PERUNDANGAN FARMASI PHARMACY LIGISLATIONS

1
PERUNDANGAN FARMASIPHARMACY LIGISLATIONS

• The are 5 types of Malaysian Pharmacy
  Legislations.
• It consist of 5 Main Acts and several regulation
  made under each Act.
• Each Act stand by itself and are specific in its
  own way and control.
• Certain requirement can be different or
  overlapping between the Acts but the public have
  to satisfy and abide to the requirement of every
  Act.

2
ORDINANCE, ACT, REGULATION GUIDELINE
3
ORDINANCE

• Laws before Merdeka Day
• For Federal they are called ORDINANCE
• For State they are known as ENACTMENT

4
ACT (AKTA)

• Laws after Merdeka Day
• Written Laws
  Federal Constitution
  Constitution of State
  Act of Parliament
• Common Laws
• Customary Laws

5
REGULATION

• Subsidiary Legislation
• Form a subsidiary to the Act with the criteria of
  supervisional
• Regulation only need to be approved by the
  Minister who will be empowered by the Parent Act.
• Do not go to Parliament for approval

6
GUIDELINES

• More for the purpose of Administrative
• Mostly no legal standing
• May have legal implication when the Parent Act or
  the regulations have provision for certain bodies
  to issues guidelines
  eg.
  The DCA
  who are promulgated under the Control of Drug and
  Cosmetic Regulations is given power under
  Regulations 20(1), 22.

7
BASIC FORMAT OF AN ACT OR A REGULATION

• Tittle of the Act/Regulation
• Short title and application ........Sec 1/Reg 1.
• Interpretation (Definition).........Sec 2/Reg 1.
• Content
  appointmen
  ts,
  powers of authorised officers,
  what you must do,
  what you must not do,
  what contributes to an
  Offence Offence Sections,
  Penalty
  Sections,
  Powers of Minister to make Regs./Exam.

8
ADA SOALAN TAK?
9
AKTA UBAT (IKLAN DAN PENJUALAN) 1956MEDICINE
(ADVETISMENT SALE)ACT 1956
10
PREAMBLE OR THE SPIRIT OF THE ACT

• It is an Act to prohibit certain advertisments
  relating to medical matters and to regulate the
  sale of substances recommended as a medicine.

11
INTERPRETATION DEFINITION OF CERTAIN IMPORTANT
WORDS AND PHRASESSECTION 2
12
Advertisment

• Definition
  advertisment includes any
  notice, circular, report, comentary, pemphlet,
  label, wrapper or other document or any
  announcement made orally or by any means of
  producing or transmitting light or sound
  
• the inclusive definition of advertisment means
  that it take into consideration the traditional
  meaning (as in the dictionaries) of and
  advertisment and it include..............

13
OTHER IMPORTANT SECTIONS

• Sec. 3
• Sec. 4
• Sec. 4A
• Sec. 4B
• Sec. 5
• Sec. 6

PRODUCT
TREATMENT
SKILL SERVICES
14
SECTION 3

• Prohibition of advertisment relating to certain
  diseases.
• Paragraph 3(1)(a) prohibition of advertisment
  relating to diseases in Schedule
• Paragraph 3(1)(b) prohibition of advertisment
  relating to contraception among human beings
• Paragraph 3(1)(c) prohibition of advertisment
  relating to improving condition or function of
  human kidney, heart, sexual function or sexual
  performance of human
• Paragraph 3(1)(d) prohibition of advertisment
  relating to diagnosis of disease as specified in
  schedule

15

• Subsection 3(1A) give power to the minister to
  amend the schedule
• Subsection 3(2) give examption for such
  prohibited advertisment ion the manner so far as
  was reasonably necessary to bring to the notice
  of person of the following classes
  - public or local
  authorities -
  public hospital governing bodies
  - registered medical practitioners
  - registered dentist
  -
  registered nurses and midwives
  - registered Pharmacist, Chemist or
  poison licence holder
  - person
  undergoing training

16
SECTION 4

• Prohibition of advertisment relating to abortion
• this section relates to advertisment for article
  used for procuring the miscarriage of woman

17
SECTION 4A

• This section prohibit advertisment relating to
  skill or service
• Paragraph 4A(a) refer to skill or service
  relating to treatment, prevention or diagnosis of
  disease, injury, infirmity or condition effecting
  the human body
• Paragraph 4A(b) added that the advertisment which
  is capable of inducing, contain an invitation to
  any person to seek the advive of the advertiser
  or any person referred to in the advertisment
• Paragraph 4A(aa) is an examption for advertisment
  of such nature by pfofessional body
• Paragraph 4A(bb) approval from MAB needed for
  such advertisment for private hosp., clinic,
  radiology or lab.

18
SECTION 4B

• Avertisment of medicines to be approved by the
  Medicines Advertisment Board (MAB) established by
  the Minister
• This approval given by the MAB do not include
  the advertisment of medicine for the treatment
  and prevention the diseases listed under the
  Schedule (because those in the schedule are
  totaly prohibited for layman advertisment)
• Subsection 4 (2) stated that the advertisment to
  be publish have to be submitted to MAB in the
  manner as regulated

19
SECTION 5 Offence, penalty, defence

• Subsection 5(1), provides the penalty for
  contravention of S.3, S.4, S.4A, and 4B.
• Subsection 5(2) provide a presumption on person
  taking part in the publication of an offensive
  advertisment of medicines or article as a
  medicine (S.3(1), S.4, S.4B)
• Subsection 5(2A) provide a presumption on person
  taking part in the publication of an offensive
  advertisment on skill and service for treatment ,
  prevention or diagnosis (S.4A)

20

• Subsection 5(3) provide a defence for the person
  charge to prove
  - paragraph 5(3)(a) to
  prove that he do not know and
  had no reason to
  believe that he was taking part in the
  publication
  - paragraph 5(3)(b)
  to prove that the
  advertisment was publish only in a
  publication of technical character
  intended for professional
  circulation

21
SECTIONS 6

• Disclosure of composition of medicines
• Such information have to be written in English or
  national language and clearly legible
• Information includes ingredient, quantity, poison
  (as in the Poison Act 1952 and its regulations),
  ..........

