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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 . 5921 ), 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

GENERAL PROVISIONS

S E C T I O N 1 . Title. - This Act shall be known as the


"Philippine P h a r m a c y Act".

SEC. 2. S t a t e m e n t of Policy. - The State recognizes the


vital role of pharmacists i n the delivery of quality health care
services t h r o n g t h e p r o v i s i o n of safe, effective, a n d q u a l i t y
2

(c) E n g a g e i
p h a r m a c e u t i c a l p r o d u c t s , p h a r m a c e u t i c a l care, d r u g i n f o r m a t i o n , pharmacy courses
patient medication counseling, a n d h e a l t h promotion.The
p h a r m a c i s t s ' p r o f e s s i o n a l s e r v i c e s s h a l l , t h e r e f o r e , be p r o m o t e d (d) D i s p e n s e
as a n i n d i s p e n s a b l e c o m p o n e n t o f t h e t o t a l h e a l t h c a r e s y s t e m t o where supervision
ensure the physical well-being of the Filipinos. . is reqtdred; or
Hence, t h e State s h a l l develop a n d n u r t u r e competent, (e) C h e m i c a l
productive, m o r a l l y upright, a n d weU-roimded pharmacists whose assay of p h a r m a c e
standards of professional practice a n d service s h a l l be excellent health supplements
and globally competitive t h r o u g h r e g u l a t o r y measures, programs,
and activities t h a t promote and sustain their continuing (f) P h y s i c o -
professional development. i n aid of a d m i n i s t

SEC. 3. Objectives. - This Act provides for and shall govern (g) A d m u i i s t
the: Food^and D r u g A d m
shall undergo the
(a) Standardization a n d regidation of pharmacy education; vaccines and m a
immunization (AEF
(b) A d m i n i s t r a t i o n o f l i c e n s u r e e x a m i n a t i o n , r e g i s t r a t i o n , training issued
and licensing of pharmacists; Professional Regu
T h a t t h e safe a d m
(c) S u p e r v i s i o n , c o n t r o l , a n d r e g u l a t i o n o f t h e p r a c t i c e o f education curricu
pharmacy i n the Phihppines;
(h) C o n d u c t
(d) D e v e l o p m e n t a n d e n h a n c e m e n t o f p r o f e s s i o n a l aspects i n v o l v i n g
competence of pliairmacists t h r o u g h continuing professional
development, research, and other related activities; and (i) Provid
is required.
(e) I n t e g r a t i o n of the p h a r m a c y profession.
Activities un
SEC. 4. S c o p e o f t h e P r a c t i c e o f P h a r m a c y . - A p e r s o n is exclusive t o hcen
d e e m e d t o be p r a c t i c i n g p h a r m a c y , w i t h i n t h e m e a n i n g o f t h i s s h a l l be c o n s t r u e
A c t , w h e n w i t h or w i t h o u t a fee, s a l a r y , percentage or o t h e r only the activiti
rewards, paid or given directly or indirectly, s h a l l : licensed pharmac
imposed by other
(a) P r e p a r e , c o m p o u n d o r m a n u f a c t u r e , p r e s e r v e , s t o r e ,
d i s t r i b u t e , p r o c u r e , seU, o r d i s p e n s e , o r b o t h , a n y p h a r m a c e u t i c a l All pharmac
product or its r a w materials; or standards such a
Pharmacists, Goo
(b) R e n d e r s e r v i c e s , s u c h as c U n i c a l p h a r m a c y s e r v i c e s , Practice, Good M
d r u g i n f o r m a t i o n services, r e g u l a t o r y services, p h a r m a c e u t i c a l Practice, w h i c h a
m a r k e t i n g , medication management, or whenever the expertise roles a n d function
a n d teclinical knowledge of the pharmacist is required; or
4

The Professional Regulatory Board of Pharmacy, (e) B r a n d n a m e r


h e r e i n a f t e r created, subject t o t h e a p p r o v a l o f t h e P R C , as the manufacturer to
provided for by Republic A c t N o . 8 9 8 1 , o t h e r w i s e k n o w n as competitors;
the " P R C M o d e r n i z a t i o n A c t of 2000", a n d i n consultation w i t h
the integrated a n d accredited professional organization (0 C i p h e r , C o d e ,
( A P O ) , m a y m o d i f y t h e a b o v e - e n u m e r a t e d acts, services, or secret w r i t i n g or u
a c t i v i t i e s , as t h e n e e d a r i s e s , i n o r d e r t o c o n f o r m t o t h e l a t e s t substituting other let
treads and developments i n t h e practice of the p h a r m a c y for t h e purpose of mi
profession: P r o v i d e d , T h a t such modifications are consistent
w i t h the e n u m e r a t i o n above. (g) C o m p o u n d i n g
by a pharmacist i n dr
SEC. 5. Definition of Terms. - A s used i n this Act: mixing, assembhng, p
result of a prescript
(a) A c c r e d i t e d p r o f e s s i o n a l o r g a n i z a t i o n , ( A P O ) r e f e r s v e t e r i a a r i a n ; or (ii)
to t h e duly i n t e g r a t e d a n d accredited professional organization teaching, or chemical
o f r e g i s t e r e d a n d licensed p h a r m a c i s t s , o f w h i c h t h e r e s h a l l be
o n l y o n e (1), a s p r e s c r i b e d u n d e r S e c t i o n 4 1 , A r t i c l e V o f t h i s A c t ; (h) C o n t i n u i n g p r o
to t h e inculcation o
(b) A d u l t v a c c i n e s r e f e r t o c e r v i c a l c a n c e r , f l u ( i n f l u e n z a ) , values i n a post-li
y pneumococcal, other pre-exposure prophylactic vaccines to multidisciplinary
' be a d m i n i s t e r e d t o p a t i e n t s aged e i g h t e e n (18) y e a r s a n d above, professional practic
a n d s u c h o t h e r v a c c i n e s as m a y be d e f i n e d b y t h e D e p a r t m e n t learning; /
of H e a l t h ( D O H ) i n a n a d m i n i s t r a t i v e issuance;
(i) C o s m e t i c s r
(c) Adulterated/Deteriorated pharmaceutical products i n t e n d e d t o be p l a c
refer to pharmaceutical products xuifit for h u m a n consumption, parts of t h e h u m a n
f o l l o w i n g t h e s t a n d a r d s of q u a h t y or p u r i t y of w h i c h , are as membranes of the ora
those stated i n the U n i t e d States P h a r m a c o p e i a / N a t i o n a l to cleaning t h e m , pe
F o r m u l a r y and P h i l i p p i n e P h a r m a c o p e i a i n its latest edition and/or correcting b
or any s t a n d a r d reference for drugs a n d medicines w h i c h are keeping t h e m i n good
g i v e n o f f i c i a l r e c o g n i t i o n as w e l l as t h o s e p r o v i d e d f o r i n No. 9711;
R e p u b K c A c t N o . 3 7 2 0 , o t h e r w i s e k n o w n as t h e "Food, D r u g ,
a n d Cosmetic Act", as amended, a n d Republic A c t N o . 9 7 1 1 , ® Counterfeit p
k n o w n as t h e "Food a n d D r u g A d m i n i s t r a t i o n A c t of 2009"; pharmaceutical produ
as c l a i m e d ; w i t h w r o n
(d) B i o p h a r m a c e u t i c a l s r e f e r t o p h a r m a c e u t i c a l p r o d u c t s or w i t h insxifficient
t h a t are used for therapeutic or for i n vivo diagnostic purposes, i n the reduction of th
s u c h a s v a c c i n e s , s e r a , a n d d r u g s d e r i v e d from l i f e f o r m s o r p u r i t y . T h e s e al
u s i n g biotechnology. T h e s e include p r o t e i n s , nucleic acids, or and fraudulently mi
living microorganisms where the virulence is reduced and source or w i t h fake
are used for therapeutic or for i n vivo diagnostic purposes; and generic products,
6

