H. No. 5 6 1 6 S. No. 2436

Begun and held in IVletro Manila, on Monday, the twenty-seventh day of July, two thousand fifteen.

[ R E P U B L I C A C T NO .10918 I

A N A C T R E G U L A T I N G A N D M O D E R N I Z I N G T H E P R A C H C E

O F P H A R M A C Y I N T H E P H I L I P P I N E S , R E P E A L I N G

F O R T H E P U R P O S E R E P U B L I C A C T N U M B E R E D

F I V E T H O U S A N D N I N E H U N D R E D T W E N T Y - O N E

( R . A . N O . 5 9 2 1 ) , O T H E R W I S E K N O W N A S T H E

P H A R M A C Y L A W

B e it e n a c t e d b y the S e n a t e and H o u s e o f R e p r e s e n t a t i v e s o f the Philippines in C o n g r e s s assembled:

A R T I C L E I

G E N E R A L P R O V I S I O N S

S E C T I O N 1 . T i t l e . - T h i s A c t s h a l l b e k n o w n a s t h e " P h i l i p p i n e P h a r m a c y A c t " .

S E C . 2 . S t a t e m e n t o f P o l i c y . - T h e S t a t e r e c o g n i z e s t h e v i t a l r o l e o f p h a r m a c i s t s i n t h e d e l i v e r y o f q u a l i t y h e a l t h c a r e s e r v i c e s t h r o n g t h e p r o v i s i o n o f s a f e , e f f e c t i v e , a n d q u a l i t y

2

phar

mace

utic

al pr

oduc

ts,

phar

mace

utic

al ca

re,

drug

in

form

atio

n,

patient

medication

coun

seli

ng,

and

health

promotion.The

phar

maci

sts'

pr

ofes

sion

al se

rvic

es

shall,

ther

efor

e, be

pr

omot

ed

as an

indi

spen

sabl

e co

mpon

ent

of t

he

tota

l health

care

sy

stem

to

en

sure

the

phys

ical

we

ll-b

eing

of

the

Fi

lipi

nos.

.

Henc

e,

the

State

shall

develop

and

nurture

comp

eten

t,

prod

ucti

ve,

mora

lly

upri

ght,

and

weU

-roi

mded

ph

arma

cist

s wh

ose

stan

dard

s of

pro

fess

iona

l pr

acti

ce and

serv

ice

shall be

ex

cell

ent

and

glob

ally

co

mpet

itiv

e th

roug

h re

gula

tory

mea

sure

s,

prog

rams

, and

activities

that

promote

and

sustain

their

continuing

prof

essi

onal

de

velo

pmen

t.

SEC.

3.

Objec

tives

. -

This

Act

pro

vide

s fo

r an

d sh

all

gove

rn

the:

(a)

Stan

dard

izat

ion

and

regi

dati

on o

f ph

arma

cy

educ

atio

n;

(b)

Admi

nist

rati

on o

f li

cens

ure

exam

inat

ion,

reg

istr

atio

n,

and

lice

nsin

g of

ph

arma

cist

s;

\ (c

) Su

perv

isio

n, c

ontr

ol,

and

regulation

of t

he

prac

tice

of

pharmacy

in

the

Phih

ppin

es;

(d)

Development

and

enhancement

of

professional

competence

of pl

iair

maci

sts

through

continuing

prof

essi

onal

de

velo

pmen

t,

rese

arch

, and

othe

r re

late

d ac

tivi

ties

; and

(e)

Inte

grat

ion

of t

he pharmacy

prof

essi

on.

SEC.

4.

Sco

peo

f th

e P

ract

ice

of P

ha

rma

cy

. -

A pe

rson

is

deemed

to

be pr

acti

cing

ph

arma

cy,

within

the

meaning

of this

Act,

when

with

or without

a fe

e,

sala

ry,

perc

enta

ge

or

othe

r re

ward

s, pa

id or

gi

ven

dire

ctly

or

indi

rect

ly,

shall:

(a)

Prep

are,

co

mpou

nd

or manufacture,

pres

erve

, st

ore,

di

stri

bute

, pr

ocur

e, se

U, o

r di

spen

se,

or b

oth,

any

phar

mace

utic

al

prod

uct

or it

s raw

materials;

or

(b)

Rend

er

serv

ices

, su

ch as

cU

nica

l pharmacy

serv

ices

, drug

info

rmat

ion

serv

ices

, regulatory

serv

ices

, ph

arma

ceut

ical

ma

rket

ing,

me

dica

tion

ma

nage

ment

, or

wh

enev

er the

expe

rtis

e and

tecl

inic

al k

nowl

edge

of

the

pharmacist

is r

equi

red;

or

3

(c)

Enga

ge in

teac

hing

sc

ient

ific

, te

chni

cal,

or

pr

ofes

sion

al

pharmacy

courses

in

a sc

hool

or

co

lleg

e of

pharmacy;

or

(d)

Dispense

pharmaceutical

products

in

situations

where

supe

rvis

ion

of di

spen

sing

of

pharmaceutical

prod

ucts

is

req

tdre

d; or

(e)

Chem

ical

, bi

olog

ical

or

mi

crob

iolo

gica

l an

alys

es

and

assa

y of

pharmaceutical

prod

ucts

, fo

od/d

ieta

ry

supp

leme

nts,

he

alth

su

pple

ment

s,

and

cosm

etic

s;

or

(f)

Phys

ico-

chem

ical

an

alys

es fo

r me

dica

l de

vice

s us

ed

in aid

of a

dmin

istr

atio

n of

pha

rmac

euti

cal

prod

ucts

; or

(g)

Admuiistration

of adult

vaccines

as ap

prov

ed

by

the

Food

^and

Drug

Administration

(FDA):

Pro

vid

ed,

That

they

shal

l un

derg

o the

training

on

the

safe

ad

mini

stra

tion

of

adult

vaccines

and

management

of

adverse

event

following

immunization

(AEFI)

for

phar

maci

sts

and

hold

a

cert

ific

ate

of

training

issued

by

an

institution

duly

accr

edit

ed

by

the

Prof

essi

onal

Regulation

Commission

(PRC

): P

rovi

ded

, fa

rth

er,

That

the

safe

administration

of vaccines

be part

of the

higher

educ

atio

n curriculum

for

phar

maci

sts;

or

(h)

Conduct

or

undertake

scie

ntif

ic

research

in

all

aspe

cts

involving pharmaceutical

prod

ucts

and

health

care

; or

(i)

Prov

ideo

ther

serv

ices

wher

epha

rmac

euti

calk

nowl

edge

is

re

quir

ed.

Acti

viti

es under

para

grap

hs

(a),

(b

), (c

),

(d)

and

(i)

are

excl

usiv

e to

hcensed

phar

maci

sts.

Ho

weve

r,

nothing

herein

shal

l be

co

nstr

ued

as

requiring

othe

r pe

rson

s carrying

out

only

the

acti

viti

es under

para

grap

hs

(e),

(f

), (g

) and

Qx)

to

be

lice

nsed

pharmacists,

subj

ect

to

any

qualification

that

is

impo

sed

by ot

her

laws

with

resp

ect

to su

ch p

arti

cula

r ac

tivi

ty.

All

pharmacists

are

expected

to

abid

e by

current

standards

such

as

the

Philippine

Prac

tice

Standards

for

Pharmacists,

Good

Laboratory

Prac

tice

, Good

Distribution

Prac

tice

, Good

Manufacturing

Prac

tice

and

Good

Clinical

Prac

tice

, which

are

deemed

vita

l in

the

perf

orma

nce

of

their

role

s and

func

tion

s in

diff

eren

t pr

acti

ce

area

s.

4

The

Professional

Regulatory

Board

of

Pharmacy,

hereinafter

created,

subject

to

the

approval

of

the

PRC,

as

provided

for

by

Republic

Act

No.

8981,

otherwise

known

as

the

"PRC

Modernization

Act

of 20

00",

and

in

consultation

with

the

integrated

and

accredited

professional

organization

(APO),

may

modify

the

above-enumerated

acts

, se

rvic

es,

or

acti

viti

es,

as the

need

aris

es,

in

orde

r to

conform

to

the

latest

treads

and

developments

in

the

practice

of

the

pharmacy

prof

essi

on:

Pro

vid

ed

, That

such

modifications

are

cons

iste

nt

with

the

enumeration

above.

SEC.

5.

De

fin

itio

n o

f T

erm

s.

- As

used

in

this

Ac

t:

(a)

Ac

cre

dit

ed

pro

fes

sio

na

l o

rga

niz

ati

on

, (A

PO

) refers

to the

duly

integrated

and

accr

edit

ed

professional

organization

of

registered

and

lice

nsed

pharmacists,

of

which

there

shall

be

only

one

(1),

as

pr

escr

ibed

under

Sect

ion

41,

Article

V of

this

Act;

(b)

Ad

ult

vac

cin

es

refer

to ce

rvic

al cancer,

flu

(inf

luen

za),

y pneumococcal,

other

pre-exposure

prophylactic

vaccines

to

' be

administered

to

patients

aged

eighteen

(18)

years

and

above,

and

such

other

vaccines

as may

be

defined

by

the

Department

of

Health

(DOH)

in

an

administrative

issu

ance

;

(c)

Ad

ult

era

ted

/De

teri

ora

ted

ph

arm

ac

eu

tic

al

pro

du

cts

refe

r to

pharmaceutical

prod

ucts

xu

ifit

fo

r human

cons

umpt

ion,

following

the

standards

of

quahty

or

purity

of

which,

are

as

those

stated

in

the

Un

ite

d S

tate

s P

ha

rma

co

pe

ia/N

ati

on

al

Fo

rmu

lary

and

Ph

ilip

pin

e P

ha

rma

co

pe

ia i

n its

latest

edition

or

any

standard

refe

renc

e fo

r drugs

and

medi

cine

s which

are

given

official

recognition

as

well

as

those

provided

for

in

RepubKc

Act

No.

3720

, otherwise

known

as

the

"Foo

d,

Drug,

and

Cosmetic

Act",

as

amended,

and

Republic

Act

No.

9711,

known

as the

"Food

and

Drug

Administration

Act

of

2009

";

(d)

Bio

ph

arm

ac

eu

tic

als r

efer

to

pharmaceutical

prod

ucts

that

are

used

for

therapeutic

or

for

in v

ivo

diag

nost

ic

purp

oses

, such

as

vaccines,

sera,

and

drugs

derived

from

li

fe

forms

using

biot

echn

olog

y.

These

include

proteins,

nucl

eic

acids,

or

living

microorganisms

where

the

virulence

is

reduced

and

are

used

for

therapeutic

or for

in v

ivo

diag

nost

ic

purp

oses

;

s

(e)

Br

an

d n

am

e refers

to

the

proprietary

name

given

by

the

manufacturer

to

distinguish

its

product

from

those

of

comp

etit

ors;

(0

Cip

he

r,

Co

de,

or

Sec

ret

Key

refers

to

a method

of

secret

writing

or

use

of

characteristic

style

or

symbol

by

subs

titu

ting

other

lett

er/s

or

ch

arac

ter/

s fo

r the

lett

er/s

intended,

for

the

purpose

of

misleading

the

cons

umer

;

(g)

Co

mp

ou

nd

ing

refe

rs to

the

sum

of p

rocesses

performed

by a

pharmacist

in

drug

preparation

including

the

calculations,

mixing,

assembhng,

packaging,

or labeling

of

a drug:

(i)

as

the

result

of

a prescription

or drug

orde

r by

a physician,

dentist,

or

veteriaarian;

or (i

i) f

or the

purpose

of,

or i

n relation

to,

research,

teaching,

or

chemical

analysis;

(h)

Co

nti

nu

ing

pro

fes

sio

na

l d

ev

elo

pm

en

t (C

PD

) refers

to

the

inculcation

of

advanced

knowledge,

sMlls,

and

ethical

values

in

a post-licensure

specialized

or

in

an

inter-

or

multidisciplinary

field

of

study

for

assimilation

into

professional

prac

tice

, self-directed

research,

and/or

lifelong

learning;

/

(i)

Co

sm

eti

cs

refer.to

a substance

or

preparation

intended

to

be

placed

in

contact

with

the

various

external

parts

of the

human

body

or

with

the

teeth

and

the

mucous

membranes

of

the

oral

cavity,

with

a view

exclusively

or

msdnly

to cleaning

them,

perfuming

them,

changing

their

appearance

and/or

correcting

body

odor,

and/or

protecting

the

body

or

keeping

them

in

good

condition,

as de

fine

d under

Republic

Act

No.

9711;

® C

ou

nte

rfe

it

ph

ar

ma

ce

ut

ica

l pro

du

cts

refer

to

pharmaceutical

products

which

do

not

contain

the

amounts

as claimed;

with

wrong

ingredients;

without

acti

ve

ingredients;

or with

insxifficient

quantity

of

acti

ve ingredients,

which

result

in

the

reduction

of

the

prod

ucts

' sa

fety

, ef

fica

cy,

quality,

strength,

or

purity.

