PHARMACY
JURISPUDENCE
AZMAN YAHYA
PRINCIPAL ASSIST. DIRECTOR
PHARMACEUTICAL SERVICES ( ENFORCEMENT) 1
www.pharmacy.gov.my
1.Registration of
Pharmacists Act 1951
1.1 Registration of
Pharmacists Regulations
1953
2.Poisons Act 1952
(Amended 1989)
2.1 Control of poisons
(psychotropic
substances) Regulations
1989
2.2 Poisons Regulations
1952
2
3.Sale of Drugs Act 1952
3.1 Control of Drugs &
Cosmetics Regulations1984
4. Dangerous Drugs Act
1952
4.1 Dangerous Drugs
Regulations 1952
5. Medicines (Sale and
Advertisement) Act
1956
5.1 Medicine
Advertisement
Board Regulations
1976
3
POISONS ACT 1952
(Amended 1989)
Define “Poison”?
S2 Any substance specified
by name in the first column
of Poison List and includes
any preparation,solution,
compound, mixture or
natural substance,
containing such substance,
other than an exempted
preparation or article or
preparation in Second
Schedule.
4
POISONS ACT 1952
(Amended 1989)
FIRST SCHEDULE
POISONS LIST
PART I
PART II
EXEMPT
(PART I) GROUP A,B,C,D
5
Poisons List
First
Schedule
Part I
Poisons
P
Group
A
Poisons
Group
B
Poisons
Group
C
Poisons
Group D
Poisons
6
Poisons List
First Schedule
Part II
Poisons
7
POISONS ACT 1952
(Amended 1989)
FIRST SCHEDULE
Group A -s20 eg adrenaline
(see table)
Group B -s21 (b) by regd.
Medical practitioner regd
dentist or vet officer for
medical treatment of his
patient,
s21 (c ) licensed pharmacist
as a dispensed medicine and
via precription as in s21(2)
eg. allupurinol
8
POISONS ACT 1952
(Amended 1989)
FIRST SCHEDULE
eg. Antibiotic
Gp A other than Gp.B,C,D
and Pt II
Gp.B p’ceutical dosage
forms and vet prep for
inclusion in animal feed
Gp.C ENT
prep,lozenges,external
Gp.D Lab use
Pt.II Premix in animal feed
9
POISONS ACT 1952
(Amended 1989)
FIRST SCHEDULE
eg. Sodium hydroxide
Pt I Gp C - Prep. For
therapeutic /diagnostic use
Pt II 12% and over unless
Pt I or exempted
Exempt Under 12%
10
POISONS ACT 1952
(Amended 1989)
SECOND SCHEDULE articles and
preparations
exempted eg.glue,
varnishes
THIRD SCHEDULE Psychotropic
substances eg. Diazepam
other subs.
Structurally
derived from 1,4benzodiazepine exept
pirenzepine,
flumezenil
11
POISONS ACT 1952
(Amended 1989)
“Dispensed medicine”
defined in S2
1) Medicine supplied by
regd med pract /regd
dentist/vet surgeon as s 19
2) Medicine supplied for
purpose of medical, dental
or animal treatment by a
licensed pharmacist on the
premise specified in his
licence
12
POISONS ACT 1952
(Amended 1989)
Import of poisonsrequires licence s8
Who issue licence?
Licensing officer as in
s26(1)
Which licences? s26
(2)(a)Type A regd.pharmacist,
s26(2)(b)Type B -fit and
proper for
W/sale,s26(2)(c)Type C-fit
and proper for retail
Gp.F,s26(2)(d) Type D fit
and proper for retail Pt II,
Type E- to import large
qty. NaoH.
13
TYPE OF LICENCES
• Type A – for Pharmacist
(free)
• Type B – fit and proper
person for
wholesale
only(RM100)
• Type C – listed seller (RM10)
• Type D – fit and proper
person for retail
only (RM20)
• Type E - import Sodium
Hyroxide
14
(RM100)
POISONS ACT 1952
(Amended 1989)
Wholesale defined in s 2
Which licences? Type A
and Type B
What consitute w/sale?