(1) T h e p h a r m a c e u t i c a l p r o d u c t i t s e l f o r t h e c o n t a i n e r (2) A n y a r t i
or labeKng thereof or any p a r t of such product, container, or mitigation, treatm
labehng, bearing w i t h o u t authorization; the trademark, trade
n a m e , or other i d e n t i f i c a t i o n m a r k s or i m p r i n t s or a n y likeness (3) A n y a r t i
to t h a t w h i c h is o w n e d or registered i n t h e I n t e l l e c t u a l P r o p e r t y structure or any f
Office ( I P O ) i n t h e n a m e o f a n o t h e r n a t u r a l or j u r i d i c a l p e r s o n ;
(4) A n y a r t i c
(2) A p h a r m a c e u t i c a l p r o d u c t r e f i l l e d i n c o n t a i n e r s b e a r i n g specified i n claus
legitimate labels or m a r k s , w i t h o u t authority; and components, parts

(3) A p h a r m a c e u t i c a l p r o d u c t w h i c h c o n t a i n s n o a m o u n t (5) H e r b a l o r
of or a different active ingredient; or less t h a n eighty percent No. 9502;
( 8 0 % ) o f t h e a c t i v e i n g r e d i e n t i t p u r p o r t s t o possess, as
d i s t i n g u i s h e d firom a n a d x i l t e r a t e d d r u g i n c l u d i n g r e d u c t i o n (n) E m e r g e n c y
o r l o s s o f efficacy d u e t o e x p i r a t i o n ; w h e r e a p a t i e n t nee
including the occu
(k) D a n g e r o u s d r u g s r e f e r t o t h o s e l i s t e d i n t h e :
(1) S c h e d u l e s a n n e x e d t o t h e 1 9 6 1 S i n g l e C o n v e n t i o n o n (o) E x p i r a t i o n
N a r c o t i c D r u g s , as a m e n d e d b y t h e 1 9 7 2 P r o t o c o l ; (2) S c h e d u l e s manufacturer can
'annexed to the 1971 Single Convention on Psychotropic claimed potency, e
S u b s t a n c e s ; a n d (3) A n n e x o f R e p u b h c A c t N o . 9 1 6 5 , o t h e r w i s e or d i s t r i b u t i o n is
^ k n o w n as t h e " C o m p r e h e n s i v e D a n g e r o u s D r u g s A c t o f 2002",
and its amendments; (p) F i l l i n g . r
m e d i c i n e s i n accx^
® D i s p e n s i n g refers t o t h e s u m of processes p e r f o r m e d
by a pharmacist f r o m reading, vahdating, and interpreting (q) F o o d / D i e t a
prescriptions; preparing; packaging; labehng; record keeping; products intended
dose c a l c u l a t i o n s ; a n d c o i m s e h n g o r g i v i n g i n f o r m a t i o n , i n r e l a t i o n one ( I ) or m o r e o
t o t h e sale o r t i ' a n s f e r o f p h a r m a c e u t i c a l p r o d u c t s , w i t h o r w i t h o u t minerals, herbs,
a prescription or medication order; substances to in
conforming to the
(m) D r u g s r e f e r t o p h a r m a c e u t i c a l p r o d u c t s t h a t p e . r t a i n nutrient intakes
to c h e m i c a l c o m p o u n d s or biological substances, o t h e r t h a n food, requirements. I t u
i n t e n d e d for use u i t h e t r e a t m e n t , prevention, or diagnosis of gels, p o w d e r s , o r p
disease i n h i i m a n s or a n i m a l s , i n c l u d i n g t h e following: food or as t h e sol
a n d m e d i c i n e s , as
(1) A n y a r t i c l e r e c o g n i z e d i n t h e o f f i c i a l U n i t e d
States P h a r m a c o p e i a / N a t i o n a l Formulary, Homeopathic (r) G e n e r i c n
P h a r m a c o p e i a of the U n i t e d States of A m e r i c a , P h i l i p p i n e internationally r
Pharmacopeia, Philippine National D r u g Formulary, approved by the F D
British Pharmacopoeia, European Pharmacopoeia, k n o w n as t h e "Gen
J a p a n e s e P h a r m a c o p o e i a , and any official compendium
or a n y supplement to t h e m ;
8

(s) H e a l t h s u p p l e m e n t r e f e r s t o a n y p r o d u c t t h a t i s s u p p o r t i n g or s
of conception; d
used to m a i n t a i n , enhance and improve the h e a l t h y function of
information for
t h e h u m a n b o d y a f i d c o n t a i n s o n e (1) o r m o r e o r a c o m b i n a t i o n o f
i n vitro e x a m i n a t i o
t h e f o l l o w i n g : (1) h e r b a l f a t t y acids, e n z y m e s , p r o b i o t i c s , a n d o t h e r
T h i s device does
b i o a c t i v e s u b s t a n c e s ; a n d (2) s u b s t a n c e s d e r i v e d firom n a t u r a l
on the h u m a n bo
sources, i n c l u d i n g a n i m a l , p l a n t , m i n e r a l , a n d b o t a n i c a l m a t e r i a l s
metabohc means,
i n the f o r m of extracts, isolates, concentrates, metaboUtes, function by such
s y n t h e t i c sources o f substances m e n t i o n e d i n (1) a n d (2). I t is
p r e s e n t e d i n dosage f o r m s o r i n s m a l l x m i t doses s u c h a s capsules,
(z) M e d i c a l
tablets, powder, hquids a n d i t shall not include any sterile
n o r m a l circumsta
p r e p a r a t i o n s (i.e. i n j e c t i b l e s , e y e d r o p s ) ;
care p r a c t i t i o n e r
cUnic, a n d h e a l
' ( t ) ' - H o u s e h o l d rem/3(Ues refer to a n y preparation containing
from humanitari
p h a r m a c e u t i c a l substances of c o m m o n or o r d i n a r y use to relieve
conducted d u r i n g
c o m m o n p h y s i c a l a i h n e n t s a n d w h i c h m a y be d i s p e n s e d w i t h o u t
or n a t u r a l and m a
a m e d i c a l prescription i n o r i g m a l packages, bottles or containers,
of w h i c h the nomenclature has been duly approved by the F D A ;
(aa) M e d i c i n
forms, w i t h assu
(u) I n s t i t u t i o n a l p h a r m a c i e s r e f e r t o p h a r m a c i e s o f
institutions, organizations, and/or coiporations t h a t provide a range animals, or both
of p h a r m a c e u t i c a l services, g i v e n exclusively to t h e employees
(bb) M e d i c a l
^ n d / o r t h e i r quaUfLed d e p e n d e n t s ;
representative refe
manufacturer,/^
(v) I n t e r n s h i p p r o g r a m r e f e r s t o a s u p e r v i s e d p r a c t i c a l
pharmaceutical p
e x p e r i e n c e t h a t i s r e q u i r e d t o be c o m p l e t e d f o r h c e n s u r e as a
their products to
registered pharmacist;
(cc) N o n t r a d
(w) L a b e l refers to a display of w r i t t e n , p r i n t e d , or graphic
appropriate gove
m a t t e r o n the immediate container of any article;
medicines based
(x) L a b e l i n g materials refer to aH labels a n d other w r i t t e n ,
(dd) O n l i n e p
p r i n t e d , or graphic m a t t e r : (1) u p o n a n y i t e m or a n y o f i t s
services of a d u
c o n t a i n e r s o r w r a p p e r s ; or (2) a c c o m p a n y i n g a n y s u c h i t e m ;
internet;
(y) M e d i c a l d e v i c e r e f e r s t o a n y i n s t r u m e n t , a p p a r a t u s ,
(ee) O v e r - t h e
i m p l e m e n t , machine, apphance, i m p l a n t , i n v i t r o reagent or
used for symptom
cahbrator, software, m a t e r i a l or other s i m i l a r or r e l a t e d article
dispensed w i t h o u
i n t e n d e d b y t h e m a n u f a c t u r e r t o be u s e d a l o n e , o r i n c o m b i n a t i o n ,
f o r h u m a n b e i n g s , f o r o n e (1) o r m o r e o f t h e s p e c i f i c p u r p o s e s (S) Pharmac
of: d i a g n o s i s , p r e v e n t i o n , m o n i t o r i n g , t r e a t m e n t , o r a l l e v i a t i o n
hcensed by appr
of disease; diagnosis, m o n i t o r i n g , t r e a t m e n t , or a l l e v i a t i o n o f or
involved i n the m
compensation for a n injury; investigation, replacement,
and distribution
m o d i f i c a t i o n or support of t h e a n a t o m y o f a physiological process;
outlets;
(gg) Pharmaceutical manufacturers refer to establishments (oo) P h a r m a c
engaged i n a n y or a l l operations i n v o l v e d i n t h e p r o d u c t i o n of compounding and d
p h a r m a c e u t i c a l products i n c l u d i n g t h e p r e p a r a t i o n , processing, institutional an
compounding, formulating, filling, packaging, repackaging, activities unde
altering, ornamenting, finishing and labehng, preparatory to described i n Sect
t h e i r storage, sale, or d i s t r i b u t i o n , except t h e c o m p o u n d i n g a n d
filUng of prescriptions i n pharmaceutical outlets; (pp) P h i l i p p i n
to the establishe
(!aii) P h a r m a c e u t i c a l m a r k e t i n g r e f e r s t o a n y a c t i v i t y and guidelines o
u n d e r t a k e n , organized, or sponsored by a p h a r m a c e u t i c a l t h e needs of the
estabhshment or outlet w h i c h is directed at p r o m o t i n g its product; to provide opti
by the integrat
(ii) P h a r m a c e u t i c a l o u t l e t s r e f e r t o e n t i t i e s h c e n s e d b y Regulatory Board
appropriate g o v e r n m e n t agencies, a n d w h i c h are i n v o l v e d i n
compounding and/or dispensmg and seUing of pharmaceutical (qq) P h y s i c i a n
products directly to patients or end-users; professionals for
i
(ij) P h a r m a c e u t i c a l p r o d u c t s r e f e r t o d r u g s , m e d i c i n e s , (rr) P r e s c r i p
biologicals, p h a r m a c e u t i c a l a n d biopharmaceutical products/ w h i c h c a n o n l y be
specialties, v e t e r i n a r y products, v e t e r i n a r y biologies a n d the presentation
v e t e r i n a r y medicinal products; or v e t e r i n a r i a n a