These

also

refer

to

prod

ucts

that

are

deliberately

and

fraudulently

mislabeled

with

respect

to

identity

and/or

source

or

with

fake

packaging,

and

can

apply

to

both

branded

and

gene

ric

prod

ucts

, including

the

following:

6

(1)

The

pharmaceutical

prod

uct

itse

lf or

the

cont

aine

r or

la

beKn

g th

ereo

f or

any

part

of su

ch

prod

uct,

co

ntai

ner,

or

la

behn

g,

bear

ing

without

authorization;

the

trademark,

trad

e na

me,

or ot

her

iden

tifi

cati

on m

arks

or imprints

or any

like

ness

to

that

which

is o

wned

or re

gist

ered

in

the

Inte

llec

tual

Pr

oper

ty

Offi

ce (I

PO)

in

the

name

of an

othe

r na

tura

l or

juridical

pers

on;

(2)

A ph

arma

ceut

ical

pr

oduc

t re

fill

ed i

n co

ntai

ners

be

arin

g le

giti

mate

la

bels

or

marks,

without

auth

orit

y;

and

(3)

A ph

arma

ceut

ical

pr

oduc

t which

cont

ains

no

amount

of or

a

diff

eren

t ac

tive

in

gred

ient

; or

le

ss than

eigh

ty

perc

ent

(80%

) of

the

acti

ve

ingredient

it

purports

to possess,

as

dist

ingu

ishe

d fi

rom

an

adxi

lter

ated

drug

incl

udin

g re

duct

ion

or lo

ss o

f ef

fica

cy

due

to

expi

rati

on;

(k)

Da

ng

ero

us

dru

gs

refer

to

those

listed

in

the:

(1)

Schedules

annexed

to

the

1961

Single

Convention

on

Narc

otic

Dr

ugs,

as

am

ende

d by

the

1972

Pr

otoc

ol;

(2)

Schedules

'ann

exed

to

the

1971

Single

Convention

on

Psychotropic

Subs

tanc

es;

and

(3)

Annex

of Repubhc

Act

No.

9165

, ot

herw

ise

^kno

wn as

the

"Com

preh

ensi

ve

Dang

erou

s Drugs

Act

of

2002

",

and

its

amen

dmen

ts;

® D

isp

ensi

ng

refe

rs to

the

sum

of processes

perf

orme

d by

a

pharmacist

from

read

ing,

vahdating,

and

interpreting

pres

crip

tion

s;

prep

arin

g; pa

ckag

ing;

la

behn

g;

reco

rd

keep

ing;

do

se c

alcu

lati

ons;

an

d co

imse

hng

or gi

ving

inf

orma

tion

, in

re

lati

on

to t

he s

ale

or t

i'an

sfer

of

phar

mace

utic

al pr

oduc

ts,

with

or

wi

thou

t a

pres

crip

tion

or

me

dica

tion

or

der;

(m)

Dru

gs

refertopharmaceuticalproductsthatpe.rtain

to ch

emic

al compounds

or b

iolo

gica

l su

bsta

nces

, ot

her

than

food

, intended

for

use

ui

the

treatment,

prev

enti

on,

or di

agno

sis

of

dise

ase

in

hiimans

or an

imal

s, i

nclu

ding

th

e fo

llow

ing:

(1)

Any

article

recognized

in

the

official

Un

ite

d S

tate

s P

ha

rma

co

pe

ia/N

ati

on

al F

orm

ula

ry,

Ho

me

op

ath

ic

Ph

arm

ac

op

eia

of

th

e U

nit

ed

Sta

tes

of

Am

eri

ca

, P

hil

ipp

ine

Ph

arm

ac

op

eia

, P

hil

ipp

ine

Na

tio

na

l D

ru

g F

orm

ula

ry,

Bri

tis

h P

ha

rma

co

po

eia

, E

ur

op

ea

n P

ha

rma

co

po

eia

, J

ap

an

es

e P

ha

rma

co

po

eia

, and

any

official

compendium

or any

supp

leme

nt

to

them;

(2)

Any

article

intended

for

use

in

diag

nosi

s,

cure

, mi

tiga

tion

, tr

eatm

ent,

or

prev

enti

on o

f di

seas

e of

manor

anim

als;

(3)

Any

arti

cle,

other

than

food

, intended

to

affe

ct

the

stru

ctur

e or

any

function

of th

e human

body

or

animals;

(4)

Any

arti

cle

inte

nded

fo

r us

e, as

a

comp

onen

t of

ar

ticl

es,

spec

ifie

d in

clau

ses

(1),

(2

) and

(3),

not

inc

ludi

ng de

vice

s or

their

comp

onen

ts,

part

s and

acce

ssor

ies;

an

d

(5)

Herbal

or tr

adit

iona

l dr

ugs

as de

fine

d in

Repubhc

Act

No.

9502

;

(n)

Em

erg

ency

ca

ses

refe

r to

Hf

e-th

reat

enin

g si

tuat

ions

wh

ere

apat

ient

nee

ds i

mmed

iate

me

dica

l at

tent

ion

and

trea

tmen

t,

incl

udin

g the

occurrence

of ep

idem

ic

or na

tura

l ca

lami

ties

;

(o)

Ex

pir

ati

on

da

te

refe

rs

to

the

end

date

when

the

manufacturer

can

guarantee

that

a pr

oduc

t possesses

its

clai

med

pote

ncy,

ef

fica

cy,

quah

ty,

and

safe

ty;

afte

r which

its

sale

or

di

stri

buti

on i

s pr

ohib

ited

;

(p)

Fill

ing

.ref

ers

to

the

act

of di

spen

sing

or

providing

medi

cine

s in ac

cx^d

ance

with

a pr

escr

ipti

on or

me

dica

tion

or

der;

(q)

Fo

od

/Die

tary

su

pp

lem

ents

refe

r to

processed

food

prod

ucts

in

tend

ed to

su

pple

ment

the

diet

that

bear

s or

co

ntai

ns

one

(I)

or more

of the

foll

owin

g di

etar

y in

gred

ient

s: vitamins,

mine

rals

, he

rbs,

or

other

bota

nica

ls,

amin

o ac

ids,

and

dietary

substances

to

incr

ease

the

tota

l daily

intake

in

amounts

conf

ormi

ng

to the

late

st Ph

ilip

pine

-rec

omme

nded

en

ergy

and

nutrient

intakes

or

internationally

agreed

minimum

daily

requ

irem

ents

. It

usu

ally

is

in t

he f

orm

of c

apsu

les,

tab

lets

, hq

uids

, ge

ls,

powd

ers,

or

piH

s and

not

repr

esen

ted

for

use

as a

conv

enti

onal

food

or as

the

sole

item

of a

meal

or di

et o

r re

plac

emen

t of

dr

ugs

and

medi

cine

s,

as de

fine

d un

der

Repubhc

Act

No.

9711

;

(r)

Ge

ne

ric

na

me

refers

to

the

scientifically

and

inte

rnat

iona

lly

recognized

name

of th

e ac

tive

in

gred

ient

s,

as

appr

oved

by

th

e FD

Apiu

rsua

nt t

o Repubhc

Act

No.

6675

, ot

herw

ise

known

as the

"Gen

eric

s Act

of

1988

";

8

(s)

He

alt

h s

up

ple

me

nt

refe

rs

to

any

product

that

is

used

to

main

tain

, en

hanc

e and

improve

the

healthy

function

of

the

human

body

afid

con

tain

s on

e (1

) or

more

or a

combination

of

the

foll

owin

g: (

1) h

erba

l fa

tty

acid

s, en

zyme

s, pr

obio

tics

, and

othe

r bi

oact

ive

subs

tanc

es;

and

(2)

subs

tanc

es

deri

ved

firo

m na

tura

l so

urce

s, in

clud

ing

anim

al,

plan

t, m

iner

al,

and

bota

nica

l ma

teri

als

in

the

form

of

extr

acts

, is

olat

es,

conc

entr

ates

, me

tabo

Utes

, sy

nthe

tic

sources

of su

bsta

nces

mentioned

in

(1)

and

(2).

It

is

pres

ente

d in do

sage

for

ms or

in

small

xmit d

oses

suc

h as

ca

psul

es,

tabl

ets,

po

wder

, hquids

and

it

shall

not

incl

ude

any

ster

ile

prep

arat

ions

(i

.e.

inje

ctib

les,

ey

edro

ps);

'(t)

'-H

ouse

hold

rem

/3(Ue

s re

fer

to a

ny

prep

arat

ion

cont

aini

ng

phar

mace

utic

al su

bsta

nces

of

co

mmon

or

ordinary

use

to re

liev

e common

phys

ical

ai

hnen

ts and

which

may

be di

spen

sed

without

a me

dica

l pr

escr

ipti

on i

n or

igma

l pa

ckag

es,

bott

les

or co

ntai

ners

, of

which

the

nomenclature

has

been

duly

appr

oved

by

the

FDA;

(u)

Inst

itu

tio

nal

p

ha

rma

cie

s refer

to

pharmacies

of

inst

itut

ions

, or

gani

zati

ons,

and

/or

coip

orat

ions

th

at p

rovi

de a

rang

e of

pharmaceutical

serv

ices

, gi

ven

excl

usiv

ely

to the

empl

oyee

s ^n

d/or

their

quaU

fLed

de

pend

ents

;

(v)

Inte

rns

hip

pro

gra

m re

fers

to

a

supe

rvis

ed

prac

tica

l ex

peri

ence

that

is required

to

be

comp

lete

d fo

r hc

ensu

re

as

a re

gist

ered

ph

arma

cist

;

(w)

Lab

el re

fers

to

a d

ispl

ay of

wri

tten

, pr

inte

d, o

r gr

aphi

c matter

on

the

immediate

cont

aine

r of

any

arti

cle;

(x)

Lab

elin

g ma

terial

s re

fer

to a

H la

bels

and

othe

r wr

itte

n,

printed,

or

grap

hic

matter:

(1)

upon

any

item

or

any

of

its

cont

aine

rs or

wr

appe

rs;

or

(2)

acco

mpan

ying

any

such

item;

(y)

Me

dic

al

devi

ce

refe

rs to

any

inst

rume

nt,

appa

ratu

s,

implement,

mach

ine,

ap

phan

ce,

implant,

in

vitr

o reagent

or

cahb

rato

r, so

ftwa

re,

mate

rial

or

ot

her

similar

or related

arti

cle

inte

nded

by

the

manu

fact

urer

to

be us

ed al

one,

or

in

comb

inat

ion,

fo

r human

bein

gs,

for

one

(1)

or more

of the

spec

ific

pu

rpos

es

of:

diag

nosi

s, prevention,

monitoring,

treatment,

or

alle

viat

ion

of di

seas

e;

diag

nosi

s,

monitoring,

treatment,

or al

levi

atio

n of

or

compensation

for

an

injury;

investigation,

replacement,

modi

fica

tion

or

sup

port

of

the

anatomy

of a

phy

siol

ogic

al pr

oces

s;

9

supporting

or

sustaining

hfe;

preventing

infection;

control

of co

ncep

tion

; di

sinf

ecti

on.o

f me

dica

l de

vice

s; and

providing

information

for

medical

or

diag

nost

ic

purp

oses

by

me

sms

of

in v

itro

examination

of s

peci

mens

de

rive

d fr

om th

e human

body.

This

device

does

not

achi

eve

its

primary

intended

acti

on in

or

on

the

human

body

by

phar

maco

logi

cal,

immunological,

or

meta

bohc

me

ans,

but

which

may

be

assi

sted

in

its

intended

func

tion

by

su

ch me

ans,

as

de

fine

d un

der

Repu

bhc

Act

No.

9711;

(z)

Me

dic

al

mis

sio

n re

fers

to

an

activity

cond

ucte

d on

normal

circ

umst

ance

s of

an

individual

or

a gr

oup

of

health

care

pr

acti

tion

ers

to p

rovi

de health

serv

ices

ou

tsid

e the

hosp

ital

, cU

nic,

and

health

care

facility

premises

as

differentiated

from

humanitarian

missions

and

relief

oper

atio

ns

which

is

cond

ucte

d during

emer

genc

y situations

such

as

ca

lami

ty,

war,

or na

tura

l and

man-made

disa

ster

s;

(aa)

M

ed

icin

es

refe

r to

dru

gs in

th

eir

appr

opri

ate

dosage

form

s, with

assu

red

quality,

safe

ty and

effi

cacy

fo

r humans

or

anim

als,

or

both;

(bb)

M

ed

ica

l re

pre

se

nta

tiv

e or

p

rofe

ss

ion

al

serv

ice

repr

esen

tati

ve

refe

rs to

on

e who

repr

esen

ts any

duly

authorized

manufacturer,/^distributor,

trader,

and

wholesaler

of

pharmaceutical

prod

ucts

and

whos

e primary

duty

is t

o promote

thei

r pr

oduc

ts to

duly

hcensed

health

prof

essi

onal

s;

(cc)

N

on

tra

dit

ion

cd

outl

ets

refe

r to

entities

hcensed

by

appr

opri

ate

government

agencies

to

disp

ense

ov

er-t

he-c

ount

er

medi

cine

s based

on

an

appr

oved

hs

t;

(dd)

O

nli

ne

ph

arm

ac

y se

rvic

es

refe

r to

pharmaceutical

serv

ices

of

a

duly

lice

nsed

ph

arma

ceut

ical

outlet

done

over

the

inte

rnet

;

(ee)

O

ver-

the-

cou

nte

r (O

TC

) m

edic

ines

refe

r to

me

dici

nes

used

fo

r symptomatic

rehef

of m

inor

ailm

ents

and

which

may

be

disp

ense

d without

a pr

escr

ipti

on;

(S)

