Ra 3720- Safety and Purity of Foods, And Cosmetics

7/25/2019 Ra 3720- Safety and Purity of Foods, And Cosmetics

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REPUBLIC ACT NO. 3720

AN ACT TO ENSURE T/E SAFET AND

PURIT OF FOODS, AND COSETICS,

AND T/E PURIT, SAFET, EFFICAC AND

UALIT OF DRU)S, AND DEICESBEIN) ADE AAILABLE TO T/E PUBLIC,

ESTIN) T/E BUREAU OF FOOD AND

DRU)S 4IT/ AUT/ORIT TO

ADINISTER AND ENFORCE T/E LA4SPERTAININ) T/ERETO, AND FOR OT/ER

PURPOSES.


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FDA < e#6orce$e#%>$-*e$e#%#g "ge#c+ &u#der DO/(

RA 3720 EO 17'?'>22>87@ FDA Ac% ?200@

FDA

BFAD

FDA


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To !!ue 2. certificate of compliance:% %ec#c"*

re=ure$e#%! %o !erve "! "!! 6or %e !!u"#ce o6 3.

license "#d 1. spot-check 6or co$-*"#ce :%

regu*"%o#! reg"rd#g o-er"%o# o6 6ood, drug "#d

co!$e%c $"#u6"c%urer! "#d e!%"*!$e#%! To *ev+, "!!e!! "#d co**ec% 6ee! 6or #!-ec%o#,

"#"*+!! "#d %e!%#g o6 -roduc%! "#d $"%er"*!

!u$%%ed

To cer%6+ "%ce! o6 "#%o%c -re-"r"%o#![antibiotic batch certification]


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Fu#c%o# "#d !co-e

EO 11 ?1>30>82@

eracit& o! ad%ertise'entsdesistance order c/o DO !ield

o!!ice*enal sanctions

EO 8'1 ?12>2>82@

eracit& o! ad%ertise'ents

desistance order c/o #FAD

*enal sanctions


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OR)ANIATIONAL STRUCTURE


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DIISIONS OF FDA

Regu*"%o# Dv!o# I < #!-ec%o# o6

ou%*e%! or re%"*er!>d!%ru%or!

Regu*"%o# Dv!o# II < #!-ec%o# o6$"#u6"c%urer!


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Devce < #!%ru$e#%, "--"r"%u!, co#%rv"#ce!, #c*ud#g%er co$-o#e#%!, -"r%!, "#d "cce!!ore!, #%e#ded 6or

u!e # %e d"g#o!!, cure, $%g"%o#, %re"%$e#%, or

-reve#%o# o6 d!e"!e # $"# or "#$"*! or %o "66ec% %e

!%ruc%ure or "#+ 6u#c%o# o6 %e od+ o6 $"# or "#$"*!

Co!$e%c! < "r%c*e! #%e#ded %o e rued, -oured,

!-r#9*ed, or !-r"+ed o#, #%roduced #%o, or o%er:!e

"--*ed %o %e u$"# od+ 6or c*e"#!#g, e"u%6+#g,

-ro$o%#g "%%r"c%ve#e!!, or "*%er#g %e "--e"r"#ce

L"e* < " d!-*"+ o6 :r%%e#, -r#%ed, or gr"-c $"%%eru-o# %e $$ed"%e co#%"#er


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Ne: drug! < co$-o!%o# o6 !uc drug %"% ! #o%

ge#er"**+ recog#ed "$o#g e-er%!, # :c %!

!"6e%+, e66c"c+, "#d =u"*%+ "! #o% +e% ee#

de%er$#ed

Drug! ?"@ co#%"##g " #e:*+ d!covered "c%ve

#grede#% ?@ co#%"##g " #e: 6ed co$#"%o# o6

drug!, e%er + $o*ecu*"r or -+!c"* co$#"%o# ? c@

#%e#ded 6or #e: #dc"%o#! ?d@ # "# "dd%o#"* $ode

o6 "d$#!%r"%o#, do!"ge, or !%re#g%


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C/APTER PRO/IBITED ACTS AND

PENALTIES

Te $"#u6"c%ure, $-or%"%o#, e-or%"%o#, !"*e, o66er#g

6or !"*e, d!%ru%o# or %r"#!6er o6 "#+ 6ood, drug, devce

or co!$e%c %"% ! "du*%er"%ed or $!r"#ded

Te "du*%er"%o# or $!r"#d#g o6 "#+ 6ood, drug,devce or co!$e%c

Re6u!"* %o -er$% e#%r+ or #!-ec%o# or %o "**o: !"$-*e!

