Republic of the Philippines

Congress of the Philippines

Metro Manila
Fourteenth Congress
Second Regular Session
Begun and held in Metro Manila, on Monday, the twenty-eighth day of July, two
thousand eight.
Republic Act No. 9711 August 18, !!9
AN AC" S"R#N$"%#N&N$ AN' RA"&(NA)&*&N$ "%# R#$+)A"(R,
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APPR(PR&A"&N$ F+N'S "%#R#(F
Be it enacted by the Senate and House of Representatives of the Philippines in
Congress assembled::
Section 1. The Bureau of Food and Drugs (BFAD) is hereby renaed the Food
and Drug Adinistration (FDA).
Section . This A!t shall be "nown as the 4Food and Drug Administration
(FDA) Act of 20094.
Section 3. #t is hereby de!lared a $oli!y of the %tate to ado$t, su$$ort, establish,
institutionali&e, i$ro'e and aintain stru!tures, $ro!esses, e!haniss and
initiati'es that are aied, dire!ted and designed to: (a) $rote!t and $roote the
right to health of the Fili$ino $eo$le( and (b) hel$ establish and aintain an
effe!ti'e health $rodu!ts regulatory syste and underta"e a$$ro$riate health
an$ower de'elo$ent and resear!h, res$onsi'e to the !ountry)s health needs
and $robles. *ursuant to this $oli!y, the %tate ust enhan!e its regulatory
!a$a!ity and strengthen its !a$ability with regard to the ins$e!tion, li!ensing and
onitoring of establishents, and the registration and onitoring of health
$rodu!ts.
Section 5. This A!t has the following ob+e!ti'es:
(a) To enhan!e and strengthen the adinistrati'e and te!hni!al !a$a!ity of
the FDA in the regulation of establishents and $rodu!ts under its
+urisdi!tion(
(b) To ensure the FDA)s onitoring and regulatory !o'erage o'er
establishents and $rodu!ts under its +urisdi!tion( and
(!) To $ro'ide !oheren!e in the FDA)s regulatory syste for
establishents and $rodu!ts under its +urisdi!tion.
Section 6. %e!tion , of -e$ubli! A!t .o. /012, as aended, is hereby further
aended to read as follows:
3%45. ,. To !arry out the $ro'isions of this A!t, there is hereby !reated an
offi!e to be !alled the Food and Drug Adinistration (FDA) in the
De$artent of 6ealth (D76). %aid Adinistration shall be under the 7ffi!e
of the %e!retary and shall ha'e the following fun!tions, $owers and duties:
3(a) To adinister the effe!ti'e i$leentation of this A!t and of the rules
and regulations issued $ursuant to the sae(
3(b) To assue $riary +urisdi!tion in the !olle!tion of sa$les of health
$rodu!ts(
3(!) To analy&e and ins$e!t health $rodu!ts in !onne!tion with the
i$leentation of this A!t(
3(d) To establish analyti!al data to ser'e as basis for the $re$aration of
health $rodu!ts standards, and to re!oend standards of identity, $urity,
safety, effi!a!y, 8uality and fill of !ontainer(
3(e) To issue !ertifi!ates of !o$lian!e with te!hni!al re8uireents to
ser'e as basis for the issuan!e of a$$ro$riate authori&ation and s$ot-
!he!" for !o$lian!e with regulations regarding o$eration of
anufa!turers, i$orters, e9$orters, distributors, wholesalers, drug outlets,
and other establishents and fa!ilities of health $rodu!ts, as deterined
by the FDA(
39 9 9
3(h) To !ondu!t a$$ro$riate tests on all a$$li!able health $rodu!ts $rior to
the issuan!e of a$$ro$riate authori&ations to ensure safety, effi!a!y, $urity,
and 8uality(
3(i) To re8uire all anufa!turers, traders, distributors, i$orters, e9$orters,
wholesalers, retailers, !onsuers, and non-!onsuer users of health
$rodu!ts to re$ort to the FDA any in!ident that reasonably indi!ates that
said $rodu!t has !aused or !ontributed to the death, serious illness or
serious in+ury to a !onsuer, a $atient, or any $erson(
3(+) To issue !ease and desist orders motu propio or u$on 'erified
!o$laint for health $roduts, whether or not registered with the
FDA Provided, That for registered health $rodu!ts, the !ease and desist
order is 'alid for thirty (/2) days and ay be e9tended for si9ty (:2) days
only after due $ro!ess has been obser'ed(
3(") After due $ro!ess, to order the ban, re!all, and;or withdrawal of any
health $rodu!t found to ha'e !aused the death, serious illness or serious
in+ury to a !onsuer or $atient, or is found to be iinently in+urious,
unsafe, dangerous, or grossly de!e$ti'e, and to re8uire all !on!erned to
i$leent the ris" anageent $lan whi!h is a re8uireent for the
issuan!e of the a$$ro$riate authori&ation(
3(l) To strengthen the $ost ar"et sur'eillan!e syste in onitoring health
$rodu!ts as defined in this A!t and in!idents of ad'erse e'ents in'ol'ing
su!h $rodu!ts(
3() To de'elo$ and issue standards and a$$ro$riate authori&ations that
would !o'er establishents, fa!ilities and health $rodu!ts(
3(n) To !ondu!t, su$er'ise, onitor and audit resear!h studies on health
and safety issues of health $rodu!ts underta"en by entities duly a$$ro'ed
by the FDA(
3(o) To $res!ribe standards, guidelines, and regulations with res$e!t to
inforation, ad'ertiseents and other ar"eting instruents and
$rootion, s$onsorshi$, and other ar"eting a!ti'ities about the health
$rodu!ts as !o'ered in this A!t(
3($) To aintain bonded warehouses and;or establish the sae, whene'er
ne!essary or a$$ro$riate, as deterined by the dire!tor-general for
!onfis!ated goods in strategi! areas of the !ountry es$e!ially at a+or
$orts of entry( and
3(8) To e9er!ise su!h other $owers and $erfor su!h other fun!tions a<
ay be ne!essary to !arry out its duties and res$onsibilities under this
A!t.3
Section 7. %e!tion = of -e$ubli! A!t .o. /012, as aended, is hereby further
aended and new subse!tions are added to read as follows:
3%45. =. The FDA shall ha'e the following !enters and offi!es:
3(a) The 5enters shall be established $er a+or $rodu!t !ategory that is
regulated, naely:
3(>) 5enter for Drug -egulation and -esear!h (to in!lude 'eterinary
edi!ine, 'a!!ines and biologi!als)(
3(1) 5enter for Food -egulation and -esear!h(
3(/) 5enter for 5oseti!s -egulation and -esear!h (to in!lude
household ha&ardous;urban substan!es)( and
3(,) 5enter for De'i!e -egulation, -adiation 6ealth, and -esear!h.