Transactions
of
poisons as stated in s15(2)
(a) -(j)
W/sale record: s15(3)
Poison w/sale Book as in
r26 Poisons Reg.’52
15
SALE BY WHOLESALE
•
Record in wholesale sale
book
• Puchaser’s written order
16
POISONS ACT 1952
(Amended 1989)
Retail sale defined in s 2
Which licences? Type A
,Type D
s16 -retail sale of poisons
s18(1)(b), s18(1)(c ) SALE
/SUPPLY of Pt.II poisons
s19- sale/supply by
regd.med.pract/ dental/
vet for purpose of medical/
dental/animal treatment of
his patient only
17
POISONS ACT 1952
(Amended 1989)
Record of retail sale or
supply
1) Poison Book -for Gp D
only s23
2) Prescription Book s24
Particulars to record:
date,name of patient and
address, name and qty. of
medicine
18
POISONS ACT 1952 (Amended 1989)
Drug Enforcement Officer (DEO)
Pharmacist in public service
appointed as DEO s31(1)
Powers of DEO:
investigate s31(2),
take statements s.31(4)-(7),
enter,search,detain s 31(8)
19
POISONS ACT 1952
(Amended 1989)
Penalities
s32(1) Failure to keep any
book / false
entry Fine not exceedingRM5000
or imprisonment not
exceeding 2 yrs or both.
s32(2) Fine not exceeding
RM3000- 5000 or
imprisonment not exceeding
- 1-2yrs or both
20
POISONS REGULATIONS
1952
r4 Import by post :
- for personal/family use
- not more than once a
month
- not more than for 1
month’s use
- to name the poison and
state qty.
21
POISONS REGULATIONS 1952
Labelling of poisons:
On storage
r 9 - name of poison, word
“POISON” in red or red background.
Sale of Pt I Poisons (other than
dispensed medicine):
r 10 - Word “POISON” in English,
Malay, Chinese, Tamil,
Name of poison,
Name & address of seller ,
“For External Use Only”,
“Not to be Taken”
22
POISONS REGULATIONS
1952
r11 Labelling of Pt II
Poisons on sale :
Name of Poison
“Poisonous”:Not To be
Taken” in English, Malay,
Chinese, Tamil
Name & Address of seller
23
POISONS REGULATIONS
1952
r12(1) Labelling of
Dispensed Medicine :
Name & Address of seller
Name of Medicine
Name & Address of Patient
Adequate directions for use
Date and Ref.no.to entry
into Prescription Book
To label with the words
“Controlled Medicine” or
“Ubat Terkawal”
24
POISONS REGULATIONS
1952
r12(3) Dispensed medicine
for external :
To label “Not To Be
Taken”/”For External Use
Only” in English, Malay,
Chinese, Tamil and in red
or red backgroud.
R13 labelling of certain
gases
25
Supply of poisons in
hospitals and institutions
s7(3)(a) & s7(3)(b) PA’52
exempts from provisions in
Act but subject to
provisions in Regulations.
r3 PR’52 exempts
regulations 4 to 22 of
hospitals & institutions BUT
subject supply of poisons to
Regulation 23.
26
Supply of poisons to outpatients in Govt. hospitals etc
r.23 (1) Only via Prescription
by a registered medical
practitioner for the purpose
of medical treatment.
27
r23Keeping of Record in
Govt. hospitals etc.
a) Record to be readily
traced
b) Record to be kept for 2
years
28
r23(i )to (iv) Particulars to
record for supply of poisons
a) name and quantity of
poison
b) date of supply
c) name and address of
patient
d) name of supplier or
prescriber
29
r23(4) Labelling of
containers
a) name and address of
institution
b) name of medicine
c) with the words
“Controlled Medicine” or
“Ubat Terkawal”
d) Poison supplied from
veterinary
hospital to be labelled “For
animal
treatment only”
30
r24 Supply of medicines containing
poison for use in the wards/other
sections (both govt & private)
must be upon a written order
signed:
by a registered medical
practitioner, or
by a nursing sister, or
by a hospital assistant (who is
authorised in writing by a
registered medical practitioner of
the institution) in charge of a ward
or other section of the institution.
r24(1) meaning of institutions for
purpose of r24,r25 -any
hospital,infirmary,dispensary,clinic,
nursing home etc.