%o e co**ec%ed

Forg#g, cou#%er6e%#g, !$u*"%#g or 6"*!e*+

re-re!e#%#g or :%ou% -ro-er "u%or%+ u!#g "#+ $"r9,

!%"$-, %"g, *"e* or o%er de#%6c"%o# devce


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A*%er"%o#, $u%*"%o#, de!%ruc%o#, o*%er"%o#, or

re$ov"* o6 %e :o*e or "#+ -"r% o6 *"e*#g o6 6ood,

drug, devce or co!$e%c %"% ! 6or !"*e "#d re!u*% #

!uc "r%c*e e#g "du*%er"%ed or $!r"#ded

Te u!e o# %e *"e*#g o6 "#+ drug or # "#+ "dver%!#g

re*"%#g %o !uc drug o6 "#+ re-re!e#%"%o# or !ugge!%o#

%"% "# "--*c"%o# :% re!-ec% %o !uc drug ! e66ec%ve

Te $"#u6"c%ure, $-or%"%o#, e-or%"%o#, !"*e, o66er#g

6or !"*e, d!%ru%o# or %r"#!6er o6 "#+ drug or devce +

"#+ -er!o# :%ou% %e *ce#!e 6ro$ %e Bure"u

Te !"*e or o66er#g 6or !"*e o6 "#+ drug or devce

e+o#d %! e-r"%o# or e-r+ d"%e Te re*e"!e 6or !"*e or d!%ru%o# o6 "%c drug!

:%ou% "%c cer%6c"%o#


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Pe#"*%e!

I$-r!o#$e#% o6 #o% *e!! %"# o#e +e"r u% #o% $ore%"# 6ve +e"r! or " 6#e o6 #o% *e!! %"# ',000 -e!o!

u% #o% $ore %"# 10,000 -e!o!, or o% !uc

$-r!o#$e#% "#d 6#e, # %e d!cre%o# o6 %e Cour%

No -er!o# !"** e !uGec% %o %e -e#"*%e! ?1@ 6or"v#g !o*d, o66ered 6or !"*e or %r"#!6erred "#+ "r%c*e

"#d de*vered %, 6 !uc de*ver+ :"! $"de # good

6"%, u#*e!! e re6u!e! %o 6ur#! o# re=ue!%, %e

-er!o# 6ro$ :o$ e -urc"!ed or receved !uc"r%c*e "#d co-e! o6 "** docu$e#%


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?2@ 6 e e!%"*!ed " gu"r"#%+ or u#der%"9#g !g#ed

+ "#d co#%"##g %e #"$e "#d "ddre!! o6 %e

-er!o# re!d#g # %e P*--#e! 6ro$ :o$ e

receved # good 6"%

?3@ :ere vo*"%o# e!%! ec"u!e %e "r%c*e !"du*%er"%ed + re"!o# o6 co#%"##g " co*or o%er %"#

%e -er$!!*e o#e, 6 !uc -er!o# e!%"*!ed "

gu"r"#%+ or u#der%"9#g !g#ed + "#d co#%"##g %e

#"$e "#d "ddre!! o6 %e $"#u6"c%urer o6 %e co*or, %oe66ec% %"% !uc co*or ! -er$!!*e


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ADULTERATED FOOD

I6 % e"r! or co#%"#! "#+ -o!o#ou! or de*e%erou! !u!%"#ce

:c $"+ re#der % #Gurou! %o e"*%

I6 % co#!!%! # :o*e or # -"r% o6 "#+ 6*%+, -u%rd, or # -"r%

deco$-o!ed !u!%"#ce, or 6 % ! o%er:!e u#6% 6or 6ood

I6 % "! ee# -re-"red, re-"c9ed, or e*d u#der u#!"#%"r+co#d%o#! :ere+ % $"+ "ve ee# co#%"$#"%ed :% 6*%, or %