3These 5enters shall regulate the anufa!ture, i$ortation,
e9$ortation, distribution, sale, offer for sale, transfer, $rootion,
ad'ertiseent, s$onsorshi$ of, and;or, where a$$ro$riate, the use
and testing of health $rodu!ts. The 5enters shall li"ewise !ondu!t
resear!h on the safety, effi!a!y, and 8uality of health $rodu!ts, and
to institute standards for the sae.
3(b) 4a!h 5enter shall be headed by a dire!tor. The 5enters shall be so
organi&ed su!h that ea!h will ha'e, at least, the following di'isions:
3(>) ?i!ensing and -egistration Di'ision, whi!h shall be res$onsible
for e'aluating health $rodu!ts and establishents as !o'ered by this
A!t for the $ur$ose of issuan!e of authori&ations and !onditions to
be obser'ed(
3(1) *rodu!t -esear!h and %tandards De'elo$ent Di'ision, whi!h
shall be res$onsible for the !ondu!t of resear!h, de'elo$ent of
standards and regulations, !o$lian!e onitoring, and the o'ersight
and audit of related resear!hes that would ensure safety, 8uality,
$urity and effi!a!y of health $rodu!ts, as !o'ered in this A!t( and
3(/) ?aboratory %u$$ort Di'ision, whi!h shall be res$onsible for the
!ondu!t of resear!h and a$$ro$riate testa and !alibration, analyses
and trials of $rodu!ts in!luding, but not liited to, assays, and the
!ondu!t of o'ersight and;or audit of !enters !ondu!ting
bioa'ailability and bioe8ui'alen!e tests and other tests as !o'ered
by this A!t. #t shall li"ewise $ro'ide dire!t line su$$ort to the !enters
whi!h shall be se$arate and distin!t $er a+or $rodu!t !ategory that
is regulated.
3(!) The Adinistration and Finan!e 7ffi!e headed by the de$uty dire!tor-
general for adinistration and finan!e shall ha'e, at least, the following
di'isions: the 6uan -esour!e De'elo$ent Di'ision( *ro$erty and
?ogisti!s Manageent Di'ision( 6uan -esour!e Manageent Di'ision(
Assets and Finan!ial Manageent Di'ision( and the #nforation and
5ouni!ation Te!hnology Manageent Di'ision.
3(d) The *oli!y and *lanning 7ffi!e whi!h shall be under the 7ffi!e of the
Dire!tor-@eneral shall ha'e, at least, a training, ad'o!a!y and
!ouni!ations di'ision and shall onitor the $erforan!e of the !enters
for $rodu!t resear!h and e'aluation and standards de'elo$ent.
3(e) The Field -egulatory 7$erations 7ffi!e headed by the de$uty dire!tor-
general for field regulatory o$erations shall in!lude, aong others, all the
field offi!es, field or satellite laboratories and the regulatory enfor!eent
units.
3(f) The ?egal %er'i!es %u$$ort 5enter shall $ro'ide legal ser'i!es to the
entire FDA and shall be dire!tly under the 7ffi!e of the Dire!tor-@eneral.3
Section 7. %e!tion : of -e$ubli! A!t .o. /012, as aended, is hereby further
aended, to read as follows:
3(a) The FDA shall be headed by a dire!tor-general, with the ran" of
underse!retary, who shall be tas"ed, aong others, to deterine the
needed $ersonnel and to a$$oint $ersonnel, below the assistant dire!tor
le'el in !oordination with the %e!retary of 6ealth.
3(b) The dire!tor-general shall be assisted by two (1) de$uty dire!tors-
general, one for adinistration and finan!e and another for field regulatory
o$erations.
3(!) The dire!tor-general and de$uty dire!tors-general shall be a$$ointed
by the *resident of the -e$ubli! of the *hili$$ines.
3(d) The dire!tor-general shall, referably, $ossess either a uni'ersity
degree in edi!ine or at least the rele'ant aster)s degree in
$hara!euti!al s!ien!es or allied s!ien!es, or e8ui'alent e9e!uti'e !ourse
in any regulatory anageent. #n addition, he;she shall ha'e anageent
e9$erien!e in his;her field of dis!i$line or $rofession and in any
de'elo$ent, anufa!turing, regulatory wor" or 8uality assuran!e of
$rodu!ts as !o'ered in this A!t.
3(e) The De$uty Dire!tor-@eneral for Field -egulatory 7$erations of the
FDA shall, $referably, $ossess the rele'ant aster)s degree in
$hara!euti!al s!ien!es or allied s!ien!es, or e8ui'alent e9e!uti'e !ourse
in any regulatory anageent. #n addition, he;she shall ha'e anageent
e9$erien!e in his;her field of dis!i$line or $rofession and in any
de'elo$ent, anufa!turing, regulatoly wor" or 8uality assuran!e of
$rodu!ts as !o'ered in this A!t.
3(f) The De$uty Dire!tor-@eneral for Adinistration and Finan!e of the FDA
shall he a !ertified $ubli! a!!ountant or shall $ossess a aster)s degree in
a!!ounting, anageent, e!onoi!s or any business !ourse, and ust
ha'e anageent e9$erien!e in a $osition related to his;her field of
dis!i$line or $rofession.
3(g) A $erson who was $re'iously e$loyed in a regular full-tie !a$a!ity
regardless of its !onsultati'e designation at higher anageent
su$er'isory le'els in regulated establishents, in!luding related
foundations, shall be dis8ualified fro a$$ointent as dire!tor-general and
de$uty dire!tor-general within three (/) years fro terination of
e$loyent with the said establishent or foundation. All $ersons who are
!andidates for a$$ointent as dire!tor-general and de$uty dire!tor-general
ust dis!lose all their in!oes for the $ast three (/) years fro all
establishents regulated by this A!t. The dire!tor-general and the two (1)
de$uty dire!tors-gen!ral shall, u$on assu$tion into offi!e, de!lare any
!onfli!t of interest with any establishent !o'ered by the FDA, in!luding
their foundiitions.
