,i  #aahth ,,congress  #ast ,session    
,h4 ,r4 #afg  ,,in ,,the ,,house ,,of   
,,representatives  ,january #i1         
#bjbc,mr4 ,griffith 7for himself and    
,mr4 ,cuellar7 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 ensure     
patients have access to certain         
urgent-use compounded medications1 and  
for other purposes4  #a4 ,short title   
,this ,act may be cited as the ,patient 
,access to ,urgent-,use ,pharmacy       
,compounding ,act of #bjbc4  #b4        
,urgent-use compounding for             
administration in hospitals or other    
clinical settings ,section #ejc;,a7a7 of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7a77
 is amended--  7#a7 in paragraph 7#a71  
by striking or at the end2  7#b7 in     
paragraph 7#b77;,b77ii77,,ii71 by       
striking the period at the end and      
inserting 2 or2 and  7#c7 by adding at  

the end the following new paragraph3    
7#c7 notwithstanding the requirement in 
the matter preceding paragraph 7#a7 that
 the drug product is compounded for an  
identified individual patient based on a
 valid prescription order or notation   
described in such matter1 is by a       
licensed pharmacist or licensed         
physician and the compounded drug       
product is compounded for distribution  
in limited quantities to a licensed     
prescriber for urgent administration to 
a patient in a hospital or other        
clinical setting1 provided that all of  
the following are met3  7,a7 ,the       
licensed prescriber certifies by        
notation on the order to the compounding
 pharmacist or physician that the       
licensed prescriber has made reasonable 
attempts to obtain1 and has not been    
able to obtain1 to address the urgent   
medical need-- 7i7 a drug product that  
is approved or authorized by the ,food  
and ,drug ,administration with the same 
active ingredient and the same route of 

administration2 or  7ii7 a drug product 
that is compounded by an outsourcing    
facility in accordance with section     
#ejc;,b with the same active ingredient 
and the same route of administration4   
7,b7 ,the compounded drug product is    
labeled with a beyond-use-date in       
accordance with applicable ,united      
,states ,pharmacopeia standards4  7,c7  
,the licensed pharmacist or licensed    
physician marks the packaging of the    
compounded drug product with text-- 7i7 
indicating that the drug product is     
provided to the hospital or other       
clinical setting only for urgent        
administration to a patient2 and  7ii7  
requesting that the hospital or other   
clinical setting provide to the         
compounding pharmacist or physician the 
records that identify the patient or    
patients to whom the drug products were 
administered within-- 7,i7 #g days of   
each such patient receiving such        
medication2 or  7,,ii7 #g days of each  
such patient being discharged4  7,d7    

,upon receipt of records requested      
pursuant to subparagraph 7,c77ii71 the  
licensed pharmacist or licensed         
physician ensures that the patient      
information in such records is linked   
with the respective order4  7,e7 ,the   
licensed pharmacist or licensed         
physician reports adverse events        
associated with the compounded drug     
product as soon as possible but no later
 than #ae days after becoming aware of  
such events to the ,med,watch ,adverse  
,event ,reporting program of the ,food  
and ,drug ,administration 7or any       
successor program74  4  #c4 ,compounding
 for shortages for administration in    
hospitals or other clinical settings    
,paragraph 7#b7 of section #ejc;,a7b7 of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4           
#cec;a7b77#b77 is amended to read as    
follows3  7#b7 ,definition ,for purposes
 of paragraph 7#a77;,d71 the term       
essentially a copy of a commercially    
available drug product does not         

include-- 7,a7 a drug product in which  
there is a 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 and the comparable      
commercially available drug product2 or 
7,b7 a drug product that meets each of  
the following conditions3 7i7 ,at the   
time of compounding1 distribution1 or   
dispensing1 the drug product appears    
on--  7,i7 the drug shortage list in    
effect under section #ejf;,e2 or  7,,ii7
 the drug shortage list maintained by   
the ,american ,society of ,hospital     
,pharmacists4  7ii7 ,if the drug product
 is not compounded for an identified    
individual patient based on a valid     
prescription order or notation1         
notwithstanding such requirement in the 
matter preceding paragraph 7#a7 of      
subsection 7a71 then the drug product-- 
7,i7 is labeled in accordance           
subparagraphs 7,b7 and 7,c7 of          

subsection 7a77#c72 and  7,,ii7 is      
documented by the compounding pharmacist
 or physician in accordance with        
subparagraphs 7,d7 and 7,e7 of          
subsection 7a77#c74  4