,,ii  #aai? ,,congress  #b;d ,session   
,s4 #dfib  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #d1 #bjbf,mr4    
,tub]ville 7= himself & ,mr4 ,lee7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to    
homeopa?ic drug products1 & = o!r       
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,homeopa?ic ,drug ,product 
,safety1 ,quality1 & ,transp>5cy ,act4  
#b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7
 ,homeopa?ic drug products h a long     
hi/ory ( use 9 ! ,unit$ ,/ates & are    
prep>$ accord+ to me?ods diff]5t f o!r  
drugs regulat$ "u ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et
 seq474  7#b7 ,f$]al regulatory ov]sight
 ( homeopa?ic drug products has be5     
implem5t$ ?r\gh me*anisms o!r ?an       
prem>ket approval1 reflect+ ! di/9ct    
*>act]i/ics1 me?ods ( prep>ation1 risk  
pr(ile1 & patt]ns ( use ( su* products4 

7#c7 ,a cle> /atutory framework consi/5t
 ) ! hi/orical regulatory treatm5t (    
homeopa?ic drug products w promote      
safety1 quality1 & access1 ensure       
consi/5t regulation1 & r$uce unc]ta9ty4 
#c4 ,regulation ( homeopa?ic drug       
products  7a7 ,def9itions ,section #bja 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cba7 is am5d$--    
7#a7 9 p>agraph 7p71 by /rik+ except a  
new animal drug or an animal fe$ be>+ or
 conta9+ a new animal drug ea* place x  
appe>s & ins]t+ except a new animal     
drug1 an animal fe$ be>+ or conta9+ a   
new animal drug1 or a homeopa?ic drug   
product2  7#b7 9 p>agraph 7v71 by add+  
at ! end ! foll[+3 ,a homeopa?ic drug   
product is n a new animal drug42 &  7#c7
 by add+ at ! end ! foll[+3  7tt7 7#a7  
,! t]m homeopa?ic drug product means a  
drug t-- 7,a7 conta9s #a or m homeopa?ic
 +r$i5ts2 &  7,b7 conta9s no o!r active 
+r$i5t4  7#b7 ,! t]m homeopa?ic +r$i5t  
means an +r$i5t-- 7,a7 li/$ 9 !         
,homeopa?ic ,ph>macopoeia ( ! ,unit$    

,/ates or a ,/ate homeopa?ic =mul>y2 or 
7,b7 prep>$ pursuant to-- 7i7 homeopa?ic
 manufactur+ me?ods & safety & quality  
/&>ds describ$ 9 ! ,homeopa?ic          
,ph>macopoeia ( ! ,unit$ ,/ates or any  
o!r (ficially recogniz$ homeopa?ic      
ph>macopoeia2 &  7ii7 o!r /&>ds         
recogniz$ by ! ,secret>y4  4  7b7       
,safety1 quality1 & label+ requirem5ts =
 homeopa?ic drug products  7#a7 ,9 g5]al
 ,sub*apt] ,a ( *apt] ,v ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act is am5d$ 
by ins]t+ aft] section #ejc;,d 7#ba     
,u4,s4,c4 #cec;d7 ! foll[+3  #ejc;,e4   
,homeopa?ic drug products  7a7 ,9 g5]al 
,homeopa?ic drug products con/itute a   
di/9ct category ( drugs & %all be       
regulat$ by ! ,secret>y 9 a mann] t is  
appropriate to _! *>act]i/ics1 me?ods ( 
prep>ation1 di/9ct risk pr(ile1 &       
patt]ns ( use4  7b7 ,provisions         
applicable to homeopa?ic drug products  
,! only sections ( ?is *apt] t %all     
apply to homeopa?ic drug products are   
?is section & sections #eja1 #ejb1 &    

#eaj4 ,homeopa?ic drug products %all n  
be subject to section #eje & %all n be  
requir$ to be ! subject ( an approv$    
application "u su* section4  7c7 ,safety
 & quality /&>ds ,! ,secret>y %all      
regulate homeopa?ic drug products us+   
/&>ds appropriate to su* products1 tak+ 
into acc\nt ! ,homeopa?ic ,ph>macopoeia 
( ! ,unit$ ,/ates & o!r /&>ds recogniz$ 
by ! ,secret>y4  7d7 ,f9al rule e/abli%+
 curr5t good manufactur+ practices &    
label+ requirem5ts  7#a7 ,9 g5]al ,n    
lat] ?an #c ye>s aft] ! date ( enactm5t 
( ?is section1 ! ,secret>y %all issue a 
f9al rule t e/abli%es curr5t good       
manufactur+ practices & label+          
requirem5ts = homeopa?ic drug products4 
7#b7 ,requirem5t ,9 e/abli%+ curr5t good
 manufactur+ practices & label+         
requirem5ts pursuant to p>agraph 7#a71 !
 ,secret>y %all ensure t su*            
requirem5ts-- 7,a7 are appropriate2     
7,b7 d n conflict ) /&>ds e/abli%$ "u   
subsection 7c72 &  7,c7 d n impose /&>ds
 = :i* !re are no curr5t & g5]ally      

