food, drugs, device and cosmetics acts v fda act

8/13/2019 Food, Drugs, Device and Cosmetics Acts v FDA Act

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Food, Drugs, Device and Cosmetics Act

RA 3720 as amended by EO 85, !,75"22 #ay, !87$ OR%&%'A(() !*3+

FDA Act - 200!

RA !7 "8 August 200!+

Section 4..o carry out t/e rovisionso- t/is Act, t/ere is /ereby created ano--ice to be caed t/e Food and Drug

Administration in t/e Deartment o-1eat/ aid Administration s/a beunder t/e O--ice o- t/e ecretary ands/a /ave t/e -oo4ing -unctions,o4ers and duties

"a+ .o administer andsuervise t/e imementationo- t/is Act and o- t/e rues and

reguations issued ursuant tot/e same

"b+ .o rovide -or t/e coectiono- sames o- -ood, drug andcosmetic

"c+ .o anay6e and insect-ood, drug and cosmetic inconnection 4it/ t/eimementation o- t/is Act

"d+ .o estabis/ anaytica datato serve as basis -or t/erearation o- -ood, drug andcosmetic standards, and torecommend standards o-identity, urity, uaity and -i o-container

"e+ .o issue certi-icate o-comiance 4it/ tec/nicareuirements to serve as basis-or t/e issuance o- icense andsotc/ec9 -or comiance 4it/reguations regarding oerationo- -ood, drug and cosmeticmanu-acturers andestabis/ments

Section 5.ection : o- Reubic Act'o 3720, as amended, is /ereby-urt/er amended to read as -oo4s

;EC : .o carry out t/erovisions o- t/is Act, t/ere is/ereby created an o--ice to becaed t/e Food and Drug

Administration "FDA+ in t/eDeartment o- 1eat/ "DO1+aid Administration s/a beunder t/e O--ice o- t/e

ecretary and s/a /ave t/e-oo4ing -unctions, o4ers andduties

;"a+ .o administer t/e e--ectiveimementation o- t/is Act ando- t/e rues and reguationsissued ursuant to t/e same$

;"b+ .o assume rimary


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"-+ .o evy, assess and coect-ees -or insection, anaysisand testing o- roducts andmaterias submitted in

comiance 4it/ t/e rovisionso- t/is Act

"g+ .o certi-y batc/es o- antibiotic and antibioticrearations in comiance4it/ t/e rovisions o- t/is Act

-or t/e issuance o- aroriateaut/ori6ation and sotc/ec9-or comiance 4it/ reguationsregarding oeration o-

manu-acturers, imorters,e=orters, distributors,4/oesaers, drug outets, andot/er estabis/ments and-aciities o- /eat/ roducts, asdetermined by t/e FDA$

;= = =

;"/+ .o conduct aroriatetests on a aicabe /eat/

roducts rior to t/e issuanceo- aroriate aut/ori6ations toensure sa-ety, e--icacy, urity,and uaity$

;"i+ .o reuire amanu-acturers, traders,distributors, imorters,e=orters, 4/oesaers,retaiers, consumers, and non

consumer users o- /eat/roducts to reort to t/e FDAany incident t/at reasonabyindicates t/at said roduct /ascaused or contributed to t/edeat/, serious iness or seriousin


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ony a-ter due rocess /asbeen observed$

;"9+ A-ter due rocess, to order

t/e ban, reca, and>or4it/dra4a o- any /eat/roduct -ound to /ave causedt/e deat/, serious iness orserious in


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romotion, sonsors/i, andot/er mar9eting activities aboutt/e /eat/ roducts as coveredin t/is Act$

;"+ .o maintain bonded4are/ouses and>or estabis/t/e same, 4/enever necessaryor aroriate, as determinedby t/e directorgenera -orcon-iscated goods in strategicareas o- t/e country eseciayat ma


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Reguation andResearc/$

;"3+ Center -or

Cosmetics Reguationand Researc/ "to incude/ouse/od/a6ardous>urbansubstances+$ and

;":+ Center -or DeviceReguation, Radiation1eat/, and Researc/

;./ese Centers s/a

reguate t/emanu-acture,imortation, e=ortation,distribution, sae, o--er-or sae, trans-er,romotion,advertisement,sonsors/i o-, and>or,4/ere aroriate, t/euse and testing o- /eat/

roducts ./e Centerss/a i9e4ise conductresearc/ on t/e sa-ety,e--icacy, and uaity o-/eat/ roducts, and toinstitute standards -ort/e same

;"b+ Eac/ Center s/a be/eaded by a director ./eCenters s/a be so organi6ed

suc/ t/at eac/ 4i /ave, ateast, t/e -oo4ing divisions

;"+ (icensing andRegistration Division,4/ic/ s/a beresonsibe -orevauating /eat/


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roducts andestabis/ments ascovered by t/is Act -ort/e urose o- issuance

o- aut/ori6ations andconditions to beobserved$

;"2+ ?roduct Researc/and tandardsDeveoment Division,4/ic/ s/a beresonsibe -or t/econduct o- researc/,deveoment o-

standards andreguations, comiancemonitoring, and t/eoversig/t and audit o-reated researc/es t/at4oud ensure sa-ety,uaity, urity ande--icacy o- /eat/roducts, as covered int/is Act$ and

