of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cha7;a77 is        
amended-- 7#a7 in the fourth sentence1  
by inserting or counterfeit device after
 counterfeit drug2 and  7#b7 by striking
 ,the ,secretary of the ,treasury shall 
cause the destruction of and all that   
follows through liable for costs        

pursuant to subsection 7c74 and         
inserting the following3 ,the ,secretary
 of the ,treasury shall cause the       
destruction of any such article refused 
admission unless such article is        
exported1 under regulations prescribed  
by the ,secretary of the ,treasury1     
within #ij days of the date of notice of
 such refusal or within such additional 
time as may be permitted pursuant to    
such regulations1 except that the       
,secretary of ,health and ,human        
,services may destroy1 without the      
opportunity for export1 any drug or     
device refused admission under this     
section1 if such drug or device is      
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 7#ai ,u4,s4,c4 #adih7;a77#a777 and
 was not brought into compliance as     
described under subsection 7b74 ,the    
,secretary of ,health and ,human        

,services shall issue regulations       
providing for notice and an opportunity 
to appear before the ,secretary of      
,health and ,human ,services and        
introduce testimony1 as described in the
 first sentence of this subsection1 on  
destruction of a drug or device under   
the seventh sentence of this subsection4
 ,the regulations shall provide that    
prior to destruction1 appropriate due   
process is available to the owner or    
consignee seeking to challenge the      
decision to destroy the drug or device4 
,where the ,secretary of ,health and    
,human ,services provides notice and an 
opportunity to appear and introduce     
testimony on the destruction of a drug  
or device1 the ,secretary of ,health and
 ,human ,services shall store and1 as   
applicable1 dispose of the drug or      
device after the issuance of the notice1
 except that the owner and consignee    
shall remain liable for costs pursuant  
to subsection 7c744  7b7 ,definition    
,section #bja7;h7 of the ,federal ,food1

 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cba7;h77 is amended-- 7#a7 by
 redesignating subparagraphs 7#a71 7#b71
 and 7#c7 as clauses 7,a71 7,b71 and    
7,c71 respectively2 and  7#b7 after     
making such redesignations-- 7,a7 by    
striking 7h7 ,the term and inserting    
7h77#a7 ,the term2 and  7,b7 by adding  
at the end the following3  7#b7 ,the    
term counterfeit device means a device  
which1 or the container1 packaging1 or  
labeling of which1 without              
authorization1 bears a trademark1 trade 
name1 or other identifying mark or      
imprint1 or any likeness thereof1 or is 
manufactured using a design1 of a device
 manufacturer1 processor1 packer1 or    
distributor other than the person or    
persons who in fact manufactured1       
processed1 packed1 or distributed such  
device and which thereby falsely        
purports or is represented to be the    
product of1 or to have been packed or   
distributed by1 such other device       
manufacturer1 processor1 packer1 or     

distributor4  4  ,secretary