22
SEC. 6A Powers of authorised officers

• The Minister may authorised in writting any
  Pharmacist in the public service to execise the
  power of authorised officers

23
SECTION 6B

• Power of Officer to investigate offences under
  the Act
• Power of officer with the cooperation of the
  court to secure attendance of witness for the
  purpose of investigation

24
SECTION 6C

• Examination of witness
• Recording statement of who ever is acquainted
  with the fact and circumstances of the case
• Proviso for caution and the right of the person
  investigated upon

25
SECTION 6D

• Power of officer to enter, search and examine
  premises related with the offence under the Act
• power of officer to inspect, remove, detain any
  related item with the offence under the Act.

26
SECTION 6E

• Penalty for obstructing or impeding an authorised
  officer

27
SECTION 6F

• Sanction by the Public Prosecutor before a case
  under this Act can be taken to court
• Authorised Officer to conduct prosecution

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SEC. 7 The Minister may make Regulations

• Regulation to establish MAB
• Manner of submitting advertisment for approval
  under Sec. 4A and 4B
• Procedure to be followed by the MAB
• Manner of appeal against the dicision of MAB

29
MEDICINE ADVERTISMENT BOARD REGULATION 1976
30
ANY QUESTION?
31
POISON ACT 1952AKTA RACUN 1952
32
PREAMBLE

• An act to regulate the importation, possession,
  manufacture, compounding, storage, transport,
  sale and use of poisons.
• This Act apply throught Malaysia

33
Generally

• For over 40 years this Act and its regulations
  provided the chief source of law relating to the
  sale and supply of medicines and other chemicals.
  
• A Poison Board was created under the Act, to
  advice the Health Minister on substances to be
  controlled and various restriction to be imposed
  upon.
• The expression Poison was defined as any
  substance specified by name in the first column
  of the poison list order under the Act.

34

• The Health Minister after consultation with the
  Poison Board has power to amend or vary the
  Poison List.
• However some of the substances listed as poison
  were not really toxic but were included in the
  List because there were no other means of
  controlling their distribution and use.
• The poison Act only allow a licensed Pharmacist
  to deal in all the substances listed in the
  poison list where this include importation,
  possession for sale, manufacture, compounding and
  retailing.
• A registered Medical Practitioner, registered
  Dentist are allowed to use the substances in the
  poison list for their own particular patient
  treatment only.

35

• A veterinary Doctor is allow to use the same
  substances for animal treatment.
• There are several Regulations being made under
  this Act to supervise matters pertaining to
  Poison.

36
Regulations

• The Poison Regulation 1952, regulate the matters
  pertaining to importation, storage, supply,
  transport, labelling, recording, colouring of
  poison and provide a special provisions relating
  to manufacture, import, sale and possession of
  Lead Tetra Ethyl.
• The Poison (Sodium Hydroxide) Regulations 1952
  regulate the purchase, store and use of NaOH.
• The Poison (Exemption) Regulation 1980 allow the
  Minister to issue an exemption to persons who in
  the course of his work use Part II Poisons in
  substantial quantity. An authorization may be
  granted subject to restrictions and conditions as
  may be specified.

37

• The Poisons (Psychotropic Substances) Regulation
  1989 is an outcome of the signing of the Single
  Convention on Psychotropic Substances 1971.
  After becoming a signatory to the said convention
  there seem to be a need to regulate a more
  standardise control tuned towards the convention.
  This Regulation regulate the possession, import
  and export, sale and supply, purchase and use,
  administration, dispensing, compounding mixing
  and manufacturing, storage, disposal and
  labelling of Psychotropic Substances.

38
SECTION 2INTERPRETATION, DEFINITIONSome
important definition
39
Interpretation and Definition of certain
important words and phrases

• The Act define poison as any substance specified
  by name in the first column of the poison list
  and include any preparation, solution, compound,
  mixture or natural substance containing such
  substance, other than an exempted preparation or
  any or preparation included for the time being in
  the second schedule of the Act

40

• Part I Poisons are Group A, B, C, D, E and F
  Poison as specified in the Poison List Order
• Part II Poison are those substances listed under
  the Part II column of the Poison List Order.
• dispensed medicine means a medicine supplied by
  a registered medical practitioner, registered
  dentist or veterinary surgeon under and in
  accordance with sec. 19 or supplied, for the
  purpose of medical, dental or animal treatment,
  of a particular individual by a licensed
  pharmacist on the premises specified in his
  licence

41

• The Act define the term possession for sale as to
  also include having in possession knowing that
  the article possessed is likely to be sold or
  expose for sale.
• Sell or Sale, include barter, offering or
  attempting to sell in the traditional meaning as
  sell or sale.
• definition of supply include the supply of
  commercial sample and dispense med. but it does
  not include the direct administration by or under
  the immediate supervision of a reg. med.
  practitioner or reg. dentist to his patient in
  the course of that patient treatment.

42

• Wholesale, the meaning of wholesale in this Act
  is, a sale to a person who intent to sell again
  and any sale by a wholesaler authorised under
  this Act.

43
Immediate Personal Supervision

• Subsection 2(2) of this Act give the presumption
  for the term immediate personal supervision,
  where it is deem to have been so done if such
  person was at the time it was done upon the
  premises where it was done and available for
  immediate consultation by the person doing such
  thing.
• Provided that, where for compounding, mixing and
  dispensing, it shall not be deem to have been so
  done unless such person has himself checked such
  compounding, mixing and dispensing.

