,,ii  #aafth ,,congress  #b;d ,session  
,s4 #dbbe  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #bj1     
#bjbj,mr4 ,enzi 7for himself and ,ms4   
,hassan7 introduced the following bill2 
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
establish authority to destroy          
counterfeit devices offered for import1 
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,safeguarding ,therapeutics ,act of     
#bjbj4  #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 mark1        
imprint1 or symbol1 or any likeness     
thereof1 or is manufactured using a     
design1 of a device manufacturer1       
packer1 or distributor other than the   
person or persons who in fact           
manufactured1 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 packer1 or distributor4   
7#c7 ,for purposes of subparagraph      
7#b7-- 7,a7 the term manufactured refers

 to any of the following activities3    
manufacture1 preparation1 propagation1  
compounding1 assembly1 or processing2   
and  7,b7 the term manufacturer means a 
person who is engaged in any of the     
activities listed in clause 7,a74  4