\) P h a r m a c i s t r e f e r s t o a h e a l t h p r o f e s s i o n a l w h o h a s (ss) R e f i l l i n
been registered and issued a v a h d Certificate of Registration dispensing the
(COR) and Professional Identiacation Card (PIC) by the P R C the prescription;
a n d t h e Professional Regulatory Board of P h a r m a c y ;
(tt) R e f e r r a l
(Jl) P h a r m a c i s t - o n l y O T C m e d i c i n e s r e f e r t o o v e r - t h e - provides consul
c o u n t e r medicines classified by appropriate g o v e r n m e n t agencies assessment of sym
t o be o b t a i n e d o n l y f r o m a h c e n s e d p h a r m a c i s t , w i t h m a n d a t o r y other h e a l t h care
p h a r m a c i s t ' s advice o n t h e i r selection a n d proper use;
( u u ) Referral r
( m m ) P h a r m a c y a i d e s refer to persons w h o assist t h e by pharmacists, l
p h a r m a c i s t s i n t h e d i f f e r e n t aspects o f p h a r m a c y o p e r a t i o n b a s e d facihtles for fur
o n e s t a b h s h e d s t a n d a r d o p e r a t i n g p r o c e d u r e s a n d processes, w i t h
v e r y m i n i m a l degree of independence or decision m a k i n g a n d (w) Refreshe
w i t h o u t direct interaction w i t h patients; p r o g r a m i n a n ac

(ww) T e l e p h a
(nn) P h a r m a c y a s s i s t a n t s refer to persons w h o assist t h e
services of a d u l
p h a r m a c i s t s i n d i f f e r e n t aspects of p h a r m a c y o p e r a t i o n based o n
t h e use of telep
e s t a b h s h e d s t a n d a r d o p e r a t i n g procedures a n d processes, w i t h a
m i n i m u m degree of independence or decision m a k i n g a n d m a y
have supervised interaction w i t h patients;
12

ARTICLE I I (a) A d m i n i s
THE PROFESSIONAL REGULATORY BOARD OF PHARMACY (b) P r o m u l g
orders, a n d issu
S E C . 6. Creation of the Professional R e g u l a t o r y B o a r d this Act;
of P h a r m a c y . - T h e r e is hereby created a Professional Regulatory
B o a r d of P h a r m a c y , hereinafter called the Board, under (c) P r e p a r e
the administrative control and supervision of the P R C , to rate the exami
be c o m p o s e d o f a C h a i r p e r s o n a n d t w o (2) m e m b e r s , t o be to t h e P R C . T h e
appointed by t h e President of t h e Philippines f r o m a h s t of the syllabi or t
t h r e e ' (a) r e c o m m e n d e e s for e a c h p o s i t i o n r a n k e d i n t h e hcensure examina
order o f preference a n d s u b m i t t e d by the P R C f r o m a h s t of the Commission o
f i v e (5) n o m i n e e s s u b m i t t e d f o r e a c h p o s i t i o n b y t h e d u l y
i n t e g r a t e d A P O of pharmacists. ^ (d) R e c o m m e
r e i n s t a t e m e n t of
S E C . 7. Q u a l i f i c a t i o n s o f t h e C h a i r p e r s o n a n d M e m b e r s ( S T P ) for t h e pra
o f the B o a r d . - T h e C h a i r p e r s o n a n d m e m b e r s o f t h e B o a r d , at
t h e t i m e of n o m i n a t i o n , m u s t : (e) A d m i n i s
this Act;
\) B e a c i t i z e n o f t h e P h i h p p i n e s a n d a r e s i d e n t f o r a t
l e a s t f i v e (5) y e a r s ; (f) Regula^f
the Philippmes;;
(b) B e a d u l y r e g i s t e r e d a n d l i c e n s e d p h a r m a c i s t i n t h e s e r v i c e s s u c h as
P h i l i p p i n e s , preferably a holder o f a m a s t e r a l degree i n P h a r m a c y , aides, a n d o t h e r
or its equivalent; measures that m
of the professio
(c) H a v e b e e n i n t h e a c t i v e p r a c t i c e o f p h a r m a c y f o r t h e academic, ethic
past t e n (10) years; ocular inspecti
higher educatio
(d) H a v e n o t b e e n c o n v i c t e d o f a c r i m e i n v o l v i n g m o r a l concerned govern
turpitude;
(g) P r o m u l g
(e) B e a m e m b e r i n g o o d s t a n d i n g o f t h e A P O f o r a t Ethics, Code of
l e a s t f i v e (5) y e a r s , b u t n o t a n o f f i c e r o r t r u s t e e t h e r e o f ; a n d the Professiona
coordination w i t
(0 A t t h e t i m e o f a p p o i n t m e n t , m u s t n e i t h e r be a m e m b e r
o f t h e f a c u l t y n o r a n a d m i n i s t r a t i v e officer o f a n y school, college (h) R e p r e s e
or u n i v e r s i t y offering degree p r o g r a m s i n p h a r m a c y n o r h a s a n y involving conce
direct or indirect pecuniary interest or connection i n a n y r e v i e w products a n d th
center or s i m i l a r institution.
(i) I n v e s t
S E C . 8. P o w e r s , F u n c t i o n s , a n d R e s p o n s i b i l i t i e s o f t h e Act, the rules a
B o a r d . - T h e Board s h a l l exercise the following powers, the Pharmacists'
functions, and responsibOities:
14

and Guidelines for t h e Professional Practice of the P h a r m a c y examination and