;"3+ (aboratory uortDivision, 4/ic/ s/a beresonsibe -or t/econduct o- researc/ andaroriate testa andcaibration, anayses andtrias o- roductsincuding, but not imitedto, assays, and t/econduct o- oversig/t

and>or audit o- centersconducting bioavaiabiityand bioeuivaence testsand ot/er tests ascovered by t/is Act %ts/a i9e4ise rovidedirect ine suort to t/ecenters 4/ic/ s/a be


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searate and distinct erma


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O--ice o- t/e Director&enera;

Section 6../e Food and Drug

Administration s/a /ave a Food andDrug Administrator 4/o s/a beaointed by t/e ecretary o- 1eat/sub


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assurance o- roducts ascovered in t/is Act

;"e+ ./e Deuty Director

&enera -or Fied ReguatoryOerations o- t/e FDA s/a,re-eraby, ossess t/ereevant master@s degree in/armaceutica sciences oraied sciences, or euivaente=ecutive course in anyreguatory management %naddition, /e>s/e s/a /avemanagement e=erience in/is>/er -ied o- disciine or

ro-ession and in anydeveoment, manu-acturing,reguatoy 4or9 or uaityassurance o- roducts ascovered in t/is Act

;"-+ ./e Deuty Director&enera -or Administration andFinance o- t/e FDA s/a /e acerti-ied ubic accountant or

s/a ossess a master@sdegree in accounting,management, economics orany business course, and must/ave management e=eriencein a osition reated to /is>/er-ied o- disciine or ro-ession

;"g+ A erson 4/o 4asreviousy emoyed in areguar -utime caacity

regardess o- its consutativedesignation at /ig/ermanagement suervisoryeves in reguatedestabis/ments, incudingreated -oundations, s/a bedisuai-ied -rom aointmentas directorgenera and deuty


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immediatey;

Section 7../e ecretary o- 1eat/

s/a rovide -or t/e additionaersonne needed to carry out t/e-unctions and duties o- t/e Food andDrug Administration

Section 8.ection 7 o- Reubic Act

'o 3720, as amended, is /ereby-urt/er amended to read as -oo4s

;./e FDA s/a revie4 itssta--ing attern and ositiontites sub


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mitigation, treatment, orrevention o- disease in man orot/er animas$ and "3+ artices"ot/er t/an -ood+ intended to

a--ect t/e structure or any-unction o- t/e body o- man oranimas$ and ":+ articesintended -or use as acomonent o- any articesseci-ied in causes "+, "2+, or"3+, but not incude devices ort/eir comonents, arts, oraccessories

"g+ ;Device; means

instruments, aaratus, orcontrivances, incuding t/eircomonents, arts, andaccessories, intended "+ -oruse in t/e diagnosis, cure,mitigation, treatment, orrevention o- disease in man oranimas$ or "2+ to a--ect t/estructure or any -unction o- t/ebody o- man or animas

"/+ ;Cosmetic; means "+artices intended to be rubbed,oured, srin9ed, or srayedon, introduced into, orot/er4ise aied to t/e /umanbody or any art t/ereo- -orceansing, beauti-ying,romoting attractiveness, oratering t/e aearance, and"2+ artices intended -or use as

a comonent o- any suc/artices

"i+ ;(abe; means a disay o-4ritten, rinted, or gra/icmatter uon t/e immediatecontainer o- any artice and areuirement made by or under

-ormuaries, incuding o--icia/omeoat/ic /armacoeias,or any documentarysuement to any o- t/em,

4/ic/ are recogni6ed andadoted by t/e FDA$ "2+artices intended -or use in t/ediagnosis, cure, mitigation,treatment, or revention o-disease in man or ot/eranimas$ "3+ artices "ot/er t/an-ood+ intended to a--ect t/estructure o- any -unction o- t/ebody o- /umans or animas$ or":+artices intended -or use as a

comonent o- any articesseci-ied in causes "+, "2+, or"3+ but do not incude devicesor t/eir comonents, arts oraccessories

;"g+ @Device@ means medicadevices, radiation devices and/eat/reated devices

;"+ @#edica device@means any instrument,aaratus, imement,mac/ine, aiance,imant, invitro reagentor caibrator, so-t4are,materia, or ot/er simiaror reated articeintended by t/emanu-acturer to be usedaone, or in combination,

-or /uman beings -or oneor more o- t/e seci-icurose"s+ o- diagnosis,revention,, monitoring,treatment or aeviationo- disease$ diagnosis,monitoring, treatment,aeviation o-, or


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aut/ority o- t/is Act t/at any4ord, statement, or ot/erin-ormation aearing on t/eabe s/a not be considered to

be comied 4it/ uness suc/4ord, statement, or ot/erin-ormation aso aears ont/e outside container or4raer, i- any t/ere be, o- t/eretai ac9age o- suc/ artice,or is easiy egibe t/roug/ t/eoutside container or 4raer