Ph

arm

ac

eu

tic

al e

sta

bli

sh

me

nts

refer

to

entities

hcensed

by

appr

opri

ate

government

agen

cies

, and

which

are

invo

lved

in

the

manu

fact

ure,

imp

orta

tion

, ex

port

atio

n, re

pack

ing,

and

dist

ribu

tion

of

pharmaceutical

prod

ucts

to

pharmaceutical

outl

ets;

(gg)

Ph

armac

eutic

al ma

nufac

turers

re

fer

to es

tabl

ishm

ents

engaged

in

any

or all

oper

atio

ns

involved

in

the

production

of

phar

mace

utic

al pr

oduc

ts in

clud

ing

the

prep

arat

ion,

pr

oces

sing

, co

mpou

ndin

g,

formulating,

fill

ing,

pa

ckag

ing,

re

pack

agin

g,

alte

ring

, ornamenting,

finishing

and

labe

hng,

preparatory

to

thei

r st

orag

e, sa

le,

or di

stri

buti

on,

except

the

comp

ound

ing

and

filU

ng of

pre

scri

ptio

ns

in p

harm

aceu

tica

l ou

tlet

s;

(!aii)

Ph

arm

ac

eu

tic

al

ma

rke

tin

g refers

to

any

activity

undertaken,

orga

nize

d,

or

spon

sore

d by

a

pharmaceutical

esta

bhsh

ment

or

out

let

which

is d

irec

ted

at p

romoting

its

prod

uct;

(ii)

P

ha

rma

ce

uti

ca

l ou

tlet

s re

fer

to entities

hcensed

by

appr

opri

ate

government

agen

cies

, and

which

are

involved

in

comp

ound

ing

and/

or di

spen

smg

and

seUi

ng of

pharmaceutical

prod

ucts

di

rect

ly t

o pa

tien

ts o

r en

d-us

ers;

(ij)

P

har

mac

euti

cal

pro

du

cts

refe

r to

dr

ugs,

me

dici

nes,

bi

olog

ical

s,

pharmaceutical

and

biop

harm

aceu

tica

l pr

oduc

ts/

spec

ialt

ies,

veterinary

prod

ucts

, veterinary

biol

ogie

s and

vete

rina

ry me

dici

nal

prod

ucts

;

\) P

ha

rma

cis

t re

fers

to

a

health

prof

essi

onal

who

has

been

re

gist

ered

and

issu

ed

a vahd

Cert

ific

ate

of

Registration

(COR)

and

Prof

essi

onal

Identiacation

Card

(PIC)

by the

PRC

and

the

Prof

essi

onal

Regulatory

Board

of

Pharmacy;

(Jl)

P

ha

rma

cis

t-o

nly

OT

C m

edic

ines

refe

r to

ov

er-t

he-

coun

ter

medi

cine

s cl

assi

fied

by

ap

prop

riat

e go

vern

ment

ag

enci

es

to be

ob

tain

ed on

ly f

rom

a hcensed

phar

maci

st,

with

mandatory

phar

maci

st's

ad

vice

on

thei

r se

lect

ion

and

prop

er

use;

(mm)

Ph

arm

ac

y ai

des

refe

r to

pers

ons

who

assi

st

the

phar

maci

sts

in

the

diff

eren

t as

pect

s of

pha

rmac

y op

erat

ion

based

ones

tabh

shed

st

anda

rd o

pera

ting

pro

cedu

res

and

proc

esse

s,

with

very

minimal

degree

of in

depe

nden

ce

or de

cisi

on

making

and

without

dire

ct in

tera

ctio

n wi

th pa

tien

ts;

(nn)

P

ha

rma

cy

assi

stan

ts

refe

r to

per

sons

who

assi

st the

phar

maci

sts

in

diff

eren

t as

pect

s of

pha

rmac

y op

erat

ion

based

on

esta

bhsh

ed

stan

dard

op

erat

ing

proc

edur

es

and

proc

esse

s, w

ith

a minimum

degree

of in

depe

nden

ce

or de

cisi

on

making

and

may

have

supe

rvis

ed in

tera

ctio

n wi

th pa

tien

ts;

11

(oo)

P

ha

rma

cy

tech

nic

ian

s re

fer

to p

erso

ns who

assi

st

in

comp

ound

ing

and

disp

ensi

ng of

med

icin

es in

comm

unit

y, ho

spit

al,

institutional

and

industrial

settings

or

engaged

in

other

activities

under

the

supervision

of

the

pharmacist

as

desc

ribe

d in

Sect

ion

39,

Article

IV

of t

his

Act;

(pp)

P

hil

ipp

ine

Pra

ctic

e S

tan

dar

ds

for

Ph

arm

acis

ts

refe

r to

the

esta

blis

hed

national

firamework

for

quahty

standards

and

guid

elin

es

of the

prac

tice

of

pharmacy

that

resp

ond

to

the

needs

of the

people

who

require

the

phar

maci

sts'

se

rvic

es

to

provide

optimal,

evidence-based

care

as

formulated

by

the

integrated

APO

and

approved

by

the

Professional

Regulatory

Board

of

Pharmacy;

(qq)

P

hysi

cian

's s

amp

les

refe

r to

med

icin

es gi

ven

to he

alth

pr

ofes

sion

als

for

promotional

purp

oses

on

ly;

i

(rr)

P

res

cri

pti

on

/Eth

ica

l med

icin

es

refe

r to

medi

cine

s which

can

only

be di

spen

sed

by a

pharmacist

to a

patient,

upon

the

pres

enta

tion

of

a vahd

pres

crip

tion

from

a ph

ysic

ian,

de

ntis

t,

or v

eter

inar

ian

and

for

which

a ph

arma

cist

's ad

vice

is

ne

cess

ary;

(ss)

R

efi

llin

g o

f a,

pre

sc

rip

tio

n refers

to

the

act

of

dispensing

the

remaining

bala

nce

of

medi

cine

s ordered

in

the

pres

crip

tion

; /

(tt)

R

efe

rra

l re

fers

to

the

process

wherein

a pharmacist

provides

consultative

serv

ices

and

conducts

preliminary

asse

ssme

nt

of symptoms

and

refe

rs the

patient

to a

physician

or

othe

r health

care

pr

ofes

sion

al;

(uu)

Re

ferral

reg

istry

refe

rs to

the

rec

ord

book

maintained

by pharmacists,

list

ing

the

pati

ents

referred

to

diff

eren

t health

faci

htle

s fo

r fu

rthe

r di

agno

sis;

(w)

Re

fre

sh

er

pro

gra

m refers

to

a pr

escr

ibed

study

program

in

an

accr

edit

ed

scho

ol of

pharmacy;

and

(ww)

T

ele

ph

arm

ac

y se

rvic

es

refer

to

pharmaceutical

serv

ices

of

a

duly

hcensed

pharmaceutical

outlet

done

through

the

use

of

tele

phon

e,

tele

conf

eren

cing

, or

fa

csim

ile.

12

ARTICLE

II

TH

E PROFESSIONAL

REGULATORY

BOARD

OF

PHARMACY

SEC.

6.

Cre

atio

n of

th

e P

rofe

ssio

nal

R

eg

ula

tory

B

oa

rd

of P

har

mac

y.

- Th

ere

is h

ereb

y cr

eate

d a

Prof

essi

onal

Re

gula

tory

Board

of

Pharmacy,

hereinafter

call

ed

the

Board,

under

the

administrative

control

and

supervision

of

the

PRC,

to

be

composed

of

a Chairperson

and

two

(2)

members,

to

be

appo

inte

d by

the

President

of the

Philippines

from

a hst

of

three'

(a)

recommendees

for

each

position

ranked

in

the

orde

r of

pref

eren

ce

and

submitted

by

the

PRC

from

a hst

of

five

(5

) nominees

submitted

for

each

position

by

the

duly

inte

grat

ed APO

of ph

arma

cist

s.

SEC.

7.

Qu

alif

icat

ion

s of

the

C

hai

rper

son

an

d M

em

be

rs

of t

he

Bo

ard

. -

The

Chairperson

and

members

of t

he Bo

ard,

at

the

time

of no

mina

tion

, must:

\)

Be

a ci

tize

n of

the

Phihppines

and

a re

side

nt fo

r at

leas

t fi

ve (5

) ye

ars;

(b)

Be

a duly

regi

ster

ed

and

lice

nsed

pharmacist

in

the

Phil

ippi

nes,

pre

fera

bly

a ho

lder

of

a m

aste

ral de

gree

in

Phar

macy

, or

it

s eq

uiva

lent

;

(c)

Have

been

in

the

acti

ve pr

acti

ce

of pharmacy

for

the

past

ten

(10)

ye

ars;

(d)

Have

not

been

conv

icte

d of

a

crim

e involving

moral

turp

itud

e;

(e)

Be

a member

in

good

standing

of the

APO

for

at

leas

t fi

ve (5

) ye

ars,

but

not

an

offi

cer

or tr

uste

e th

ereo

f;

and

(0

At

the

time

of a

ppoi

ntme

nt,

must

neit

her

be a

member

of t

he fa

cult

y nor

an

admi

nist

rati

ve of

fice

r of

any

scho

ol,

coll

ege

or university

offe

ring

de

gree

pro

gram

s in

phar

macy

no

r ha

s an

y di

rect

or

in

dire

ct p

ecun

iary

in

tere

st o

r co

nnec

tion

in

any

review

cent

er or

similar

inst

itut

ion.

SEC.

8.

Po

wer

s,

Fu

nct

ion

s,

an

d R

esp

on

sib

ilit

ies

of

the

Bo

ard

. -

The

Board

shall

exercise

the

following

powers,

func

tion

s,

and

resp

onsi

bOit

ies:

13

(a)

Administer

and

implement

the

prov

isio

ns of

th

is Ac

t;

(b)

Promulgate

rules

and

regulations,

administrative

orde

rs,

and

issu

amce

s necessary

to

carr

y out

the

prov

isio

ns

of

this

Ac

t;

(c)

Prepare

hcen

sure

examination

ques

tion

s, sc

ore,

and

rate

the

examinations

and

submit

the

results

thereof

to the

PRC.

The

Board

shall

prep

are,

ad

opt,

is

sue,

or

amend

the

syllabi

or

tabl

es

of

spec

ific

atio

ns

of the

subj

ects

in

the

hcen

sure

examination,

in

consultation

with

the

academe

and

the

Commission

on

Higher

Education

(CHED);

^ (d

) Recommend

the

issu

ance

, su

spen

sion

, re

voca

tion

, or

reinstatement

of the

COR,

PIC

or Sp

ecia

l/Te

mpor

ary

Permits

(STP

) fo

r the

prac

tice

of

pharmacy;

(e)

Administer

oath

s in

accordance

with

the

prov

isio

ns

of

this

Ac

t;

(f)

Regu

la^f

e and

monitor

the

prac

tice

of

pharmacy

in

the

Philippmes;;

including

the

prac

tice

of

subprofessional

serv

ices

su

ch

as pharmacy

tech

nici

ans,

pharmacy

assi

stan

ts,

aide

s, and

othe

r me

dici

ne ha

ndle

rs,

as de

scri

bed

in th

is A

ct;

adop

t me

asur

es

that

may

be

deemed

prop

er

for

the

enhancement

of the

prof

essi

on

and

the

maintenance

of high

prof

essi

onal

, academic,

ethical,

and

technical

standards;

and

conduct

ocular

inspection

of

pharmaceutical

establishments

and

higher

education

institutions

(HEI

s),

in

coordination

with

concerned

gove

rnme

nt ag

enci

es;

(g)

Promulgate

and

pres

crib

e the

Pharmacists'

Code

of

Ethics,

Code

of

Technical

Standards

and

Guidelines

for

the

Professional

Practice

of

the

Pharmacy

Profession,

in

coor

dina

tion

with

the

APO;

(h)

Represent

the

pharmacy

profession

in

all

fora

involving

concerns

and

issu

es

related

to

pharmaceutical

prod

ucts

and

the

prac

tice

of

pharmacy;

(i)

Investigate

cases

arising

from

violations

of

this

Ac

t, the

rules

and

regu

lati

ons

promulgated

pursuant

ther

eto,

th

e Pharmacists'

Code

of Et

hics

, Code

of Te

chni

cal

Standards

14

and

Guid

elin

es

for

the

Prof

essi

onal

Pr

acti

ce

of the

Pharmacy

Prof

essi

on,

and

othe

r Board

issu

ance

s; is

sue

sxmi

mons

, su

bp

oen

a a

d te

sti

fic

an

du

m and

sub

po

ena

du

ces

tec

um

to

secure

the

atte

ndan

ce of

wit

ness

es or

pro

duct

ion

of d

ocum

ents

, or

bot

h,

and

othe

r evidence

necessary

for

such

investigation

or hearing;

and

rend

er de

cisi

on thereon

which

shah

, im

less

ap

peal

ed t

o the

PRC,

become

fina

l and

exec

utor

y af

ter

fift

een

(15)

days

from

rece

ipt

of no

tice

of

judgment

or

deci

sion

;

Q)

Dele

gate

th

e he

arin

g or

inv

esti

gati

on o

f ad

mini

stra

tive

ca

ses-

file

d before

the

Board,

except

where

the

issue

or

question

involves

the

prac

tice

of

the

prof

essi

on,

in

which

case

, the

hearing

shall

be

pres

ided

ov

er

by

at

leas

t on

e (1

) member

of the

Board,

to be

as

sist

ed

by

a Legal

or

Hearing

Offi

cer

of

the

PRC;

(k)

Cond

uct,

through

the

Legal

Offi

cers

of

the

PRC,

summary

proceedings

on

minor

violations

of

this

Act,

the

General

Instruction

to

the

Examinees,

including

the

implementing

rules

and

regulations

issu

ed

by

the

Board,

and

to

render

summary

judgment

thereon

which

shal

l,

unle

ss

appealed

to

the

PRC,

become

fina

l and

executory

after

fift

een

(15)

days

from

rece

ipt

of n

otic

e of

judgment

or

deci

sion

;

0)

Issue

and

promulgate

guidelines

on

CPD,

in

coor

dina

tion

with

the

APO;

(m)

Recommend

the

accr

edit

atio

n of

the

stan

dard

ized

training

programs

for

and

certifications

of

medical

repr

esen

tati

ves

or p

rofe

ssio

nal

serv

ice

repr

esen

tati

ves,

ph

arma

cy

technicians,

pharmacy

assistants,

pharmacy

aides

and

other

medi

cine

handlers

covered

in

Sect

ion

39,

Article

IV

of

this

Act.