31
r25-Storage of Poisons in
institutions
Poisons stored under a person
appointed for the purpose by
the institution.
Poison to be stored in a
cupboard reserved solely for
storage of poisons.
Inspected at regular intervals
of time not exceeding three
months by a registered
pharmacist/ other appointed
person.
32
POISONS (PSYCHOTROPIC
SUBSTANCES)
REGULATIONS 1989
What is Psychotropic
Substance?
Anything found in Third
Schedule of the Poisons Act
1952 (see s30PA’52)
eg : Clobazam ,Pentazocin
Diazepam and 1,4benzodiazepines
Barbiturates,Phentermine
33
POISONS (SODIUM
HYDROXIDE)
REGULATIONS 1962
• Permit to purchase and use
sodium
hydroxide
• Stated quantity
• Fee RM20
34
POISONS (PSYCHOTROPIC
SUBSTANCES) REGULATIONS
1989
• Import, export,
manufacture,
compound, dispense, sell,
supply,
administer and possess/
• Fine RM10,000 or 4 years
imprisonment
35
Control on supply of psychotropic
substance for medical/dental or
animal treatment (r 11)
r11(1) To be sold or supplied by
regd med pract, regd dentist
Div.I, vet surgeon or licensed
pharmacist upon a prescription.
Validity of presciption: not more
than 90 days after the date of
prescription (r11(3)(d) and can be
repeated for 3 times (r11(2)(e).
Keep prescription for 2 years
(r11(7).
36
Control on supply of psychotropic
substance for purposes other
than medical/dental or animal
treatment (r 12)
r12(2)(b) Control on quantity and
frequency
Seller/supplier to obtain:
( i ) buyer’s signature in
supply register
or signed written order
( ii ) written attestation
37
Permit to purchase & use
psychotropic subs.
r14(a) ,(b) - To whom?
Professional person/tradesman
and game warden
r15(1) to (7) How to apply?
Control of administration
Who can administer psychotropic
substance? Regd med pract, regd
dentist, vet surgeon , person
acting in accordance with the
direction of the former.(r16)
38
Control of dispensing etc
psychotropic substance
r 17 Only by licensed pharmacist /
pharmacist in public service
Control of manufacture of
psychotropic substances
r 18 Only by licensed pharmacist /
pharmacist in public service /
person under immediate personal
supervision of the former who will
check and endorse in writing such
weighing, measuring or mixing.
39
Storage of Psychotropic Subtances
(r24)
A) To be stored in a oom,cabinet,
safe or receptacle which shall remain
locked
B) Keys to be kept by authorised
person to possess
C) Store to be sufficient security
to prevent theft or diversion
40
Record for Purposes of
medical,dental or animal
treatment
Record entitled Prescription
Register for Psychotropic
Substances (r19)
Particulars of record:
- true particulars to be
entered on the day psy.subs
is supplied
- date , name and strength of
psy.subs. qty.supplied,
name and address of patient
- qty received, total stock,
name & address of supplier and
date of receipt
41
Record for Purposes other than
medical, dental or animal treatment
Record entitled Supply Register for
Psychotropic Substances (r20)
Particulars of record: name &
address of purchaser, date,name,
strength & quantity, purpose(r2(a)
and ref.no of written order (r2(b).
r20(b): purchaser signed in the supply
register/ by written order
42
Record of manufacture entitled
Production Register of
Psychotropic Substances (r20)
Particulars of record: date &
amount used,p’cetical dosage
form & strength/unit dose,
theoretical yield & batch no.,
actual yield, total units used in
Q.C, total units for
sale/supply.
43
Keeping & Maintainance of
Register (r22)
Separate part of the register
with respect to each type of
psychotropic substances in
chronological order.
No cancellation,obliteration or
alteration of an entry.
Correction by way of marginal
note or a footnote and to be
dated.