"


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in suc/ investigations, beenused to a materia e=tent or -ora materia time under suc/conditions

"m+ %- an artice is aeged to bemisbranded because t/eabeing is miseading, t/en indetermining 4/et/er t/eabeing is miseading t/eres/a be ta9en into account"among ot/er t/ings+ not onyreresentations made orsuggested by statement, 4ord,design, device, or any

combination t/ereo-, but asot/e e=tent to 4/ic/ t/e abeing-ais to revea -acts materia int/e ig/t o- suc/reresentations or materia 4it/resect to conseuences 4/ic/may resut -rom t/e use o- t/eartice to 4/ic/ t/e abeingreates under t/e conditions o-use rescribed in t/e abeing

t/ereo- or under suc/conditions o- use as arecustomary or usua

"n+ ;Food additive; means anysubstance t/e intended use o-4/ic/ resuts or mayreasonaby be e=ected toresut, directy or indirecty, inits becoming a comonent orot/er4ise a--ecting t/e

c/aracteristics o- any -ood"incuding any substanceintended -or use in roducing,manu-acturing, ac9ing,rocessing, rearing, treating,ac9aging, transorting, or/oding -ood$ and incuding anysource o- radiation intended -or

;"3+ @1eat/reateddevice@ means anydevice not used in /eat/care but /as been

determined by t/e FDAto adversey a--ect t/e/eat/ o- t/e eoe

;"/+ @Cosmetics@ means anysubstance or rearationintended to be aced incontact 4it/ t/e variouse=terna arts o- t/e /umanbody or 4it/ t/e teet/ and t/emucous membranes o- t/e ora

cavity, 4it/ a vie4 e=cusiveyor mainy to ceaning t/em,er-uming t/em, c/anging t/eiraearance and>or correctingbody odor, and>or rotectingt/e body or 9eeing t/em ingood condition

;"i+ @(abe@ means a disay o-4ritten, rinted, or gra/ic

matter uon, t/e immediatecontainer o- any artice and areuirement made by or underaut/ority o- t/is Act t/at any4ord, statement, or ot/erin-ormation aearing on t/eabe s/a not be considered tobe comied 4it/ uness suc/4ord, statement, or ot/erin-ormation aso aears ont/e outside container or

4raer, i- any t/ere be, o- t/eretai ac9age o- suc/ artice,or easiy egibe t/roug/ t/eoutside container or 4raer

;= = =

;"+ @Directorgenera@ means


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any suc/ use+, i- suc/substance is not generayrecogni6ed, among e=ertsuai-ied by scienti-ic training

and e=erience to evauate itssa-ety, as /aving beenadeuatey s/o4n t/roug/scienti-ic rocedures to be sa-eunder t/e conditions o- itsintended use

t/e /ead o- t/e FDA

;"r+ @Distribute@ means t/edeivery or sae o- any /eat/

roduct -or uroses o-distribution in commerce,e=cet t/at suc/ term does notincude t/e manu-acture orretai o- suc/ roduct

;= = =

;"v+ @#anu-acturer@, in reationto a /eat/ roduct, means anestabis/ment engaged in any

and a oerations invoved int/e roduction o- /eat/roducts incuding rearation,rocessing, comounding,-ormnating, -iing, ac9ing,reac9ing, atering,ornamenting, -inis/ing andabeing 4it/ t/e end in vie4 o-its storage, sae ordistribution Provided, ./at t/e

term s/a not ay to t/ecomounding and -iing o-rescritions in drugstores and/osita /armacies A traders/a be categori6ed as amanu-acturer

;"4+ @eterinary drugs@ meansdrugs intended -or use -oranimas incuding any drugintended -or use in anima

-eeds but not incuding anima-eeds 4it/in t/e contemationo- t/e imementing rues andreguations

;"=+ @Assay@ is an anaysis todetermine t/e "+ resence o- asubstance and t/e amount o-


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t/at substance, or "2+ t/e/armaceutica otency o- adrug

;"y+ @Aut/ori6ation@ means aermission embodied in adocument granted by t/e FDAto a natura or or,4/ere aroriate, t/e use,testing, romotion, advertising,

or sonsors/i o- /eat/roducts ./e aut/ori6ation canta9e t/e -orm o- a ermit, aicense, a certi-icate o-registration, o- accreditation, o-comiance, or o- e=emtion, orany simiar document

;"6+ @ioavaiabiity@ means t/erate and e=tent to 4/ic/ t/e

active ingredient or t/eraeuticingredient is absorbed -rom adrug and becomes avaiabe att/e site o- drug action

;"aa+ @ioeuivaence@ meanst/e rate and e=tent o-absortion to 4/ic/ t/e drugsdo not s/o4 a signi-icantdi--erence -rom t/e rate ande=tent o- t/e isted drug 4/en

administered at t/e same moardose o- t/e t/eraeuticingredient under simiare=erimenta conditions ineit/er a singe dose or mutiedoses ioeuivaence s/aaso re-er to t/e absence o- asigniticant di--erence on t/e