The

Board

shall

promulgate

the

criteria

and

guidehnes

in

the

accreditation

of

training

programs

and

cert

ific

atio

ns as

described

abov

e, in

coor

chna

tion

with

the

APO

and

with

other

concerned

gove

rnme

nt ag

enci

es;

(n)

Accredit

Spec

ialt

y Boards

of

Pharmacy

based

on

the

criteria

that

it

shaU

es

tabh

sh

and

pres

crib

e;

and

(o)

Perform

and

disc

harg

e su

ch

other

functions

and

resp

onsi

bili

ties

, as

may

be

deemed

imphed,

inci

dent

al,

and

necessary,

to pr

eser

ve

the

integrity

of the

pharmacy

hcen

sure

16

examination

and

to

enha

nce

and

upgr

ade

the

prac

tice

of

the

pharmacy

prof

essi

on in

the

coun

try.

SEC.

9.

Te

rm

of

Offic

e of

the

Me

mb

ers

of

the

Bo

ard

. -

The

Chairperson

and

members

of the

Board

shaU

hold

offi

ce

for

a term

of three

(3)

year

s from

the

date

of

appointment

or

untU

. th

eir

successors

shall

have

been

qual

ifie

d and

appo

inte

d.

They

may

be

reap

poin

ted

in

the

same

of

fice

fo

r an

othe

r term

of three

(3)

year

s immediately

afte

r the

expiry

of th

eir

term:

Pro

vid

ed,

That

no

member

of

the

Board

shall

hold

of&c

e fo

r more

than

two

(2)

terms

or n

ot

more

than

sis

(6)

year

s:

Pro

vid

ed,

furt

he

r.

That

the

firs

t Board

appointed

under

this

Act

shah

hold

the

se terms

of o

ffic

e: th

e Ch

airp

erso

n fo

r th

ree

(3)

year

s,

the

firs

t member

for

two

(2)

year

s, an

ci the

second

member

for

one

(1)

year

: P

rovi

ded

, fi

nall

y. That

an

appo

inte

e to

a

vacancy

shah

serv

e only

the

unexpired

portion

of t

he term

of o

ffic

e.

The

Chairperson

and

members

of

the

Board

shah

duly

take

thei

r oath

of o

ffic

e be

fore

a

duly

auth

oriz

ed

offi

cer.

SEC.

10.

Co

mp

en

sa

tio

n a

nd

All

ow

an

ce

s of

the

B

oa

rd.

-The

Chairperson

and

members

of

the

Board

shall

rece

ive

comp

ensa

tion

aiid

aUow

ance

s co

mpar

able

to

the

comp

ensa

tion

and

allo

wanc

es

rece

ived

by

the

members

of the

othe

r existing

prof

essi

onal

re

gula

tory

boards

under

the

PRC,

as pr

ovid

ed fo

r in

the

General

Appr

opri

atio

ns Ac

t.

SEC.

11.

Gro

un

ds

for

Su

spen

sio

n or

R

em

ov

al

fro

m Of

fice

of t

he C

hairp

et'so

n or

M

em

be

r of

the

Bo

ard

. -

The

President

of

the

Phih

ppin

es may,

upon

reco

mmen

dati

on

of t

he PRC

and

afte

r du

e pr

oces

s, s

uspe

nd or

re

move

the

Chairperson

or any

member

of t

he Board

on

any

of t

he fohowing

groi

mds:

(a)

Gros

s ne

glec

t,

inco

mpet

ence

, or

di

shon

esty

in

the

disc

harg

e of

du

ty;

(b)

Involvement

in

the

manipulation,

tampering,

or

rigging

of the

hcen

sure

examination,

its

ques

tion

s or

re

sult

s,

or

both,

and

in

the

clis

clos

ure

of

clas

sifi

ed

and

conf

iden

tial

in

form

atio

n pertaining to

the

hcen

sure

examination;

(c)

Conv

icti

on of

an

offe

nse

involving

moral

turpitude

by

a co

urt

of c

ompe

tent

ju

risd

icti

on;

and

16

(d)

Unpr

ofes

sion

al,

vmet

hica

l, i

mmoral,

or

dish

onor

able

co

nduc

t.

The

PRC,

in

the

conduct

of i

nves

tiga

tion

, shaU

be

guid

ed

by Se

ctio

ns 7

and

15 of

Repubhc

Act

No.

8981,

the

exis

ting

rules

on

admimstrative

inve

stig

atio

n, a

nd

the

Rule

s of

Co

urt.

SEC.

12.

Cu

sto

dia

n o

f it

s R

ec

ord

s,

Se

cre

tari

at

an

d S

up

po

rt

Ser

vice

s.

- AU

records

of th

e Board,

pertaining

to the

applications

for

examinations,

administrative

and

other

inve

stig

ativ

e he

arin

gs conducted

by the

Boar

d, sh

aU be

under

the

cust

ody

of the

PRC.

The

PRC

shall

desi

gnat

e a

Secr

etar

y who

shallprovide

the

Board

with

se

cret

aria

t and

othe

r su

ppor

t se

rvic

es to

implement

the

prov

isio

ns of

tli

is Ac

t.

ARTICLE

III

EXAMINATION,

REGISTRATION,

AND

LICENSURE

\. 13

. L

icen

sure

Ex

am

ina

tio

n R

eq

uir

em

en

t. —

Unless

exempted

therefrom,

ah

apph

cant

s fo

r registration

for

the

prac

tice

of

pharmacy

shall

be

required

to

pass

a hcensure

examination,

as

prov

ided

fo

r in

this

Act

and

Sect

ion

7(d)

of

Repubhc

Act

No.

8981.

SEC.

14.

Qua

lifi

cati

ons

for

the

Lic

ensu

re E

xam

inat

ion

. -

An

apph

cant

fo

r the

Phar

maci

sts'

Li

cens

ure

Examination

shall

esta

blis

h to

the

sati

sfac

tion

of

the

Board

that

the

following

qual

ific

atio

ns ar

e met:

(a)

A ci

tize

n of

the

Phihppines

or of

a

fore

ign

country

which

has

a law

or pohcy

on

reci

proc

ity

for

the

prac

tice

of

th

e pharmacy

prof

essi

on;

(b)

Of

good

moral

char

acte

r and

repu

tati

on;

(c)

A de

gree

ho

lder

of

Ba

chel

or

of Sc

ienc

e in

Pharmacy

or it

s eq

uiva

lent

de

gree

co

nfer

red

by an

HEI

in

the

Phil

ippi

nes

or an

inst

itut

ion

of le

arni

ng in

a fo

reig

n co

untr

y du

ly re

cogn

ized

bythe

CHED;

and

(d)

Has

comp

lete

d an

inte

rnsh

ip program

appr

oved

by

th

e Board,

pursuant

to

such

gu

idel

ines

as

may

hereinafter

be

17

prom

ulga

ted,

in

cons

ulta

tion

wit

h th

e du

ly r

ecog

nize

d as

soci

atio

ns

of p

harmacy

scho

ols

and

the

CHED.

SEC.

15.

Scope

of

Ex

am

ina

tio

n.

~ The

Pharmacists'

Lice

nsur

e Examination

shaU

cover

the

fohowing

subj

ects

on

Pharmacy

Science

and

Prac

tice

: Inorganic

Pharmaceutical

Chem

istr

y, Or

gani

c Ph

arma

ceut

ical

Ch

emis

try,

Qua

htat

ive

and

Quan

tita

tive

Pharmaceutical

Chemistry,

Phar

maco

gnos

y and

Plan

t Chemistry,

Phar

mace

utic

al

Bioc

hemi

stry

, Mi

crob

iolo

gy

and

Parasitology,

Physical

Pharmacy,

Biopharmaceutics,

Pharmacology

and

Toxicology,

Manufacturing,

Quality

Assu

ranc

e and

Inst

rume

ntat

ion,

Ph

arma

ceut

ical

Ca

lcul

atio

ns,

Drug

Dehvery

Syst

ems,

Ho

spit

al P

harm

acy,

Ch

nica

l Pharmacy,

Dispensing

and

Medication

Counseling,

Pharmaceutical

Admi

nist

rati

on a

nd M

anag

emen

t, Pu

bhc

Heal

th,

Lega

l Ph

arma

cy,

and

Ethi

cs.

The

Board,

subj

ect

to

the

approval

of

the

PRC,

may

intr

oduc

e relevant

changes

on

the

subj

ect

area

s, format,

and

cont

ent

of the

examination,

as well

as on

the

relative

weight

attr

ibut

ed t

o each

examination

subj

ect,

as

the

need

aris

es,

and

in

cons

ulta

tion

wi1

^ the

duly

recognized

asso

ciat

ions

of

pharmacy

scho

ols

and

the

CHED.

SEC.

16.

Ho

ldin

g o

f E

mm

ina

tio

n.

- The

Pharmacists'

Lice

nsur

e Examination

shah

be

given

two

(2)

times

a year

in

places

and

date

s as

the

PRC

may

desi

gnat

e in

the

Resolution

providing

for

the

master

schedule

of a

h hc

ensu

re

examinations

pursuant

to S

ecti

on 7(

d) of

Repubhc

Act

No.

8981.

SEC.

17.

Ra

tin

gs

in the

L

icen

sure

Exa

min

atio

n.

- In

or

der

to

be

regi

ster

ed

and

hcensed

as

a pharmacist,

a ca

ndid

ate

must

obtain

a general

weighted

average

of

seventy-five

perc

ent

(75%

),

with

no

rating

lower

than

fifty

perc

ent

(50%

) in

an

y of

the

subj

ects

.

An

apph

cant

who

failed

in

the

hcen

sure

examination

for

the

thir

d (^^^)

time

shal

l no

t be

al

lowe

d to

tak

e th

e ne

xt su

ccee

ding

examinations

without

having

undertaken

a re

fres

her

program

in a

duly

accr

edit

ed

inst

itut

ion.

The

Board

shah

issu

e gu

idel

ines

on

the

refr

eshe

r program

requirement.

18

SEC.

18.

Rep

ort

of

Rat

ing

. -

The

Board

shah

submit

to

the

PRC

the

ratings

obta

ined

by

ea

ch ca

ndid

ate

with

in three

(3)

working

days

after

the

last

day

of the

examination,

unle

ss

exte

nded

fo

r Ju

st ca

use.

Upon

the

rele

ase

of the

results

of the

exam

inat

ion,

the

PRC

shah

send

by

mail

the

rati

ng ob

tain

ed by

ea

ch examinee

at

the

given

addr

ess

using

the

niaihng

enve

lope

su

bmit

ted

diur

ing

the

examination.

SEC.

19.

Oa

th o

f P

rofe

ssio

n. -

ALL

succ

essf

id.

cand

idat

es

in the

hcen

sure

examination shaU

take

thei

r oath

of pr

ofes

sion

be

fore

any

member

of t

he Bo

ard,

off

icer

of

the

PRC,

or an

y pe

rson

authorized

by

law

to administer

oath

s, prior

to entering

the

prac

tice

of

the

pharmacy

prof

essi

on.

SEC.

20.

Iss

ua

nc

e o

f C

ert

ific

ate

of

Re

gis

tra

tio

n a

nd

Pro

fess

iona

l Id

enti

fica

tion

C

ard

. -

A COR

as a

pharmacist

shall

be

issued

to

those

who

passed

the

licensure

examination,

subj

ect

to

compliance

with

the

registration

requirements

and

payment

of the

pres

crib

ed

fees

. The

COR

^•sh

ah be

ar

the

registration

number,

the

date

of

its

issu

ance

, and

the

signatures

of

the

Chairperson

of

the

PRC

and

the

members

of the

Board,

stamped

with

the

offi

cial

se

als

of

the

PRC

and

of the

Board,

certifying

that

the

pers

on

named

ther

ein

is entitled

to the

prac

tice

of

the

prof

essi

on,

with

aU

the

priv

ileg

es appurtenant

thereto.

This

COR

shah

remain

in

full

force

and

effect

until

suspended

or

revoked

in

accordance

with

this

Ac

t.

A PIC

bearing

the

registration

number

and

date

s of

its

issu

ance

and

expi

ry,

dxal

y si

gned

by

the

Chairperson

of the

PRC,

shah

hkewise

be is

sued

to

eve

ry re

gist

rant

, upon

payment

of t

he pr

escr

ibed

fe

es.