44
Form of register (r23)
In the form of a bound book
or in the form which has the
written approval of the
Licensing Officer
To be preserved for a period
of two years from the date of
the last entry in such register
45
Disposal of Psychotropic
Substances (r25)
To be disposed in the
presence and in accordance
with the instruction of a Drug
Enforcement Officer (DEO)
Particulars to be entered in
the register and acknowledged
by DEO
‘dispose’ -bury, burn or
otherwise to prevent recovery.
46
Labelling of Psychotropic Substances
On storage -r 26
For purpose other than medical,
dental / animal treatment -r27
For purpose of medical, dental
/animal treatment -r28
47
Prohibitory Order of Minister -r29
EXEMPTIONS :
For pharmacy assistants/ medical
assistants r32,
Master of Ship r33,
Fees for Government officers r34
PENALTY:
s30(5) Poisons Act 1952 :
Fine not exceeding Rm10,000
or imprisonment not exceeding 4 yrs
or both
48
SALE OF DRUGS ACT 1952
(Amended 2000)
s2 New definition:
“drug” includes any
substance, product or
article intended to be used
or capable, or purported or
claimed to be capable, of
being used on human or
animal, whether internally
or externally, for medicinal
purpose.
49
SALE OF DRUGS ACT 1952
(Amended 2000)
s2 New definition:
“medicinal purpose” (a)
alleviating, treating, curing
or preventing a disease or
pathological condition or
symptoms of disease, (b)
diagnosing a disease or
ascertaining the existence,
degree, extent of
physiological or pathological
conditions
50
SALE OF DRUGS ACT 1952
(Amended 2000)
s2 New definition:
“medicinal purpose” (c) contaception,
(d) inducing anaesthesia, (e)
maintaining, modifying, preventing,
restoring or interfering with, the
normal operation of a physiological
function, (f) controlling body weight
(g) general maintainance or promotion
of well-being
51
SALE OF DRUGS ACT 1952
(Amended 2000)
s2 New definition
“sell/sale”: To delete the
words “refers only to sale
for human consumption or
use”
s 17 - to include the word
“animal” after every word
“human”
52
SALE OF DRUGS ACT 1952
(Amended 2000)
s12(1)New Penalty for Act &
Regulations
Individual: Fine not exceeding
RM25,000 or imprisonment not
exceeding 3 yrs or both.
2nd and subsequent offence:
Fine not exceeding RM50,000
or imprisonment not exceeding
5 yrs or both
53
SALE OF DRUGS ACT 1952
(Amended 2000)
s12(2)New Penalty for Act &
Regulations
Body Corporate: Fine not
exceeding RM50,000.
2nd and subsequent offence:
Fine not exceeding
RM100,000
Amendment of r30 Control of
Drugs & Cosmetics Regulations
1989- subsection (2) deleted.
54
CONTROL OF DRUGS AND
COSMETICS REGULATIONS
1984
Amendments 2001
r2 -new definition : “possess
for sale” includes keeping or
storing for sale or supply or
having in possession knowing
that the product is likely to
be sold or exposed for sale
r7(1) to include the word
“ possess for sale”
55
CONTROL OF DRUGS AND
COSMETICS REGULATIONS 1984
Part I: Definitions of product,
cosmetics herbal remedy etc (r2)
Part II: Drug Control Authority
(r3)
Part III: Control of manufacture,
sale, supply,possess for sale and
import
(r7) (a) product to be registered
(b) person to be licensed
(r8) Registration of products
56
CONTROL OF DRUGS AND
COSMETICS REGULATIONS 1984
Part III:
r9- Register of products
r9(3)- Any person may
inspect the register.
r12
(a)
(b)
(c)
(d)
:Licences
manufacturer’s licence
wholesaler’s licence
clinical trial import licence
import licence
57
CONTROL OF DRUGS AND
COSMETICS REGULATIONS 1984
Part III:
r14 DCA can refuse licence
r15(1)-(6) DCA gives exemptions
r16 DCA may issue certification
r17 DCA may suspend, cancel or
revoke registration /licence.