$"+ "ve ee# re#dered #Gurou! %o e"*%

I6 % !, # :o*e or # -"r%, %e -roduc% o6 " d!e"!ed "#$"* or o6

"# "#$"* :c "! ded o%er:!e %"# + !*"ug%er

I6 d"$"ge or #6eror%+ "! ee# co#ce"*ed # "#+ $"##er


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ADULTERATED FOOD

I6 "#+ !u!%"#ce "! ee# "dded %ere%o or $ed or -"c9ed !o

"! %o #cre"!e u*9 or :eg or reduce %! =u"*%+ or !%re#g% or

$"9e % "--e"r e%%er or o6 gre"%er v"*ue

I6 % e"r! or co#%"#! co"*H%"r co*or o%er %"# o# :c !

-er$!!*e u#der e!%#g regu*"%o#! I6 % ! o*eo$"rg"r#e or $"rg"r#e or u%%er "#d "#+ o6 %e r":

$"%er"* u!ed co#!!% # :o*e or -"r% o6 "#+ 6*%+, -u%rd or

deco$-o!ed !u!%"#ce


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Canned Goods


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Filth


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Filth


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ISBRANDED FOOD

I6 %! *"e*#g ! 6"*!e or $!*e"d#g # "#+ -"r%cu*"r

I6 % o66ered 6or !"*e u#der %e #"$e o6 "#o%er 6ood

I6 % ! "# $%"%o# o6 "#o%er 6ood, u#*e!! %! *"e* e"r! # %+-e o6

u#6or$ !e "#d -ro$#e#ce, %e :ord $%"%o#J, %e #"$e o6

%e 6ood $%"%ed I6 # -"c9"ge 6or$ u#*e!! % e"r! %e *"e* co#%"##g %e #"$e

"#d -*"ce o6 u!#e!! o6 %e $"#u6"c%urer, -"c9er, d!%ru%or

"#d "# "ccur"%e !%"%e$e#% o6 %e =u"#%%+ o6 %e co#%e#% # %er$!

o6 :eg%, $e"!ure "#d #u$erc"* cou#%.

I6 "#+ :ord or o%er #6or$"%o# re=ured + or u#der "u%or%+ o6%e "c% %o "--e"r o# %e *"e* or *"e*#g ! #o% -ro$#e#%*+

-*"ced %ereo# :% !uc co#!-cuou!#e!!


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ISBRANDED FOOD

A 6ood 6or :c " !%"#d"rd o6 =u"*%+ "! ee# -re!cred +

regu*"%o#! "#d %! =u"*%+ 6"**! e*o: !uc !%"#d"rd, u#*e!! *"e*

e"r! " !%"%e$e#% %"% % 6"**! e*o: !uc !%"#d"rd

I6 % ! -ur-or%! %o e or ! -re!e#%ed 6or !-ec"* de%"r+ u!e!,

u#*e!! %! *"e* e"r! !uc #6or$"%o# co#cer##g %! v%"$#,$#er"* "! %e Secre%"r+ de%er$#e! %o e "#d + regu*"%o#!

-re!cre! "! #ece!!"r+ # order %o 6u**+ #6or$ -urc"!er! "! %o

%! v"*ue 6or !uc u!e!

I6 % e"r! or co#%"#! "#+ "r%6c"* 6*"vor#g, "r%6c"* co*or#g, or

ce$c"* -re!erv"%ve u#*e!! % e"r! *"e*#g !%"%#g %"% 6"c%


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TOLERANCE FOR POISONOUS

IN)REDIENTS IN FOOD A#+ -o!o#ou! !u!%"#ce "dded %o "#+

6ood !"** e dee$ed %o e u#!"6e

ece-% :e# !uc !u!%"#ce !

re=ured or c"##o% e "voded # %!