3(h) 4a!h !enter and field offi!e shall be headed by a dire!tor dire!tor who
shall be assisted by an assistant dire!tor. These dire!tors shall be
a$$ointed by the %e!retary of 6ealth.
3(i) The e9isting dire!tors of the Bureau of 6ealth De'i!es and Te!hnology
(B6DT) and di'ision !hiefs of the BFAD shall be gi'en $referen!e for
a$$ointent as dire!tors and assistant dire!tors of their res$e!ti'e
!enters: Provided, That if the !urrent offi!ers of the BFAD and the B6DT
a$$lying for the abo'e $ositions la!" the re8uired third le'el !i'il ser'i!e
eligibility, they will ha'e to !o$ly with the said re8uireent within three (/)
yearn fro their a$$ointent, otherwise their a$$ointent shall be re'o"ed
iediately.3
Section 8. %e!tion 0 of -e$ubli! A!t .o. /012, as aended, is hereby further
aended to read as follows:
3The FDA shall re'iew its staffing $attern and $osition titles sub+e!t to the
a$$ro'al of the %e!retary of 6ealth.3
Section 9. %e!tion >2, subse!tions (a), (e), (f), (g), (h), (i), (8),(r), ('), and (w) of
-e$ubli! A!t .o. /012, as aended, are hereby further aended, and new
subse!tions (9), (y), (&), (aa), (bb), (!!), (dd), (ee), (ff), (gg), (hh), (ii), (++), (""), (ll),
and () are hereby added to read as follows:
3%45. >2. For the $ur$oses of this A!t, the ter:
3(a) )FDA) eans the Food and Drug Adinistration.
39 9 9
3(e) )Food) eans any $ro!essed substan!e whi!h is intended for huan
!onsu$tion and in!ludes drin" for an, be'erages, !hewing gu and any
substan!es whi!h ha'e been used as an ingredient in the anufa!ture,
$re$aration or treatent of food.
3(f) )Drug) eans: (>) arti!les re!ogni&ed in offi!ial $hara!o$eias and
forularies, in!luding offi!ial hoeo$athi! $hara!o$eias, or any
do!uentary su$$leent to any of the, whi!h are re!ogni&ed and
ado$ted by the FDA( (1) arti!les intended for use in the diagnosis, !ure,
itigation, treatent, or $re'ention of disease in an or other anials( (/)
arti!les (other than food) intended to affe!t the stru!ture of any fun!tion of
the body of huans or anials( or (,)arti!les intended for use as a
!o$onent of any arti!les s$e!ified in !lauses (>), (1), or (/) but do not
in!lude de'i!es or their !o$onents, $arts or a!!essories.
3(g) )De'i!e) eans edi!al de'i!es, radiation de'i!es and health-related
de'i!es.
3(>) )Medi!al de'i!e) eans any instruent, a$$aratus, i$leent,
a!hine, a$$lian!e, i$lant, in-'itro reagent or !alibrator, software,
aterial, or other siilar or related arti!le intended by the
anufa!turer to be used alone, or in !obination, for huan beings
for one or ore of the s$e!ifi! $ur$ose(s) of: diagnosis, $re'ention,,
onitoring, treatent or alle'iation of disease( diagnosis,
onitoring, treatent, alle'iation of, or !o$ensation for an in+ury(
in'estigation, re$la!eent, odifi!ation, or su$$ort of the anatoy
or of a $hysiologi!al $ro!ess( su$$orting or sustaining life(
$re'enting infe!tion( !ontrol of !on!e$tion( disinfe!tion of edi!al
de'i!es( and $ro'iding inforation for edi!al or diagnosti!
$ur$oses by eans of in-'itro e9aination of s$e!iens deri'ed
fro the huan body. This de'i!e does not a!hie'e its $riary
intended a!tion in or on the huan body by $hara!ologi!al,
iunologi!al, or etaboli! eans but whi!h ay be assisted in its
intended fun!tion by su!h eans.
3(1) )-adiation de'i!e) eans an ele!tri!al or ele!troni! a$$aratus
eitting any ioni&ing or non-ioni&ing ele!troagneti! or $arti!ulate
radiation( or any soni!( infrasoni!, or ultrasoni! wa'e. #t in!ludes
ioni&ing radiation eitting e8ui$ent whi!h is not intentionally
designed to $rodu!e radioa!ti'e aterials.
3(/) )6ealth-related de'i!e) eans any de'i!e not used in health !are
but has been deterined by the FDA to ad'ersely affe!t the health of
the $eo$le.
3(h) )5oseti!s) eans any substan!e or $re$aration intended to be
$la!ed in !onta!t with the 'arious e9ternal $arts of the huan body or with
the teeth and the u!ous ebranes of the oral !a'ity, with a 'iew
e9!lusi'ely or ainly to !leaning the, $erfuing the, !hanging their
a$$earan!e and;or !orre!ting body odor, and;or $rote!ting the body or
"ee$ing the in good !ondition.
3(i) )?abel) eans a dis$lay of written, $rinted, or gra$hi! atter u$on, the
iediate !ontainer of any arti!le and a re8uireent ade by or under
authority of this A!t that any word, stateent, or other inforation
a$$earing on the label shall not be !onsidered to be !o$lied with unless
su!h word, stateent, or other inforation also a$$ears on the outside
!ontainer or wra$$er, if any there be, of the retail $a!"age of su!h arti!le,
or easily legible through the outside !ontainer or wra$$er.
39 9 9
3(8) )Dire!tor-general) eans the head of the FDA.
3(r) )Distribute) eans the deli'ery or sale of any health $rodu!t for
$ur$oses of distribution in !oer!e, e9!e$t that su!h ter does not
in!lude the anufa!ture or retail of su!h $rodu!t.