58
CONTROL OF DRUGS AND
COSMETICS REGULATIONS 1984
Part IV: Provides for GMP
(r19,r20,r21,r22, r22, r23, r24,
r25)
Part V:
r26- Power of Enforcement officer
to enter, seize product, palnt,
equipment, book, documents
59
CONTROL OF DRUGS AND
COSMETICS REGULATIONS 1984
Part V:
r27- Records of transactions
Importer & W/saler: proper
records kept for 5 years
W/sale particulars to record date,
name & address of purchaser, name
& qty of product, Regn No, Invoice
No/D.O
60
CONTROL OF DRUGS AND
COSMETICS REGULATIONS 1984
Part V:
r28- Reporting ADR
r29- DCA directives for product
recall and disposal is binding
otherwise the person commits an
offence.
61
DANGEROUS DRUG ACT 1952
What is Dangerous Drug ?
Anything found in the First
Schedule of Dangerous Drugs
Act 1952
eg: Morphine,pethidine,fentanyl
62
DANGEROUS DRUG ACT 1952
Purpose of the Act: see
preamble
Scope of the Act: As for licit
& international control, the
competent authority is the
Pharmacy Division MOH which
collaborate with INCB. Powers
to Director of Pharmaceutical
Services given under s44 DDA
to control import, export, mfg,
sale & use (s12,19,20,22)
63
DANGEROUS DRUG ACT 1952
Control of illicit activities
relating to DD
Enforcement by Police/Customs
Specific sections on
investigations & court actions
(s26 to s42)
64
DANGEROUS DRUG ACT 1952
Amendments
1) Definition s2 “licensed
pharmacist” means registered
pharmacist who is the holder
of Type A Licence issued under
th Poisons Act 1952. (1998)
2)s12 - New fine RM 100,000
(1998)
3)Part III First Schedule
amended to include
Amphetamine,Methamphetamine
(1997), Ketamine
65
DANGEROUS DRUG ACT 1952
Amendment 2001
1) To delete no.1 in Part V of
First Schedule DDA ‘52
The implications:
Requires an export
authorisation besides an
import authorisation (s12)
Eg. To export codeine
preparations requires an
export authorisation. To
import such preparation
requires an import
authorisation.
66
DANGEROUS DRUG ACT 1952
Latest amendments
1) Gazette 2004
2) Amend Third Schedule
3) Registered Products
containing pholcodeine and
its equiv.
4) As Group C to control as
dispensed medicine
67
DANGEROUS DRUGS
REGULATIONS 1952
AUTHORITY
r4- to manufacture DD
r5- supplying ,procuring &
advertising for sale
r6- Possession of DD
r8- Persons to possess & supply
DD
r9- to manufacture & retail DD
68
DANGEROUS DRUGS
REGULATIONS 1952
- r11- To be supplied only via a
valid prescription
- r12 (3) Can be repeated thrice
if indicated by presriber
- r12 (4)To mark date of supply
on prescription
- r14- marking of packages and
bottles
69
DANGEROUS DRUGS
REGULATIONS 1952
RECORD of DD
1) Licensed Pharmacist : Record
for W/sale
r15(1)(a) to record entry in
Form of register
( see Part I and Part II
Registers in Second Schedule)
2) Licensed Pharmacist :Record
for retail sale
r15(2)(b) to record in
Prescription Book and to make
entry of Ref.No. into PartII
Register (DD supplied) and Part
I Register (DD obtained)
70
DANGEROUS DRUGS REGULATIONS
1952
RECORD of DD
1) Registered Medical Practitioner/
Dentist( private hospitals and clinics)
r15(2)(a) Day Book and Separate
Book
71
Preservation of records of
dangerous drugs:
Keep for 2 years from date of
last entry
eg. Records include registers,
records, books, prescriptions,
signed orders and other
documents.