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rate and e=tentto4/ic/ t/eactive ingredient"s+ o- t/esame and re-erence drugbecomes avaiabe at t/e site o-

drug action 4/en administeredunder t/e same moar doseand under simiar conditions

;"bb+@Distributor>imorter>e=orter@means any estabis/ment t/atimorts or e=orts ra4materias, active ingredientsand>or -inis/ed roducts -or itso4n use or -or 4/oesae

distribution to ot/erestabis/ments or outets %- t/edistributor>imorter>e=orterses to t/e genera ubic, its/a be considered a retaier

;"cc+ @Distributor>4/oesaer@means any estabis/ment t/atrocures ra4 materias, activeingredients and>or -inis/ed

roducts -rom ocaestabis/ments -or ocadistribution on 4/oesae basis

;"dd+ @Estabis/ment@ means asoe rorietors/i, aartners/i, a cororation, aninstitution, an association, or anorgani6ation engaged in t/emanu-acture, imortation,e=ortation, sae, o--er -or sae,

distribution, donation, trans-er,use, testing, romotion,advertising, or sonsors/i o-/eat/ roducts incuding t/e-aciities and instaationsneeded -or its activities

;"ee+ @Food>dietary suement@


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means a rocessed -oodroduct intended tosuement t/e diet t/at bearsor contains one or more o- t/e

-oo4ing dietary ingredientsvitamin, minera, /erb, or ot/erbotanica, amino acid, anddietary substance to increaset/e tota daiy inta9e in amountscon-orming to t/e atest?/iiine recommendedenergy and nutrient inta9es orinternationay agreed minimumdaiy reuirements %t usuay isin t/e -orm o- casues, tabets,

iuids, ges, o4ders or isand not reresented -or use asa conventiona -ood or as t/esoe item o- a mea or diet orreacement o- drugs andmedicines

;"--+ @1eat/ roducts@ means-ood, drugs, cosmetics,devices, bioogicas, vaccines,

invitro diagnostic reagents and/ouse/od>urban /a6ardoussubstances and>or acombination o- and>or aderivative t/ereo- %t s/a asore-er to roducts t/at may /avean e--ect on /eat/ 4/ic/reuire reguations asdetermined by t/e FDA

;"gg+ @1ouse/od>urban

/a6ardous substance@ is

;"+ Any substance ormi=ture o- substancesintended -or individua orimited uroses and4/ic/ is to=ic, corrosive,an irritant, a strong


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sensiti6er, is -ammabeor combustibe, orgenerates ressuret/roug/ decomosition,

/eat or ot/er means, i-suc/ substance ormi=ture o- substancesmay cause substantiain


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re-rigeration system o- a/ouse, but suc/ terms/a ay to any artice4/ic/ is not in itse- an

agricutura esticide but4/ic/ is a /a6ardoussubstance, as construedin aragra/ "+ o- t/issection, by reason o-bearing or containingsuc/ /arm-u substancesdescribed t/erein

;"//+ @%nvitro diagnosticreagents@ are reagents and

systems intended -or use in t/ediagnosis o- disease or ot/erconditions, incuding adetermination o- t/e state o-/eat/, in order to cure,mitigate, treat or reventdisease or its seueae

;"ii+ @(icensing@ means t/erocess o- arova o- an

aication to oerate orestabis/ an estabis/mentrior to engaging in t/emanu-acture, imortation,e=ortation, sae, o--er -or sae,distribution, trans-er, and 4/ereaicabe t/e use, testing,romotion, advertisement,and>or sonsors/i o- /eat/roducts

;"


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inteectua roertyi9einstruments

;"99+ @Registration@ means t/e

rocess o- arova o- anaication to register /eat/roducts rior to engaging int/e manu-acture, imortation,e=ortation, sae, o--er -or sae,distribution, trans-er, and 4/ereaicabe, t/e use, testing,romotion, advertisement,and>or sonsors/i o- /eat/roducts

;"+ @.rader@ means anyestabis/ment 4/ic/ is aregistered o4ner o- a /eat/roduct and rocures t/e ra4materias and ac9ingcomonents and rovides t/eroduction monogra/s, uaitycontro standards androcedures, but subcontractt/e manu-acture o- suc/

roduct to a icensedmanu-acturer %n addition, atrader may aso engage in t/edistribution and>or mar9eting o-its roducts

;"mm+ @Retaier@ means anyestabis/ment 4/ic/ ses oro--ers to se any /eat/ roductdirecty to t/e genera ubic;

Section 11../e -oo4ing acts andt/e causing t/ereo- are /erebyro/ibited "a+ ./e manu-acture, sae,o--ering -or sae or trans-er o- any-ood, drug, device or cosmetic t/at isaduterated or misbranded

Section 10.ection , subsections"a+, "b+, "d+, "g+, "


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"b+ ./e aduteration ormisbranding o- any -ood, drug,device, or cosmetic

"c+ ./e re-usa to ermit entryor insection as aut/ori6ed byection t4entyseven /ereo- orto ao4 sames to becoected

