1 AZMAN YAHYA PRINCIPAL ASSIST. DIRECTOR PHARMACEUTICAL SERVICES ( ENFORCEMENT) PHARMACY...

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AZMAN YAHYA

PRINCIPAL ASSIST. DIRECTOR

PHARMACEUTICAL SERVICES ( ENFORCEMENT)www.pharmacy.gov.my

PHARMACY JURISPUDENC

E

http://www.pharmacy.gov.my/



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1.Registration of Pharmacists Act 19511.1 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

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3.Sale of Drugs Act 19523.1 Control of Drugs &

Cosmetics Regulations19844. Dangerous Drugs Act

19524.1 Dangerous Drugs

Regulations 1952

5. Medicines (Sale and Advertisement)

Act 19565.1 Medicine

AdvertisementBoard Regulations

1976

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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.

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POISONS ACT 1952

(Amended 1989)

FIRST SCHEDULE

POISONS LIST

PART I PART II EXEMPT

(PART I) GROUP A,B,C,D

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Poisons List

First Schedule

Group A

Poisons

Group B

Poisons

Group C

Poisons

Group D

Poisons

Part I Poisons

P

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Poisons List

First Schedule

Part II Poisons

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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

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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

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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%

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SECOND SCHEDULE - articles and preparations exempted eg.glue, varnishes

THIRD SCHEDULE -Psychotropicsubstances eg. Diazepam other subs.

Structurally derived from 1,4-benzodiazepine exept pirenzepine, flumezenil

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“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

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Import of poisons-requires 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.

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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 (RM100)

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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

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SALE BY WHOLESALE

• Record in wholesale sale book• Puchaser’s written order

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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

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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

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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)

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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

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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.

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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”

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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

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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”

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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

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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.

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Supply of poisons to out-patients in Govt. hospitals etc

r.23 (1) Only via Prescription by a registered medical practitioner for the purpose of medical treatment.

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r23Keeping of Record in Govt. hospitals etc.

a) Record to be readily traced

b) Record to be kept for 2 years

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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

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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”

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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.

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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.

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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 1,4-benzodiazepines

Barbiturates,Phentermine

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POISONS (SODIUM HYDROXIDE) REGULATIONS 1962

• Permit to purchase and use sodium hydroxide• Stated quantity• Fee RM20

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POISONS (PSYCHOTROPIC SUBSTANCES) REGULATIONS 1989

• Import, export, manufacture, compound, dispense, sell, supply, administer and possess/• Fine RM10,000 or 4 years imprisonment

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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).

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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

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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)

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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.

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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

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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

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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

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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.

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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.

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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

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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.

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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

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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

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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.

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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

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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

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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”

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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

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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.

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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”

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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

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Part III:

r9- Register of products

r9(3)- Any person may inspect the register.

r12 :Licences(a) manufacturer’s

licence (b) wholesaler’s licence (c) clinical trial import licence (d) import licence

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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.

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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

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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

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Part V:

r28- Reporting ADR

r29- DCA directives for product recall and disposal is binding otherwise the person commits an offence.

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DANGEROUS DRUG ACT 1952

What is Dangerous Drug ?

Anything found in the First Schedule of Dangerous Drugs Act 1952

eg: Morphine,pethidine,fentanyl

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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)

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Control of illicit activities relating to DD

Enforcement by Police/Customs

Specific sections on investigations & court actions (s26 to s42)

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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

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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.

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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

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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

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- 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

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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)

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RECORD of DD

1) Registered Medical Practitioner/ Dentist( private hospitals and clinics)

r15(2)(a) Day Book and Separate Book

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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.

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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.

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•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

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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, state name of patient/R.N

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...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/out-patient, 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.

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...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.

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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)

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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

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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.

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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)

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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.

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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

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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.

1 AZMAN YAHYA PRINCIPAL ASSIST. DIRECTOR PHARMACEUTICAL SERVICES ( ENFORCEMENT) PHARMACY...

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