72
DANGEROUS DRUGS REGULATIONS
1952
WHOLESALE LICENCE
R18 -To apply licence for wholosale
dealing
EXEMPTIONS
s25 DDA’52 - Exempts travellers
r25 DDReg’52 - Exempts regulations
for preparations of Third Schedule (but
not r15(8) and r16)
Implicatioons of r25 DDR’52:
Codeine preparations are controlled as
Group C Poisons under PA’52. To be
supplied as dispensed medicine.
73
•DANGEROUS DRUGS
(HOSPITAL ETC) (GENERAL
EXEMPTION) ORDER 1952
•r2- Exempts from the
operation of DDReg’52 for
govt. hospitals/clinics for DD
in Part III of First Schedule
DDA’52
74
DD (Hospitals,etc) General Exemption
Order 1952
Control of Dangerous Drugs in Public
hospitals :
SCHEDULE A
1) Orders for supply to be signed by
pharmacist or doctor
2) -Supplies to be received and kept by
pharmacist
- To record DD obtained as Part I
Register, separate page for
ecah class of DD
3)-To dispense prescription per patient
per ocassion
-Presription to be in writing, dated
and signed/initialled by doctor,
75
state name of patient/R.N
...Public hospital:
4) –To stamp/ mark the
prescription as proof of
dispensing
-Dispensing to be recorded
as the date, name of
doctor/prescriber,name of
patient or R.N.
5) Keep prescriptions for 2
years
6) Stock DD in wards/outpatient, To supply on written
requisition of sister i/c who
keeps under lock & key, to
mark requisition and keep in
dispensary and a copy to sister
i/c.
76
...Public hospital:
SCHEDULE B:
1) Supply to ward to be obtained by/
on written order of doctor.
2) Supplies to be received by
matron/senior HA/ senior nurse who
keep under lock & key
To record DD obtained as in Part I
Register, Separate page for each
class of DD.
3) Matron/HA/nurse to administer in
accordance with directions of doctor.
77
Disposal of Dangerous Drug:
To be disposed as required by
the Environmental Quality
(Scheduled Wastes)
Regulations 1989
The authorised person shall
furnish particulars with
respect to any stock to the
Director General of Health.
R15(1)(e)
78
MEDICINES (ADVERTISEMENT &
SALES) ACT 1956
What constitutes an advertisement?
See definition s.2
Which advertisement is controlled?
Advertisement of article(medicine,
appliances or remedy) skill/service.
How is the control?
For prevention/ treatment/ diagnosis
of diseases/ conditions of human body
79
MEDICINES
(ADVERTISEMENT & SALES)
ACT )1956
Who is the authority?
Medicine Advertisement Board
(MAB)
What is the role of MAB?
Approval of Advertisement
Any exemption?
S3 advertisement published by
govt.
80
MEDICINES (ADVERTISEMENT &
SALES) ACT 1956
s 3 : Absolute prohibition to take
part in publication of advertisement,
to lead to the use of articles for
purpose of
(a) prevention/treatment of diseases
& conditions of human beings as in
Schedule
(b) practising contraception
(c ) improving the condition/
functioning of kidney, heart,sexual
function/performance
(d) diagnosis of disease as in
Schedule. (see Schedule - list of 20
diseases)
81
MEDICINES (ADVERTISEMENT &
SALES) ACT 1956
s 4:Prohibit advertising abortion
s4A: Prohibit advertising skill or
service except s4A(aa):Minister
approval for professional body
s4A(bb):MAB approval for private
clinic/radiological/ medical lab.
s4B: Prior approval from MAB to
advertise article to prevent/ treat/
diagnose other conditions of human
body.
82
MEDICINE (ADVERTISEMENT &
SALE) ACT 1956
s6:to label active ingredients in
Malay/ English for sale of
substances recommended as medicine.
MEDICINES ADVERTISEMENT
BOARD REGULATIONS 1976
Procedure for MAB approval (KKLIU)
r5,r6,r7,r8
83
MEDICINES
(ADVERTISEMENT & SALES
ACT 1956)
Penalty s 5:
1st conviction: Fine not
exceeding RM3,000 or
imprisonment not exeeding 1
year or both
2nd and subsequent: Fine not
exceeding RM5,000 or
impriosnment not exceeding 2
yrs or both.
84