"d+ ./e giving o- a guaranty orunderta9ing re-erred to inection t4eve "b+ /ereo- 4/ic/guaranty or underta9ing is-ase, e=cet by a erson 4/o

reied uon a guaranty orunderta9ing to t/e same e--ectsigned by, and containing t/ename and address o-, t/eerson residing in t/e?/iiines -rom 4/om /ereceived in good -ait/ t/e -ood,drug, device, or cosmetic or t/egiving o- a guaranty orunderta9ing re-erred to in

ection t4eve "b+ 4/ic/guaranty or underta9ing is-ase

"e+ Forging, counter-eiting,simuating, or -aseyreresenting or 4it/out roeraut/ority using any mar9,stam, tag abe, or ot/eridenti-ication device aut/ori6edor reuired by reguations

romugated under t/erovisions o- t/is Act

"-+ ./e using by any erson to/is o4n advantage, orreveaing, ot/er t/an to t/eecretary or o--icers oremoyees o- t/e Deartment

and t/e causing t/ereo- are/ereby ro/ibited

;"a+ ./e manu-acture,

imortation, e=ortation, sae,o--ering -or sae, distribution,trans-er, nonconsumer use,romotion, advertising, orsonsors/i o- any /eat/roduct t/at is aduterated,unregistered or misbranded

;"b+ ./e aduteration ormisbranding o- any /eat/roduct

;= = =

;"d+ ./e giving o- a guaranty orunderta9ing re-erred to inection t4eve "b+ /ereo- 4/ic/guaranty or underta9ing is-ase, e=cet by a erson 4/oreied uon a guaranty orunderta9ing to t/e same e--ect,signed by, and containing t/ename and address o- t/eerson or entity -rom 4/om /ereceived in good -ait/ t/e/eat/ roducts or t/e giving o-a guaranty or underta9ingre-erred to in ection t4eve "b+4/ic/ guaranty or underta9ingis -ase

;= = =

;"g+ ./e ateration, mutiation,destruction, obiteration, orremova o- t/e 4/oe or anyart o- t/e abeing o-, or t/edoing o- any ot/er act 4it/resect to /eat/ roducts i-suc/ act is done 4/ie suc/


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or to t/e courts 4/en reevantin any


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aicabe

;= = =

;./e ro/ibited acts mentioned/erein s/a cover a aicabe/eat/ roducts;

Section 12."a+ Any erson 4/ovioates any o- t/e rovisions o-ection eeven /ereo- s/a, uonconviction, be sub


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in t/e ?/iiines -rom 4/om/e received in good -ait/ t/eartice, or "3+ -or /avingvioated ection eeven "a+,

4/ere t/e vioation e=istsbecause t/e artice isaduterated by reason o-containing a coatar coor notermissibe under reguationsromugated by t/e ecretaryunder t/is Act, i- suc/ ersonestabis/es a guaranty orunderta9ing signed by, andcontaining t/e name andaddress, o- t/e manu-acturer o-

t/e coatar coor, to t/e e--ectt/at suc/ coor is ermissibe,under aicabe reguationsromugated by t/e ecretaryunder t/is Act

"c+ Any artice o- -ood, drug,device, or cosmetic t/at isaduterated or misbranded4/en introduced into t/e

domestic commerce may besei6ed and /ed in custodyending roceedings ursuantto ection t4entysi= "d+/ereo-, 4it/out a /earing orcourt order, 4/en t/eecretary /as robabe causeto beieve -rom -acts -ound by/im or any o--icer or emoyeeo- t/e Food and Drug

Administration t/at t/e

misbranded artice isdangerous to /eat/, or t/at t/eabeing o- t/e misbrandedartices is -rauduent, or 4oudbe in a materia resectmiseading to t/e in/er oran aut/ori6ed o--icer oremoyee o- t/e FDA t/at suc/

/eat/ roducts may causein


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consumer

Section 26."a+ E=cet as ot/er4ise

rovided in t/is section, t/e ecretaryo- 1eat/ s/a, uon recommendationo- t/e Food and Drug Administrator,issue rues and reguations as may benecessary to en-orce e--ectivey t/erovisions o- t/is Act

"b+ ./e Commissioner o-Customs, t/e Commissioner o-%nterna Revenue and t/eecretary o- 1eat/ s/a


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/e s/a cause notice t/ereo- tobe given to t/e erson orersons concerned and suc/erson or ersons s/a be

given an oortunity to be/eard be-ore t/e oard o- Foodand Drug %nsection and tosubmit evidence imeac/ingt/e correctness o- t/e -indingor c/arge in uestion

"e+ /en a vioation o- anyrovisions o- t/is Act comes tot/e 9no4edge o- t/e Food andDrug Administrator o- suc/

c/aracter t/at a criminarosecution oug/t to beinstituted against t/e o--ender,/e s/a certi-y t/e -acts to t/eecretary o- ustice t/roug/t/e ecretary o- 1eat/,toget/er 4it/ t/e c/emist@sreort, t/e -indings o- t/eoard o- Food and Drug%nsection, or ot/er

documentary evidence on4/ic/ t/e c/arge is based

"-+ 'ot/ing in t/is Act s/a beconstrued as reuiring t/eFood and Drug Administrator tocerti-y -or rosecution ursuantto subaragra/ "e+ /ereo-,minor vioations o- t/is Act4/enever /e beieves t/atubic interest 4i be

adeuatey served by asuitabe 4ritten notice or4arning

Section 29."a+ ./e ecretary maycause to be disseminated in-ormationregarding -ood, drugs, devices, or