44
The Poison Board

• Section 3 laid out the establishment of the
  poisons Board, appointment of member of the
  Board, who to be appointed and from which office.
  
• Section provide that the Board may regulate its
  own procedure and action.
• The Board must advice the Minister on matter
  concerning poisons and this is also provided
  under section 6 where the Minister have to
  consult the Board before amending or varying the
  Poison List Order and section 7 where the
  Minister can exempt any substance or preparation
  and put them in the Second schedule after
  consultation with the Poisons Board

45
constituent of the Board

• outlined in Section 3 of the Act. It consist of
  13 members, where 12 member are appointed by the
  Minister.
• The Director General shall be the an ex-officio
  member and section 4 laid that he shall be the
  chairman of the Board and preside at all meeting
  that he attends.
• In his absent one member shall be elected to
  preside. The chairman shall have an original
  vote and a casting vote and he may also decide
  the place where the Board may meet.

46

• The 12 member appointed by the Minister
• a) one pharmacist holding office in the
  Government service,
• b) one officer of the Chemistry Department,
• c) one officer from the Agriculture Department,
• d) one officer from the Veterinary Department,
• e) eight person who is resident of Malaysia and
  not in the Government service, who shall be
  nominated as follows
• i) one by Malaysian Medical Association,
• ii) one by the Malaysian Medical Council,
• iii) one by the Malaysian International Chamber
  of Commerce Industry,
• iv) one by the Association of Chinese Chamber of
  Commerce and Industry of Malaysia,
• v) one by the Malay Chamber of Commerce,
• vi) one by the Association of Indian Chamber of
  Commerce, Malaysia,
• vii) one by the Malaysian Pharmaceutical
  Association,
• viii) one by the Malaysian Rubber Producer's
  Council.

47

• All members other than the ex-officio member
  shall hold office for a period of three years and
  the can be reappointed by the Minister. The
  Minister may also appoint a similar qualified
  person to be a temporary member during illness or
  absence from Malaysia of any member other than
  the Ex-officio member. Four members including
  the Chairman or member presiding shall form a
  quorum.
• Section 5(2) provides the procedure of the Board
  cannot be question on the ground of vacancy in
  membership, constitution of the Board or
  omission, defect or irregularities in procedure
  not effecting the merits of the case.

48
Poison List Order

• The Poison List Order is illustrated in the First
  Schedule of the Act.
• This list divide Poisons into Part I and Part II
• Part I Poisons are further divided into Group A,
  Group B, Group C, Group D, Group E and Group F.
• There is also a column in the list specifying
  items which are exempted from all the requirement
  of the Act, where these items are usually those
  with a low concentration or in the form that
  could not be use as medicine and not in any way
  be a hazard or a threat to human health.
• The Poisons List can be amended from time to time
  in the manner set in Section 6.

49

• The Minister may from time to time amend by
  adding, removing, reinstating, transferring or
  including in any column of the Poisons List.
• The Minister have to consult the Poison Board
  Before amending this List and all the amendment
  have to be gazetted by notification in an Order.
• Amendment also include the exemption of any
  preparation or amendment of any definition of any
  poison in the Poisons List. (Sec.6)

50
The Second Schedule

• The second schedule in the Act list articles and
  preparations which are exempted from the
  provisions of this Act.
• Most of the article listed are poisons or class
  of poisons used in industrial or those use in
  trade which does not involve them to be consumed
  as a medicine.
• It is interesting to note that items like machine
  spread plaster (with lead content) and surgical
  dressing are also listed in this second schedule.
  
• Section 7 confirm that the Act shall not apply to
  item listed in this second schedule and the
  Minister may by Order notified in the Gazette
  add to or remove from the second schedule any
  article or preparation after consultation with
  the Poison Board.

51
General control on all Poison

• Since this Act divided Poison in various grouping
  and each of these group have specific control, it
  is important to discuss the control of all poison
  in general before going into each specific group.
  

52
Control of import of poisons

• All importation of poisons are prohibited except
  by person licensed under this Act (s.8(1)).
• Under section 8(3), it is an offence for any
  person to import poison without a valid licence
  issued under this Act.

53

• Exemption are given for import of poison by
• i) person arriving in Malaysia with poison as
  part of their personal luggage solely for his
  personal use or for the use of his family, in the
  form of prepared medicine for one month use for
  one person (s.8(2))
• ii) person importing poison by parcel post and
  solely for his personal use or for the use of his
  family, in the form of prepared medicine for one
  month use for one person (s.8(2)). Reg. 4 of the
  Poisons Regulation 1952 further regulate that the
  parcel should have the name of the person to whom
  it is consigned, the name of poison, the quantity
  and the date of posting
• iii) any government officer importing any poison
  in the course of his duties (s.8(2))
• iv) any person who the Minister may absolutely
  or conditionally exempt (s.8(2)).

54
Packaging , Labelling Storing of Poison.

• Section 9 prohibit the sale, supply, keeping or
  having in possession or having under control or
  store any poison, not in accordance with any
  regulation made relating to the possession,
  containers, packaging, labelling or storing.
• This section in general make it an offence for
  infringing any of the regulations pertaining to
  packaging, labelling and storing as set out in
  the Poison Regulation 1952. This regulation
  regulates these matter as follows

55

• Poison shall be stored in container impervious
  to the poison and sufficiently stout to prevent
  leakage (r. 5)
• Regulation 6 further regulate the manner that
  poisons have to be stored where it have to
  separated from non poison, distinguishable from
  other preparation interm of container and kept
  under lock and key. There is also a proviso
  under regulation 6 where it allows the storage of
  poisons in dispensary, retail shop or premises to
  be kept in a part of the premises which partition
  or separated from the remainder of the premises
  and to which customer are not permitted access.
• Regulation 9 regulate that the poison have to
  be labelled with the accepted name of the poison
  as in the Poisons List or as specify by British
  Pharmacopoeia or British Pharmaceutical Codex and
  have to also be labelled with the word "Poison"
  in red or red background. Exemption is give for
  smaller packing such as ampoule or cachet if the
  next larger packing have been labelled as such
  (r. 9(4). Labelling requirement will be more
  specific for specific types of Poison (Part I or
  Part II).