Profession, a n d o t h e r B o a r d issuances; issue sxmimons, s u b p o e n a pharmacy professi
a d t e s t i f i c a n d u m a n d s u b p o e n a duces t e c u m to secure the
attendance of witnesses or production of documents, or both, a n d S E C . 9. Term
other evidence necessary for such i n v e s t i g a t i o n or h e a r i n g ; a n d The Chairperson
render decision t h e r e o n w h i c h shah, imless appealed to t h e P R C , for a t e r m of th
b e c o m e f i n a l a n d e x e c u t o r y a f t e r f i f t e e n (15) d a y s f r o m r e c e i p t untU. t h e i r succe
of notice of j u d g m e n t or decision; T h e y m a y be r e a p
o f t h r e e (3) y e a r
Q) Delegate t h e h e a r i n g or investigation of a d m i n i s t r a t i v e Provided, T h a t no
cases-filed before t h e Board, except w h e r e t h e issue or m o r e t h a n t w o (2)
question involves t h e practice of t h e profession, i n w h i c h further. That the
case, t h e h e a r i n g s h a l l be p r e s i d e d o v e r b y a t l e a s t o n e (1) s h a h hold these t e
m e m b e r o f t h e B o a r d , t o be a s s i s t e d b y a L e g a l o r H e a r i n g the first member
Officer of t h e P R C ; o n e (1) y e a r : P r o v
s h a h serve o n l y t
(k) C o n d u c t , t h r o u g h t h e L e g a l O f f i c e r s o f t h e P R C , Chairperson and
s u m m a r y proceedings on m i n o r violations of this Act, the o a t h o f office b e f
G e n e r a l I n s t r u c t i o n to t h e E x a m i n e e s , i n c l u d i n g the
i m p l e m e n t i n g rules and regulations issued by the Board, S E C . 10. C o m
and to render s u m m a r y judgment thereon which shall, unless The Chairperson
appealed to t h e P R C , become final and executory after compensation aii
fifteen ( 1 5 ) d a y s f r o m r e c e i p t o f n o t i c e o f j u d g m e n t o r d e c i s i o n ; and allowances r
professional regu
0) I s s u e a n d p r o m u l g a t e guidelines on CPD, in the General Appro
coordination w i t h the A P O ;
S E C . 11. G r o
(m) Recommend the accreditation of the standardized o f t h e Chairpet'son or
t r a i n i n g programs for and certifications of medical the Phihppines ma
r e p r e s e n t a t i v e s o r p r o f e s s i o n a l service r e p r e s e n t a t i v e s , p h a r m a c y due process, susp
technicians, p h a r m a c y assistants, pharmacy aides and of the B o a r d o n a
o t h e r m e d i c i n e h a n d l e r s covered i n S e c t i o n 39, A r t i c l e I V of
this Act. The Board shall promulgate the criteria and (a) G r o s s
guidehnes i n t h e accreditation of t r a i n i n g p r o g r a m s a n d discharge of duty
certifications as described above, i n coorchnation w i t h t h e A P O
a n d w i t h o t h e r concerned g o v e r n m e n t agencies; (b) I n v o l v
rigging of the h
(n) A c c r e d i t S p e c i a l t y B o a r d s of P h a r m a c y b a s e d o n or both, a n d i n
t h e c r i t e r i a t h a t i t shaU estabhsh a n d prescribe; a n d information pert

(o) P e r f o r m a n d d i s c h a r g e s u c h o t h e r f u n c t i o n s a n d (c) C o n v i c
r e s p o n s i b i l i t i e s , a s m a y be d e e m e d i m p h e d , i n c i d e n t a l , a n d a court of compet
necessary, to preserve the integrity of the pharmacy hcensure
16

(d) U n p r o f e s s i o n a l , v m e t h i c a l , i m m o r a l , o r d i s h o n o r a b l e promulgated, i n co
conduct. of p h a r m a c y schoo

T h e P R C , i n t h e c o n d u c t o f i n v e s t i g a t i o n , s h a U be g u i d e d S E C . 15. Sco
b y S e c t i o n s 7 a n d 15 o f R e p u b h c A c t N o . 8 9 8 1 , t h e e x i s t i n g r u l e s Licensure E x a m i n
on admimstrative investigation, and the Rules of Court. P h a r m a c y Scienc
Chemistry, Organi
S E C . 12. C u s t o d i a n o f i t s R e c o r d s , S e c r e t a r i a t a n d Quantitative Phar
S u p p o r t Services. - A U records of the Board, p e r t a i n i n g to the Plant Chemistry,
applications for examinations, administrative and other and Parasitology
i n v e s t i g a t i v e h e a r i n g s c o n d u c t e d b y t h e B o a r d , s h a U be u n d e r Pharmacology an
the custody of t h e P R C . T h e P R C s h a l l designate a Secretary Assurance and In
who shallprovide the Board w i t h secretariat and other support D r u g Dehvery Syst
services to i m p l e m e n t t h e provisions of tliis Act. Dispensing and
Administration and
ARTICLE I I I and Ethics.

EXAMINATION, REGISTRATION, AND LICENSURE The Board,


introduce releva
\. 1 3 . L i c e n s u r e E x a m i n a t i o n R e q u i r e m e n t . — U n l e s s content of the e
exempted therefrom, a h apphcants for registration for the attributed to eac
p r a c t i c e o f p h a r m a c y s h a l l be r e q u i r e d t o p a s s a h c e n s u r e consultation w i 1 ^
e x a m i n a t i o n , as p r o v i d e d f o r i n t h i s A c t a n d S e c t i o n 7(d) o f schools a n d t h e C
Repubhc Act No. 8981.
S E C . 16. H o l
S E C . 14. Q u a l i f i c a t i o n s for t h e L i c e n s u r e E x a m i n a t i o n . - Licensure E x a m i n
A n apphcant for the Pharmacists' Licensure E x a m i n a t i o n shall places a n d dates
establish to the satisfaction of the Board t h a t the following providing for the
qualifications are met: p u r s u a n t to Secti

(a) A c i t i z e n o f t h e P h i h p p i n e s o r o f a f o r e i g n c o u n t r y S E C . 17. R a t i
w h i c h has a l a w or pohcy o n reciprocity for t h e practice of t o be r e g i s t e r e d
t h e p h a r m a c y profession; must obtain a
percent (75%), w
(b) O f good m o r a l character a n d reputation; i n any of t h e s

(c) A d e g r e e h o l d e r o f B a c h e l o r o f S c i e n c e i n P h a r m a c y A n apphcant
or i t s e q u i v a l e n t degree conferred by a n H E I i n t h e Philippines t h e t h i r d (^^^) tim
or a n i n s t i t u t i o n o f learning i n a foreign country d u l y recognized examinations wit
bythe C H E D ; and i n a d u l y accredi
on the refresher
(d) H a s c o m p l e t e d a n i n t e r n s h i p p r o g r a m a p p r o v e d b y t h e
B o a r d , p u r s u a n t t o s u c h g u i d e l i n e s a s m a y h e r e i n a f t e r be
18

S E C . 18. R e p o r t o f R a t i n g . - T h e B o a r d s h a h s u b m i t to admitted to hcen


