,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #gjej  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,janu>y #ad1 #bjbf,mr4
 ,sessions 7= himself1 ,mr4 ,k5n$y (    
,utah1 & ,mr4 ,jackson ( ,ill9ois7      
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act ) respect to homeopa?ic
 drug products1 & = o!r purposes4  #a4  
,%ort title2 table ( cont5ts  7a7 ,%ort 
title ,?is ,act may be cit$ z !         
,homeopa?ic ,drug ,product ,safety1     
,quality1 & ,transp>5cy ,act4  7b7      
,table ( cont5ts ,! table ( cont5ts =   
?is ,act is z foll[s3 ,sec4 #a4 ,%ort   
title2 table ( cont5ts4,sec4 #b4        
,purpose2 s5se ( ,congress4,sec4 #c4    
,def9itions4,sec4 #d4 ,safety1 quality1 
& transp>5cy requirem5ts = homeopa?ic   
drug products4,sec4 #e4 ,con=m+         
am5dm5ts4,sec4 #f4 ,)drawal (           
guidance4,sec4 #g4 ,sev]ability4  #b4   
,purpose2 s5se ( ,congress  7a7 ,purpose
 ,! purpose ( ?is ,act is to address    

consum] & practition] ne$s = cont9u$    
access to homeopa?ic drug products t    
meet requirem5ts = safety1 quality1 &   
transp>5cy4  7b7 ,s5se ( ,congress ,x is
 ! s5se ( ,congress t-- 7#a7 homeopa?ic 
m$ic9es are important to millions (     
,am]ican consum]s1 & cont9u$ consum]    
access to safe homeopa?ic products is   
be/ ensur$ by enact+ a di/9ct /atutory  
pa?way = ! regulation ( homeopa?ic drug 
products2 &  7#b7 :ile ! ,f$]al         
,gov]nm5t %\ld cont9ue to take          
appropriate action aga9/ products t are 
adult]at$ or misbr&$1 ,f$]al ag5cies    
%\ld n impose regulatory b>ri]s t       
unreasonably limit or prev5t consum] &  
heal? c>e provid] access to safe        
products & accurate in=mation4  #c4     
,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 ins]t+
 be=e ! p]iod at ! end ! foll[+3 1 & t a
 homeopa?ic drug product is n a new     
animal drug2 &  7#c7 by add+ at ! end ! 
foll[+3  7tt7 ,! 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  7uu7 ,!  
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     
homeopa?ic safety & quality /&>ds       
describ$ 9-- 7,a7 ! ,homeopa?ic         
,ph>macopoeia ( ! ,unit$ ,/ates or any  
o!r (ficially recogniz$ homeopa?ic      
ph>macopoeia2 or  7,b7 any accr$it$     
volunt>y cons5sus /&>d = homeopa?ic drug
 products1 z det]m9$ by ! ,secret>y 9   
compliance ) section #ab7;d7 ( !        
,national ,te*nology ,transf] &         
,advancem5t ,act ( #aiie4  4  #d4       
,safety1 quality1 & transp>5cy          

requirem5ts = homeopa?ic drug products  
,sub*apt] ,a ( *apt] ,v ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea et seq47 is am5d$ by     
ins]t+ aft] section #ejc;,d 7#ba        
,u4,s4,c4 #cec;d7 ! foll[+3  #ejc;,e4   
,homeopa?ic drug products  7a7          
,provisions applicable to homeopa?ic    
drug products  7#a7 ,*apt] ,v provisions
 ,no section ( ?is *apt] %all apply to  
homeopa?ic drug products except ?is     
section & sections #eja1 #ejb1 & #eaj4  
7#b7 ,requirem5ts = all provisions ,no  
provision ( law1 a regulation1 or a     
guidance docum5t 7includ+ sections #eja1
 #ejb1 & #eaj & any applicable          
provisions ( ?is ,act outside ( ?is     
*apt]7 %all apply to homeopa?ic drug    
products unless su* provision-- 7,a7    
does n conflict ) ?is section2 &  7,b7  
does n impose /&>ds t are 9 conflict )  
/&>ds 9 ! ,homeopa?ic ,ph>macopoeia ( ! 
,unit$ ,/ates or 9 an accr$it$ volunt>y 
cons5sus /&>d = homeopa?ic drug         
products1 z det]m9$ by ! ,secret>y 9    