56
Transportation of Poison

• Poisons have to be transported in accordance with
  regulation made under this Act (s. 10). The
  Poison Regulation set that the poison which are
  to be transported have to be
• pack in such a way to avoid leakage (r.8(1))
• to be labelled with the name of the poison and
  to follow all the labelling requirement as being
  mention in any of the regulation made under this
  Act (r. (2))
• to be transported on a vehicle separately from
  food to avoid contamination (r. 8(3))

57
Compounding, Dispensing or Mixing of Poisons for
use in Med. Treatment.

• Section 12 allows
• Registered Pharmacist and any person working
  under his immediate supervision,
• Registered Medical Practitioners and any body
  working under his immediate supervision
• any person employed in the government hospital in
  the course of his duties.
• This section also set out that any person doing
  Compounding, Dispensing or Mixing have to do them
  in accordance to the regulations made under this
  Act.

58
Supply of Poison for the purpose of treatment by
professional man.

• In general all poison listed under the PLO are
  allowed to be sold, supp. admin. by the
  following professionals for purpose of treatment
  except Group A Poison
• a registered medical professional for his
  particular patient treatment
• a registered Division I dentist for his
  particular patient dental treatment, whereas a
  Division II dentist is allowed to sell, supply or
  administered any poison except Group A and Group
  B poisons.
• a veterinary officer for his client for the
  purpose of animal treatment
• All Poison sold, supplied or administered by the
  these professional man have to be done by them or
  under their immediate supervision.

59
Sale of poison by Wholesale

• Poison can only be wholesale by person who are
  having a wholesale licence issued under this Act
  and such sale have to be in accordance to the
  term and condition as specified in the Licence
  (s. 15(1)). The Act set that Poisons can only be
  Wholesale to (s. 15(2))
• (a) a person licensed to retail such poison, so
  it is the responsibility of the wholesaler to
  ascertain that the poison is sold to a genuine
  license holder
• (b) a purchase outside Malaysia, this mean that
  the poison is to be exported out of Malaysia
• (c) to another license wholesaler and it applies
  the same as (a) where the first wholesaler have
  to make sure that the person have a valid
  wholesale license

60

• (d) to an estate manager or person on his
  behalf, where this sale is for the purpose of
  estate hospital where it become the responsible
  of the estate manager
• (e) to a professional person or tradesman for
  their own use and not for resale, for example the
  sale of Theophylline to a tradesman for the use
  in the industry dealing with polishing
• (f) to a registered medical practitioner,
  registered dentist and registered veterinary
  surgeon for treatment of their own patient only
• (g) to licensed Pharmacist for wholesale or for
  retail
• (h) to a Government Department, Local
  Authorities or Public Body
• (i) to any treatment institution run by
  government, public fund or a charity body
• (j) to any institute concern with scientific
  education and research such as the Universities

61

• Section 15(3) goes further into identifying the
  requirement on documentation and recording for
  wholesale sale.
• A Wholesaler should keep a wholesale record book
  where he should enter the particular such as name
  and address of the purchaser, date of sale, name
  and quantity of the poison sold and the purpose
• A wholesaler can only deliver any poison after
  receiving a sign order (SO) from the purchaser,
  the SO have to be retain by the seller and a
  reference of the fail in which the SO is retained
  is entered in the earlier mention record book in
  place of the purchaser signature.
• If a poison is needed urgently and its SO cant
  be procured the seller can deliver the poison
  after entry in the record book stating the reason
  along with all the other particulars mention
  earlier. In such cases the poison Act required
  the SO in respect of such sale to be obtain by
  the seller within 7 days after the date of the
  delivery (15(3)).
• The format of the poison wholesale sale record
  book is prescribed in Form A of the First
  Schedule in the Poison Regulations 1952 (r.
  26(1).

62
Sale of Poison By Retail.

• Retail of Poisons can only be done by a person
  license to retail such poison under the Act.
• The Licensed retailer have to follow the term and
  condition set in the license and can only the
  done upon the premises stated in the licensed and
  by the person referred to in the license or under
  his immediate supervision (s. 16).
• Retailing poisons can be the act of filling up
  priscribtion by medical practitioner, dentist or
  veterinary surgeon or it can also be the sale of
  certain group poison by a licence Pharmacist for
  a particular patient treatment The sale of poison
  by retail have to be recorded either in the
  "Priscribtion book" or "Poison book".

63

• Priscibtion book (s. 24) is kept for the sale of
  poison by filling up priscribtion (s. 21) or for
  recording the dispensing of any poison as a
  "dispense medicine" or an ingredient in a
  dispensed medicine (r. 12), (s. 22).
• Poison book is kept for recording those poison
  which are Group D poison and not a dispense
  medicine or any ingredient in a dispensed
  medicines (s 23(2)). The format for the poison
  book is being prescribed in the First Schedule,
  Form A. (r. 26(2)) .

64
Prohibition of sale to persons under 18 years old.

• Section 17 make it an offence for anyone to sell
  poison to person below 18 year old otherwise only
  for the purpose of his medical treatment.

65
Control of Part I Poisons

• We have discuss the general control on Poison
  these control applies also in general for Part I
  poisons. In this Chapter we will discuss the
  specific control on Part I Poisons in order of
  their specific Groups, A, B, C, and D

66
Control of Group A Poisons

• This group of poison have the strictest control
  in the poison List.
• It can also be assumed that any poison listed
  into this Group is as good as being ban for use
  in human treatment, where they can only be
  limited for use in other trade or in scientific
  research.
• This statement is true if we look back into the
  problem on the use of Beta agonist in animal feed
  supplement in 1992. (Adrenaline and other
  substance structurally derived from
  Phenethylamine .....(item 13 in the Poison List
  order)).