t h e P R C t h e r a t i n g s o b t a i n e d b y e a c h c a n d i d a t e w i t h i n t h r e e (3) as p h a r m a c i s t n o
w o r k i n g days after the last day of t h e examination, unless this Act.
extended for Just cause.Upon t h e release of t h e results of t h e
examination, the P R C s h a h send by m a i l the rating obtained by S E C . 22. P r a c
each examinee a t t h e g i v e n address u s i n g t h e n i a i h n g envelope (STP). - T h e pract
s u b m i t t e d diuring t h e e x a m i n a t i o n . h m i t e d to n a t u r
the provisions o
S E C . 1 9 . O a t h o f P r o f e s s i o n . - ALL successfid. c a n d i d a t e s pertinent theret
i n the hcensure e x a m i n a t i o n shaU take their o a t h of profession has gained entr
b e f o r e a n y m e m b e r o f t h e B o a r d , officer o f t h e P R C , o r a n y p e r s o n services w i t h i n
authorized by l a w to administer oaths, prior to entering the including the foh
practice of t h e p h a r m a c y profession. or assisted proj
empioyed by a F i h
S E C . 20. I s s u a n c e o f C e r t i f i c a t e o f R e g i s t r a t i o n a n d free services i
P r o f e s s i o n a l I d e n t i f i c a t i o n C a r d . - A C O R as a p h a r m a c i s t visiting faculty
s h a l l be i s s u e d t o t h o s e w h o p a s s e d t h e l i c e n s u r e shall, before
examination, subject to compliance w i t h the registration responsibilities
r e q u i r e m e n t s a n d p a y m e n t o f t h e p r e s c r i b e d fees. T h e C O R PRC, under the
^•shah b e a r t h e r e g i s t r a t i o n n u m b e r , t h e d a t e o f i t s i s s u a n c e ,
and the signatures of the Chairperson of the P R C and (1) T h e p e r s
t h e m e m b e r s of t h e B o a r d , s t a m p e d w i t h t h e official seals of o r e x p e r t i n a fi^
the P R C and of the Board, certifying that the person n a m e d
t h e r e i n is e n t i t l e d to the practice of t h e profession, w i t h aU (2) T h e p e r s
the privileges appurtenant thereto. T h i s C O R s h a h r e m a i n i n service w h i c h is d
f u l l force a n d effect u n t i l suspended or r e v o k e d i n speciahstor expe
accordance w i t h t h i s Act.
(3) T h e p e r
A P I C b e a r i n g t h e r e g i s t r a t i o n n u m b e r a n d dates of counterpart, a na
i t s i s s u a n c e a n d e x p i r y , dxaly s i g n e d b y t h e C h a i r p e r s o n o f t h e pharmacist.
P R C , s h a h h k e w i s e be issued t o e v e r y r e g i s t r a n t , u p o n p a y m e n t
o f t h e p r e s c r i b e d f e e s . T h e P I C s h a U be r e n e w e d e v e r y t h r e e (3) S E C . 23. G r o
years, upon presentation of the Certificate of Good Standing not register any
(COGS) f r o m the A P O a n d proof of completion of the C P D
requirements. (a) C o n v i c t
a court of compet
S E C . 2 1 . F o r e i g n R e c i p r o c i t y . - U n l e s s t h e c o u n t r y or
state o f w h i c h t h e f o r e i g n p h a r m a c i s t is a subject or citizen, (b) S u m m a r
specificaUy p e r m i t s F h i p i n o p h a r m a c i s t s to practice w i t h i n i t s misrepresentation
t e r r i t o r i a l l i m i t s o n t h e s a m e basis as t h e subjects or the apphcation f
citizens of t h e said foreign country or state under reciprocity Instructions to E
a n d u n d e r i n t e r n a t i o n a l a g r e e m e n t s , n o f o r e i g n e r s h a l l be
20

(c) F o u n d g u i l t y o f i m m o r a l o r d i s h o n o r a b l e c o n d u c t b y The CORs, PI


the Board; standing shah have
w e r e issued o n or
(d) M e d i c a h y p r o v e n t o be a d d i c t e d t o a n y d r u g o r a l c o h o l
by a medical or d r u g testing facOity aca-edited by t h e government; S E C . 26. A f f i x i
and Name. - Only du
shah have the righ
(e) D e c l a r e d o f u n s o u n d m i n d b y a c o u r t o f competent Pharmacist" or " R
jurisdiction.
S E C . 27. I n d i c a
I n ^refusing t h e r e g i s t r a t i o n , t h e B o a r d s h a h g i v e a w r i t t e n be r e q u i r e d t o i n d
s t a t e m e n t s e t t i n g f o r t h t h e reasons therefor a n d s h a h file a copy of the pharmacist'
t h e r e o f i n i t s r e c o r d s . S h o t d d g r o u n d (d) be p r o v e n t o be n o l o n g e r on aU pertinent doc
existent, the Board s h a h issue a Board Resolution ahowing the
issuance of such COR. S E C . 28. R e g i s t
P R C shall prepare
S E C . 2 4 . R e i s s m n c e of R e v o k e d Certificate of Registration, r e s i d e n c e s o r offic
R e p l a c e m e n t o f L o s t or D a m a g e d C e r t i f i c a t e o f R e g i s t r a t i o n , area of practice o
P r o f e s s i o n a l I d e n t i f i c a t i o n C a r d or S p e c i a l / T e m p o r a r y P e r m i t . updated annuahy, i
+ T h e Board m a y , u p o n petition, reinstate or reissue a revoked s h a h be m a d e a v a i
C O R a f t e r t h e e x p i r a t i o n o f t w o (2) y e a r s f r o m t h e d a t e o f i t s subject to such gui
revocation. T h e B o a r d may, i n its discretion, require t h e apphcant
to take another hcensure examination. T h e petitioner shah prove S E C . 29. D i s p l
to the Board t h a t there is a v a h d reason for such reinstatement. be t h e d u t y of ever
F o r t h e g r a n t of t h e p e t i t i o n , t h e B o a r d shaU issue a B o a r d i n private or under
R e s o l u t i o n , t o be a p p r o v e d b y t h e P R C . copy of one's C O R
drug establishment
A duphcate copy of t h e C O R for display i n Category B capacity as p h a r m a c
e s t a b h s h m e n t s m a y be i s s u e d . R e p l a c e m e n t o f l o s t o r d a m a g e d C a t e g o r y B , as d e f
C O R , P I C o r S T P m a y be i s s u e d i n a c c o r d a n c e w i t h t h e p e r t i n e n t copy o f t h e pharmac
r u l e s t h a t s h a h be i s s u e d t h e r e o n .
No pharmacis
ARTICLE displayed i n a n est
as a professional
REGULATION OF T H E PRACTICE OF PHARMACY
S E C . 30. D i s p e
S E C . 25. V e s t e d R i g h t s ; A u t o m a t i c R e g i s t r a t i o n . - All - No pharmaceuti
pharmacists registered before the effectivity of this Act shah s h a h be c o m p o u n d e
a u t o m a t i c a l l y be r e g i s t e r e d h e r e u n d e r , s u b j e c t t o c o m p h a n c e a s be m a d e a v a i l a b l e
to future requirements. retail drug outlet

Prescription
s h a U be dispense
22

p h a r m a c i s t , e x c e p t i n e m e r g e n c y cases, w h e r e t h e s e r v i c e s o f a estabhshments w i
registered and hcensed pharmacist are not available: P r o v i d e d , m a n u f a c t u r e , as
T h a t a r e p o r t s h a h be m a d e t o t h e s u p e r v i s i n g p h a r m a c i s t w i t h i n development, quaht
t w e n t y - f o u r (24) h o u r s a f t e r t h e o c c u r r e n c e o f t h e e m e r g e n c y so d i s t r i b u t i o n , sal
t h a t p r o d u c t r e c o r d i n g i n t h e p r e s c r i p t i o n b o o k s c a n be d o n e . quantities greatly

C o m p o u n d i n g a n d dispensing s h a h be done o n l y b y d u l y (4) G o v e r n m e


registered a n d hcensed pharmacists, i n accordance w i t h c u r r e n t first t o t h i r d c l
Good M a n x i f a c t u r i n g Practice, laboratory practice, P h i l i p p i n e organizations and/
Practice Standards for Pharmacists and dispensing guidehnes. distribution, disp
A registered and hcensed pharmacist m a y refuse to compound,
dispense or seh drugs a n d pharmaceutical products, i f not i n (b) C a t e g o r y
accordance w i t h t h i s A c t a n d t h e abovementioned standards. where the supervi
hcen^d pharmacist
Licensed manufacturers, importers, distributors, and including:
wholesalers of pharmaceutical products are authorised to seh their
products only to duly hcensed pharmaceutical outlets. (1) R e t a i l o
d r u g s as d i f f e r e n t
SEC. 3 1 . P h a r m a c i s t Requirement. - Estabhshments/
outlets w h i c h are required to employ and/or r e t a i n a n d m a i n t a i n (2) S a t e U i t e
the professional services of d u l y registered and licensed solely t o employee
p h a r m a c i s t s s h a h be c l a s s i f i e d a s f o h o w s : qualified dependen
organization or in
(a) C a t e g o r y A - P h a r m a c e u t i c a l e s t a b h s h m e n t s / o u t l e t s
w h e r e t h e direct a n d i m m e d i a t e control and supervision of a duly (3) F o u r t h ,
registered a n d hcensed p h a r m a c i s t is required, per estabhshment, involved i n the pro
w h e t h e r in-store or onhne, including: of pharmaceutical