compliance ) section #ab7;d7 ( !        
,national ,te*nology ,transf] &         
,advancem5t ,act ( #aiie4  7b7          
,adult]ation2 good manufactur+ practice 
/&>ds  7#a7 ,adult]ation ,a homeopa?ic  
drug product %all be deem$ to be        
adult]at$ if x does n comply )-- 7,a7 ! 
safety & quality /&>ds & manufactur+    
practices describ$ 9-- 7i7 ! ,homeopa?ic
 ,ph>macopoeia ( ! ,unit$ ,/ates or any 
o!r (ficially recogniz$ homeopa?ic      
ph>macopoeia2 or  7ii7 an accr$it$      
volunt>y cons5sus /&>d = homeopa?ic drug
 products1 z det]m9$ by ! ,secret>y 9   
compliance ) section #ab7;d7 ( !        
,national ,te*nology ,transf] &         
,advancem5t ,act ( #aiie2 or  7,b7 9 !  
case t no /&>d or manufactur+ practice  
describ$ 9 subp>agraph 7,a7 applies to  
su* homeopa?ic drug product1 !          
regulations describ$ 9 p>agraph 7#b74   
7#b7 ,alt]native regulations ,!         
regulations describ$ 9 ?is p>agraph are 
! foll[+3 7,a7 ,good manufactur+        
practice regulations promulgat$ "u      

section #eja7;a77#b7 or relat$ guidance 
docum5ts1 provid$ t su* regulations or  
relat$ guidance docum5ts d n conflict ) 
any o!r provision ( ?is section4  7,b7  
,9 ! case t no regulation describ$ 9    
subp>agraph 7,a7 applies to ! homeopa?ic
 drug product1 a new good manufactur+   
practice regulation1 :i* %all be        
promulgat$ by ! ,secret>y aft] notice & 
opportunity = public comm5t pursuant to 
*apt] #e ( title #e1 ,unit$ ,/ates      
,code-- 7i7 t does n conflict ) any o!r 
provision ( ?is section2  7ii7 t is     
specific to & appropriate = homeopa?ic  
drug products2 &  7iii7 ) respect to :i*
 ! ,secret>y has reque/$ & receiv$ a    
favorable recomm5dation f ! ,homeopa?ic 
,drug ,product ,advisory ,committee4    
7#c7 ,petition = exemption1 v>iance1 or 
alt]native /&>d or practice  7,a7       
,petition ,a manufactur] ( a homeopa?ic 
drug product subject to a good          
manufactur+ practice regulation may     
submit to ! ,secret>y a petition = an   
exemption1 v>iance1 or alt]native /&>d  

or practice ) respect to su* product4 ,!
 ,secret>y %all ref] su* petition to !  
,homeopa?ic ,drug ,product ,advisory    
,committee1 :i* %all report its         
recomm5dation to ! ,secret>y n lat] ?an 
#fj days aft] receiv+ su* petition4     
7,b7 ,deadl9e = approval ,! ,secret>y   
%all make a decision on a petition      
submitt$ "u subp>agraph 7,a7 n lat] ?an 
#ahj days aft] ! submission ( !         
petition4 ,if ! ,secret>y fails to make 
a decision on su* a petition )9 su*     
#ahj-;day p]iod1 ! petition %all be     
deem$ approv$ & ! propos$ exemption1    
v>iance1 or alt]native /&>d or practice 
e/abli%$4  7,c7 ,/&>d = approval ,!     
,secret>y may approve a petition        
submitt$ "u subp>agraph 7,a7 & e/abli% !
 propos$ exemption1 v>iance1 or         
alt]native /&>d or practice ) respect to
 ! homeopa?ic drug product only if su*  
exemption1 v>iance1 or alt]native /&>d  
or practice does n affect ! safety ( !  
homeopa?ic drug product4  7,d7 ,judicial
 review ,= ! purposes ( *apt] #g ( title

 #e1 ,unit$ ,/ates ,code1 a decision ( !
 ,secret>y on a petition submitt$ "u    
subp>agraph 7,a7 %all be consid]$ f9al  
ag5cy action4  7#d7 ,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$iate te/+ = c]ta9 />t+      
mat]ials  7i7 ,9 g5]al ,! manufactur] ( 
a homeopa?ic drug product made f a />t+ 
mat]ial conta9+ a sub/ance :i* may      
pres5t a sub/antial risk ( illness or   
injury 9 its undilut$ =m %all ensure &  
docum5t t ! am\nt ( 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>y "u 