available analytical me?odologies =     
homeopa?ic drug products4  7e7 ,f9al &  
int]m$iate product te/+  7#a7 ,f9al     
product te/+ ,a f9i%$ homeopa?ic drug   
product %all be exempt f ! requirem5t = 
a laboratory det]m9ation ( id5tity &    
/r5g? ( ea* active +r$i5t describ$ 9    
section #baa4afe7;a7 ( title #ba1 ,code 
( ,f$]al ,regulations 7or any successor 
regulation71 b %all cont9ue to be       
requir$ to meet o!r f9al specifications1
 su* z te/+ = contam9ants & defects ( ! 
f9i%$ product1 consi/5t ) ?is section4  
7#b7 ,int]m$iate te/+ = c]ta9 />t+      
mat]ials  7,a7 ,9 g5]al ,! manufactur] (
 a homeopa?ic drug product made f a />t+
 mat]ial conta9+ a sub/ance :i* may     
pres5t a sub/antial risk ( illness or   
injury 9 its undilut$ =m %all ensure &  
docum5t t ! quantity ( su* sub/ance 9 an
 int]m$iate level prep>ation us$ to make
 all fur!r att5uations does n exce$ a   
safe level1 z det]m9$ by ! ,secret>y4   
7,b7 ,safe level def9$ ,9 ?is p>agraph1 
! t]m safe level means-- 7i7 a level set

 by nationally recogniz$ /&>ds = safety1
 su* z ! ,homeopa?ic ,ph>macopoeia ( !  
,unit$ ,/ates or an accr$it$ volunt>y   
cons5sus /&>d = homeopa?ic drug         
products2 or  7ii7 9 ! abs5ce ( a /&>d  
describ$ 9 clause 7i71 a level bel[ an  
analytically detectable pres5ce4  7f7   
,label+2 int5d$ use2 claims  7#a7       
,label+ requirem5ts ,homeopa?ic drug    
products %all comply ) label+           
requirem5ts "u ?is ,act1 except t dosage
 units may be express$ 9 homeopa?ic     
att5uations & sub/antiation may include 
traditional homeopa?ic evid5ce4  7#b7   
,int5d$ use  7,a7 ,9 g5]al ,homeopa?ic  
drug products int5d$ = retail sale %all 
conta9-- 7i7 #a or m int5d$ uses = #a or
 m self-limit+ conditions2 &  7ii7 !    
foll[+ /atem5t3 ,^! int5d$ uses h n be5 
evaluat$ by ! ,food & ,drug             
,adm9i/ration4 ,?is product is int5d$ = 
traditional homeopa?ic uses44  7,b7     
,exception ,a homeopa?ic drug product n 
int5d$ = retail sale %all n be requir$  
to conta9 #a or m int5d$ uses4  7#c7    

,claims ,any claim made ) respect to a  
homeopa?ic drug product-- 7,a7 %all be  
support$ by compet5t & reliable evid5ce 
appropriate to ! nature & risk pr(ile ( 
! homeopa?ic drug product1 includ+      
traditional homeopa?ic pr9ciples1       
ph>macopoeial /&>ds1 & real-_w evid5ce2 
&  7,b7 t relates to a specific         
condition %all be prec$$ by ! foll[+3   
,traditionally us$ =4  7#d7 ,effect ,a  
homeopa?ic drug product t conta9s an    
int5d$ use1 or = :i* a claim is made1 t 
is 9 compliance ) ?is ,act may n be     
consid]$ a false adv]tisem5t or an      
unfair or deceptive act or practice 9 or
 affect+ comm]ce = purposes ( section #e
 or #ab ( ! ,f$]al ,trade ,commission   
,act4  7g7 ,homeopa?ic ,drug ,product   
,advisory ,committee  7#a7 ,e/abli%m5t  
,! ,secret>y %all e/abli% a ,homeopa?ic 
,drug ,product ,advisory ,committee 79  
?is subsection ref]r$ to z ! ,committee7
 to provide advice & recomm5dations     
reg>d+ ! regulation ( homeopa?ic drug   
products4  7#b7 ,memb]%ip ,9 appo9t+    