The

PIC

shaU

be renewed

ever

y th

ree

(3)

year

s, upon

presentation

of

the

Cert

ific

ate

of Good

Standing

(COGS)

from

the

APO

and

proof

of

completion

of the

CPD

requ

irem

ents

.

SEC.

21.

Fo

reig

n R

ecip

roci

ty.

- Unless

the

country

or

stat

e of

which

the

foreign

pharmacist

is a

subj

ect

or ci

tize

n,

spec

ific

aUy

permits

Fhipino

pharmacists

to pr

acti

ce

with

in its

territorial

limits

on

the

same

basis

as

the

subjects

or

citi

zens

of

the

said

foreign

country

or st

ate

under

reci

proc

ity

and

under

inte

rnat

iona

l agreements,

no

fore

igne

r shall

be

19

admitted

to hc

ensu

re

examinations,

given

a COR

to

prac

tice

as

pharmacist

nor

be

entitled

to

any

of the

priv

ileg

es

under

this

Act.

SEC.

22.

Pra

cti

ce

Th

rou

gh

Sp

ec

ial/

Te

mp

ora

ry

Pe

rmit

(ST

P).

- The

prac

tice

of

pharmacy

in

the

Phihppines

shaU

be

hmited

to

natural

persons

only

and

shall

be

governed

by

the

prov

isio

ns

of

Repubhc

Act

No.

8981

and

other

issu

ance

s pertinent

thereto:

Pro

vid

ed

, That

any

foreign

citizen

who

has

gain

ed

entry

in

the

Philippines

to perform

prof

essi

onal

services

within

the

scope

of

the

practice

of

pharmacy,

incl

udin

g the

fohowing:

(a)

bein

g a

consultant

in

fore

ign-

fund

ed

or

assi

sted

pr

ojec

ts

of

the

government;

(b)

bein

g engaged

or

empi

oyed

by

a

Fihpino

employer

or es

tabh

shme

nt;

(c)

providing

free

serv

ices

in

humanitarian

missions;

and

(d)

being

a vi

siti

ng faculty

member

in

any

field

or sp

ecia

lty

in

pharmacy

shall,

before

assuming

such

duties,

functions

and

responsibilities,

secure

an

STP

from

the

Board

and

the

PRC,

under

the

fohowing

cond

itio

ns:

(1)

The

pers

on is

an

inte

rnat

iona

hy renowned

pharmacist

or expert

in

a fi

^ld

or sp

ecia

lty

of

pharmacy;

(2)

The

pers

on is

engaged

in th

e pr

ovis

ion

of a

pr

ofes

sion

al

serv

ice

which

is determined

to b

e ne

cess

ary

due

to l

ack

of Fi

hpin

o sp

ecia

hsto

r ex

pert

; and

(3)

The

person

is

required

to

work

with

a Filipino

coun

terp

art,

a

natu

ral

person

who

is a

regi

ster

ed and

lice

nsed

ph

arma

cist

.

SEC.

23.

Gro

un

ds

for

Non

-reg

istr

atio

n.

- The

Board

shah

not

regi

ster

any

succ

essf

ul

examinee

who

has

been

:

(a)

Conv

icte

d of

an

offe

nse

involving

moral

turpitude

by

a co

urt

of c

ompe

tent

ju

risd

icti

on;

(b)

Summarily

adjudged

by

the

Board

as

guilty

for

misr

epre

sent

atio

n or

fal

sifi

cati

on o

f do

cume

nts

in

conn

ecti

on

with

th

e apphcation

for

examination

or fo

r vi

olat

ion

of the

General

Inst

ruct

ions

to

Examinees;

20

(c)

Found

guil

ty of

immoral

or di

shon

orab

le

conduct

by

the

Boar

d;

(d)

Medi

cahy

pr

oven

to

be

ad

dict

ed

to an

y drug

or

alco

hol

by a

medi

cal

or dr

ug t

esti

ng f

acOi

ty a

ca-e

dite

d by

th

e go

vern

ment

; an

d

(e)

Decl

ared

of

unsound

mind

by

a co

urt

of

comp

eten

t ju

risd

icti

on.

In ^r

efus

ing

the

regi

stra

tion

, th

e Board

shah

give

a

writ

ten

stat

emen

t se

ttin

g fo

rth

the

reas

ons

ther

efor

and

shah

file

a copy

ther

eof

in

its

reco

rds.

Sh

otdd

gr

ound

(d

) be

pr

oven

to

be

no

long

er

exis

tent

, the

Board

shah

issu

e a

Board

Resolution

ahowing

the

issu

ance

of

su

ch

COR.

SEC.

24.

Rei

ssm

nce

of

Rev

oked

Ce

rtific

ate

of

Regis

tratio

n, R

epla

cem

ent

of

Lost

or

D

am

ag

ed

Cer

tifi

cate

of

Reg

istr

atio

n,

Pro

fess

iona

l Id

enti

fica

tion

Ca

rd o

r S

pe

cia

l/T

em

po

rary

P

erm

it.

+ The

Board

may,

upon

peti

tion

, re

inst

ate

or re

issu

e a

revo

ked

COR

afte

r the

expiration

of two

(2)

year

s from

the

date

of

its

revo

cati

on.

The

Boar

d ma

y, in

its

dis

cret

ion,

re

quir

e th

e ap

phca

nt

to t

ake

anot

her

hcen

sure

ex

amin

atio

n. T

he

peti

tion

er s

hah

prov

e to

the

Board

that

ther

e is

a

vahd

reas

on fo

r su

ch

rein

stat

emen

t.

For

the

grant

of the

peti

tion

, th

e Board

shaU

is

sue

a Board

Reso

luti

on,

to b

e ap

prov

ed

by th

e PRC.

A du

phca

te

copy

of the

COR

for

disp

lay

in

Cate

gory

B

esta

bhsh

ment

s may

be is

sued

. Re

plac

emen

t of

los

t or

damaged

COR,

PIC

or STP

may

be is

sued

in accordance

with

the

pert

inen

t ru

les

that

shah

be is

sued

th

ereo

n.

ARTICLE

rv

REGULATION

OF

TH

E PRACTICE

OF

PHARMACY

SEC.

25.

Vest

ed

Rig

hts

; A

uto

ma

tic

Reg

istr

atio

n.

- All

phar

maci

sts

regi

ster

ed

before

the

effe

ctiv

ity

of this

Act

shah

automatically

be re

gist

ered

he

reun

der,

su

bjec

t to

comphance

as

to future

requ

irem

ents

.

21

The

CORs

, PICs

or

STPs

held

by

su

ch

persons

m good

stan

ding

shah

have

the

same

fo

rce

and

effe

ct,

as though

they

were

issu

ed on

or af

ter

the

effe

ctiv

ity

of t

his

Act.

SEC.

26.

Aff

ixin

g R

Ph

Aft

er

a R

egis

tere

d P

ha

rma

cis

t's

Na

me

. -

Only

duly

registered

and

hcensed

pharmacists

shah

have

th

e right

to af

fix

to on

e's

name

, th

e ti

tle

"Reg

iste

red

Phar

maci

st"

or

"RPh".

SEC.

27.

Ind

icat

ion

of I

nfo

rmat

ion

. -

A ph

arma

cist

shah

be

requ

ired

to

in

dica

te

the

seri

al nu

mber

s,

the

date

of

expiry

of the

phar

maci

st's

PIC

and

APO

Cert

ific

ate

of

Membership

on

aU p

ertinent

docu

ment

s si

gned

by

hi

m/he

r.

SEC.

28.

Reg

istr

y of

P

ha

rma

cis

ts.

- The

Board

and

the

PRC

shall

prep

are

and

maintain

a registry

of

the

names,

resi

denc

es or

of

fice

ad

dres

ses,

or

bo

th,

stat

us of

reg

istr

atio

n and

area

of

pr

acti

ce

of aU

regi

ster

ed

phar

maci

sts,

which

shah

be

upda

ted

annuahy,

in

coor

dina

tion

with

the

APO.

This

registry

shah

be

made

av

aila

ble

to the

publ

ic

upon

inquiry

or

requ

est,

su

bjec

t to

su

ch gu

idel

ines

that

shaU

be

esta

bhsh

ed

ther

efor

.

SEC.

29.

Dis

pla

y of

Cer

tifi

cate

of

Reg

istr

atio

n.

- It

shall

be th

e du

ty of

eve

ry ph

arma

cist

engaged

in

the

prac

tice

, v/

heth

er

in pr

ivat

e or

un

der

the

empl

oy

of a

noth

er,

to di

spla

y th

e original

copy

of on

e's

COR

in

a prominent

and

conspicuous

place

in

the

drug

esta

blis

hmen

t in

which

one

is em

ploy

ed

in

a pr

ofes

sion

al

capa

city

as

ph

arma

cist

. When

empl

oyed

in

es

tabh

shme

nts

unde

r Ca

tego

ry

B, as

de

fine

d in

Sect

ion

31

of this

Act,

the

dupl

icat

e copy

of t

he ph

arma

cist

's

COR

shaU

al

so be

di

spla

yed

therein.

No

pharmacist

shall

knowingly

aUow

the

COR

to

be

disp

laye

d in

an

esta

bhsh

ment

where

one

is n

ot a

ctua

lly

empl

oyed

as

a

prof

essi

onal

ph

arma

cist

.

SEC.

30.

Dis

pe

ns

ing

/Sa

le

of

Ph

arm

ac

eu

tic

al

Pro

du

cts.

-

No

phar

mace

utic

al

prod

uct,

of

wh

atev

er

nature

and

kind,

shah

be

compounded,

dispensed,

sold

or

re

sold

, or

ot

herw

ise

be

made

av

aila

ble

to the

consuming

pubhc,

except

through

a re

tail

drug

outl

et d

uly

hcensed

by the

FDA.

Pres

crip

tion

dr

ugs

and

phar

maci

st-o

nly

OTC

medi

cine

s shaU

be

dispensed

only

by

a duly

regi

ster

ed

and

lice

nsed

22

phar

maci

st,

except

in

emergency

case

s, where

the

serv

ices

of

a

regi

ster

ed and

hcensed

pharmacist

are

not

avai

labl

e:

Pro

vid

ed,

That

a re

port

shah

be ma

de to

the

supe

rvis

ing

phar

maci

st

with

in

twen

ty-f

our

(24)

hours

afte

r the

occurrence

of t

he emergency

so

that

pr

oduc

t re

cord

ing

in

the

pres

crip

tion

books

can

be do

ne.

Compounding

and

disp

ensi

ng

shah

be done

only

by

duly

regi

ster

ed and

hcensed

phar

maci

sts,

in accordance

with

current

Good

Manxifacturing

Prac

tice

, la

bora

tory

pr

acti

ce,

Philippine

Prac

tice

Standards

for

Pharmacists

and

disp

ensi

ng

guid

ehne

s.

A re

gist

ered

and

hcensed

pharmacist

may

refu

se to

co

mpou

nd,

dispense

or se

h dr

ugs

and

pharmaceutical

prod

ucts

, if

not

in

accordance

with

th

is A

ct

and

the

abov

emen

tion

ed

stan

dard

s.

Lice

nsed

manufacturers,

importers,

distributors,

and

whol

esal

ers

of p

harm

aceu

tica

l pr

oduc

ts ar

e au

thor

ised

to

seh

thei

r pr

oduc

ts on

ly t

o duly

hcensed

phar

mace

utic

al ou

tlet

s.

SEC.

31.

Ph

arm

ac

ist

Re

qu

ire

me

nt.