39 9 9
3(') )Manufa!turer), in relation to a health $rodu!t, eans an establishent
engaged in any and all o$erations in'ol'ed in the $rodu!tion of health
$rodu!ts in!luding $re$aration, $ro!essing, !o$ounding, fornlating,
filling, $a!"ing, re$a!"ing, altering, ornaenting, finishing and labeling with
the end in 'iew of its storage, sale or distribution: Provided, That the ter
shall not a$$ly to the !o$ounding and filling of $res!ri$tions in drugstores
and hos$ital $hara!ies. A trader shall be !ategori&ed as a anufa!turer.
3(w) )Aeterinary drugs) eans drugs intended for use for anials in!luding
any drug intended for use in anial feeds but not in!luding anial feeds
within the !onte$lation of the i$leenting rules and regulations.
3(9) )Assay) is an analysis to deterine the (>) $resen!e of a substan!e
and the aount of that substan!e, or (1) the $hara!euti!al $oten!y of a
drug.
3(y) )Authori&ation) eans a $erission ebodied in a do!uent granted
by the FDA to a natural or +uridi!al $erson who has subitted an
a$$li!ation to i$leent the anufa!ture, i$ortation, e9$ortation, sale,
offer for sale, distribution, transfer, and;or, where a$$ro$riate, the use,
testing, $rootion, ad'ertising, or s$onsorshi$ of health $rodu!ts. The
authori&ation !an ta"e the for of a $erit, a li!ense, a !ertifi!ate of
registration, of a!!reditation, of !o$lian!e, or of e9e$tion, or any siilar
do!uent.
3(&) )Bioa'ailability) eans the rate and e9tent to whi!h the a!ti'e
ingredient or thera$euti! ingredient is absorbed fro a drug and be!oes
a'ailable at the site of drug a!tion.
3(aa) )Bioe8ui'alen!e) eans the rate and e9tent of absor$tion to whi!h the
drugs do not show a signifi!ant differen!e fro the rate and e9tent of the
listed drug when adinistered at the sae olar dose of the thera$euti!
ingredient under siilar e9$eriental !onditions in either a single dose or
ulti$le doses. Bioe8ui'alen!e shall also refer to the absen!e of a
signiti!ant differen!e on the rate and e9tent-to-whi!h the a!ti'e
ingredient(s) of the sa$le and referen!e drug be!oes a'ailable at the
site of drug a!tion when adinistered under the sae olar dose and
under siilar !onditions.
3(bb) )Distributor;i$orter;e9$orter) eans any establishent that i$orts
or e9$orts raw aterials, a!ti'e ingredients and;or finished $rodu!ts for its
own use or for wholesale distribution to other establishents or outlets. #f
the distributor;i$orter;e9$orter sells to the general $ubli!, it shall be
!onsidered a retailer.
3(!!) )Distributor;wholesaler) eans any establishent that $ro!ures raw
aterials, a!ti'e ingredients and;or finished $rodu!ts fro lo!al
establishents for lo!al distribution on wholesale basis.
3(dd) )4stablishent) eans a sole $ro$rietorshi$, a $artnershi$, a
!or$oration, an institution, an asso!iation, or an organi&ation engaged in
the anufa!ture, i$ortation, e9$ortation, sale, offer for sale, distribution,
donation, transfer, use, testing, $rootion, ad'ertising, or s$onsorshi$ of
health $rodu!ts in!luding the fa!ilities and installations needed for its
a!ti'ities.
3(ee) )Food;dietary su$$leent) eans a $ro!essed food $rodu!t intended
to su$$leent the diet that bears or !ontains one or ore of the following
dietary ingredients: 'itain, ineral, herb, or other botani!al, aino a!id,
and dietary substan!e to in!rease the total daily inta"e in aounts
!onforing to the latest *hili$$ine re!oended energy and nutrient
inta"es or internationally agreed iniu daily re8uireents. #t usually is
in the for of !a$sules, tablets, li8uids, gels, $owders or $ills and not
re$resented for use as a !on'entional food or as the sole ite of a eal or
diet or re$la!eent of drugs and edi!ines.
3(ff) )6ealth $rodu!ts) eans food, drugs, !oseti!s, de'i!es, biologi!als,
'a!!ines, in-'itro diagnosti! reagents and household;urban ha&ardous
substan!es and;or a !obination of and;or a deri'ati'e thereof. #t shall
also refer to $rodu!ts that ay ha'e an effe!t on health whi!h re8uire
regulations as deterined by the FDA.
3(gg) )6ousehold;urban ha&ardous substan!e) is:
3(>) Any substan!e or i9ture of substan!es intended for indi'idual
or liited $ur$oses and whi!h is to9i!, !orrosi'e, an irritant, a strong
sensiti&er, is flaable or !obustible, or generates $ressure
through de!o$osition, heat or other eans, if su!h substan!e or
i9ture of substan!es ay !ause substantial in+ury or substantial
illness during or as a $ro9iate result of any !ustoary or
reasonably foreseeable ingestion by !hildren, but shall not in!lude
agri!ultural fertili&er, $esti!ide, and inse!ti!ide, and other e!onoi!
$oisons, radioa!ti'e substan!e, or substan!es intended for use as
fuels, !oolants, refrigerants and the li"e(
3(1) Any substan!e whi!h the FDA finds to be under the !ategories
enuerated in !lause (>) of this $aragra$h(
3(/) Any toy or other arti!les intended for use by !hildren whi!h the
FDA ay deterine to $ose an ele!tri!al, !hei!al, $hysi!al, or
theral ha&ard( and
3(,) This ter shall not a$$ly to food, drugs, !oseti!s, de'i!es, or
to substan!es intended for use as fuels when stored in !ontainers
and used in the heating, !oo"ing or refrigeration syste of a house,
but su!h ter shall a$$ly to any arti!le whi!h is not in itself an
agri!ultural $esti!ide but whi!h is a ha&ardous substan!e, as
!onstrued in $aragra$h (>) of this se!tion, by reason of bearing or
!ontaining su!h harful substan!es des!ribed therein.
3(hh) )#n-'itro diagnosti! reagents) are reagents and systes intended for
use in the diagnosis of disease or other !onditions, in!luding a
deterination of the state of health, in order to !ure, itigate, treat or
$re'ent disease or its se8uelae.