Section 1$.ection 2!A o- ReubicAct 'o 3720, as amended, is /ereby-urt/er amended, and ne4


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cosmetics in situations invoving, int/e oinion o- t/e ecretary, imminentdanger to /eat/, or gross decetiono- t/e consumer 'ot/ing in t/isection s/a be construed to ro/ibit

t/e ecretary -rom coecting,reorting, and iustrating t/e resutso- t/e investigations o- t/eDeartment

subsections are added to read as-oo4s

;EC 2!AAdministrativeSanctions /ere t/ere is

-inding o- ro/ibited actionsand determination o- t/eersons iabe t/ereto, a-ternotice and /earing, t/edirectorgenera is emo4eredto imose one or more o- t/e-oo4ing administrativeenaties

;"+ Canceation o- anyaut/ori6ation 4/ic/ may /ave

been granted by t/e FDA, orsusension o- t/e vaidityt/ereo- -or suc/ eriod o- timeas t/e directorgenera maydeem reasonabe 4/ic/ s/anot e=ceed one "+ year

;"2+ A -ine o- not ess t/an Fi-tyt/ousand esos "?50,00000+but not more t/an Five /undred

t/ousand esos "?500,00000+An additiona -ine o- not moret/an One t/ousand esos"?,00000+ s/a be imosed-or eac/ day o- continuingvioation$ and

;"3+ Destruction and>oraroriate disosition o- t/esuborcosure o- t/e estabis/ment -or

any vioation o- t/is Act, asdetermined by t/e directorgenera;

Section 14.A ne4 ection 30 and ane4 /eadnote ;Additiona ?o4ers andFunctions o- t/e Director&enera; are


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/ereby added to Reubic Act 'o3720, 4/ic/ s/a read as -oo4s

;EC 30 ./e Director&enera s/a aso e=ercise t/e

-oo4ing o4ers

;"+ .o /od in direct or indirectcontemt any erson 4/odisregards orders or 4rits /e ors/e issues and imose t/earoriate enaties -oo4ingt/e same rocedures andenaties rovided in t/e Rueso- Court$

;"2+ .o administer oat/s anda--irmations andissue subpoena ducestecumand subpoena adtestificandumreuiring t/eroduction o- suc/ boo9s,contracts, corresondence,records, statement o- accountsand ot/er documents and>ort/e attendance and testimony

o- arties and 4itnesses asmay be materia to t/einvestigation conducted by t/eFDA$

;"3+ .o obtain in-ormation -romany o--icer or o--ice o- t/enationa or oca governments,government agencies and itsinstrumentaities$

;":+ .o issue orders o- sei6ure,to sei6e and /od in custodyany artice or artices o- -ood,device, cosmetics, /ouse/od/a6ardous substances and/eat/ roducts t/at isaduterated, counter-eited,misbranded or unregistered, or


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drug, invitro diagnosticreagent, bioogicas, andvaccine t/at is aduterated ormisbranded, 4/en introduced

into domestic commerceending t/e aut/ori6ed /earingunder Reubic Act 'o 3720,as amended, E=ecutive Order'o 75 "!87+, and Reubic

Act 'o 73!:, ot/er4ise 9no4nas t/e Consumers Act o- t/e?/iiines$

;"5+ .o ca on t/e assistance o-any deartment, o--ice or

agency and deuti6e memberso- t/e ?/iiine 'ationa?oice or any a4 en-orcementagency -or t/e e--ectiveimementation o- t/is Act$ and

;"*+ .o e=ercise suc/ o4ersand -unctions as may benecessary -or t/e e--ectiveimementation o- t/is Act;

Section 15..4o ne4 sections s/abe added, 4/ic/ s/a be t/e ne4ections 3 and 32 o- Reubic Act'o 3720, as amended, 4/ic/ s/aread as -oo4s

;EC 3 ./e orders, ruingsor decisions o- t/e FDA s/abecome -ina and e=ecutory

-i-teen "5+ days a-ter t/ereceit o- a coy t/ereo- by t/earty adversey a--ected uness4it/in t/at eriod, anadministrative aea /as beener-ected One motion -orreconsideration may be -ied,4/ic/ s/a susend t/e


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running o- t/e said eriod;

;EC 32 ./e orders, ruingsor decisions o- t/e FDA s/a

be aeaabe to t/e ecretaryo- 1eat/ An aea s/a bedeemed er-ected uon -iingo- t/e notice o- aea andosting o- t/e corresondingaea bond

;An aea s/a not stay t/edecision aeaed -rom unessan order -rom t/e ecretary o-1eat/ is issued to stay t/e

e=ecution t/ereo-;