-roduc%o# or $"#u6"c%ure


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LIST OF COAL TAR COLORS

APPROED B FDA FD&C Blue No. 1< Br**"#% B*ue FCF, E133 ?*ue !"de@

FDKC B*ue No. 2 < I#dgo%#e, E132 ?#dgo !"de@

FDKC )ree# No. 3 < F"!% )ree# FCF, E13 ?%ur=uo!e

!"de@ FD&C Red No. 40< A**ur" Red AC, E12 ?red !"de@

FDKC Red No. 3 < Er+%ro!#e, E127 ?-#9 !"de,

co$$o#*+ u!ed # g*"c cerre!@

FD&C Yellow No. 5< T"r%r"#e, E102 ?+e**o: !"de@ FD&C Yellow No. 6< Su#!e% e**o: FCF, E110 ?or"#ge

!"de@


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ADULTERATED DRU)S AND

DEICES I6 %e drug #"$e o6 :c recog#ed # "# o66c"*

co$-e#du$ "#d %! !%re#g% d66er! 6ro$ %! 6or$ or %!

!"6e%+, e66c"c+, =u"*%+ or -ur%+ 6"**! e*o: !%"#d"rd!

I6 % ! " drug or devce "! ee# $ed or -"c9ed :% "#+!u!%"#ce "! ee# !u!%%u%ed :o**+ or # -"r% !o "! %o

reduce %! !"6e%+, e66c"c+, =u"*%+, !%re#g% or -ur%+

I6 %e $e%od! u!ed or %e 6"c*%e! or co#%ro*! u!ed 6or %!

$"#u6"c%ure do #o% co#6or$ :% curre#% good

$"#u6"c%ur#g -r"c%ce %o "!!ure %"% !uc drug $ee%! %e

re=ure$e#%!


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ISBRANDED DRU)S AND

DEICES I6 % ! " drug "#d %! co#%"#er ! !o $"de, 6or$ed or 6**ed "! %o

e $!*e"d#g

I6 % ! "# $%"%o# o6 "#o%er drug I6 % ! o66ered 6or !"*e u#der %e #"$e o6 "#o%er drug

I6 % ! d"#gerou! %o e"*% :e# u!ed # %e do!"ge or :% %e

6re=ue#c+ o6 dur"%o# -re!cred, reco$$e#ded or !ugge!%ed #

%e *"e*#g


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Anticounter!etin

'ec-anis's


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Rana& 4aoratories 4i'ited is an .ndian

'ultinational *-ar'aceutical co'*an& t-at

+as incor*orated in .ndia in 1916 ,-e

co'*an& +ent *ulic in 1973 and a*anese

*-ar'aceutical co'*an& Daiic-i an&o

ac:uired a controllin s-are in 20086


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No -er!o# !"** $"#u6"c%ure!, !e**, o66er 6or

!"*e, $-or%, e-or%, d!%ru%e or %r"#!6er "#+

drug or devce :%ou% !ecur#g " LICENSE %o

o-er"%e 6ro$ %e Bure"u "6%er due co$-*"#ce:% %ec#c"* re=ure$e#%! # "ccord"#ce :%

ru*e! "#d regu*"%o#!


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CERTIFICATION OF DRU)S

CONTAININ) ANTIBIOTICS Te Secre%"r+ !"** -rovde 6or %e

cer%6c"%o# o6 "%ce! o6 drug! co$-o!ed

:o**+ or -"r%"**+ o6 "#+ 9#d o6 "#%o%c. A"%c o6 !uc drug !"** e cer%6ed 6 % $ee%!

c"r"c%er!%c! o6 de#%%+, !%re#g%, =u"*%+

"#d -ur%+


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EMEPTIONS IN ACUIRIN)

BATC/ CERTIFICATION Drug! %"% "re %o e !%ored, -roce!!ed, *"e*ed or

re-"c9ed o%er %"# %o!e :ere $"#u6"c%ured, o#

co#d%o# %"% !uc drug! co$-*+ :% "** !uc

re=ure$e#%! Drug! :c co#6or$ %o "--*c"*e !%"#d"rd! o6

de#%%+, !%re#g%, =u"*%+, "#d -ur%+ #%e#ded 6or u!e

# $"#u6"c%ur#g o%er drug!

Drug! :c "re #%e#ded 6or #ve!%g"%o#"* u!e +e-er%! =u"*6ed + !ce#%6c %r"##g "#d e-ere#ce

%o #ve!%g"%e %e !"6e%+ "#d e66c"c+ o6 drug!


