Professional Documents
Culture Documents
5 6 1 6
S. No. 2436
[ 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
A R T I C L E I
GENERAL PROVISIONS
(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
(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
(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.
(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
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
(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
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
ARTICLE V
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
• (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
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
"'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