- Estabhshments/

outl

ets

which

are

requ

ired

to

empl

oy an

d/or

re

tain

and

main

tain

the

professional

services

of

duly

registered

and

lice

nsed

ph

arma

cist

s shah

be cl

assi

fied

as

fo

hows

:

(a)

Cate

gory

A

- Pharmaceutical

esta

bhsh

ment

s/ou

tlet

s where

the

dire

ct and

immediate

cont

rol

and

supe

rvis

ion

of a

du

ly

regi

ster

ed and

hcen

sed

phar

maci

st i

s re

quir

ed,

per

esta

bhsh

ment

, whether

in-s

tore

or

onhn

e, in

clud

ing:

(1)

Pharmaceutical

establishments/outlets

selling

or

otherwise

making

available

to

the

consuming

public

prescription/ethical

medicines,

combination

products

(med

ical

device

and

drug

s)

clas

sifi

ed

as

drug

s according

to

the

primary

intended

mode

of

acti

on,

pharmacist-only

OTC

medidne,

whether

owne

d by

the

government

or by

a

priv

ate

pers

on or

firm,

whet

her

sold

at

who

lesa

le or

re

tail

;

(2)

Establishments

involved

in

the

manufacture,

impo

rtat

ion,

ex

port

atio

n, d

istr

ibut

ion,

and

sale

of

co

mbin

atio

n pr

oduc

ts (m

edic

al de

vice

and

drug

s) cl

assi

fied

as

dr

ugs

acco

rdin

g to

the

primary

inte

nded

mode

of ac

tion

;

(3)

Departments/Divisions/Units

of

pharmaceutical

labo

rato

ries

, ph

arma

ceut

ical

manufacturing

labo

rato

ries

, or

ot

her

28

estabhshments

with

processes

involving

the

preparation,

manufacture,

assay,

regulation,

product

research

and

deve

lopm

ent,

qu

ahty

con

trol

, re

pack

ing,

im

port

atio

n, ex

port

atio

n,

dist

ribu

tion

, sa

le

or

transfer

of pharmaceutical

prod

ucts

in

quan

titi

es gr

eatl

y in excess

of s

ingl

e th

erap

euti

c do

ses;

and

(4)

Government

unit

s, including

loca

l go

vern

ment

, ci

ty,

firs

t to

th

ird

class

municipal

health

unit

s,

nongovernment

orga

niza

tion

s an

d/or

as

soci

atio

ns

involved

in

the

proc

urem

ent,

di

stri

buti

on,

disp

ensi

ng and

stor

age

of p

harm

aceu

tica

l pr

oduc

ts;

(b)

Cate

gory

B

- Pharmaceutical

esta

bhsh

ment

s/ou

tlet

s where

the

supe

rvis

ion

and

over

sigh

t of

a

duly

regi

ster

ed

and

hcen^d

phar

maci

st is

req

uire

d un

der

pert

inen

t pr

ovis

ions

of

la

w,

incl

udin

g:

(1)

Reta

il

outl

ets

sell

ing

hous

ehol

d re

medi

es

and

OTC

drug

s as

di

ffer

enti

ated

from

the

phar

maci

st-o

nly

OTC

medi

cine

s;

(2)

Sate

Uite

ins

titu

tion

al p

harm

acie

s pr

ovid

ing

medi

cine

s so

lely

to

empl

oyee

s of

the

ir r

espe

ctiv

e co

mpan

ies

or t

he

empl

oyee

s'

qual

ifie

d de

pend

ents

, or

both;

or members

of a

duly

regi

ster

ed

orga

niza

tion

or

in

stit

utio

n;

(3)

Four

th,

fift

h and

sixt

h cl

ass

municipal

health

unit

s in

volv

ed i

n th

e pr

octf

feme

nt,

dist

ribu

tion

, di

spen

sing

, an

d st

orag

e of

pha

rmac

euti

cal

prod

ucts

;

(4)

Inst

itut

ions

providing

tele

phar

macy

se

rvic

es;

and

(5)

Nontraditional

outl

ets

of ph

arma

ceut

ical

pr

oduc

ts:

Pro

vid

ed,

That

no pr

escr

ipti

on me

dici

nes

and

pharmacist-only

OTC

medi

cine

s ar

e so

ld.

The

FDA,

in

coordination

with

the

Board,

and

the

approval

of the

PRC,

may

add

to,

dele

te,

recl

assi

fy,

or

modify

the

above

hst

of es

tabl

ishm

ents

, as

the

need

aris

es,

in

orde

r to

keep

pace

with

the

deve

lopm

ents

in

the

pharmacy

prac

tice

.

A pharmacist

working

in

a Ca

tego

ry A

esta

bhsh

ment

may

be ahowed

to simultaneously

work

or re

nder

pharmacy

serv

ices

in

Ca

tego

ry B

esta

bhsh

ment

s, the

maximmn

number

of h

ours

of

which

shah

be determined,

in

accordance

with

su

ch

guid

elin

es

24

as may

be es

tabl

ishe

d th

eref

or b

y the

Boar

d, in

coor

dina

tion

wi

th

the

FDA,

and

othe

r ag

enci

es,

esta

bhsh

ment

s, in

stit

utio

ns,

and

regu

lato

ry bo

dies

.

Procurement,

stor

age,

di

stri

buti

on,

or di

spen

sing

of

any

pharmaceutical

prod

uct

in

the

national

government

and

loca

l government

units

shaU

be

made

on

ly un

der

the

supe

rvis

ion

of a

did.

y re

gist

ered

and

hcensed

phar

maci

st.

Ah

units

or su

b-un

its

of es

tabh

shme

nts,

in

stit

utio

ns,

and

regu

lato

ry bo

dies

whether

government

or p

riva

te w

ith

func

tion

s and

acti

viti

es t

hat

are

excl

usiv

e fo

r ph

arma

cist

s, as

de

fine

d m

Sect

ion

4, p

arag

raph

s (a

), (b

), (c

), (d

) and

(i),

shahbe

headed

and

mana

ged

by a

quah

fied

du

ly r

egis

tere

d an

d hcensed

phar

maci

st:

Pro

vid

ed,

That

an

appointment

in

government

serv

ice

shall

comp

ly

with

th

e pr

ovis

ions

of

oth

er pertinent

laws.

SEC.

32.

Res

po

nsi

bil

ity

for

Qu

ali

ty o

f P

ha

rma

ce

uti

ca

l P

rod

uct

s.

- It

shah

be th

e duty

of a

duly

hcensed

and

regi

ster

ed

pharmacist

of a

pharmaceutical

estabhshment

and

outlet

to

ensure

that

all

pharmaceutical

products

conform

to

standards

of sa

fety

, quahty

and

effi

cacy

, as

pr

ovid

ed

for

in

this

Act

and

other

pertinent

rules

and

regulations

and

issu

ance

s.

Owners,

managers,

or

pharmacists

in

charge

of

the

operation

of pharmaceutical

estabhshments

and

outl

ets

shaU

be

held

join

tly

resp

onsi

ble

for

nonconformance

with

thes

e st

anda

rds.

It shah

be un

lawf

ul f

or an

y pe

rson

to

man

ufac

ture

, pr

epar

e,

seh,

or

di

spen

se an

y ph

arma

ceut

ical

pr

oduc

t under

a fraudulent

name,

or pr

eten

se or

to

ad

ulte

rate

any

pharmaceutical

prod

uct

offe

red

for

sale

.

In

cases

of p

harm

aceu

tica

l pr

oduc

ts

sold

in

thei

r original

package,

the

seal

of

which

has

not

been

broken

or ta

mper

ed

with

, the

habihty

that

may

aris

e because

of th

eir

quahty

and

puri

ty

rests

upon

the

manufacturer

or

importer,

the

distributor,

repr

esen

tati

ve,

or de

aler

who

is r

espo

nsib

le fo

r th

eir

dist

ribu

tion

or

sa

le.

SEC.

33.

Fill

ing

an

d P

arti

al F

illi

ng o

f Pre

scri

ptio

n.

- Ah

pres

crip

tion

s and

phar

maci

st-o

nly

OTC

medi

cine

s shah

be

fill

ed,

compounded

and

dispensed

only

by

a re

gist

ered

and

hcensed

25

phar

maci

st,

in ac

cord

ance

with

the

Phhi

ppin

e Pr

acti

ce

Stan

dard

s fo

r Pharmacists,

Dispensing

Guid

ehne

s and

othe

r st

anda

rds

pertaining

to

puri

ty,

safety

and

quality.

Completely

fill

ed

prescriptions

should

be

surrendered

to

the

pharmacist

for

reco

rdin

g.

Part

ial

fihi

ng

of pr

escr

ipti

on le

ss than

the

tota

l quantity

indicated

in

the

prescription

shall

be

allowed,

subj

ect

to

disp

ensi

ng gu

ideh

nes

as pr

ovid

ed in

the

immediately

prec

edin

g paragraph.

It

is

the

responsibility

of

the

pharmacist

disp

ensi

ng

the

last

quantity

comp

leti

ng

the

prescription

to

keep

the

prescription

according

to

proper

prescription

reco

rdin

g gu

idel

ines

.

Pres

crip

tion

me

dici

nes

may

be dispensed

only

by a

duly

registered

and

lice

nsed

pharmacist

and

only

with

a valid

pres

crip

tion

of

a p

hysi

cian

, de

ntis

t, o

r ve

teri

nari

an.

SEC.

34.

Ph

ysic

ian

's S

am

ple

. -

Phar

mace

utic

al

prod

ucts

given

or intended

to be

gi

ven

free

to

any

health

prof

essi

onal

by

a

manufacturer

pv

distributor

or

its

professional

serv

ice

repr

esen

tati

ve as

'par

t of

its

program

or promotion

shaU

not

be

sold

to

any

pharmaceutical

outlet

or the

cons

umin

g pubhc.

The

statement

"Sam

ple,

Not

for

Sale

", or

its

equi

vale

nt,

shal

l appear

cons

picu

ousl

y on

the

primary

and

secondary

packaging

of

the

drug

or

combination

products

(medical

device

and

drug

) cl

assi

fied

as

drug

according

to th

e primary

intended

mode

of ac

tion

to

be

gi

ven.

It

shah

be

unlawful

to

remo

ve,

eras

e, de

face

or

mark

the

original

labe

ls of

sa

mple

s.

Pharmaceutical

prod

ucts

cl

assi

fied

as

antimicrobials,

incl

udin

g an

ti-T

B me

dici

nes

and

othe

r cl

assi

fica

tion

s of

me

didn

es,

as may

be pr

escr

ibed

by

the

FDA,

shah

not

be gi

ven

or di

stri

bute

d as

ph

ysic

ian'

s sa

mple

s.

SEC.

35.

Pro

hib

itio

n Ag

ain

st

the

Use

of Ci

pher,

C

odes

, o

r U

nu

su

al

Te

rms

in

Pre

sc

rip

tio

ns

an

d P

res

cri

pti

on

Sub

stit

utio

n.

- Pharmacists

shaU

not

compound

or

dispense

pres

crip

tion

s, re

cipe

s, o

r formulas

which

are

writ

ten

in

ciph

ers,

codes

or se

cret

key

s or

pre

scri

ptio

ns of

pha

rmac

euti

cal

prod

ucts

with

unusual

names

which

diff

er

from

thos

e in

standard

phar

maco

peia

s or

fo

rmul

arie

s.

26

The

phar

maci

st di

spen

sing

or

co

mpoi

mdin

g pr

escr

ipti

ons

shah

not

subs

titu

te th

e me

dici

ne

cahed

for

in

the

pres

crip

tion

wi

th

any

othe

r dr

ug,

subs

tanc

e or

in

gred

ient

, without

prio

r co

nsul

tati

on w

ith,

an

d wr

itte

n co

nsen

t of

the

pe

rson

pr

escr

ibin

g,

except

in

accordance

with

Repubhc

Act

No.

6675

, as

am

ende

d,

othe

rwis

e Imown

as t

he "

Gene

rics

Ac

t of

198

8",

and

othe

r pe

rtin

ent

laws

and

regu

lati

ons.

SEC.

36.

Lab

el

of D

ispe

nsed

M

edic

ines

. -

Upon

ever

y bo

x, bo

ttle

, or

package

of m

edic

ines

compounded

or di

spen

sed

by

a re

gist

ered

an

d hcensed

phar

maci

st based

on pr

escr

ipti

on,

ther

e sh

ahbe

pa

sted

, af

fixe

d, o

r im

prin

ted

a se

al o

r la

bel

bear

ing,

am

ong

othe

rs,

the

name

of pa

tien

t an

d ge

neri

c name

of dr

ug;

brand

name

, if

an

y, st

reng

th,

expi

ry da

te,

dire

ctio

ns fo

r us

e; and

name

and

address

of ph

arma

cy,

name

of the

doct

or,

the

disp

ensi

ng

phar

maci

st and

othe

r re

quir

emen

ts pr

escr

ibed

in

the

Phih

ppin

e Pr

acti

ce St

anda

rds

for

Phar

maci

sts

and

Disp

ensi

ng

Guid

ehne

s,

Repu

blic

Act

No.

9502

, ot

herw

ise

known

as

the

"Universahy

, Accessible

Chea

per

and

Quahty

Medi

cine

s Act

of

2008

",

its

1* '

implementing

rule

s and

regu

lati

ons

and

such

ot

her

guid

elin

es

that

may

be pr

omix

lgat

ed by

th

e Bo

ard.

Auxiliary

labels

containing

special

pharmacists'

inst

ruct

ions

fo

r th

e pa

tien

t shall

be re

quir

ed as

pr

escr

ibed

fo

r da

nger

ous

drug

s,

exte

rnal

-use

-onl

y dr

ugs,

dr

ugs

with

spec

ial

stor

age

and

admi

nist

rati

on i

nstr

ucti

ons

and

such

ot

her

drug

s as

may

be re

quir

ed by

law.

SEC.

37.

Rec

ord

ing

of P

atie

nt

Me

dic

ati

on

Pro

file

. -

Ah

pres

crip

tion

s di

spen

sed

hi

the

phar

macy

sh

aU b

e recorded

in

an

appr

opri

ate

reco

rdin

g sy

stem

in

dica

ting

therein,

among

othe

r th

ings

, the

name

and

addr

ess

of t

he pa

tien

t, n

ame

of

pres

crib

er,

gene

ric

name

and

bran

d, dosage

stre

ngth

, quantity

of drug

and

init

ials

of

ph

arma

cist

. It

shah

be

open

for

insp

ecti

on

by

the

repr

esen

tati

ves

of th

e Board

or th

e FDA,

or bo

th,

at

any

time

of

the

day,

when

the

phar

macy

is

op

en,

and

must

be

kept

fo

r a

peri

od of

not

less

than

two

(2)

year

s af

ter

the

last

entry.

Ah

requ

ired

information

on

dang

erou

s dr

ugs

dispensed

by

a pharmacy

shah

be re

cord

ed i

n th

e Da

nger

ous

Drug

s Bo

ok or

an

equi

vgde

nt re

cord

ing

syst

em as

req

uire

d by

Repubhc

Act

No.