67

• Section 20 of the Act stated that Group A Poisons
  shall be sold or supply by wholesale or retail by
  a licensed wholesaler to a licensed Pharmacist or
  another licensed Wholesaler or to be exported to
  a purchaser outside Malaysia.
• The retail of Group A Poison is allowed for other
  purpose except for medical treatment where the
  medical practitioners, the dentist or the
  veterinary surgeon are not allowed to prescribed
  Group A Poison for the purpose of treatment.

68
Control of Group B Poisons

• Group B poison are those items in the Group B
  column of the Poisons List.
• This category of poison can only be supplied for
  the purpose of treatment by a medical
  practitioner, division I dentist or a veterinary
  surgeon.
• All the supply by these professional have to be
  for a specific or particular patient treatment
  (s. 21). This means that these professional
  cannot supply poison to a person who will then
  sell or supply again to another person.

69

• The Act also allows licensed Pharmacist to supply
  Group B Poisons as a "dispensed medicine" and in
  accordance with a priscribtion
• Subsection 21(6) allow the supply of Group B
  Poison by a licensed Pharmacist without a
  priscibtion for urgent treatment upon request
  from a medical practitioner who is personally
  known to him by verble or telephone. He can
  dispense it by first recording in the
  priscribtion book and the priscribtion have
  follow within one day of the sale or supply.
  This Act regulate that both the medical
  practitoner and the Pharmacist are responsible to
  ensure that this requirement is followed.

70
Control of Group C Poisons

• Group C Poisons are those item under the Group C
  column of the PLO.
• The specific control involving Group C poison is
  that they can be sold or supplied by retail to
  any person as a "dispense medicine" by a licensed
  Pharmacist or by any person under the Pharmacist
  immediate supervision.
• Every sale of Group C poisons have to be recorded
  in the prescription book.
• The labelling have to follow the requirement set
  in regulation 12 of the Poison Regulation 1952
  regarding the labelling od "dispense medicine"
  (this requirement will be discuss in the coming
  chapter)

71
Control of Group D Poisons

• Group D poisons are those in the Group D column
  of the PLO.
• This category of poison can only be sold by a
  licensed Pharmacist to a person known personally
  to him or introduced to him personally by another
  person known to him.
• If this Group D poison is a dispense medicine or
  an ingredient in a dispense medicine, the record
  of the sale have to be maintained in the
  prescription book (s. 24). If not, the sale need
  to be recorded into the Poison Book (s. 23(2))
  (regulation 26(2) regulate the format of the
  Poison Book where it should be as prescribed in
  Form B of the First Schedule) and the purchaser
  have to put his signature on the Poison Book.

72

• If in this case the purchaser are not present to
  sign on the poison book the he has to send a
  written sign order before the delivery can be
  made. The Written sign order have to be kept in
  a file and the reference to it shall be use to
  replace the purchaser signiture.
• If a Group D poison is needed urgenly and and it
  is impossible to obtain the signature or its
  sign order can be procured the seller can deliver
  the poison after entery in the poison book
  stating the reason of his action. In such cases
  the poison Act required the sign order in respect
  of such sale to be obtain by the saler within
  seven days after the date of the delivery (s.
  23(3))

73
Control of Part II Poison

• Part II Poison might be dangerous if their
  handling such as storage, transport and labelling
  are not control.
• So those tradesman who handle such poisons have
  to be licensed so that the requirement of this
  Act and its Regulation are being followed and can
  be enforce on them.
• Any one who want to sell or supply a Part II
  poisons have to be licensed (s. 25) under these
  Act. These applicant can apply for either Type D
  License (to store and sell) where the name of
  poison they can dealt with will stated in this
  license or a Type E Licensed which is more
  specific for importation, storing and use Sodium
  Hydroxide.

74
Control of Acetylating Substances

• Acetylating substances such as Acetly-bromide or
  Acetic-anhydride are control in a special manner
  because these substances can be use in the
  acetylation process on opiates.
• Mere possession of acethylating agent without
  authorisation is an offence (s. 14(1)) under this
  act unless the possessor can prove that he is
• (a) that he is licensed under this Act
• (b) That he is authorised under this Act
• (c) That the acethylating substance is in his
  possession for a lawful purpose

75

• Acethylating Substances are also listed under the
  custom prohibition list and their importation
  need to be authorised by the Ministry of Health
  through the issuence of Authorisation Permit
  (AP).
• The penalty for infringing the control of
  acethylating substances under this Act is very
  severe. An offender shall be liable to be
  imprisoned for a term not exceeding fourteen
  years and not less than three years, and shall
  also be punished with whipping of not less than
  six strokes (s. 14(3)). Any person charged for
  this offence concerning acethylating substances
  shall not be granted bail (s. 14(4)).

76
Control of Lead tetraethyl

• Prohibition of manufacturing of lead tetraethyl
  in Malaysia (r. 16).
• Importation of lead tetraethyl by those who are
  licensed by the licensing officer (r. 17 (this
  regulation also laid down the fee of RM 100.00
  and the terms and condition of the license)).
• Regulation 18 goes further in prohibiting the
  import, sale or possession of ethyl petrol
  containing more than 1/750 in proportion of lead
  tetraethyl

77

• Regulation 19 restrict the import, sale or have
  in possession of ethyl petrol containing more
  than 1/150 in proportion of lead tetraethyl with
  the following conditions
• for the used in aircraft or any other purpose
  authorised by the Director of Medical services
• such ethyl petrol have to be distinctively
  coloured inaccodance with a British Standard (r.
  19)
• all container and appliances use in dealing with
  such ethyl petrol have to be conspicously and
  distinctively labelled or marked with the words
  "This spirit contains LEAD to be used for
  aircraft or motor fuel only" in English, Malay,
  Chinese and Tamil.
• Regulation 16 to 22 of the Poison Regulation 1952
  is very specific for lead tetraethyl and
  regulation 22 exempt all other requirement (other
  than regulation 16 to 22) of the Act or
  Regulation relating to import, possession, sale,
  supply, packing, storage, transport, colouring or
  labelling of poisons to be applicable on lead
  tetraethyl.