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BATC/ CERTIFICATION A!ter otainin *ro'isin data !ro' laorator& studies; t-e dru

de%elo*ers tae t-e net ste* and su'itt an .n%estiationalNe+ Dru (.ND) a**lication to FDA

Once t-e .ND a**lication is in e!!ect; t-e dru s*onsor could

ein t-eir clinical trials6 A!ter a s*onsor su'its an .ND

a**lication; it 'ust +ait 30 da&s e!ore startin a clinical trial toallo+ FDA ti'e to re%ie+ t-e *ros*ecti%e stud&6 .! FDA !inds a

*role'; it can order a


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BATC/ CERTIFICATION ,-e s*onsor su'itts a Ne+ Dru A**lication (NDA) +it-

!ull in!or'ation on 'anu!acturin s*eci!ications; stailit&and ioa%ailalilit& data; 'et-od o! anal&sis o! eac- o! t-e

dosae !or's t-e s*onsor intends to 'aret; *acain and

laelin !or ot- *-&sician and consu'er

A tea' o! =DER *-&sicians; statisticians; c-e'ists;*-ar'acoloists; and ot-er scientists re%ie+s t-e s*onsor>s

NDA containin t-e data and *ro*osed laelin6


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BATC/ CERTIFICATION


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BATC/ CERTIFICATION

BATC/ CERTIFICATION
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm


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BATC/ CERTIFICATION


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FACTOR INSPECTION

O66cer! u-o# -re!e#%#g "--ro-r"%e crede#%"*! %o

%e o:#er, o-er"%or "re "u%ored ?1@ %o e#%er, "%

re"!o#"*e our!, "#+ 6"c%or+, :"reou!e or

e!%"*!$e#% ?2@ %o #!-ec%, # " re"!o#"*e $"##er!uc 6"c%or+, :"reou!e, e!%"*!$e#% "** -er%#e#%

e=u-$e#%, 6#!ed or u#6#!ed $"%er"*!,

co#%"#er! "#d *"e*#g


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IPORTS AND EMPORTS

%e Co$$!!o#er o6 Cu!%o$! !"** c"u!e %o ede*vered %o %e Bure"u !"$-*e! %"9e# "% %e r"#do$

6ro$ ever+ #co$#g !-$e#% :c "re e#g

$-or%ed #%o %e P*--#e!, gv#g #o%ce %o %e

o:#er or co#!g#ee.

I6 % "--e"r 6ro$ %e e"$#"%o# ?1@ !uc "r%c*e "!

#o% ee# $"#u6"c%ured u#der !"#%"r+ co#d%o#! ?2@

6ordde# or re!%rc%ed 6ro$ !"*e # %e cou#%r+ #

:c % :"! -roduced ?3@ !uc "r%c*e ! "du*%er"%ed or

$!r"#ded, %e Drec%or !"** #6or$ Co$$!!o#er"#d !uc "r%c*e !"** e re6u!ed "d$!!o#.

Te Co$$!!o#er o6 Cu!%o$! !"** %e# c"u!e %e

de!%ruc%o# :%# 0 d"+! o6 %e d"%e o6 #o%ce


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Food, Drug!, Devce! "#d Co!$e%c! Ac%

:"! "--roved *"!% u#e 22, 13


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QUIZ ON RA 3720

56 -at is t-e co''onl& used adulterant t-at

increases t-e ul o! 'il *roducts?

6 -at set o! *olicies o%erns t-e *re%ention

o! adulteration in !ood?

76 -at a**lication is secured !or drus

+-ic- -a%e *assed clinical trials?

86 -at c-a*ter in RA 3720 is de*icted in t-e

slide aout O*tri'a?

96 -at c-a*ter in RA 3720 is %iolated in t-e

%ideo aout 3# !raud?


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QUIZ ON RA 3720

106 -at sustance is used to detect t-e

*resence o! starc- in 'il *roducts?


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QUIZ ON RA 5921

Amendments -at is t-e reason !or t-e a'end'ent o!

RA 5921 ection 25 under RA 9502?

-at are t-e c-anes and +-at do t-e&*ro'ote to ac-ie%e t-e oals o! RA 9502?

rite &our ans+ers in B s-eet o! *a*er

4i'it &our ans+ers to 5 sentences onl&

Documents

Ra 3720- Safety and Purity of Foods, And Cosmetics