3(ii) )?i!ensing) eans the $ro!ess of a$$ro'al of an a$$li!ation to o$erate
or establish an establishent $rior to engaging in the anufa!ture,
i$ortation, e9$ortation, sale, offer for sale, distribution, transfer, and
where a$$li!able the use, testing, $rootion, ad'ertiseent, and;or
s$onsorshi$ of health $rodu!ts.
3(++) )Misbranding) eans, in addition to definitions in e9isting laws,
isinforation or isleading inforation on the label or other inforation
aterials authori&ed by the FDA. #t shall not refer to !o$yright, tradear",
or other intelle!tual $ro$erty-li"e instruents.
3("") )-egistration) eans the $ro!ess of a$$ro'al of an a$$li!ation to
register health $rodu!ts $rior to engaging in the anufa!ture, i$ortation,
e9$ortation, sale, offer for sale, distribution, transfer, and where a$$li!able,
the use, testing, $rootion, ad'ertiseent, and;or s$onsorshi$ of health
$rodu!ts.
3(ll) )Trader) eans any establishent whi!h is a registered owner of a
health $rodu!t and $ro!ures the raw aterials and $a!"ing !o$onents
and $ro'ides the $rodu!tion onogra$hs, 8uality !ontrol standards and
$ro!edures, but sub!ontra!t the anufa!ture of su!h $rodu!t to a li!ensed
anufa!turer. #n addition, a trader ay also engage in the distribution
and;or ar"eting of its $rodu!ts.
3() )-etailer) eans any establishent whi!h sells or offers to sell any
health $rodu!t dire!tly to the general $ubli!.3
Section 1!. %e!tion >>, subse!tions (a), (b), (d), (g), (+),(") and (l) of -e$ubli! A!t
.o. /012, as aended, are hereby further aended to read as follows:
3%45. >>. The following a!ts and the !ausing thereof are hereby
$rohibited:
3(a) The anufa!ture, i$ortation, e9$ortation, sale, offering for sale,
distribution, transfer, non-!onsuer use, $rootion, ad'ertising, or
s$onsorshi$ of any health $rodu!t that is adulterated, unregistered or
isbranded.
3(b) The adulteration or isbranding of any health $rodu!t.
39 9 9
3(d) The gi'ing of a guaranty or underta"ing referred to in %e!tion twel'e
(b) hereof whi!h guaranty or underta"ing is false, e9!e$t by a $erson who
relied u$on a guaranty or underta"ing to the sae effe!t, signed by, and
!ontaining the nae and address of the $erson or entity fro who he
re!ei'ed in good faith the health $rodu!ts or the gi'ing of a guaranty or
underta"ing referred to in %e!tion twel'e (b) whi!h guaranty or underta"ing
is false.
39 9 9
3(g) The alteration, utilation, destru!tion, obliteration, or reo'al of the
whole or any $art of the labeling of, or the doing of any other a!t with
res$e!t to health $rodu!ts if su!h a!t is done while su!h arti!le is held for
sale (whether or not the first sale) and results in su!h arti!le being
adulterated or isbranded Provided, That a retailer ay sell in saller
8uantities, sub+e!t to guidelines issued by the FDA.
39 9 9
3(+) The anufa!ture, i$ortation, e9$ortation, sale, offering for sale,
distribution, transfer, non-!onsuer use, $rootion, ad'ertiseent, or
s$onsorshi$ of any health $rodu!t whi!h, although re8uiring registration, is
not registered. with the FDA $ursuant to this A!t.
3(") The anufa!ture, i$ortation, e9$ortation, sale, offering for sale,
distribution, transfer, or retail of any drug, de'i!e or in-'itro diagnosti!
reagent( the anufa!ture, i$ortation, e9$ortation, transfer or distribution
of any food, !oseti! or household;urban ha&ardous substan!e( or the
o$eration of a radiation or $est !ontrol establishent by any natural or
+uridi!al $erson without the li!ense to o$erate fro the FDA re8uired under
this A!t.
3(l) The sale, offering for sale, i$ortation, e9$ortation, distribution or
transfer of any health $rodu!t beyond its e9$iration or e9$iry date, if
a$$li!able.
39 9 9
3The $rohibited a!ts entioned herein shall !o'er all a$$li!able health
$rodu!ts.3
Section 11. %e!tion >1, subse!tion (a) of -e$ubli! A!t .o, /012, as aended, is
hereby further aended to read as follows:
3%45. >1. (a) Any $erson who 'iolates any of the $ro'isions of %e!tion
ele'en hereof shall, u$on !on'i!tion, suffer the $enalty of i$risonent
ranging fro one (>) year but not ore than ten (>2) years or a fine of not
less than Fifty thousand $esos (*=2,222.22) but not ore than Fi'e
hundred thousand $esos (*=22,222.22), or both, at the dis!retion of the
!ourt: Provided, That if the offender is a anufa!turer, i$orter or
distributor of any health $rodu!t, the $enalty of at least fi'e (=) years
i$risonent but not ore than ten (>2) years and a fine of at least Fi'e
hundred thousand $esos (*=22,222.22) but not ore than Fi'e illion
$esos (*=,222,222.22) shall be i$osed Provided, further, That an
additional fine of one $er!ent (>B) of the e!onoi! 'alue;!ost of the
'iolati'e $rodu!t or 'iolation, or 7ne thousand $esos (*>,222.22),
whi!he'er is higher, shall be i$osed for ea!h day of !ontinuing
'iolation: Provided, finally, That health $rodu!ts found in 'iolation of the
$ro'isions of this A!t and other rele'ant laws, rules and regulations ay be
sei&ed and held in !ustody $ending $ro!eedings, without hearing or !ourt
order, when the dire!tor-general has reasonable !ause to belie'e fro
fa!ts found by hi;her or an authori&ed offi!er or e$loyee of the FDA that
su!h health $rodu!ts ay !ause in+ury or $re+udi!e to the !onsuing
$ubli!.
39 9 9
3%hould the offense be !oitted by a +uridi!al $erson, the 5hairan of
the Board of Dire!tors, the $resident, general anager, or the $artners
and;or the $ersons dire!tly res$onsible therefore shall he $enali&ed.
3%hould the offense be !oitted by a foreign national, he;she shall, in
addition to the $enalties $res!ribed, be de$orted without further
$ro!eedings after ser'i!e of senten!e.