78
Control of Colouring of Poison

• Regulation 15 of the Poison Regulation 1952
  stated that a distinctive dye have to be added to
  poisons for use in agriculture or horticulture
  for the destruction of pests, fungi, or bacteria.
  
• This dye have to be soluble in water is the
  poison is needed to be diluted with water.
• Regulation 15(2) specifically mention the need to
  colour sodium arsenite or any other arsenic
  preparation used in agriculture or horticulture
  but regulation 15(3) exempt the need to colour
  lead arsenate paste or lead arsenate powder along
  with poison which are already distinct in colour
  or any such poison for the purpose or export.

79
Licences needed in dealing in Poison

• One of the main function of this Act and its
  Regulations is to control poison by way of
  licensing.
• This Act appointed the Director General of Health
  or the Director of Pharmaceutical Services or the
  Director of Medical Services of the state
  appointed by the Director General of Health to be
  the Licensing Officers(s. 26).
• The type of license that can be issued under
  this Act are as follows

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Type A Licence

• This Licence is only issued to registered
  Pharmacist.
• It allows the Pharmacist to deal in all poisons.
  
• In general it allows poisons to be imported,
  stored and sold.
• In term of sale this licence can be specific for
  wholesale only, retail only or for both wholesale
  or retail depending on the application made by
  the pharmacist to the licensing officer.

81
Type B Licence

• This licence is issued to any person the
  Licensing Officer may consider to be fit and
  proper person to hold such licence, or issued to
  a responsible officer of a company incorperated
  under the Companies Act 1965.
• This type B licence allows a person to import,
  store and sell by wholesale only such poison as
  may be specified in the licence.
• This licence is restricted only in dealing on
  specific poisons excluding the Group A poison.
• The Poison Act also have proviso which do not
  allow this type B licence to be issued to any
  person or officer who is engaged or concern in
  selling goods by retail.

82
Type C Licence

• The Licensing Officer is issued to listed seller
  a Type C Licence when there is no pharmacist in
  within a local authority licensed to carry on a
  business in such area.
• This license will allow the listed seller to
  sell by retail and store Group F poisons.
• As the number of licensed pharmacist increase
  tremendously the Poison Board view that they
  should up grade all Group F poisons.
• Untill 1989 there is no more Group F poison in
  the Poison List so there is no more Type C
  licence issued by the Licensing Officer.

83
Type D Licence

• This licence is issued to any person whom the
  licensing may consider to be fit and proper to
  hold such license to store and sell by retail
  such Part II Poisons as may be specified(ususlly
  after an inspection of the applicant premise by
  the enforcement officer to acertain that the
  applicant and their premises are fit to handler
  such poison in term of storage and safety)

84
Type E Licence

• This licence is for any person who uses Sodium
  Hydroxide in the course of his business in a
  substantial quantity where this licence allows
  the holder to import, store and use.
• The enforcement unit of the state will have to
  ensure that the person and the premises is fit
  and proper for such activity before this licence
  can be considered by the Licensing Officer.

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General on license

• All the format of licences are prescribed by the
  Act
• Licensing Officer have freedom to instate terms
  and condition in every licence where he deem it
  is fit, proper and which are not inconsistent
  with this Act or its Regulations. If the terms
  and condition stated in the licence is not
  aggreable by the applicant, the applicant can
  appeal to the minister (s. 26(3) and 26(4)).
• All licence is personal to the licensee named in
  the licence and are not tranferable.
• The person named in the licence have to be
  responsible for authorising any sale of the
  poison and any dealing in such poison have to be
  personally supervised by him.

86

• Each licence is specific to the premise where the
  addresses are stated in the lic. Any change of
  add. have to be made by application to the
  Licensing Officer and he will amend the address
  as he see fit (s. 26(6).
• Section 26(5) give powers to the Licensing
  Officer to refuse issuance any such licence or he
  may may cancel a licence that had been issued.
  Anybody aggrieved by such action may appeal to
  the Minister. The Minister decision on the
  appeal shall be final
• All licensed shall be numbered by the State
  consecutively in respect of each type and of year
  in which it was issued and commencing each year
  with the number one.
• A Register recording all the particular of each
  lic. and records any event on cancellation or
  amendment have to be kept for all licence issued
  by the Licensing Officer of every State. This
  register shall be accepted in any court case as a
  prima facie evidence (s. 27).
• The Director General of Health shall publish the
  name of all licence holder in a Gazette annually
  in about the month of February each year. This
  Government Gazette shall also be prima facie
  evidence in any court proceeding (s. 28).

87
Enforcement of the Act

• Section 2 define "Drug Enforcement Officer as,
  any registered Pharmacist in the Public service,
  duly authorised in writting by the Licensing
  Officer, (where the Director General of Health is
  the Licensing Officer).
• In order to enforce an Act, there shall be
  authorised person who are given power appropriate
  to the needs of the Act. Under the Poison Act the
  Drug Enforcement Officer (DEO) are given the
  following powers

88
Power to investigate

• A DEO is given the power to investigate under
  section 31(2). Power in oral examination of any
  body acquinted with the fact and circumstances of
  the case is also given (s. 31(3)) where it means
  that they are given the power to record statement
  of witnesses and the acused. Section 31(4), (5),
  and (6) laid the the caution involve in taking
  the statement.