Section 16.ection 30 o- ReubicAct 'o 3720, as amended, s/a berenumbered as ection 33, and t/esubseuent sections s/a aso berenumbered accordingy

Section $1../e amount o- onemiion esos is /ereby aroriated-rom any -unds in t/e 'ationa.reasury not ot/er4ise aroriatedto augment t/e -unds trans-erred tot/is O--ice under ection eig/t -or t/eimementation o- t/is Act A incomederived -rom -ees aut/ori6ed inection Four o- t/is Act s/a accrueto t/e &enera Fund

Section 17.ection 3, C/ater G%%%o- Reubic Act 'o 3720, asamended, is /ereby -urt/er amendedto read as -oo4s

;EC 3: Fees and OtherIncome

;"a+ Bon t/e soe arova o-t/e ecretary, t/e aut/ori6ationand ot/er -ees s/a annuaybe determined and revie4ed byt/e FDA and any roosed

increase s/a be ubis/ed int4o "2+ eading ne4saers o-genera circuation

;"b+ ./ere s/a be determinedand constituted additiona -eessuc/ as sae o- ubicationsand services, assessment -ees,


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-ines, enaties, and ot/er -eesand c/arges outside t/e usuaicensing and registration -ees,to be 9no4n as @ot/er reated

reguatory -ees@

;"c+ ./e Director&enera o- t/eFDA, uon arova o- t/eecretary, s/a be aut/ori6edto romugate rues andreguations governing t/ecoection o- t/e @ot/er reatedreguatory -ees@ Bon arovao- t/e ecretary, t/ese -eess/a i9e4ise be revie4ed

eriodicay and any roosedincrease s/a be ubis/ed int4o "2+ eading ne4saers o-genera circuation;

Section 18.A income t/at t/e FDAis ao4ed to retain under ection 3o- t/e Bniversay Accessibe C/eaer

and Huaity #edicines Act o- 2008s/a, any rovision o- a4 to t/econtrary not4it/standing, bedeosited in an aut/ori6edgovernment deository ban9 as asecia reguatory -und Any interestearned by suc/ -und s/a -orm art o-t/e retained income uc/ -und s/abe used rimariy -or t/e acuisition o-o--ice and aboratory sace, /umanresource deveoment and

e=ansion, urc/ase o- aboratoryeuiment and motor ve/ices, t/eugrading o- its current -aciities andeuiment and maintenance, ot/eroerating e=enses o-t/e centrao--ice aboratory divisions and sateiteaboratories in Davao, Cebu andot/er testing aboratories, in case t/e


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above aboratories 4i be increased,and ot/er activities or services o- t/eagency in t/e er-ormance o- itsmandate

./e -und s/a be ao4ed to accetgrants, donations and a ot/erendo4ments -rom oca and e=ternasources in accordance 4it/ ertinenta4s, rues and reguations

./e retention, use and aication o-t/is -und s/a not be deayed,amended, atered or modi-ied, ora--ected in any 4ay by an order or

directive -rom any e=ecutive o--ice,but 4i be sub


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-or a eriod not e=ceeding -ive "5+years -rom t/e e--ectivity o- t/is Act %ts/a be comosed o- at east -ive "5+uai-ied ersonne in every region4/o s/a be directy under t/e contro

and suervision o- t/e DeutyDirector&enera -or Fied ReguatoryOerations and s/a beadministrativey suorted by t/e -iedo--ices ./ey s/a

"a+ ear arms, 4ear o--iciauni-orms and insignias ands/a be cassi-ied as a4en-orcement agents$

"b+ erve and e=ecute ruings,orders, and decisions o- t/eDirector&enera o- t/e FDA$and

"c+ E=ecute and serve searc/4arrants and arrest 4arrantsissued by t/e courts inconnection 4it/ vioationsunder t/is Act and reated a4s

concerning t/e reguation o-/eat/ roducts

A a4 en-orcement agents s/aundergo t/e aroriate training toeui t/em 4it/ t/e necessary s9isneeded -or t/is urose ./eiraut/ority and -unctions s/a bestricty imited to t/e imementationo- t/e FDA@s reguatory -unctions

A regiona reguatory en-orcementunits s/a be /eaded by a a4yer4/o is at east t/irty "30+ years od butnot oder t/an -i-ty "50+, an %ntegratedar o- t/e ?/iiines "%?+ membero- good standing, and s/a /ave aran9 o- a Division Director$ and anassistant 4/o must be at t/e very


35/40

east a a4 graduate 4/o s/a /ave aran9 o- an Assistant Division Director

Section 20.A ne4 c/ater G% andt/ree ne4 sections, ections 35, 3*,and 37 s/a be introduced, 4/ic/s/a read as -oo4s

