,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #feji  ,,in ,,the ,,house ,,of  
,,representatives  ,december #i1        
#bjbe,mr4 ,yakym 7for himself and ,mr4  
,carson7 introduced the following bill2 
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to further regulate      
compounding pharmacies and outsourcing  
facilities1 and for other purposes4  #a4
 ,short title ,this ,act may be cited as
 the ,safeguarding ,americans from      
,fraudulent and ,experimental ,drugs    
,act of #bjbe or the ,,safe ,drugs ,act 
of #bjbe4  #b4 ,definitions relating to 
compounding of drug products ,section   
#ejc;,a7b7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cec;a7b77 is amended-- 7#a7 by amending
 paragraph 7#a77;,d7 to read as follows3
  7,d7 does not1 more than #bj times in 
a single month1 compound any drug       
product that is essentially a copy of a 
commercially available drug product4  2 

and  7#b7 by amending paragraph 7#b7 to 
read as follows3  7#b7 ,definitions     
7,a7 ,for purposes of paragraph         
7#a77;,d71 the term essentially a copy  
of a commercially available drug product
 means any drug product-- 7i7 that      
contains any active ingredient found in 
a commercially available drug product2  
and  7ii7 in which there is no change1  
made for an identified individual       
patient1 which produces for that patient
 a significant difference1 as determined
 by the prescribing practitioner1       
between the compounded drug product and 
the comparable commercially available   
drug product4  7,b7 ,for purposes of    
subparagraph 7,a71 the term commercially
 available drug product includes any    
drug product that-- 7i7 is sold in the  
commercial marketplace in the ,united   
,states and manufactured in one or more 
facilities required to comply with      
section #eja7;a77#b77;,b72 and  7ii7 is 
not included in the discontinued section
 of the list of products described in   

section #eje7;j77#g77;,a74  4  #c4      
,reporting requirement ,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 7d7 and 7e7 as subsections  
7e7 and 7f71 respectively2 and  7#b7 by 
inserting after subsection 7c7 the      
following3  7d7 ,reporting requirement  
7#a7 ,in general ,for calendar year     
#bjbe and each calendar year thereafter1
 if a pharmacy1 facility1 or physician  
compounds1 more than #bj times in a     
single month for patients who reside    
outside the ,state in which the         
compounding occurs1 any drug product    
that contains any active ingredient     
found in a commercially available drug  
product 7as defined in subsection       
7b77#b77;,b771 such pharmacy1 facility1 
or physician shall submit a report to   
the ,secretary4  7#b7 ,contents ,each   
report under paragraph 7#a7 shall       
identify-- 7,a7 each type of drug       
product described in paragraph 7#a7 that

 is compounded for a patient described  
in such paragraph2 and  7,b7 for each   
month1 the total number of times each   
such type is so compounded4  7#c7       
,timing ,for any calendar year for which
 paragraph 7#a7 applies1 the pharmacy1  
facility1 or physician shall submit the 
report under such paragraph not later   
than the end of such calendar year4     
7#d7 ,form and manner ,a pharmacy1      
facility1 or physician shall submit each
 report under paragraph 7#a7 in such    
form and manner as the ,secretary may   
prescribe4  7#e7 ,hospital pharmacy     
exclusion ,this subsection does not     
apply to the compounding of any drug    
products for hospital patients by a     
pharmacy located on the premises of the 
hospital4  4  #d4 ,large-scale          
outsourcing facilities  7a7 ,inspections
 ,section #ejc;,b7b7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cec;b7b77 is amended by      
adding at the end the following3  7#f7  
,inspections of large-scale outsourcing 

facilities  7,a7 ,in general ,in the    
case of a large-scale outsourcing       
facility1 the risk-based inspections    
under paragraph 7#d7 shall include-- 7i7
 an inspection prior to such facility   
compounding any drug product for the    
first time2 and  7ii7 the reinspection  
of such facility not less than          
biennially4  7,b7 ,large-scale          
outsourcing facility defined ,for       
purposes of this paragraph1 the term    
large-scale outsourcing facility means  
any outsourcing facility that compounds1
 more than #ajj times in a single       
calendar year1 any drug product4  4  7b7
 ,registration and reporting requirement
 ,section #eaj7;g77#a7 of such ,act 7#ba
 ,u4,s4,c4 #cfj7;g77#a77 is amended by  
inserting before the semicolon at the   
end the following3 1 except that the    
exemption in this paragraph shall not   
apply to any outsourcing facility 7as   
defined in section #ejc;,b7d77#d774  7c7
 ,delayed applicability ,the amendments 
made by subsections 7a7 and 7b7 apply   

beginning #f months after the date of   
enactment of this ,act4  #e4 ,base      
establishment fee ,section              
#gdd,k7c77#a77;,a77i7 of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cgi;j-#fb7;c77#a77;,a77i77 is
 amended by striking #ae1jjj and        
inserting a base amount deemed          
appropriate by the ,secretary to fund   
activities to ensure the safety of      
compounded drug products4