(1) P h a r m a c e u t i c a l e s t a b l i s h m e n t s / o u t l e t s s e l l i n g (4) I n s t i t u t i
or otherwise m a k i n g available to the consuming public
prescription/ethical medicines, combination products (5) N o n t r a d i
( m e d i c a l device a n d d r u g s ) classified as d r u g s a c c o r d i n g t o Provided, T h a t no p
the p r i m a r y intended mode of action, pharmacist-only O T C O T C medicines are
medidne, w h e t h e r owned by the government or by a private
p e r s o n o r firm, w h e t h e r s o l d a t w h o l e s a l e o r r e t a i l ; The FDA, i n
approval of the P
(2) E s t a b l i s h m e n t s i n v o l v e d i n t h e m a n u f a c t u r e , t h e above h s t of
i m p o r t a t i o n , exportation, distribution, a n d sale of combination t o keep pace w i t h
p r o d u c t s ( m e d i c a l d e v i c e a n d d r u g s ) c l a s s i f i e d as d r u g s a c c o r d i n g
to the p r i m a r y intended mode of action; A pharmacist
be a h o w e d to s i m u
(3) D e p a r t m e n t s / D i v i s i o n s / U n i t s o f p h a r m a c e u t i c a l i n Category B esta
laboratories, pharmaceutical m a n u f a c t u r i n g laboratories, or other w h i c h s h a h be d e t
24

as m a y be e s t a b l i s h e d t h e r e f o r b y t h e B o a r d , i n c o o r d i n a t i o n w i t h p h a r m a c i s t , i n acc
t h e F D A , a n d o t h e r agencies, e s t a b h s h m e n t s , i n s t i t u t i o n s , a n d for Pharmacists,
r e g u l a t o r y bodies. pertaining to pu
prescriptions sho
P r o c u r e m e n t , storage, distribution, or dispensing of a n y recording.
pharmaceutical product i n the n a t i o n a l government a n d local
g o v e r n m e n t u n i t s s h a U be m a d e o n l y u n d e r t h e s u p e r v i s i o n o f a P a r t i a l fihing
did.y r e g i s t e r e d a n d h c e n s e d p h a r m a c i s t . indicated i n the
dispensing guidehn
A h u n i t s or sub-units of estabhshments, institutions, a n d paragraph. I t
r e g u l a t o r y bodies w h e t h e r g o v e r n m e n t or p r i v a t e w i t h functions dispensing the la
a n d a c t i v i t i e s t h a t are exclusive f o r p h a r m a c i s t s , as d e f i n e d m keep the prescr
S e c t i o n 4, p a r a g r a p h s (a), (b), (c), (d) a n d ( i ) , s h a h b e h e a d e d a n d recording guidelin
managed by a quahfied duly registered and hcensed pharmacist:
P r o v i d e d , T h a t a n a p p o i n t m e n t i n g o v e r n m e n t service s h a l l Prescription
comply w i t h the provisions of other pertinent laws. registered and l
prescription of a
S E C . 32. R e s p o n s i b i l i t y for Q u a l i t y of P h a r m a c e u t i c a l
Products. - It s h a h be t h e d u t y o f a d u l y h c e n s e d a n d r e g i s t e r e d S E C . 34. P h y s i
p h a r m a c i s t of a pharmaceutical estabhshment a n d outlet to given or intended
ensure that all pharmaceutical products conform to a m a n u f a c t u r e r pv
s t a n d a r d s o f safety, q u a h t y a n d efficacy, as p r o v i d e d f o r i n representative as'
this Act and other pertinent rules and regulations and sold to a n y p h a r m a
issuances. Owners, managers, or pharmacists i n charge of
the operation of pharmaceutical estabhshments a n d outlets The statemen
s h a U be h e l d j o i n t l y r e s p o n s i b l e f o r n o n c o n f o r m a n c e w i t h shall appear cons
these standards. packaging of the
device a n d drug)
I t s h a h be u n l a w f u l f o r a n y p e r s o n t o m a n u f a c t u r e , p r e p a r e , intended mode of
seh, or dispense any pharmaceutical product u n d e r a f r a u d u l e n t r e m o v e , erase, def
n a m e , or pretense or to adulterate a n y p h a r m a c e u t i c a l product
o f f e r e d f o r sale. Pharmaceutic
including anti-TB m
I n cases o f p h a r m a c e u t i c a l p r o d u c t s sold i n t h e i r o r i g i n a l as m a y be p r e s c r i b e
package, the seal of w h i c h has not been b r o k e n or tampered w i t h , as p h y s i c i a n ' s s a m
t h e h a b i h t y t h a t m a y arise because of their q u a h t y a n d p u r i t y
rests u p o n the manufacturer or importer, the distributor, S E C . 35. P r o h i
representative, or dealer w h o is responsible for t h e i r d i s t r i b u t i o n or U n u s u a l T e r m s
or sale. Substitution. - Phar
prescriptions, rec
S E C . 33. Filling a n d Partial Filling of Prescription. - Ah codes o r s e c r e t k e
p r e s c r i p t i o n s a n d p h a r m a c i s t - o n l y O T C m e d i c i n e s s h a h be f i l l e d , with unusual nam
compounded and dispensed only by a registered a n d hcensed pharmacopeias or f
26

T h e pharmacist dispensing or compoimding prescriptions A U referrals s


s h a h n o t substitute the medicine cahed for i n the prescription the pharmaceutical
w i t h a n y other drug, substance or ingredient, w i t h o u t prior Registry and shal
consultation w i t h , a n d w r i t t e n consent of the person prescribing, representative of t
except i n accordance w i t h R e p u b h c A c t N o . 6675, as a m e n d e d , or both, at a n y t i m
o t h e r w i s e I m o w n as t h e " G e n e r i c s A c t o f 1988", a n d o t h e r p e r t i n e n t m u s t be k e p t f o r a
laws and regulations. last entry.

U p o n every
S E C . 3 6 . L a b e l of D i s p e n s e d M e d i c i n e s . - S E C . 38. R e q u i r
box, b o t t l e , o r p a c k a g e o f m e d i c i n e s c o m p o u n d e d o r d i s p e n s e d b y Retail Pharmaceutical O
a registered and hcensed pharmacist based o n prescription, there of a retail pharmace
s h a h b e pasted, affixed, or i m p r i n t e d a seal or label bearing, a m o n g to requirements pr
others, the n a m e of patient and generic n a m e of drug; b r a n d regulations prescri
n a m e , i f any, strength, expiry date, directions for use; a n d n a m e i.
a n d address of pharmacy, n a m e of t h e doctor, t h e dispensing The apphcation
p h a r m a c i s t a n d other requirements prescribed i n t h e P h i h p p i n e d r u g outlet or othe
Practice Standards for Pharmacists a n d Dispensing Guidehnes, approved, unless ap
R e p u b l i c A c t N o . 9502, o t h e r w i s e k n o w n as t h e " U n i v e r s a h y pharmacist, either a
, Accessible Cheaper a n d Q u a h t y Medicines A c t of 2008", its to the provisions o
1* ' i m p l e m e n t i n g rules a n d regulations a n d such other guidelines
t h a t m a y be promixlgated by t h e B o a r d . S E C . 39. H a n d l i
Other Than a Phfirmaci
A u x i l i a r y labels containing special pharmacists' persons handling
i n s t r u c t i o n s f o r t h e p a t i e n t s h a l l be r e q u i r e d a s p r e s c r i b e d f o r pharmacist, which
dangerous drugs, external-use-only drugs, drugs w i t h special non-pharmacists, me
storage a n d a d m i n i s t r a t i o n i n s t r u c t i o n s a n d such o t h e r drugs as representatives,
m a y be r e q u i r e d by l a w . technicians, pharma
assist pharmacists
S E C . 37. Recording of Patient M e d i c a t i o n Profile. - Ah other person perfo
p r e s c r i p t i o n s d i s p e n s e d h i t h e p h a r m a c y s h a U be r e c o r d e d i n a n pharmaceutical prod
appropriate recording system indicating therein, among other g o v e r n m e n t agencie
t h i n g s , t h e n a m e a n d address of t h e p a t i e n t , n a m e of prescriber, propam.
generic n a m e a n d b r a n d , dosage s t r e n g t h , q u a n t i t y of d r u g a n d
i n i t i a l s o f p h a r m a c i s t . I t s h a h be o p e n f o r i n s p e c t i o n b y t h e N o p e r s o n , exc
representatives of t h e B o a r d or t h e F D A , or both, a t a n y t i m e of render such servi
t h e d a y , w h e n t h e p h a r m a c y i s o p e n , a n d m u s t be k e p t f o r a standardized t r a i n i n
p e r i o d o f n o t l e s s t h a n t w o (2) y e a r s a f t e r t h e l a s t e n t r y . is defined i n t h e i