?is subp>agraph4  7ii7 ,safe level def9$
 ,9 ?is subp>agraph1 ! t]m safe level   
means-- 7,i7 a level set by nationally  
recogniz$ /&>ds = safety1 includ+ !     
,homeopa?ic ,ph>macopoeia ( ! ,unit$    
,/ates or an accr$it$ volunt>y cons5sus 
/&>d = homeopa?ic drug products1 z      
det]m9$ by ! ,secret>y 9 compliance )   
section #ab7;d7 ( ! ,national ,te*nology
 ,transf] & ,advancem5t ,act ( #aiie2 or
  7,,ii7 9 ! abs5ce ( a /&>d describ$ 9 
subclause 7,i71 a level bel[ an         
analytically detectable pres5ce4  7iii7 
,publication ( safe levels ,! ,secret>y 
may issue an ord]1 notice ( :i* %all be 
publi%$ 9 ! ,f$]al ,regi/]1 e/abli%+ a  
safe level1 bas$ on appropriate         
sci5tific & te*nical data1 = a sub/ance 
"u clause 7i74 ,su* notice %all         
include-- 7,i7 a /atem5t ( ! basis = !  
,secret>y's f9d+ t !re is a reasonable  
probability t ! sub/ance may pres5t a   
sub/antial risk ( illness or injury 9   
its undilut$ =m2  7,,ii7 a /atem5t ( !  
basis = ! e/abli%m5t ( ! safe level1    

includ+ any available me?ods to e/abli% 
su* level2 &  7,,iii7 a reque/ = public 
comm5ts4  7c7 ,misbr&+  7#a7 ,9 g5]al ,a
 drug %all be deem$ to be misbr&$ if--  
7,a7 x 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
 det]m9$ by ! ,secret>y2 or  7,b7 x is a
 homeopa?ic drug product1 & its label+  
does n comply ) ! requirem5ts describ$ 9
 p>agraph 7#b74  7#b7 ,label+           
requirem5ts ,) respect to ! label+ ( a  
homeopa?ic drug product1 ! requirem5ts  
describ$ 9 ?is p>agraph are !           
requirem5ts = ! label+ ( a drug "u ?is  
,act1 subject to ! foll[+3 7,a7 ,!      
label+ ne$ n adh]e to any requirem5t t  
does n apply to homeopa?ic drug products
 "u subsection 7a74  7,b7 ,! dosage     
units ( ! homeopa?ic +r$i5ts %all be    
express$ z att5uations p>ticul> to      
homeopa?ic +r$i5ts 7su* z #cx or #f;c74 
7,c7 ,if ! homeopa?ic drug product is n 
int5d$ = retail sale1 ! label ( su*     
product ne$ n conta9 a purpose or       

indication = use4  7,d7 ,if ! homeopa?ic
 drug product is int5d$ = retail sale1 !
 label ( su* product %all conta9-- 7i7  
#a or m purposes or indications = use = 
self-limit+ conditions t are support$   
by-- 7,i7 ! ,homeopa?ic ,ph>macopoeia ( 
! ,unit$ ,/ates1 an (ficial ph>macopeia 
( ano!r c\ntry :]e ! practice (         
homeopa?y is lic5s$ or c]tifi$1 or an   
accr$it$ volunt>y cons5sus /&>d =       
homeopa?ic drug products1 z det]m9$ by !
 ,secret>y 9 compliance ) section       
#ab7;d7 ( ! ,national ,te*nology        
,transf] & ,advancem5t ,act ( #aiie2    
7,,ii7 a traditional homeopa?ic ref]5ce1
 includ+ a homeopa?ic ,mat]ia ,m$ica 9  
g5]al use by lic5s$ m$ical practition]s 
:o practice homeopa?y or c]tifi$        
homeopa?s 9 ! ,unit$ ,/ates or ano!r    
c\ntry2  7,,iii7 a pe]-review$ m$ical   
j\rnal1 includ+ any homeopa?ic m$ical   
j\rnal2  7,,iv7 citation to sci5tific   
evid5ce1 includ+ cl9ical data or trials2
  7,v7 b5eficial cl9ical usage docum5t$ 
by cl9ical reports f national or        

int]national organizations1             
pr(essionally recogniz$ publications (  
cl9ical indications & contra9dications1 
national or int]national in/ructional   
c\rses provid+ tra9+ 9 ! use (          
homeopa?ic drug products1 or pr(essional
 pe] review pres5tations ( physicians'  
usage results ) homeopa?ic drug products
 at local1 c\nty1 ,/ate1 national1 or   
int]national meet+s2 or  7,,vi7 quality 
real-_w data t provides suffici5t       
evid5ce to support su* purposes or      
indications = use2 &  7ii7 adjac5t to   
su* purposes or indications = use1 !    
foll[+ /atem5t3 ,^! indications h n be5 
evaluat$ by ! ,food & ,drug             
,adm9i/ration4 ,?is product is int5d$ = 
traditional homeopa?ic uses44  7,e7 ,!  
label+ %all n be consid]$ false or      
mislead+ = ! purposes ( section         
#ejb7;a77#a7 due to ! inclusion ( a     
purpose or indication = use t is        
support$ by any s\rce describ$ 9        
subclauses 7,i7 ?r\gh 7,,vi7 (          
subp>agraph 7,d77i74  7,f7 7i7 ,subject 