memb]s ( ! ,committee1 ! ,secret>y %all 
ensure t ! memb]%ip ( ! ,committee      
reflects a prop] balance ( p]spectives f
 ! homeopa?ic practition]1 manufactur]1 
education1 & consum] communities1       
includ+ l>ge & small dome/ic            
manufactur]s1 lic5s$ & c]tifi$ heal? c>e
 practition]s ) n less ?an #c ye>s (    
active homeopa?ic practices &           
repres5tatives ( homeopa?ic /&>ds &     
consum] organizations4  7#c7 ,duties ,) 
respect to ! regulation ( homeopa?ic    
drug products "u ?is ,act1 !            
,committee-- 7,a7 %all-- 7i7 provide    
recomm5dations on safety1 quality1 &    
label+ /&>ds2  7ii7 advise on           
appropriate regulatory approa*es2  7iii7
 review guidance & rulemak+2 &  7iv7    
evaluate relevant sci5tific1            
traditional1 & real-_w evid5ce2 &  7,b7 
may inve/igate any report ( a homeopa?ic
 drug product to ! ,food & ,drug        
,adm9i/ration ,adv]se ,ev5t ,monitor+   
,sy/em to assi/ 9 po/m>ket surveillance4
  7#d7 ,trigg]$ consultation ,!         

,secret>y %all consult ) ! ,committee   
prior-- 7,a7 to issu+ or revis+ guidance
 reg>d+ homeopa?ic drug products2  7,b7 
to initiat+ or f9aliz+ rulemak+ reg>d+  
homeopa?ic drug products2  7,c7 to      
adopt+ or revis+ good manufactur+       
practice requirem5ts applicable to      
homeopa?ic drug products2 or  7,d7 to   
und]tak+ any en=cem5t initiative ( g5]al
 applicability ) respect to homeopa?ic  
drug products4  7#e7 ,adm9i/rative      
record ,! ,secret>y %all include 9 !    
adm9i/rative record a writt5 response to
 significant recomm5dations ( !         
,committee4  7#f7 ,limitation ,no?+ 9   
?is subsection %all require ! ,secret>y 
to foll[ a recomm5dation ( ! ,committee4
  7#g7 ,t]m9ation ,not)/&+ section #ajac
 ( title #e1 ,unit$ ,/ates ,code1 !     
,committee %all t]m9ate on ! date t is  
#g ye>s aft] ! date on :i* ! ,committee 
is e/abli%$4  4  7#b7 ,misbr&+  7,a7    
,diet>y supplem5ts ,section #djc ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cdc7 is am5d$ by add+ at

 ! end ! foll[+3  7z7 ,if x is a diet>y 
supplem5t & its label+ be>s ! t]m       
homeopa?ic1 homeopa?y1 homeopa?1 or su* 
simil> t]m z is det]m9$ by ! ,secret>y4 
4  7,b7 ,drugs ,section #ejb ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #ceb7 is am5d$ by add+ at !   
end ! foll[+3  7hh7 ,if x is a drug t is
 n a homeopa?ic drug product1 & its     
label+ be>s ! t]m homeopa?ic1 homeopa?y1
 homeopa?1 or su* simil> t]m z is       
det]m9$ by ! ,secret>y4  4  7,c7        
,cosmetics ,section #fjb ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfb7 is am5d$ by add+ at !   
end ! foll[+3  7g7 ,if x is a cosmetic &
 its label+ be>s ! t]m homeopa?ic1      
homeopa?y1 homeopa?1 or su* simil> t]m z
 is det]m9$ by ! ,secret>y4  4  7c7     
,con=m+ am5dm5ts  7#a7 ,ph>maceutical   
di/ribution supply *a9 ,section #eha7ac7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj;eee7#ac77 is   
am5d$ by /rik+ homeopa?ic drugs m>ket$ 9
 accordance ) applicable guidance "u ?is

 ,act & ins]t+ homeopa?ic drug products 
m>ket$ 9 accordance ) ?is ,act4  7#b7   
,s]i\s adv]se ev5t report+ ,section #gfj
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cgi;aa7 is am5d$-- 
7,a7 9 ! section head+1 by ins]t+ &     
homeopa?ic drug products aft]           
nonprescription drugs2  7,b7 by ins]t+  
or homeopa?ic drug product aft]         
nonprescription drug ea* place x appe>s 
7o!r ?an 9 subsection 7a77#b772 &  7,c7 
by ins]t+ or homeopa?ic drug products   
aft] nonprescription drugs ea* place x  
appe>s4  7#c7 ,exemption f regulation ( 
biological products ,section            
#cea7;i77#a7 ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7;i77#a77 is    
am5d$ by add+ at ! end ! foll[+3 ,su*   
t]m does n include a homeopa?ic drug    
product 7z def9$ 9 section #bja ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act744
  7d7 ,)drawal ( guidance ,! guidance ( 
! ,food & ,drug ,adm9i/ration entitl$   
,homeopa?ic ,drug ,products2 ,guidance =
 ,,fda ,/aff & ,indu/ry 7#hg ,f$4 ,reg4 

#gejed 7,decemb] #g1 #bjbb77 %all h no  
=ce or effect4