89
Power to enter primises

• Section 31(8) give power of entry to the DEO and
  any body accompanying him and who work under his
  instruction. This section goes on allowing the
  DEO to break open any doors or remove any
  obstruction in gaining his entry. His entry have
  to be at reasonable time and with reasonable
  cause to believe that an offence under this Act
  has been or is being committed in the premises.

90
Power to inspect, detain, remove any item
reasonably related to the case.

• A DEO may search, inspect, detain and remove any
  substance reasonably believed to be a poison,
  book, document, equipment, instrument, material
  or any other article found in any premises in his
  opinion may furnish evidence (s. 31(8)). Under
  this section the DEO is also given the power to
  detain any person foun in such premises untill
  the DEO finishes his search. Section 31(10)
  provide that it is an offence for any person to
  obstruct or impedes a DOE in the performance of
  his duties under this Act

91
Power of the police and custom officer under this
Act.

• Section 31(9) give power the a police officer not
  lower than the rank of an inspector and a senior
  custom officer to exercise the same power as
  given to the DEO under section 31(8) along with
  an extra power to arrest any person if that
  person is believed to conceal or deposit any
  poison or any related articles.

92
Penalties and Court Proceeding

• Penalties under the Act can be specific under any
  offence sections in the Act or for general
  offences or where those offences without the
  statement of penalty, section 32 will invoke and
  section 32 in general can be divided into two
  categories as follows
• i) A penalty punishable by fine not exceeding
  five thousand ringgit or by imprisonment for a
  term not exceeding two years or both for offences
  pertaining to keeping of record or false entery
  of records
• ii) A penalty punishable by a fine not
  exceeding three thousand ringgit or by
  imprisonment for a term not exceeding one year or
  both for offences which no penalty spesified
  under the Act or its regulations.

93

• Section 32 goes further into specifiying the
  liability of body corporate, its officers and
  directors to be charge jointly under this Act and
  the officer or directors are deem to be guilty
  the same untill they can prove to the court that
  they have no knowledge what so ever or they have
  taken precaution to stop the offence from being
  commited (s. 32(3)(4)).
• Section 32(5) any poison related to the case in
  which an offence under this Act has been
  committed shall be forfieted and delivered to the
  Director General of Health for disposal.
• Section 33 provide that the Sessions Court or a
  First Class Mejistrate Court in West Malaysia or
  a Sessions Court in the East Malaysia Shall have
  full jurisdiction over offences against this Act.
  Prosecution instituted under this Act or its
  regulations shall need to be sanction by the
  Public Prosecutor and the prosecutor can be a
  registered Pharmacist in the public service
  authorised in writting by the Public Prosecutor
  (s. 34).

94
Regulations

• Section 35 gives power to the Minister to make
  regulations to carry out the purpose of this Act
  and these regulations may be in respect or for
  the purpose related to poisons such as
  importation, manufacturing, sale, storage,
  transport, labelling, containers, compounding,
  dispensing, record, qualification of poison
  guardian, providing exemption, prescribing form
  of licences and register, the act of dealing in
  specific poison such as lead tetraethyl,
  presccribing penalties for offence againts the
  regulations and regulate the control of
  Psychotropics substance.

95
The Control Psychotropic Substances

• In 1989 Malaysia become a signatory to the
  International Psychotropic Convention 1971.
  After signing this Convention there is a need to
  include special control on Psychotropic
  Substances in the Poison Act and there also seem
  to be aneed to regulate more standardised control
  tuned toward this Convention.
• To cater for these needs the Poison Act was
  amended to include section 30 in the Act which
  control Import, export, manufacture, sale and
  other dealing in Psychotropic Substances.

96
Third Schedule

• This Act define Psychotropic Substances as those
  listed in Third Schedule of the Act (s. 30(1).
• The third Schedule listed out all the
  Psichotropic Substances under the control of this
  Act.
• not all psychotropic drugs as classified by way
  of their Pharmacological action are listed under
  this Schedule. Those listed are those
  Psychotropic which have abuse tendencies.
• The Minister from time to time can vary the Third
  Schedule by way of Gazzett.
• Section 30(3) provide that all dealing in Psy.
  Subst. have to be in accordence with the
  regulations made under this Act.

97
Poisons (Psychotropic Substances) Regulations 1989

• This Regulations regulate the possession, import,
  export, sale, supply, purchase,use,
  administration, dispensing, compounding, mixing,
  manufacturing, storage, disposal and labelling of
  Psychotropic Substances.

98
Possession of Psychotropic Substance

• Regulation 3 of the Poisons (Psychotropic
  Substances) Regulation 1989 prohibit any person
  from possessing Psychotropic Substances unsless
  such possession is authorised and such
  Psychotropic Substances is for alawful purpose
  and is obtained in accordance with this
  Regulation and Reg. 4(2) listed the person or
  class of person who shall be authorised to
  possess Psychotropic Substances and the are as
  follows
• (a) a licensed Pharmacist
• (b) a registered Medical Practitioner

99

• (c) a registered Dentist Division 1
• (d) a veterinary surgeon
• (e) a permit holder issued under reg. 15 of this
  regulation, to purchase and use Psy. Subst. such
  person can be a game warden or any tradesman who
  use Psy. Subst. in his trade.
• (f) a person incharge of any ward, operating
  theatre or section to posseess Psychtropic
  Substance for the use of such places.
• (g) a person who is concern with scintific
  reaseach or chemical analysis in Uni. or any
  inst., own by Govt or approve by the Director
  General of Health
• (h) a pharmacist in the public service

100

• (i) Custom, police or postal officer in the
  course of their duty
• (j) a Drug Enforcement Officer
• (k) a perso engaged in the delivery of
  Psychotropic Substances
• (l) a person whose Psy. Sub. is lawfully
  supplied by person in (b),(c), or (d)
• (m) a person acting on behalf of any class of
  authorised person who lawfully possess
• (n) a peson possessing psychotropic substsnces
  to be administered to a patient as directed by
  person in (b), (c), or (d).