%&'()*+ -%)*S)-/ '!+')+-*S

'/" 3-*" 33-*S

;EC 35 ./e FDA is /erebymandated to imrove, ugrade

and increase t/e caabiity o-t/e agency, to test, caibrate,assay and e=amine sames o-/eat/ roducts For t/eurose o- ac/ieving t/e abovemandate, t/ere s/a beestabis/ed at east one "+testing aboratory eac/ in(u6on, isayas and #indanao,4/ic/ s/a /ave t/e necessaryand aroriate stateo-t/eartaboratory euiment andersonne comement ./emain testing aboratories at t/ecentra o--ice s/a bemaintained and s/a serve asa suort unit to t/e centers -orroduct researc/ andevauation and standardsdeveoment and s/a serveas testing centers t/at 4oud

incude assay and t/e conduct,suervision, oversig/t and>oraudit o- bioeuivaence andbioavaiabiity test>researc/es,among ot/ers ./e e=istingaboratories in Cebu andDavao 4i be ugraded andtrans-ormed as uaity


36/40

assurance aboratories, 4/ieanot/er one 4i be estabis/edin ubic, Iambaes

;./e testing aboratories maybe increased by t/e directorgenera, uon arova o- t/eecretary #oreover, t/edirectorgenera, uon arovao- t/e ecretary, may ca uonot/er government and rivatetesting aboratories to conducttesting, caibration, assay ande=amination o- sames o-/eat/ roducts Provided, ./at

t/e rivate testing aboratoriesare accredited by t/e ?/iiine

Accreditation O--ice "?AO+ o-t/e Deartment o- .rade andindustry "D.%+ and t/e DO1;

;EC 3* ./e FDA s/aestabis/ -ied o--ices in aregions o- t/e country toe--ectivey imement its

reguatory -unctions ./ecurrent regiona -ood and drugreguatory o--icers and regiona/eat/ /ysicists in everyregiona o--ice o- t/e DO1 s/ano4 be ut under t/e FDA@ssoe contro and suervision./e regiona -ied o--ice s/aaso assume rimary

/er assignedregion and 4/ere it aearst/at said items or roductssatis-y any o- t/e conditions asrovided -or in ection 33"a+ o-


37/40

Reubic Act 'o 3720, asamended, 4it/out re


38/40

Act ./erea-ter, suc/ sums as may benecessary -or its continuedimementation s/a be incuded int/e annua &enera Aroriations

Act

Section 22. Implementing Rulesand Regulatiorts. ./e DO1 s/aromugate, in consutation 4it/ t/eFDA, t/e imementing rues andreguations o- t/is Act 4it/in one/undred t4enty "20+ days a-ter t/eassage o- t/is Act

Section 2$. CongressionalOversight Committee. A

Congressiona Oversig/t Committee"COC+ is /ereby created comosed o-t/e C/airersons o- t/e Committeeson 1eat/ and Aroriations o- t/e1ouse o- Reresentatives and t4o "2+#embers to be aointed by t/eea9er, t/e C/airersons o- t/eCommittees on 1eat/ and Finance o-t/e enate and t4o "2+ #embers to/e aointed by t/e ?resident o- t/e

enate, to oversee t/eimementation o- t/is Act -or a eriodo- -ive "5+ years and to revie4 t/eaccomis/ments and t/e utii6ationo- income o- t/e FDA ./e secretariato- t/e COC s/a be dra4n -rom t/ee=isting ersonne o- t/e committeescomrising t/e COC

Section 24. Transitory Provisions../e FAD Director and Deuty

Director s/a serve as FDA Director&enera and Deuty Director&enera-or Fied Reguatory Oerations,resectivey ./e current o--icias andemoyees o- t/e FAD s/a betrans-erred as -ar as racticabe to t/earoriate unit in t/e FDA asdetermined by t/e Director&enera


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./e current o--icias and emoyeeso- t/e 1D. s/a be trans-erred tot/e Center -or Device Reguation,Radiation 1eat/, and Researc/ ./e

current regiona -ood and drugreguatory o--icers and regiona /eat//ysicists under t/e Centers -or1eat/ Deveoment o- t/e DO1 s/abe trans-erred as -ar as racticabe tot/e aroriate unit in t/e FDA asdetermined by t/e Director&enera./ere s/a be no demotion in ran9sand ositions and no diminution insaaries bene-its, ao4ances andemouments o- a FAD, 1D. and

indicated Center -or 1eat/ andDeveoment "C1D+ ersonnetrans-erred to t/e FDA A ositions,o4ers, -unctions and duties toget/er4it/ t/e -aciities, euiment,suies, records, -ies,aroriations, and -unds -or t/esebureaus and t/e indicated C1Dersonne s/a be trans-erred to t/eFDA

Section 25. Coverage. ./is Acts/a govern a /eat/roducts Provided, ./at not/ing int/is Act s/a be deemed to modi-yt/e soe and e=cusive


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arts t/ereo- 4/ic/ are not a--ectedt/ereby s/a remain in -u -orce ande--ect

Section 27. Repealing Clause.(a4s or art o- a4s, e=ecutiveorders, circuars, reguations andmemoranda inconsistent 4it/ t/is Actare /ereby reeaed or amendedaccordingy

Section 28. Effectivity Clause../is Act s/a ta9e e--ect -i-teen "5+days a-ter its ubication in t/e O--icia&a6ette or in t4o "2+ ne4saers o-

genera circuation

food, drugs, device and cosmetics acts v fda act

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