39 9 9.3
Section 1. %e!tion 1:, subse!tions (!) and (d) of -e$ubli! A!t .o. /012, as
aended, are hereby further aended and subse!tion (g) is hereby added
thereto to read as follows:
39 9 9
3(!) 6earings authori&ed or re8uired by this A!t shall be !ondu!ted by the
FDA.
3(d) C$on $reliinary findings of the !ondu!t of $rohibited a!t;s, the
dire!tor-general shall issue the $ro$er noti!es or orders to the $erson or
$ersons !on!erned and su!h $erson or $ersons shall be gi'en an
o$$ortunity to be heard before the FDA.
39 9 9
3(g) Both !riinal and adinistrati'e a!tions ay be instituted se$arately
and inde$endent of one another.3
Section 13. %e!tion 1D-A of -e$ubli! A!t .o. /012, as aended, is hereby
further aended, and new subse!tions are added to read as follows:
3%45. 1D-A. Administrative Sanctions. - Ehere there is finding of
$rohibited a!tions and deterination of the $ersons liable thereto, after
noti!e and hearing, the dire!tor-general is e$owered to i$ose one or
ore of the following adinistrati'e $enalties:
3(>) 5an!ellation of any authori&ation whi!h ay ha'e been granted by the
FDA, or sus$ension of the 'alidity thereof for su!h $eriod of tie as the
dire!tor-general ay dee reasonable whi!h shall not e9!eed one (>)
year:
3(1) A fine of not less than Fifty thousand $esos (*=2,222.22) but not ore
than Fi'e hundred thousand $esos (*=22,222.22). An additional fine of not
ore than 7ne thousand $esos (*>,222.22) shall be i$osed for ea!h day
of !ontinuing 'iolation( and
3(/) Destru!tion and;or a$$ro$riate dis$osition of the sub+e!t health
$rodu!t, and;or !losure of the establishent for any 'iolation of this A!t, as
deterined by the dire!tor-general.3
Section 15. A new %e!tion /2 and a new headnote 3Additional *owers and
Fun!tions of the Dire!tor-@eneral3 are hereby added to -e$ubli! A!t .o. /012,
whi!h shall read as follows:
3%45. /2. The Dire!tor-@eneral shall also e9er!ise the following $owers:
3(>) To hold in dire!t or indire!t !onte$t any $erson who disregards
orders or writs he or she issues and i$ose the a$$ro$riate $enalties
following the sae $ro!edures and $enalties $ro'ided in the -ules of
5ourt(
3(1) To adinister oaths and affirations and issue subpoena duces
tecum and subpoena ad testificandumre8uiring the $rodu!tion of su!h
boo"s, !ontra!ts, !orres$onden!e, re!ords, stateent of a!!ounts and
other do!uents and;or the attendan!e and testiony of $arties and
witnesses as ay be aterial to the in'estigation !ondu!ted by the FDA(
3(/) To obtain inforation fro any offi!er or offi!e of the national or lo!al
go'ernents, go'ernent agen!ies and its instruentalities(
3(,) To issue orders of sei&ure, to sei&e and hold in !ustody any arti!le or
arti!les of food, de'i!e, !oseti!s, household ha&ardous substan!es and
health $rodu!ts that is adulterated, !ounterfeited, isbranded or
unregistered, or drug, in-'itro diagnosti! reagent, biologi!als, and 'a!!ine
that is adulterated or isbranded, when introdu!ed into doesti!
!oer!e $ending the authori&ed hearing under -e$ubli! A!t .o. /012,
as aended, 49e!uti'e 7rder .o. >0= (>D<0), and -e$ubli! A!t .o. 0/D,,
otherwise "nown as the 5onsuers A!t of the *hili$$ines(
3(=) To !all on the assistan!e of any de$artent, offi!e or agen!y and
de$uti&e ebers of the *hili$$ine .ational *oli!e or any law
enfor!eent agen!y for the effe!ti'e i$leentation of this A!t( and
3(:) To e9er!ise su!h $owers and fun!tions as ay be ne!essary for the
effe!ti'e i$leentation of this A!t.3
Section 16. Two new se!tions shall be added, whi!h shall be the new %e!tions
/> and /1 of -e$ubli! A!t .o. /012, as aended, whi!h shall read as follows:
3%45. />. The orders, rulings or de!isions of the FDA shall be!oe final
and e9e!utory fifteen (>=) days after the re!ei$t of a !o$y thereof by the
$arty ad'ersely affe!ted unless within that $eriod, an adinistrati'e a$$eal
has been $erfe!ted. 7ne otion for re!onsideration ay be filled, whi!h
shall sus$end the running of the said $eriod.3
3%45. /1. The orders, rulings or de!isions of the FDA shall be a$$ealable
to the %e!retary of 6ealth. An a$$eal shall be deeed $erfe!ted u$on
filing of the noti!e of a$$eal and $osting of the !orres$onding a$$eal bond.
3An a$$eal shall not stay the de!ision a$$ealed fro unless an order fro
the %e!retary of 6ealth is issued to stay the e9e!ution thereof.3
Section 17. %e!tion /2 of -e$ubli! A!t .o. /012, as aended, shall be
renubered as %e!tion //, and the subse8uent se!tions shall also be
renubered a!!ordingly.
Section 17. %e!tion />, 5ha$ter F### of -e$ubli! A!t .o. /012, as aended, is
hereby further aended to read as follows:
3%45. /,. Fees and Other ncome. -
3(a) C$on the sole a$$ro'al of the %e!retary, the authori&ation and other
fees shall annually be deterined and re'iewed by the FDA and any
$ro$osed in!rease shall be $ublished in two (1) leading news$a$ers of
general !ir!ulation.
3(b) There shall be deterined and !onstituted additional fees su!h as sale
of $ubli!ations and ser'i!es, assessent fees, fines, $enalties, and other
fees and !harges outside the usual li!ensing and registration fees, to be
"nown as )other related regulatory fees).