to clause 7ii71 ! label %all describe-- 
7,i7 ! s\rce reli$ ^u = ea* purpose or  
indication = use "u subp>agraph 7,d77i72
 &  7,,ii7 if applicable1 ! "n & place (
 bus9ess ( any p>5t1 subsidi>y1 or      
affiliate company ( ! manufactur] ( !   
homeopa?ic drug product1 if "u common   
own]%ip or control4  7ii7 ,if ! label   
has insuffici5t space = ! in=mation     
requir$ by clause 7i71 9 lieu ( su*     
in=mation ! label may conta9 a quick    
response code 7commonly kn[n z a ,,qr   
code7 or simil> me*anism t l9ks to a    
publicly accessible website conta9+ su* 
in=mation4  7#c7 ,application ( o!r     
misbr&+-relat$ provisions  7,a7 ,,ftc   
,act ,label+ or m>ket+ claims associat$ 
) a homeopa?ic drug product t are 9     
compliance ) ?is subsection 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$]al ,trade ,commission   
,act4  7,b7 ,o!r provisions ( ,f$]al or 
,/ate law ,if a homeopa?ic drug         

product's label1 label+1 adv]tis+1 &    
m>ket+ mat]ials are 9 compliance ) ?is  
subsection1 no o!r sub/antiation        
requirem5t 9 ,f$]al or ,/ate law %all   
apply to su* product4  7,c7 ,private    
rights ( action ,no private "r ( action 
= false or deceptive adv]tis+ may be    
pr$icat$ on ! lack ( cl9ical trials to  
sub/antiate indications = a homeopa?ic  
drug product4  7d7 ,regi/ration & li/+  
,= purposes ( drug e/abli%m5t           
regi/ration & drug li/+ "u section #eaj1
 ! ,secret>y %all-- 7#a7 designate a    
homeopa?ic drug product e/abli%m5t z a  
homeopa?ic e/abli%m5t2 &  7#b7 li/ a    
homeopa?ic drug product z homeopa?ic1 ) 
no o!r designation4  7e7 ,no prem>ket   
approval ,! ,secret>y may n require     
prem>ket approval ( a homeopa?ic drug   
product4  7f7 ,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 advise ! ,secret>y on ! regulation (

 homeopa?ic drug products4  7#b7        
,memb]%ip  7,a7 ,9 g5]al ,subject to    
subp>agraph 7,b71 ! ,committee %all be  
compos$ ( #aj memb]s1 to be appo9t$ by !
 ,secret>y1 z foll[s3 7i7 #a            
repres5tative f an organization (       
homeopa?ic product consum]s t has be5   
op]at+ = a m9imum ( #c cont9u\s ye>s ) a
 m9imum ( #aj1jjj memb]s1 :o %all s]ve z
 ! ,*air ( ! ,committee4  7ii7 #a       
repres5tative f a dome/ic homeopa?ic    
drug manufactur] t produces at lea/ #ej 
di/9ct homeopa?ic drug products & has no
 few] ?an #ej employees4  7iii7 #a      
repres5tative f a dome/ic homeopa?ic    
drug manufactur] t produces at lea/ #ej 
di/9ct homeopa?ic drug products & has no
 m ?an #ej employees4  7iv7 #a          
repres5tative f ! ,homeopa?ic           
,ph>macopoeia ,conv5tion ( ! ,unit$     
,/ates4  7v7 #a repres5tative f an      
accr$it$ volunt>y cons5sus /&>ds body = 
homeopa?ic drug products t has be5      
op]at+ = a m9imum ( #c cont9u\s ye>s4   
7vi7 #a lic5s$ m$ical doctor 7,m4,d47 or