9165

and

other

apphcable

laws

an

d is

suan

ces.

27

AU

refe

rral

s su

ch as

tu

berc

ulos

is pa

tien

ts undertaken

by

the

phar

mace

utic

al

outl

ets

shah

be

recorded

in

the

Referral

Registry

and

shall

be

open

for

insp

ecti

on

by

the

Boar

d,

or

repr

esen

tati

ve of

the

Department

of H

ealth

(DOH)

or the

FDA,

or bo

th,

at

any

time

of the

day

when

the

phar

macy

is

op

en,

and

must

be kept

for

a pe

riod

of

not

less

than

two

(2)

year

s af

ter

the

last

entry.

SEC.

38.

Req

uir

emen

ts f

or

the

Op

en

ing

an

d Op

eratio

n of

R

etai

l P

har

mac

euti

cal

Ou

tlet

or

Est

abli

shm

ent.

-

TTie

op

enin

g of

a r

etai

l ph

arma

ceut

ical

ou

tlet

or

esta

bhsh

ment

sh

ah b

e su

bjec

t to

requirements

prov

ided

fo

r in

this

Act

and

the

rule

s and

regu

lati

ons

pres

crib

ed

by the

FDA.

i. The

apph

cati

on

for

the

open

ing

and

oper

atio

n of

a

retah

drug

outl

et o

r ot

her

similar

busi

ness

es

tabh

shme

nts

shah

no

t be

ap

prov

ed,

unle

ss apphed

for

by a

FOip

hio

regi

ster

ed an

d hcensed

phar

maci

st,

eith

er a

s ow

ner

or a

s ph

arma

cist

-in-

char

ge,

pursuant

to the

prov

isio

ns of

thi

s Ac

t.

SEC.

39.

Ha

nd

lin

g of

ph

arm

aceu

tica

l Pr

oduc

ts by

P

erso

ns

Oth

er

Th

an

a P

hfi

rmac

ist.

-

For

the

purp

ose

of th

is

sect

ion,

persons

handling

pharmaceutical

prod

ucts

, ot

her

than

the

phar

maci

st,

which

shah

incl

ude

pharmacy

owne

rs

who

are

non-

phar

maci

sts,

me

dica

l re

pres

enta

tive

s or

pro

fess

iona

l se

rvic

e representatives,

pharmacy

support

personnel,

pharmacy

tech

nici

ans,

pharmacy

assi

stan

ts,

phar

macy

ai

des,

persons

who

assi

st ph

arma

cist

s in

any

part

of a

pharmacy

oper

atio

n, or

any

othe

r pe

rson

performing

fiinctions

invo

lved

in

the

handling

of

phar

mace

utic

al pr

oduc

ts,

shah

be

duly

cert

ifie

d by

ap

prop

riat

e government

agencies

afte

r un

derg

oing

an

accr

edit

ed

trai

ning

propam.

No pe

rson

, ex

cept

ph

arma

cy

grad

uate

s,

shah

be

al

lowe

d to

render

such

services

without

undergoing

a co

mpre

hens

ive

stan

dard

ized

tr

aini

ng pr

ogra

m:

Prov

ided,

That

the

job

desc

aipt

ion

is de

fine

d in

the

impl

emen

ting

ru

les

and

regu

lati

ons

of th

is

Act.

SEC.

40.

Ad

min

istr

atio

n of

Ad

ult

Vac

cines

. —

Inadchtion

to the

requirement

prov

ided

in

Sect

ion

4, paragraph

(g)

of

this

Ac

t,

hcensed

and

trained

pharmacist

who

shall

administer

adult

vaccines

shah

ensu

re

that

the

vaccine

to b

e ad

mini

ster

ed

28

shaE

have

a do

ctor

's p

resc

ript

ion

which

is not

more

than

seve

n (7

) days

old

and

submit

a monthly

vacc

inat

ion

repo

rt and

AEFI

repo

rt t

o DOH

regi

onal

off

ices

using

the

pres

crib

ed

form.

ARTICLE

V

ACCREDITED

PROFESSIONAL

ORGANIZATION

SEC.

41.

Th

e In

teg

rate

d a

nd

Ac

cre

dit

ed

Pro

fess

ion

al

Org

aniz

atio

n (A

PO)

of P

har

mac

ists

. -

The

pharmacy

prof

essi

on

shah

bg-i

nteg

rate

d into

one

(1)

national or

gani

zati

on re

gist

ered

wi

th th

e Se

curi

ties

and

Exch

ange

Co

mmis

sion

(S

EC)

which

shah

be recognized

by the

Board

and

the

PRC

as th

e on

e and

only

in

tegr

ated

and

accr

edit

ed pr

ofes

sion

al or

gani

zati

on o

f ph

arma

cist

s.

A pharmacist

duly

registered

with

the

Board

shall

automatically

become

a member

of

the

integrated

and

accr

edit

ed

professional

organization

of

pharmacists,

and

shal

l re

ceiv

e the

bene

fits

and

priv

ileg

es

appurtenant

thereto

upon

payment

of the

reqmred

fees

and

dues

.

Membership

in

the

inte

grat

ed APO

shah

not

be

a ba

r to

membership

in

othe

r as

soci

atio

ns

of ph

arma

cist

s.

SEC.

42.

Me

mb

ers

hip

to

the

Inte

gra

ted

an

d A

ccre

dit

ed

Pro

fess

ion

al

Org

aniz

atio

n.

- Ah

regi

ster

ed ph

arma

cist

s must

be

members

of

the

APO

and

must

maintain

membership

throughout

the

duration

of the

prac

tice

of

the

prof

essi

on.

The

PIC

shah

not

be re

newe

d if

the

requirements

for

membership

with

the

APO

are

not

met

including

cred

it units

for

atte

ndan

ce

to duly

accr

edit

ed

CPD.

All

pharmacy

supp

ort

pers

onne

l must

be

regi

ster

ed

as

affi

hate

members

of

the

APO

and

must

likewise

maintain

membership

throughout

the

duration

of

employment

in

pharmaceutical

esta

bhsh

ment

s and

outl

ets.

SEC.

43.

Spec

ialty

Bo

ard

s in

Va

rio

us

Are

as o

f P

ha

rma

cy

Pra

ctic

e.

- Sp

ecia

lty

Boar

ds

in

various

area

s of

pharmacy

practice

shall

be

crea

ted,

su

bjec

t to

accreditation

by

the

Board

and

the

PRC.

The

Board

shaU

issu

e gu

idel

ines

in

the

accreditation

of

specialty

boards

in

various

areas

of

pharmacy

prac

tice

, which

shall

include

the

standards

of

29

practice

within

different

spec

ialt

ies,

qualifications,

and

requirements

for

the

certification

of

practitioners

under

each

spec

ialt

y, among

othe

rs.

ARTICLE

VI

VIOLATIONS,

ADMINISTRATIVE

SANCTIONS,

AND

PROCEDURES

SEC.

44.

Rev

oca

tio

n or

S

usp

ensi

on

of

the

Certi

ficate

o

f R

egis

trat

ion

an

d C

ance

llat

ion

of S

pec

ial/

Tem

po

rary

P

erm

it.

-Th

e Board

shah

have

the

powe

r,

upon

noti

ce

and

hearing,

to

revoke

or

suspend

the

COR

of

a registered

pharmacist

or

to

cancel

an

STP

of

a foreign

pharmacist

on

any

of

the

foho

wjng

gr

ound

s:

(a)

Violation

of any

provision

of this

Act,

it

s ru

les

and

regulations,

the

Pharmacists'

Code

of

Ethics,

Code

of

Technical

Standards

for

the

Professional

Practice

of

the

Pharmacy

Profession,

Code

of

Good

Governance

and

all

other

guidehnes,

poUcies

and

regulatory

measures

of

the

Board

and/or

the

PRC

relating

to

the

practice

of

the

phar

macy

pr

ofes

s j^

n;

(b)

Conv

icti

on of

an

offe

nse

involving

moral

turpitude

by

a co

urt

of c

ompe

tent

ju

risd

icti

on;

(c)

Unprofessionalism,

immorality,

malpractice,

inco

mpet

ence

, gross

neghgence,

or im

prud

ence

in

the

prac

tice

of

the

pr

ofes

sion

;

(d)

Fraud

or deceit

in

the

acqu

isit

ion

of th

e COR,

PIC

or STP,

or renewal

ther

eof;

(e)

Allowing

the

COR

to

be

used

or

displayed

in

esta

bhsh

ment

s where

the

pharmacist

is not

actuahy

empl

oyed

and

prac

tici

ng;

(f)

Addi

ctio

n to al

coho

hc b

ever

ages

or

to a

ny

habi

t-fo

rmin

g drug

rendering

a pharmacist

incompetent

to

prac

tice

the

prof

essi

on as

pr

ovid

ed fo

r in

Sect

ion

23

here

of;

(g)

Aiding

or ab

etti

ng t

he i

hega

l pr

acti

ce of

a

non-

regi

ster

ed

and

hcensed

pers

on;

30

(h.)

In

sani

ty or

any

mental

diso

rder

th

at would

rend

er the

pers

on incompetent

to p

ract

ice

phar

macy

;

(i)

False,

extravagant,

or unethical

adve

rtis

emen

ts

and

endo

rsem

ents

of

pha

rmac

euti

cal

prod

ucts

, ph

arma

ceut

ical

ou

tlet

s and

establishments

where

the

pharmacist's

name

or

the

pharmacist's

professional

organization

and

similar

info

rmat

ion,

or

both,

axe

used

;

(j)

Manufacture,

sale

, of

feri

ng fo

r sa

le

of

coun

terf

eit,

sp

urio

us,

substandard

and

fals

ifie

d pharmaceutical

prod

ucts

and

committing

other

acts

in

viol

atio

n of

Repubhc

Act

No.

9165

and

Repubhc

Act

No.

8203

, ot

herw

ise

loiown

as the

"Spe

cial

Law

on

Counterfeit

Drugs";

(k)

Ihegal

manufacture,

sale

, possession,

disp

ensi

ng

of

dang

erou

s dr

ugs

and

other

acts

in

viol

atio

n of

Repubhc

Act

No.

9165

, and

other

apphcable

laws

and

issu

ance

s;

(I)

Committing

acts

in

violation

of

Section

6 of

Presidential

Decree

No.

881,

entitled

"Empowering

the

Secretary

of

Health

to

Regulate

the

Labeling,

Sale

and

Distribution

of

Hazardous

Subs

tanc

es"

and

Section

11

of

Repubhc

Act

No.

3720

, as

am

ende

d;

(m)

Prac

tici

ng p

harm

acy

with

a

suspended

COR

or

e^qi

ired

PIC;

(n)

Unauthorized

disp

ens

ing

of pharmaceutical

prod

ucts

through

unre

gist

ered

on

hne

serv

ices

or

dire

ct se

ttin

g bt

isin

esse

s;

and

(o)

Being

found

guil

ty

of

immoral,

unprofessional,

or

dish

onor

able

conduct

by the

Board.

ARTICLE

VII

PENAL

PROVISIONS

SEC.

45.

Pe

na

l P

rovi

sio

ns.

-

Any

person

who

shaU

commit

any

of

the

fohowing

acts

shah,

upon

conv

icti

on,

be

sentenced

to

pay

a fine

of

not

less

than

two

hundred

fift

y

31

thousand

pesos

(P250,000.00),

but

not

exceeding

five

hundred

thousand

pesos

(P50

0,00

0.00

) or

imprisonment

of

not

less

than

one

(1)

year

and

one

(1)

day

but

not

more

than

six

(6)

year

s, or

both,

at

the

disc

reti

on of

the

cour

t:

(a)

Commissionof

any

act

in

viol

atio

n of

Se

ctio

ns

30

and

31 of

th

is

Act;

(b)

Ahowing

the

disp

lay

of o

ne's

COR

in

a pharmaceutical

establishment

where

the

pharmacist

is

not

employed

and

prac

ticu

ig;

(c)

Displaying

of

the

pharmacist's

COR

by

pharmacy

owne

Bs/o

pera

tors

in

a pharmaceutical

estabhshment

where

the

pharmacist

is n

ot

empl

oyed

and

prac

tici

ng;

(d)

Dispensing

or

ahowing

the

dispensing

or

offering

for

sale

of

prescription

drugs

or

pharmaceutical

products

in a

place

not

hcensedby

the

FDA

as a

pharmaceutical

outl

et;

(e)

Dispensing

of

prescription

and

pharmacist-only

OTC

pharmaceutical

prod

ucts

by

a

person

other

than

thos

e under

the

direct

and

immediate

supervision

of

a duly

regi

ster

ed

and

hcensed

pharmacist;

(£)

Allowing

the

disp

ensi

ng of

pre

scri

ptio

n and

phar

maci

st-

only

OTC

pharmaceutical

prod

ucts

, without

the

dire

ct

and

immediate

supervision

of

a duly

registered

and

licensed

pharmacist;

(g)

Compounding

and

dispensing

not

in

accordance

with

current

Good

Manufacturing

Prac

tice

, Good

Laboratory

Prac

tice

and

Phihppine

Prac

tice

Standards

for

Pharmacists,

and

such

other

stan

dard

s and

guid

ehne

s is

sued

by

the

Board;

(b)

Sehing

of

prescription

and

pharmacist-only

OTC

drugs

by

manufacturers,

importers,

and

wholesalers

to

unhc

ense

d pharmaceutical

outl

ets

and

other

estabhshments;

(i)

Substituting

prescription

drugs

which

are

not

gene

rica

hy

equivalent

to what

was

on

the

pres

crip

tion

, without

the

consent

of

the

prescriber

or

not

in

accordance

with

Repubhc

Act

No.