3(!) The Dire!tor-@eneral of the FDA, u$on a$$ro'al of the %e!retary, shall
be authori&ed to $roulgate rules and regulations go'erning the !olle!tion
of the )other related regulatory fees). C$on a$$ro'al of the %e!retary, these
fees shall li"ewise be re'iewed $eriodi!ally and any $ro$osed in!rease
shall be $ublished in two (1) leading news$a$ers of general !ir!ulation.3
Section 18. All in!oe that the FDA is allowed to retain under %e!tion /> of the
Cni'ersally A!!essible 5hea$er and Guality Medi!ines A!t of 122< shall, any
$ro'ision of law to the !ontrary notwithstanding, be de$osited in an authori&ed
go'ernent de$ository ban" as a s$e!ial regulatory fund. Any interest earned by
su!h fund shall for $art of the retained in!oe. %u!h fund shall be used
$riarily for the a!8uisition of offi!e and laboratory s$a!e, huan resour!e
de'elo$ent and e9$ansion, $ur!hase of laboratory e8ui$ent and otor
'ehi!les, the u$grading of its !urrent fa!ilities and e8ui$ent and aintenan!e,
other o$erating e9$enses ofthe !entral offi!e laboratory di'isions and satellite
laboratories in Da'ao, 5ebu and other testing laboratories, in !ase the abo'e
laboratories will be in!reased, and other a!ti'ities or ser'i!es of the agen!y in the
$erforan!e of its andate.
The fund shall be allowed to a!!e$t grants, donations and all other endowents
fro lo!al and e9ternal sour!es in a!!ordan!e with $ertinent laws, rules and
regulations.
The retention, use and a$$li!ation of this fund shall not be delayed, aended,
altered or odified, or affe!ted in any way by an order or dire!ti'e fro any
e9e!uti'e offi!e, but will be sub+e!t only to the general a!!ounting rules and
guidelines by the 5oission on Audit (57A). The $riary $ur$ose of the fund
as herein stated shall $re'ail o'er any other $ur$ose that ay be $ursued by the
FDA on its own initiati'e or through an order or dire!ti'e by any higher offi!e. The
FDA shall subit to the %e!retary of 6ealth, the %e!retary of Budget and
Manageent and the 5ongressional 7'ersight 5oittee, !reated under
%e!tion 1/ of this A!t, a re$ort on how the funds were utili&ed, in!luding its
a!!o$lishents.
There shall also be established a legal fund out of the interest earned fro the
retained in!oe for use in !ase of legal a!tions against the offi!ials and
e$loyees of the FDA in the !ourse of the e9er!ise of their offi!ial fun!tions and
duties.
Section 19. The FDA shall establish a -egulatory 4nfor!eent Cnit (-4C) for a
$eriod not e9!eeding fi'e (=) years fro the effe!ti'ity of this A!t. #t shall be
!o$osed of at least fi'e (=) 8ualified $ersonnel in e'ery region who shall be
dire!tly under the !ontrol and su$er'ision of the De$uty Dire!tor-@eneral for
Field -egulatory 7$erations and shall be adinistrati'ely su$$orted by the field
offi!es. They shall:
(a) Bear ars, wear offi!ial unifors and insignias and shall be !lassified
as law enfor!eent agents(
(b) %er'e and e9e!ute rulings, orders, and de!isions of the Dire!tor-
@eneral of the FDA( and
(!) 49e!ute and ser'e sear!h warrants and arrest warrants issued by the
!ourts in !onne!tion with 'iolations under this A!t and related laws
!on!erning the regulation of health $rodu!ts.
All law enfor!eent agents shall undergo the a$$ro$riate training to e8ui$ the
with the ne!essary s"ills needed for this $ur$ose. Their authority and fun!tions
shall be stri!tly liited to the i$leentation of the FDA)s regulatory fun!tions.
All regional regulatory enfor!eent units shall be headed by a lawyer who is at
least thirty (/2) years old but not older than fifty (=2), an #ntegrated Bar of the
*hili$$ines (#B*) eber of good standing, and shall ha'e a ran" of a Di'ision
Dire!tor( and an assistant who ust be at the 'ery least a law graduate who shall
ha'e a ran" of an Assistant Di'ision Dire!tor.
Section !. A new !ha$ter F#A and three new se!tions, %e!tions /=, /:, and /0
shall be introdu!ed, whi!h shall read as follows:
4C%AP"#R 8&2
4"#S"&N$ )A-(RA"(R&#S AN' F&#)' (FF&C#S
3%45. /=. The FDA is hereby andated to i$ro'e, u$grade and in!rease
the !a$ability of the agen!y, to test, !alibrate, assay and e9aine sa$les
of health $rodu!ts. For the $ur$ose of a!hie'ing the abo'e andate, there
shall be established at least one (>) testing laboratory ea!h in ?u&on,
Aisayas and Mindanao, whi!h shall ha'e the ne!essary and a$$ro$riate
state-of-the-art laboratory e8ui$ent and $ersonnel !o$leent. The
ain testing laboratories at the !entral offi!e shall be aintained and shall
ser'e as a su$$ort unit to the !enters for $rodu!t resear!h and e'aluation
and standards de'elo$ent and shall ser'e as testing !enters that would
in!lude assay and the !ondu!t, su$er'ision, o'ersight and;or audit of
bioe8ui'alen!e and bioa'ailability test;resear!hes, aong others. The
e9isting laboratories in 5ebu and Da'ao will be u$graded and transfored
as 8uality assuran!e laboratories, while another one will be established in
%ubi!, Habales.
3The testing laboratories ay be in!reased by the dire!tor-general, u$on
a$$ro'al of the %e!retary. Moreo'er, the dire!tor-general, u$on a$$ro'al of
the %e!retary, ay !all u$on other go'ernent and $ri'ate testing
laboratories to !ondu!t testing, !alibration, assay and e9aination of
sa$les of health $rodu!ts: Provided, That the $ri'ate testing laboratories
are a!!redited by the *hili$$ine A!!reditation 7ffi!e (*A7) of the
De$artent of Trade and industry (DT#) and the D76.3
3%45. /:. The FDA shall establish field offi!es in all regions of the !ountry
to effe!ti'ely i$leent its regulatory fun!tions. The !urrent regional food
and drug regulatory offi!ers and regional health $hysi!ists in e'ery regional
offi!e of the D76 shall now be $ut under the FDA)s sole !ontrol and
su$er'ision. The regional field offi!e shall also assue $riary +urisdi!tion
in the !olle!tion of sa$les of food, drugs, de'i!es and !oseti!s being
i$orted or offered for i$ort at a $ort of entry other than Manila in his;her
assigned region and where it a$$ears that said ites or $rodu!ts satisfy
any of the !onditions as $ro'ided for in %e!tion //(a) of -e$ubli! A!t .o.