A h required i n f o r m a t i o n o n dangerous drugs dispensed by S E C . 40. A d m i n


a p h a r m a c y s h a h be r e c o r d e d i n t h e D a n g e r o u s D r u g s B o o k o r a n to the requirement
e q u i v g d e n t r e c o r d i n g s y s t e m as r e q u i r e d b y R e p u b h c A c t N o . 9 1 6 5 Act, hcensed and
a n d o t h e r apphcable l a w s a n d issuances. a d u l t vaccines s h a
28

s h a E h a v e a doctor's prescription w h i c h is n o t m o r e t h a n seven practice w i t h i n d


(7) d a y s o l d a n d s u b m i t a m o n t h l y v a c c i n a t i o n r e p o r t a n d A E F I requirements for
r e p o r t t o D O H r e g i o n a l offices u s i n g t h e p r e s c r i b e d f o r m . each specialty, a m o

ARTICLE V

ACCREDITED PROFESSIONAL ORGANIZATION VIOLATIONS, ADMINIST

SEC. 41. T h e I n t e g r a t e d a n d Accredited Professional S E C . 44. R e v o c


O r g a n i z a t i o n (APO) of P h a r m a c i s t s . - The pharmacy profession Registration a n d Cancel
s h a h b g - i n t e g r a t e d i n t o o n e (1) n a t i o n a l o r g a n i z a t i o n r e g i s t e r e d The Board shah ha
w i t h the Securities and Exchange Commission (SEC) w h i c h shah to r e v o k e or s u s p
be r e c o g n i z e d b y t h e B o a r d a n d t h e P R C a s t h e o n e a n d o n l y or to cancel a n S
i n t e g r a t e d a n d accredited p r o f e s s i o n a l o r g a n i z a t i o n o f p h a r m a c i s t s . fohowjng grounds:

A pharmacist duly registered w i t h the Board shall (a) V i o l a t i o n


automatically become a member of the integrated and regulations, the
accredited professional organization of pharmacists, and Technical Standar
s h a l l receive t h e benefits a n d privileges a p p u r t e n a n t thereto Pharmacy Professi
u p o n p a y m e n t o f t h e r e q m r e d fees a n d dues. other guidehnes,
Board and/or the
M e m b e r s h i p i n t h e i n t e g r a t e d A P O s h a h n o t be a b a r t o p h a r m a c y profess j ^ n
m e m b e r s h i p i n o t h e r associations of p h a r m a c i s t s .
(b) C o n v i c t i o
S E C . 4 2 . M e m b e r s h i p to t h e I n t e g r a t e d a n d A c c r e d i t e d a court of competen
Professional O r g a n i z a t i o n . - A h registered pharmacists m u s t
be m e m b e r s o f t h e A P O and must maintain membership (c) U n p r o f e s
throughout the duration of t h e practice of t h e profession. T h e incompetence, gros
P I C s h a h n o t be r e n e w e d i f the r e q u i r e m e n t s for m e m b e r s h i p of the profession;
w i t h t h e A P O are not met including credit u n i t s for attendance
to d u l y accredited C P D . (d) F r a u d o r
or S T P , or r e n e w a l
A l l p h a r m a c y s u p p o r t p e r s o n n e l m u s t be r e g i s t e r e d a s
affihate members of the A P O and m u s t likewise m a i n t a i n (e) A l l o w i n g
membership t h r o u g h o u t the d u r a t i o n of employment i n estabhshments wher
pharmaceutical estabhshments and outlets. and practicing;

S E C . 4 3 . Specialty B o a r d s i n V a r i o u s A r e a s of P h a r m a c y (f) A d d i c t i o n
Practice. - Specialty Boards i n various areas of p h a r m a c y drug rendering a
p r a c t i c e s h a l l be c r e a t e d , s u b j e c t t o a c c r e d i t a t i o n b y t h e profession as p r o v i
B o a r d a n d t h e P R C . T h e B o a r d shaU issue guidelines i n t h e
accreditation of specialty boards i n various areas of (g) A i d i n g o r
p h a r m a c y practice, w h i c h s h a l l include the standards of a n d hcensed person;
30

(h.) I n s a n i t y o r a n y m e n t a l d i s o r d e r t h a t w o u l d r e n d e r t h e t h o u s a n d pesos
person i n c o m p e t e n t to practice p h a r m a c y ; hundred thousand
n o t less t h a n one
(i) F a l s e , e x t r a v a g a n t , o r u n e t h i c a l a d v e r t i s e m e n t s a n d s i x (6) y e a r s , o r b
endorsements o f pharmaceutical products, pharmaceutical outlets
and establishments where the pharmacist's name or the (a) C o m m i s s i
pharmacist's professional organization and similar 31 of this Act;
i n f o r m a t i o n , o r b o t h , axe u s e d ;
(b) A h o w i n g
(j) M a n u f a c t u r e , s a l e , o f f e r i n g f o r s a l e o f c o u n t e r f e i t , establishment wh
spurious, substandard and falsified pharmaceutical products practicuig;
a n d c o m m i t t i n g o t h e r acts i n v i o l a t i o n of R e p u b h c A c t N o . 9 1 6 5
a n d R e p u b h c A c t N o . 8 2 0 3 , o t h e r w i s e l o i o w n as t h e " S p e c i a l L a w (c) D i s p l a y i
on Counterfeit Drugs"; owneBs/operators i
t h e p h a r m a c i s t is
(k) I h e g a l m a n u f a c t u r e , s a l e , p o s s e s s i o n , d i s p e n s i n g o f
dangerous d r u g s a n d o t h e r acts i n v i o l a t i o n o f R e p u b h c A c t (d) D i s p e n s i
N o . 9165, a n d o t h e r apphcable l a w s a n d issuances; for sale o f p r e s c
i n a place n o t h c e
(I) C o m m i t t i n g a c t s i n v i o l a t i o n o f S e c t i o n 6 o f
Presidential Decree No. 881, entitled "Empowering the (e) D i s p e n s i
Secretary of H e a l t h to Regulate the Labeling, Sale a n d O T C pharmaceutica
D i s t r i b u t i o n of Hazardous Substances" and Section 11 of under the direct
R e p u b h c A c t N o . 3 7 2 0 , as a m e n d e d ; registered and hc
( m ) P r a c t i c i n g p h a r m a c y w i t h a s u s p e n d e d C O R o r e^qiired (£) A l l o w i n g
PIC; only O T C pharmac
immediate superv
(n) U n a u t h o r i z e d disp e n s i n g of p h a r m a c e u t i c a l products pharmacist;
t h r o u g h u n r e g i s t e r e d o n h n e services or direct setting btisinesses;
and (g) C o m p o u n d
w i t h current Good
(o) B e i n g f o u n d g u i l t y o f i m m o r a l , u n p r o f e s s i o n a l , or Practice and Phih
dishonorable conduct by the Board. and such other sta
ARTICLE V I I (b) S e h i n g o
drugs by m a n u f a c
PENAL PROVISIONS unhcensed pharmac
S E C . 45. P e n a l P r o v i s i o n s . - A n y person who shaU (i) S u b s t i t u
c o m m i t a n y o f t h e f o h o w i n g acts s h a h , u p o n conviction, be genericahy equiva
sentenced t o pay a fine of n o t less t h a n t w o h u n d r e d fifty t h e consent of t
Repubhc Act No. 6
32