 doctor ( o/eopa?y 7,d4,o47 :o holds a  
,diplomate1 ,am]ican ,bo>d ( ,homeopa?ic
 ,m$ic9e 7,,dabhm7 or ,diplomate1       
,homeo!rapeutics 7,d,ht7 & :o ma9ta9s a 
homeopa?ic practice t has be5 9 op]ation
 = a m9imum ( #c cont9u\s ye>s4  7vii7  
#a lic5s$ naturopa?ic doctor 7,n4,d47 :o
 holds a ,diplomate1 ,am]ican ,bo>d (   
,homeopa?ic ,m$ic9e 7,,dabhm7 or        
,diplomate1 ,homeopa?ic ,academy (      
,naturopa?ic ,physicians 7,,dhanp7 & :o 
ma9ta9s a homeopa?ic practice t has be5 
9 op]ation = a m9imum ( #c cont9u\s     
ye>s4  7viii7 #a lic5s$ ph>maci/ or     
*emi/ actively engag$ 9 ! prep>ation (  
homeopa?ic drug products = a m9imum ( #c
 cont9u\s ye>s4  7ix7 #a lic5s$         
vet]9>ian c]tifi$ by ! ,academy (       
,vet]9>y ,homeopa?y or accr$it$ by a    
recogniz$ homeopa?y in/itution :o       
ma9ta9s a practice t has be5 9 op]ation 
= a m9imum ( #c cont9u\s ye>s4  7x7 ,!  
,commission] ( ,food & ,drugs4  7,b7    
,alt]native memb]s ,if ! ,secret>y is   
unable to f9d a suitable individual to  

s]ve 9 ! position ( a repres5tative     
describ$ 9 clauses 7i7 ?r\gh 7ix71 ! o!r
 memb]s ( ! ,committee may appo9t to su*
 position1 by majority vote1 su* o!r    
exp]t 9 ! field ( homeopa?ic drug       
products z ! ,committee det]m9es        
appropriate4  7,c7 ,balance ( memb]%ip  
,9 mak+ appo9tm5ts "u subp>agraph 7,a71 
! ,secret>y %all ensure t ! memb]%ip ( !
 ,committee reflects a prop] balance (  
p]spectives f ! homeopa?ic practition]1 
manufactur]1 & consum] communities4     
7,d7 ,no comp5sation ,! memb]s ( !      
,committee %all s]ve )\t comp5sation4   
7#c7 ,frequ5cy ( sessions ,! ,secret>y  
%all call ! ,committee into session at  
su* times & 9 su* places z ! ,secret>y  
det]m9es appropriate1 b 9 no case less  
frequ5tly ?an once e #c mon?s4  7#d7    
,inve/igations ,! ,committee may        
inve/igate any report ( a homeopa?ic    
drug product to ! ,,fda ,adv]se ,ev5t   
,report+ ,sy/em to assi/ 9 po/-m>ket    
surveillance4  7#e7 ,t]m9ation ,section 
#ajac ( *apt] #e1 ,unit$ ,/ates ,code   

7relat+ to t]m9ation ( advisory         
committees71 %all n apply to !          
,committee4  7g7 ,inspectors ,all ,f$]al
 inspectors ^: duties or au?orities     
ext5d to homeopa?ic drug products %all  
be famili> ) ! requirem5ts ( ?is        
section1 includ+ ! safety & quality     
manufactur+ /&>ds 9 ! ,homeopa?ic       
,ph>macopoeia ( ! ,unit$ ,/ates or an   
accr$it$ volunt>y cons5sus /&>d =       
homeopa?ic drug products4  7h7          
,non-,preemption ( ,/ate law on practice
 ( homeopa?y ,no?+ 9 ?is section %all be
 con/ru$ to preempt1 limit1 or int]f]e )
 ,/ate jurisdiction conc]n+ ! practice (
 homeopa?y & relat$ activities )9 !     
scope ( ! heal? c>e pr(essional-pati5t  
relation%ip4  7i7 ,burd5 ( pro( ,!      
,unit$ ,/ates %all be> ! burd5 ( pro( to
 e/abli% a violation ( ?is section4 ,any
 ,f$]al c\rt ) jurisdiction %all decide 
any matt] "u ?is section on a de novo   
basis4  4  #e4 ,con=m+ am5dm5ts  7a7    
,ph>maceutical ,di/ribution ,supply ,*a9
 ,section #eha7ac7 ( ! ,f$]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  7b7 ,s]i\s      
adv]se ev5t report+ = nonprescription   
drugs ,section #gfj7;a77#b7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;aa7a77#b77 is am5d$ to   
read z foll[s3  7#b7 ,nonprescription   
drug ,! t]m nonprescription drug-- 7,a7 
means a drug t is-- 7i7 n subject to    
section #ejc7;b72 &  7ii7 n subject to  
approval 9 an application submitt$ "u   
section #eje2 &  7,b7 includes a        
homeopa?ic drug product4  4  7c7        
,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  #f4 ,)drawal

 ( guidance ,! guidance ( ! ,food &     
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