/012, as aended, without $re+udi!e to the e9er!ise of the $owers of the
dire!tor-general $ro'ided under %e!tions >/ and >, of this A!t in the
e9er!ise of the agen!y)s regulatory fun!tions. The field offi!es shall be
!o$rised of the following: (a) li!ensing, ins$e!tion and !o$lian!e
di'ision, whi!h shall ha'e !harge of the ins$e!tion of food, drugs and
!oseti! establishents engaged in their anufa!ture, i$ortation,
distribution, and sale( (b) satellite laboratory di'ision( and (!) adinistrati'e
di'ision.3
3%45. /0. The FDA, with the a$$ro'al of the %e!retary, shall !reate
organi&ational units whi!h are deeed ne!essary to address eerging
!on!erns and to be abreast with internationally a!!e$table standards.
There shall be !reated additional $lantilla $ositions to augent the huan
resour!e !o$leent of the FDA, sub+e!t to e9isting rules and
regulations.3
Section 1. Appropriations. - The a$$ro$riations for the BFAD and the B6DT
in!luded in the budget of the D76 under the !urrent @eneral A$$ro$riations A!t
shall be used to !arry out the i$leentation of this A!t. The a$$ro$riation ay
be augented by the in!oe whi!h the agen!y is authori&ed to use under this
A!t. Thereafter, su!h sus as ay be ne!essary for its !ontinued
i$leentation shall be in!luded in the annual @eneral A$$ro$riations A!t.
Section . Implementing Rules and Regulatiorts. - The D76 shall
$roulgate, in !onsultation with the FDA, the i$leenting rules and regulations
of this A!t within one hundred twenty (>12) days after the $assage of this A!t.
Section 3. Congressional Oversight Committee. - A 5ongressional 7'ersight
5oittee (575) is hereby !reated !o$osed of the 5hair$ersons of the
5oittees on 6ealth and A$$ro$riations of the 6ouse of -e$resentati'es and
two (1) Mebers to be a$$ointed by the %$ea"er, the 5hair$ersons of the
5oittees on 6ealth and Finan!e of the %enate and two (1) Mebers to he
a$$ointed by the *resident of the %enate, to o'ersee the i$leentation of this
A!t for a $eriod of fi'e (=) years and to re'iew the a!!o$lishents and the
utili&ation of in!oe of the FDA. The se!retariat of the 575 shall be drawn fro
the e9isting $ersonnel of the !oittees !o$rising the 575.
Section 5. ransitor! "rovisions. - The BFAD Dire!tor and De$uty Dire!tor
shall ser'e as FDA Dire!tor-@eneral and De$uty Dire!tor-@eneral for Field
-egulatory 7$erations, res$e!ti'ely. The !urrent offi!ials and e$loyees of the
BFAD shall be transferred as far as $ra!ti!able to the a$$ro$riate unit in the FDA
as deterined by the Dire!tor-@eneral. The !urrent offi!ials and e$loyees of
the B6DT shall be transferred to the 5enter for De'i!e -egulation, -adiation
6ealth, and -esear!h. The !urrent regional food and drug regulatory offi!ers and
regional health $hysi!ists under the 5enters for 6ealth De'elo$ent of the D76
shall be transferred as far as $ra!ti!able to the a$$ro$riate unit in the FDA as
deterined by the Dire!tor-@eneral. There shall be no deotion in ran"s and
$ositions and no diinution in salaries. benefits, allowan!es and eoluents of
all BFAD, B6DT and indi!ated 5enter for 6ealth and De'elo$ent (56D)
$ersonnel transferred to the FDA. All $ositions, $owers, fun!tions and duties
together with the fa!ilities, e8ui$ent, su$$lies, re!ords, files, a$$ro$riations,
and funds for these bureaus and the indi!ated 56D $ersonnel shall be
transferred to the FDA.
Section 6. Coverage. - This A!t shall go'ern all health $rodu!ts: Provided, That
nothing in this A!t shall be deeed to odify the sole and e9!lusi'e +urisdi!tion
of other s$e!iali&ed agen!ies and s$e!ial laws only insofar as the a!ts !o'ered
by these s$e!iali&ed agen!ies and laws, in!luding, but not liited to, those
!o'ered by -e$ubli! A!t .o. D1>>, 49e!uti'e 7rder .o. 1,=, 49e!uti'e 7rder
.o. ><, and *residential De!ree .o. >,:<.
Section 7. #epara$ilit! Clause. - #f any $art, se!tion or $ro'ision of this A!t
shall be de!lared in'alid or un!onstitutional, other $ro'isions or $arts thereof
whi!h are not affe!ted thereby shall reain in full for!e and effe!t.
Section 7. Repealing Clause. - ?aws or $art of laws, e9e!uti'e orders,
!ir!ulars, regulations and eoranda in!onsistent with this A!t are hereby
re$ealed or aended a!!ordingly.
Section 8. %ffectivit! Clause. - This A!t shall ta"e effe!t fifteen (>=) days after
its $ubli!ation in the 7ffi!ial @a&ette or in two (1) news$a$ers of generhl
!ir!ulation.
A$$ro'ed,
(%gd.) PR(SP#R( C.
N($RA)#S
%$ea"er of the 6ouse of
-e$resentati'es
(%gd.) 9+AN P(NC#
#NR&)#
*resident of the %enate
This A!t whi!h is a !onsolidation of %enate Bill .o. 1:,= and 6ouse Bill .o. /1D/
was finally $assed by the %enate and the 6ouse of -e$resentati'es on June /,
122D.
(%gd.) 1AR&),N -. -AR+A:
,AP
%e!retary @eneral
6ouse of -e$resenati'es
(%gd.) #11A )&R&(:R#,#S
%e!retary of %enate
A$$ro'ed: A+$ 18 !!9
(%gd.) $)(R&A 1ACAPA$A):ARR(,(
President of the Philippines