© F o r c i n g , coercing, o r i n t i m i d a t i n g a d v i y registered a n d
(v) A h o t h e r
licensed p h a r m a c i s t to compound or dispense medical a n d
pharmaceutical products i n violation of the provisions of this S E C . 4 6 . Other
Act; any of the fohowin
pay a fine of n o
(k) P r e p a r i n g a n d compounding of pharmaceutical products (P100,000.00), b u t
i n q u a n t i t i e s g r e a t l y i n excess o f s i n g l e t h e r a p e u t i c doses, w i t h o u t (P200,000.00) or
the presence a n d supervision of a duly registered a n d hcensed days b u t not more t
pharmacist; the court:
© Noncomphance w i t h the labehng requirements for
(a) A f f i x i n g
dispensed medicines by a pharmaceutical outlet; registered and hce
(m) M a n u f a c t u r i n g a n d s e l l i n g of p h a r m a c e u t i c a l
(b) P r a c t i c i n
products under fraudulent n a m e or address, or both; w i t h o k a vahd COR
(n) A d u l t e r a t i n g a n d m i s b r a n d i n g o f pharmaceutical
(c) N o n - i n d i c
products;
professional t a x re
such information;
(o) M a n u f a c t u r i n g a n d s e h i n g o f u n s a f e , s u b s t a n d a r d a n d
coimterfeit pharmaceutical products;
(d) R e f u s a l t
p r o m i n e n t a n d cons
(p) O p e r a t i n g a n u n l i c e n s e d p h a r m a c e u t i c a l o u t l e t
where the pharmaci
such as o n l i n e p h a r m a c y service or direct s e l l i n g n o t
authorized by the F D A ;
(e) N o n c o m p h
pharmacist with th
(q) O p e r a t i n g a C a t e g o r y A e s t a b h s h m e n t w h i c h o p e n s f o r
business w i t h o u t a d i J y registered and hcensed pharmacist;
(f) N o n c o m p h
pharmacist on the r
(r) O p e r a t i n g a Category B e s t a b h s h m e n t w i t h o u t t h e
supervision a n d oversight of a duly registered a n d hcensed
(g) S e h i n g o f
pharmacist;
(b) D i s t r i b u t
(s) P r a c t i c i n g p h a r m a c y w i t h a n e x p i r e d , s u s p e n d e d o r
and other product
revoked hcense; physician's sample
(t) F i l l i n g a n d r e f i l l i n g o f p r e s c r i p t i o n a n d p h a r m a c i s t - o n l y
(i) R e m o v a l ,
O T C pharmaceutical products by a person other t h a n a duly
physician's sample
registered and hcensed pharmacist w i t h o u t the direct and
immediate supervision;
(j) U s e o f c i
or t e r m s i n prescr
(u) D i s p e n s i n g p r e s c r i p t i o n drugs a n d p h a r m a c i s t - o n l y
O T C drugs by r u r a l h e a l t h units w i t h o u t the supervision of a
(k) F i h i n g o f
d u l y registered and licensed pharmacist; a n d keys or u n u s u a l na
34

Q.) N o n c o m p l i a n c e with labeling requirements for T h e penalties


dispensed medicines; prejudice to other
of other apphcabl
(m) Noncomphance w i t h the requirements o n the keeping
of record books by a pharmaceutical outlet; The owner/ope
outlets and the
(n) E m p l o y m e n t o f p e r s o n n e l i n a p h a r m a c y o r pharmacy support
pharmaceutical operation without the required training and violation of any p
certification;

• (o) R e f u s a l o f a n o n - p h a r m a c i s t o w n e r / o p e r a t o r o f a
pharmaceutical outlet to undergo training and certification;

(p) R e f u s a l b y t h e o w n e r / o p e r a t o r t o a h o w a n d r e q u i r e d u l y jfSEC. 4 7 . E n f o
registered and hcensed pharmacists and pharmacy support of the B o a r d an
personnel to undergo C P D , training and certification; provisions of thi
agencies a n d off
(q) R e n d e r i n g d i s p e n s i n g - r e l a t e d s e r v i c e s b y n o n - municipal governm
pharmacists i n a pharmaceutical outlet without undergoing the shah ensure the
required training and certification; of the provisions

(r) D i s p e n s i n g p h a r m a c e u t i c a l p r o d u c t s i n m e d i c a l SEC. 48. Appro


missions w i t h o u t the supervision of a duly registered a n d hcensed shah immediate^
pharmacist; of this Act, t h e
their current yea
(s) N o n c o m p l i a n c e w i t h t h e r e q u i r e d t r a i n i n g a n d annual General Ap
certification of professional service or medical representatives or
professional service representatives, p h a r m a c y technicians, SEC. 49. T r a n
p h a r m a q y a s s i s t a n t s , p h a r m a c y aides, p h a r m a c y c l e r k s , a n d o t h e r Chairperson and m
medicine handlers of pharmaceutical products. B o t h t h e medical capacity, c o n t i n u e
representatives or professional service representatives, p h a r m a c y members of the ne
technicians, p h a r m a c y assistants, p h a r m a c y aides, p h a r m a c y been appointed and
clerks, or medicine handlers and the p h a r m a c e u t i c a l
e s t a b h s h m e n t a n d o u t l e t e m p l o y i n g a n y s u c h i n d i v i d u a l s h a h be S E C . 50. I m p l e
held jointly hable; and one h u n d r e d t w e n t
Board, subject to
(t) V i o l a t i o n o f a n y p r o v i s i o n o f t h i s A c t a n d i t s r u l e s with the APO, shah
a n d r e g u l a t i o n s n o t a f o r e m e n t i o n e d above. to i m p l e m e n t t h e p

A n y person, other t h a n t h e citizens of the Phihppines, SEC. 51. Sepa


h a v i n g b e e n f o i m d g u h t y o f a n y v i o l a t i o n as p r o v i d e d f o r i n paragraph or part
this section a n d the preceding section shah, after h a v i n g paid the invahd, such decl
fine o r h a v i n g s e r v e d t h e s e n t e n c e , o r b o t h , w h e n so a d j u d g e d , the other provisio
s h a h a l s o be s u b j e c t t o i m m e d i a t e d e p o r t a t i o n .
36

SEC. 5 2 . R e p e a l i n g C l a u s e . - Republic A c t No. 5 9 2 1 , as


a m e n d e d , i s h e r e b y repealed. A l l o t h e r l a w s , p r e s i d e n t i a l decrees,
executive orders a n d other a d m i n i s t r a t i v e issuances o r p a r t s
t h e r e o f w h i c h a r e conta-ary 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 are hereby repealed, amended, o r modified accordingly.

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 effect fifteen
(15) 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 Gazette or i n a
newspaper of general drculation.

Approved,

,0N F E L I C I A N O B E L M O N T E J R .
President o f the Senate Speaker o f the H o u s e
J of Representatives

This A c t was« p a s s e d by t h e House of


Representatives a s House Bill N o . 5 6 1 6 o n M a y 2 3 , 2 0 1 6
and adopted b y t h e Senate as a n a m e n d m e n t t o Senate
Bill No. 2 4 3 6 o n M a y 3 0 , 2 0 1 6 .

"'OSC^SJGZ'YABES ~^M^[JNB^ARUA^JP^^
Secretary o f the Senate Secretary General
House of Representatives

Approved:

BENIGNO 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
Z7 (1) of the ConiJta-jtiOft