,,ii  #aadth ,,congress  #ast ,session  
,s4 #adjf  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #bj1 #bjae
 ,mr4 ,vitter introduced the following  
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act with respect  
to pharmacy compounding4  #a4 ,short    
title  ,this ,act may be cited as the   
,saving ,access to ,compounded          
,medications for ,special ,needs        
,patients ,act4  #b4 ,pharmacy          
compounding ,section #ejc;,a of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cec;a7 is amended--
 7#a7 by redesignating subsections 7b7  
through 7e7 as subsections 7c7 through  
7f71 respectively2  7#b7 by inserting   
after subsection 7a7 the following3  7b7
 ,drug products for distribution to     
practitioners ,sections                 
#eja7;a77#b77;,b71 #ejb7;f77#a71 and    
#eje shall not apply to a drug product  

if the drug product is compounded and   
distributed to a practitioner where1 as 
permitted under ,state law1 the drug    
product is used in the treatment of or  
administered to a patient of the        
practitioner1 and if the compounding is 
by--  7#a7 a licensed pharmacist in a   
,state licensed pharmacy or a ,federal  
facility2 or  7#b7 a licensed physician4
  2  7#c7 in subsection 7c71 as so      
redesignated-- 7,a7 in paragraph 7#a7-- 
7i7 in the matter preceding subparagraph
 7,a71 by striking subsection 7a7 and   
inserting subsection 7a7 or 7b72  7ii7  
in subparagraph 7,a77i77,,iii71 by      
striking subsection 7c7 and inserting   
subsection 7d72  7iii7 in subparagraph  
7,c71 by striking 2 and and inserting 22
  7iv7 in subparagraph 7,d71 by striking
 the period and inserting 2 and2 and    
7v7 by adding at the end the following3 
7,e7 complies with standards contained  
within the ,united ,states              
,pharmacopeial ,convention ,general     
,chapters pertaining to the compounding 

of drug products4  2  7,b7 in paragraph 
7#b71 by striking identified individual 
patient1 which produces for that patient
 and inserting identified individual    
patient for whom the drug product is    
compounded under subsection 7a7 or      
patients of a practitioner to whom the  
drug product is compounded and dispensed
 under subsection 7b71 which produces   
for that patient or patients2  7,c7 in  
paragraph 7#c7-- 7i7 in the matter      
preceding subparagraph 7,a71 by striking
 subsection 7a7 and inserting subsection
 7a7 or 7b72  7ii7 in subparagraph      
7,b7-- 7,i7 by amending clause 7i7 to   
read as follows3  7i7 that has entered  
into a memorandum of understanding with 
the ,secretary that provides for        
appropriate investigation by a ,state   
agency of complaints relating to        
compounded drug products distributed    
outside such ,state2 or  2 and  7,,ii7  
by amending clause 7ii7 to read as      
follows3  7ii7 that has not entered into
 a memorandum of understanding described

 in clause 7i7 and the licensed         
pharmacist1 licensed pharmacy1 or       
licensed physician distributes 7or      
causes to be distributed7 compounded    
drug products out of the ,state in which
 such products are compounded in        
quantities that do not exceed #e percent
 of the total prescription orders       
dispensed or distributed by such        
pharmacy or physician4  2 and  7iii7 in 
the flush text1 by striking ,national   
,association of ,boards of ,pharmacy and
 inserting ,states2 and  7,d7 by adding 
at the end the following3  7#d7         
,limitation on memorandum of            
understanding ,a memorandum of          
understanding entered into under        
paragraph 7#c77;,b77i7 shall not create 
an unfunded mandate on a ,state4  2     
7#d7 in subsection 7d71 as so           
redesignated-- 7,a7 in paragraph 7#a71  
by striking subsections                 
7b77#a77;,a77i77,,iii71 7b77#a77;,c71 or
 7b77#c77;,a7 and inserting subsections 
7c77#a77;,a77i77,,iii71 7c77#a77;,c71 or

 7c77#c77;,a72 and  7,b7 in paragraph   
7#b71 by striking subsection            
7b77#a77;,a77i77,,iii7 and inserting    
subsection 7c77#a77;,a77i77,,iii72 and  
7#e7 by amending subsection 7f71 as so  
redesignated to read as follows3  7f7   
,definitions  7#a7 ,compounding ,as used
 in this section1 the term compounding  
does not include mixing1 reconstituting1
 or other such acts that are performed  
in accordance with directions contained 
in approved labeling provided by the    
product's manufacturer and other        
manufacturer directions consistent with 
that labeling4  7#b7 ,distribute ,for   
purposes of this section1 the term      
distribute does not include the         
dispensing of a compounded drug product 
for an identified individual patient4  4