101
Import and export of Psychotropic Substances

• This Regulation supervise import and export of
  Psy. Subst. and it follow closely the format
  suggested by the Convention.
• every importation to be authorised by the
  importing country and the exporting country need
  ti authorised the eportation.
• All transection pertaining to import and export
  will be reported to the International Narcotic
  Control Board INCB in Vienna Austria which is the
  body who ensure that the agreement in the
  Convention is followed by the member country.
• This requirement on import and export
  authorization is laid out in regulation 4(1).

102
Exemption on import for personal use

• regulation 4(2) exempt any person arriving or
  leaving Malaysia with one month supplies for
  himself or any member of the family a prepared
  packed medicine containing Pschotropic substances
  which is genuinely priscribed by a qualified
  medical practitioner or any ship, aircraft or any
  form of international transport leaving or coming
  into Malaysia with alimited quantities of
  psychotropic substances for emergency use on
  their voyage.

103
application of import and export

• Reg. 5 and 6 further laid out the procedure on
  application of import and export authorization
  and indicates that it is the prerogative of the
  Licensing Officer to issue these authorization.
• For each authorisation if approved, will be
  issued out in triplicate where two copies will
  be given to the applicant where the applicant
  will then send one copy to the supplier in the
  other country and the Licensing Officer will sent
  one copy to the Competent authority of the other
  country.

104

• These regulation priscribed the format for import
  authorization as Form B in the regulations and
  export authorization as Form C.
• The fee for import and export Authorization is
  ahundred ringgit (r.7)
• Due to the agreement in the Convention, certain
  pychotropic substances such as the amphetamine,
  methaqualone, secobarbital and etc. is compulsory
  to be to followed with an export authorization if
  they are imported or in transit so reg. 9 was
  promulgated so that this requirement is followed
  and a list of such psychotropic substance is
  listed in Second Schedule of these regulations.
• All psychotropic substances in transit shall not
  be tempered with and the packing shall not be
  change without a written consent of the Licensing
  Officer.

105
Sale and Supply of Psy.Substance

• Regulation 11 regulates that all psy. Subst. have
  to prescribed only by reg. medical practioner,
  reg. division 1 dentist or a veterinary surgeon
  and this catogories of professionals can do the
  supply themself or their priscribtion can be
  dispensed by a registered pharmacist or any
  pharmacist who is employed by the government
  treatment institution or any institution approved
  by the Director General of Health.
• Asupply can also be made to any person who is
  authorised to administered such pschotropic upon
  a priscribtion.
• This regulation further priscribed the format for
  psy. prescription and how this prescriptions are
  dealt with.

106
Prescription for Psy. Substances

• Regulation 11(2) - every Psychotropic
  priscribtion should
• a) be writtern, sign and dated by the
  prisciber
• b) identify the priscriber by having in the
  priscibtion, his name, address and telephone
  number
• c) indicate the age, full name and address of
  the patient and for veterinary purpose should
  indicate the same particulars of the person to
  which the items is to be dilivered
• d) indicate the total amount and the dose to be
  supplied
• e) spacify the number of time can the
  priscribtion be dispensed and at what interval
  (this paragraph allows the priscribtion to be
  dispensed for the maximum of three times)

107

• all pschotripic's priscribtion can only be valid
  for 90 days.
• Any Pharmacist dispensing this priscribtion have
  to endose upon the face of the priscibtion above
  the prisciber signiture, his full name and
  address and the date of dispensing.
• For urgent cases or an emegency upon the request
  of a medical practitioner, a Dvision 1 dentist or
  a veterinary surgeon the pharmacist can dispense
  a one day supply of psychotropic substance to a
  patient after he have made a record in the
  psychotropic register and a priscribtion have to
  follow up immediately the next day.
• All priscibtion pertaining to psychotropic
  substances have to be kept for a period of not
  less than two years.

108
Psy. for other than human animal purpose

• Regulation 12 provides that a licensed pharmacist
  or a pharmacist in public services can sell or
  supply psychotropic substance other than to
  medical practitioner, dentist or veterinary
  surgeon for the purpose of treatment. Such sale
  and supply can be to
• another licensed pharmacist or pharmacist in
  public service
• a person concern with scientific reasearch
• a person holding a permit under regulation 15,
  where reading together regulation 14 and 15 we
  will understant that a permit for purchase and
  use of pys.subs.may be issued by the Licensing
  Officer to a profesional person or tradesman
  for their profession or trade only (for example
  ) or to an authorised game warden for the
  use on animals only.
• to be legally exported to a puchaser outside
  Malaysia following the procedure in regulation 4.

109

• Giving of Commercial sample are not allowed under
  regulation 12(2)(a) where there are only
  allowence for clinical trial sample and the
  issuence of this clinical trial sample have to be
  authorised by an import license under The Control
  Drug and Cosmetic Regulation 1984
• Any authorised person under the poison Act or
  this regulation to purchase psychotropic
  substances, purchasing an unusually large amount
  acting in his ordinary course of duty shall be
  required to give an attestation to the seller
  before the sale and supply can be made
  (12(2)(b)).

110
Administration, Dispensing, Compounding, Mixing
and Mnufacturing of Psy. Substance

• Regulation 16 provide that only registered
  medical practitioner, Division 1 dentist or
  veterinary surgeon or any person directed by
  them.
• Regulation 17 stated that only licensed
  pharmacist or a pharmacist in the public service
  are allowed to dispense, compound and mix.
• Reg. 18 provides that only licensed pharmacist
  and pharmacist in the public service a