6675

;

32

© Fo

rcin

g, co

erci

ng,

or i

ntim

idat

ing

a d

viy

regi

ster

ed

and

lice

nsed

pharmacist

to

compound

or

dispense

medical

and

pharmaceutical

prod

ucts

in

violation

of

the

prov

isio

ns of

th

is

Act;

(k)

Prep

arin

g an

d co

mpou

ndin

g of

pha

rmac

euti

cal

prod

ucts

in

qu

anti

ties

gre

atly

in ex

cess

of

sing

le th

erap

euti

c do

ses,

wi

thou

t th

e presence

and

supe

rvis

ion

of a

duly

re

gist

ered

and

hcensed

phar

maci

st;

© Noncomphance

with

the

labe

hng

requirements

for

dispensed

medi

cine

s by

a

phar

mace

utic

al ou

tlet

;

(m)

Manufacturing

and

selling

of

pharmaceutical

prod

ucts

under

frau

dule

nt

name

or

addr

ess,

or

bo

th;

(n)

Adulterating

and

misbranding

of

pharmaceutical

prod

ucts

;

(o)

Manufacturing

and

sehi

ng of

uns

afe,

su

bsta

ndar

d and

coim

terf

eit

phar

mace

utic

al

prod

ucts

;

(p) Operating

an

unlicensed

pharmaceutical

outlet

such

as

online

pharmacy

service

or

direct

selling

not

authorized

by

the

FDA;

(q)

Oper

atin

g a

Cate

gory

A

esta

bhsh

ment

which

opens

for

busi

ness

without

a diJy

regi

ster

ed and

hcensed

phar

maci

st;

(r)

Operating

a Ca

tego

ry

B estabhshment

without

the

supervision

and

over

sigh

t of

a

duly

regi

ster

ed

and

hcensed

phar

maci

st;

(s)

Prac

tici

ng pharmacy

with

an

expi

red,

suspended

or

revo

ked

hcen

se;

(t)

Fill

ing

and

refi

llin

g of

pre

scri

ptio

n an

d ph

arma

cist

-onl

y OTC

pharmaceutical

prod

ucts

by

a

pers

on

othe

r than

a duly

registered

and

hcensed

pharmacist

without

the

dire

ct

and

immediate

supe

rvis

ion;

(u)

Disp

ensi

ng

pres

crip

tion

dr

ugs

and

pharmacist-only

OTC

drug

s by

ru

ral

health

unit

s wi

thou

t the

supervision

of

a du

ly re

gist

ered

an

d li

cens

ed ph

arma

cist

; and

33

(v)

Ah

othe

r ac

ts o

r om

issi

ons

anal

ogou

s to

the

fore

goin

g.

SEC.

46.

Othe

r P

enal

ties

. -

Any

pers

on who

shah

commit

any

of

the

fohowing

acts

sha

ll,

upon

conv

icti

on,

be sentenced

to

pay

a fine

of

not

less

than

one

hundred

thousand

pesos

(P10

0,00

0.00

),

but

not

exceeding

two

hundred

thousand

pesos

(P20

0,00

0.00

) or

imprisonment

of

not

less

than

thir

ty

(30)

days

but

not

more

than

one

(1)

year

, or

bot

h, at

the

disc

reti

on of

the

cour

t:

(a)

Affi

xing

of

the

tit

le "RPh"

by a

pers

on who

is n

ot

a duly

regi

ster

ed an

d hcensed

phar

maci

st;

(b)

Prac

tici

ng t

he

pharmacy

prof

essi

on in

the

Phihppiaes

withok

a vahd

COR,

PIC

or STP;

(c)

Non-indication

of a

pharmacist

of hi

s/he

r COR

and

prof

essi

onal

tax

rece

ipt

numbers

in

offi

cial

doc

umen

ts

requiring

such

in

form

atio

n;

(d)

Refusal

to

disp

lay

the

COR

of the

pharmacist

in

a prominent

and

cons

picu

ous

plac

e in

the

esta

bhsh

ment

and

outl

et

where

the

pharmacist

is e

mplo

yed

and

prac

tici

ng;

(e)

Noncomphance

by

a duly

regi

ster

ed

and

lice

nsed

pharmacist

with

the

requirements

on

the

fhhng

of pr

escr

ipti

on;

(f)

Noncomphance

by

a duly

regi

ster

ed

and

hcensed

pharmacist

on

the

requ

irem

ents

fo

r partiahy-fihed

pres

crip

tion

;

(g)

Sehing

of p

hysi

cian

's

samp

les;

(b)

Dist

ribu

tion

of

antu

nicr

obia

ls,

incl

udin

g an

ti-T

B dr

ugs

and

othe

r pr

oduc

t cl

assi

fica

tion

as

may

be prohibited

by law

as

phys

icia

n's

samp

les;

(i)

Removal,

eras

ure

and

alte

rati

on of

mark

or label

of

phys

icia

n's

samp

le;

(j)

Use

of ci

pher

, codes,

or se

cret

ke

ys or

unusual

names

or terms

in

pres

crip

tion

s;

(k)

Fihing

of pr

escr

ipti

ons

where

ciph

er,

codes,

or secret

keys

or

unusual

names

or terms

are

used

;

34

Q.) Noncompliance

with

labeling

requirements

for

disp

ense

d me

dici

nes;

(m)

Noncomphance

with

the

requ

irem

ents

on

the

keep

ing

of r

ecor

d books

by a

pharmaceutical

outl

et;

(n)

Employment

of

personnel

in

a pharmacy

or

pharmaceutical

oper

atio

n without

the

requ

ired

tr

aini

ng

and

cert

ific

atio

n;

• (o

) Refusal

of

a non-pharmacist

owner/operator

of

a ph

arma

ceut

ical

ou

tlet

to

unde

rgo

trai

ning

and

cert

ific

atio

n;

(p)

Refu

sal

by th

e ow

ner/

oper

ator

to

aho

w and

requ

ire

duly

re

gist

ered

and

hcensed

pharmacists

and

pharmacy

supp

ort

pers

onne

l to

un

derg

o CPD,

trai

ning

and

cert

ific

atio

n;

(q)

Rendering

dispensing-related

services

by

non-

phar

maci

sts

in

a ph

arma

ceut

ical

ou

tlet

wit

hout

un

derg

oing

the

requ

ired

tra

inin

g and

cert

ific

atio

n;

(r)

Dispensing

pharmaceutical

products

in

medical

miss

ions

wi

thou

t th

e su

perv

isio

n of

a d

uly

regi

ster

ed and

hcensed

phar

maci

st;

(s)

Noncompliance

with

the

required

training

and

cert

ific

atio

n of

pro

fess

iona

l se

rvic

e or

me

dica

l re

pres

enta

tive

s or

pr

ofes

sion

al

serv

ice

repr

esen

tati

ves,

pharmacy

tech

nici

ans,

ph

arma

qy as

sist

ants

, ph

arma

cy ai

des,

ph

arma

cy cl

erks

, and

othe

r me

dici

ne ha

ndle

rs of

pha

rmac

euti

cal

prod

ucts

. Both

the

medi

cal

repr

esen

tati

ves

or p

rofe

ssio

nal

serv

ice

repr

esen

tati

ves,

ph

arma

cy

tech

nici

ans,

pharmacy

assi

stan

ts,

pharmacy

aide

s,

pharmacy

clerks,

or

medicine

handlers

and

the

pharmaceutical

esta

bhsh

ment

an

d ou

tlet

emp

loyi

ng an

y su

ch in

divi

dual

shah

be

held

join

tly

habl

e;

and

(t)

Viol

atio

n of

any

provision

of th

is Act

and

its

rules

and

regu

lati

ons

not

afor

emen

tion

ed

abov

e.

Any

pers

on,

othe

r than

the

citi

zens

of

the

Phihppines,

having

been

foimd

guhty

of any

violation

as pr

ovid

ed

for

in

this

se

ctio

n and

the

prec

edin

g se

ctio

n sh

ah,

afte

r having

paid

th

e fi

ne

or having

serv

ed the

sent

ence

, or

bo

th,

when

so

adjudged,

shah

also

be

su

bjec

t to

immediate

depo

rtat

ion.

38

The

pena

ltie

s and

habi

htie

s he

rein

pro

vide

d sh

ah b

e wi

ibho

ut

prej

udic

e to

other

sanc

tion

/s

that

may

be imposed

for

violation

of o

ther

apphcable

laws

, po

lici

es,

rules

and

regu

lati

ons.

The

owne

r/op

erat

or of

the

pha

rmac

euti

cal

esta

bhsh

ment

s/

outl

ets

and

the

duly

registered

and

licensed

pharmacists/

pharmacy

supp

ort

pers

onne

l ar

e jo

intl

y ha

ble

for

the

wUlf

ul

viol

atio

n of

any

prov

isio

n of

thi

s Ac

t.

ARTICLE

Vni

PINAL

PROVISIONS

jfSE

C. 47.

En

forc

em

en

t.

- It

shah

be

the

primary

duty

of

the

Board

and

the

PRC

to

effectively

enforce

the

prov

isio

ns

of

this

Ac

t. All

duly

cons

titu

ted

law

enfo

rcem

ent

agencies

and

offi

cers

of

the

national,

provincial,

city

or

municipal

government

or

of any

poht

ical

su

bdiv

isio

n thereof

shah

ensu

re

the

effe

ctiv

e enforcement

and

implementation

of the

prov

isio

ns

of

this

Ac

t.

SEC.

48.

Ap

pro

pri

ati

on

s. -

The

Chairperson

of the

PRC

shah

immediate^

incl

ude

in

its

programs

the

implementation

of

this

Act,

the

funding

of

which

shal

l be

charged

against

thei

r current

years'

appropriations

and

thereafter,

in

the

annual

General

Appropriations

Act.

SEC.

49.

Tra

ns

ito

ry

Pro

vis

ion

s.

- The

incumbent

Chairperson

and

members

of

the

Board

shah

, in

an

interim

capa

city

, co

ntin

ue to

function

as su

ch unth

the

Chai

rper

son

and

members

of

the

new

Board,

crea

ted

under

tlii

s Ac

t, shah

have

been

appo

inte

d and

qual

ifie

d.

SEC.

50.

Imp

lem

en

tin

g R

ule

s a

nd

Reg

ulat

ions

. -

Within

one

hundred

twenty

(120

) days

afte

r the

appr

oval

of

th

is A

ct,

the

Boar

d, subject

to

the

approval

by the

PRC,

and

in

consultation

with

the

APO,

shah

form

ulat

e and

issu

e th

e ru

les

and

regu

lati

ons

to implement

the

prov

isio

ns of

th

is Ac

t.

SEC.

51.

Se

pa

rab

ilit

y Cla

use

. -

If any

clau

se,

provision,

paragraph

or part

hereof

shah

be declared

unconstitutional

or

inva

hd,

such

de

clar

atio

n shah

not

affe

ct,

invahdate,

or impair

the

othe

r pr

ovis

ions

ot

herw

ise

vahd

and

effe

ctiv

e.

3 6

S E C . 5 2 . R e p e a l i n g C l a u s e . - R e p u b l i c A c t N o . 5 9 2 1 , a s a m e n d e d , i s h e r e b y r e p e a l e d . A l l o t h e r l a w s , p r e s i d e n t i a l d ecrees, e x e c u t i v e o r d e r s a n d o t h e r a d m i n i s t r a t i v e i s s u a n c e s o r p a r t s t h e r e o f w h i c h a r e c o n t a - a r y t o o r i a c o n s i s t e n t w i t h t h e p r o v i s i o n s o f t h i s A c t a r e h e r e b y r e p e a l e d , a m e n d e d , o r m o d i f i e d a c c o r d i n g l y .

S E C . 5 3 . E f f e c t i v i t y . - T h i s A c t s h a l l t a k e e f f e c t fifteen ( 1 5 ) d a y s a f t e r i t s p u b M c a t i o n i n t h e Official G a z e t t e o r i n a n e w s p a p e r o f g e n e r a l d r c u l a t i o n .

A p p r o v e d ,

, 0 N F E L I C I A N O B E L M O N T E J R . President o f the S e n a t e Speaker o f the H o u s e

J o f Representatives

T h i s A c t was« p a s s e d b y t h e H o u s e o f R e p r e s e n t a t i v e s a s H o u s e B i l l N o . 5 6 1 6 o n M a y 2 3 , 2 0 1 6 a n d a d o p t e d b y t h e S e n a t e a s a n a m e n d m e n t t o S e n a t e B i l l N o . 2 4 3 6 o n M a y 3 0 , 2 0 1 6 .

"'OSC^SJGZ'YABES ~ ^ M ^ [ J N B ^ A R U A ^ J P ^ ^ Secretary o f the Senate Secretary G e n e r a l

H o u s e o f Representatives

Approved:

B E N I G N O S . AQUINO H I President o f the Philippines

Lapsed snto faw on JUL t I m Without t h e s i g n a t u r e o f I h e P r e s i d e n t

5n a c c o r d a n c e v v i t h A r t i c l e V I . S e c f i o n f

Z 7 (1) of the C o n i J t a - j t i O f t