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70 views31 pages

Sample 1

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arahilmy
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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PHARMACY LAW 100 QUESTIONS

For questions 1-30, please refer to the Poisons Act 1952 and its Regulations

1. A licensed pharmacist may supply by retail any of the following EXCEPT:

-
A. Group A Poisons (by wholesale)

B. Group B Poisons

C. Group C Poisons

D. Group D Poisons

2. Mr. AB, a registered pharmacist, owns a retail pharmacy in Kuala Krai. He is licensed under the
Act to do retail at his business premises. Under the Act Mr. AB may
group [
2
I. Import mefenamic acid BP powder. -> page
* all Poison
group C

II. Supply by retail diclofenac 50 mg tablet to patient.


group B
III. Sell wholesale amoxicillin 250 mg capsule to pet shops.
~

IV. Purchase dexamethasone 8 mg injection locally for resale by wholesale.

O
A. I and II only ↳ steroid private -
license type A

B. I, III, and IV only / -


or al
injection
C. I and IV only B
C

D. II and III only

3. A physiotherapist may supply to a patient:


need valid
group s -> prescription
->
I. Hydrocortisone cream 1.0% w/v. tak bolen supply as physio
group C

II. A pack of 24 ibuprofen 200 mg tablets.


group c-parenteral
III. A pack of 50 paracetamol 500 mg tablets. - non-poison
group (

IV. A pack of 16 acetylsalicylic acid 300 mg tablets. -


non-poison

A. I and II only

B. II and III only

O
C. III and IV only

D. II, III, and IV only

4. Type A licensed holder shall make an entry into the Poisons Wholesale Sales Book for the sale to
a government hospital of the following items:
Group
C
I. Salbutamol inhaler - Ru book

1
II. Tetracycline capsules

III. Sulphuric acid 10% solution

IV. Adenosine in raw cordyceps

A. I only

B. I, II, and III only

C. II and III only

D. All of the above

5. A licensed pharmacist shall maintain a ‘Prescription Book’ when he sells:

I. Agriculture poisons for the purpose of plant treatment.

II. Amlodipine 4 mg tablet as a dispensed medicine with prescription.

III. Sildenafil 50 mg for the purpose of medical treatment with prescription.

IV. Cloxacillin 250 mg capsule for the purpose of animal treatment with prescription.

A. I, II, and III only

B. I and IV only

C. II, III, and IV only

D. All of the above

6. A strip of bisacodyl 5 mg tablet was dispensed by a pharmacy assistant without a prescription while
the licensed pharmacist was in the same room within the premises. The sale was not recorded in
a Prescription Book. The following is TRUE regarding the sale:

I. The sale does not require a prescription.

II. The sale contravened section 22 (b) of the Act.

III. The sale has to be recorded in the Poisons Book.

IV. The offence is liable for a fine not exceeding RM 2000.00.

A. I only

B. II only

C. II and IV only

D. I, III, and IV only

7. Licensed pharmacist selling atenolol 100 mg on a prescription shall, at the time of selling, endorse
upon the face of the prescription, above the signature of the prescriber, with the following
particulars:

I. The quantity of such medicine supplied.

II. The date on which such medicine was sold.

III. The licensed pharmacist telephone number.

IV. The licensed pharmacist full name and address.

2
A. I, II, and III only

B. I and III only

C. II and IV only

D. None of the above

8. The following articles and preparations are exempted under the Act:

I. COVID-19 test kits

II. Fusidic acid surgical dressings

III. Medical device containing heparin

IV. Cell culture medium containing vancomycin for laboratory use

A. I and II only

B. I and III only

C. II, III, and IV only

D. All of the above

9. A traditional healer center was suspected of dispensing antibiotic capsules to their customers. The
state drug enforcement officers were tasked to conduct a raid on the premise. The following
statements are TRUE regarding the power of an authorized officer:

I. He can make an arrest of the staff working at the premise

II. He can search and remove the documents from the premise

III. He can enter the premise by breaking open the door of the premise

IV. He can destroy the antibiotics in the presence of the owner of the premise

A. I and II only

B. I and III only

C. II and III only

D. III and IV only

10. The Licensing Officer for each State

I. Shall keep a register of all licences issued

II. May issue licenses for the purposes of the Act

III. Shall publish the name of the licence holders in the gazette annually

IV. May authorize in writing any registered pharmacist to exercise the powers of a Drug
Enforcement Officer

A. I and II only

B. I and IV only

C. II and III only

3
D. All of the above

11. The following persons shall be a Licensing Officer:

I. Director General of Health

II. Director of Pharmaceutical Services

III. State Director of Medical and Health Services

IV. Head of Pharmacy Enforcement Division of the State

A. I, II and III only

B. I and IV only

C. II, III and IV only

D. All of the above

12. The following statements are TRUE regarding registered diltiazem 30 mg tablet:

I. Retail sale shall be recorded in a Prescription Book

II. A registered medical practitioner is allowed to import

III. Supply by a licensed pharmacist requires a prescription

IV. A permit to purchase and use is required by a tradesman for the purpose of such person’s
trade only

A. I and II only

B. I and III only

C. II, III and IV only

D. All of the above

13. Under the Act and its Regulations:

I. “Sell” includes offering or attempting to sell

II. “Medical treatment” means the treatment of human and animal diseases

III. “Licensed wholesale” means a person holding a licence issued to him to sell poisons by
wholesale and retail

IV. “Conveyance” includes ship, train, vehicle, aircraft or any other means of transport by which
persons or goods can be carried

A. I and II only

B. I, II and III only

C. I and IV only

D. IV only

14. The following statements are TRUE:

I. A seller sold Sodium Hydroxide 15% to Tung Shin Hospital shall record the sale in the Poisons
Book

4
II. A retailer sold Group D Poisons other than as dispensed medicine, shall record the sale in the
Poisons Book

III. A licensed pharmacist sold atenolol 100 mg tablet as dispensed medicine, shall enter the
sales into the Prescription Book

IV. A licenced chemical company sold 20 drums hydrochloric acid 20% to Shell Malaysia shall
make an entry into the Poisons Wholesale Sales Book

A. I and II only

B. II, III and IV only

C. III and IV only

D. All the above

15. The following statements are TRUE of the Act and its Regulations:

I. Type A licence holder may import any poison in the Poisons List

II. Any amendment to the Poisons List shall be made by the Poison Board

III. Dispensed medicine involves the supply of Group A, Group B and Group C poisons on a
prescription only

IV. Supply of metformin tablet by a licensed pharmacist without a prescription does not
contravene any provision under the Act.

A. I and II only

B. I and IV only

C. II and III only

D. II and IV only

16. The following are the labelling requirements of cortisone cream as a dispensed medicine:

I. Name of Medicine

II. Name and address of the seller

III. The word “Poison” in red or on a red background

IV. The words “Not the be Taken” in English, Malay, Chinese, and Tamil in red or in a red
background

A. I, and III only

B. I, II and IV only

C. II and IV only

D. All of the above

17. The following statements are TRUE regarding classifications of poisons:

I. All preparations of arsenic are in Group B unless in Group A.

II. A registered metoprolol product is classified as Group B Poison.

5
III. All miconazole preparations are in Group B, unless it is in Group C.

IV. All preparations of chloramphenicol in pharmaceutical dosage form are in Group B unless in
Group C and Group D.

A. I and III only

B. I, II and IV only

C. II, III and IV only

D. All of the above

18. The following combinations are TRUE regarding offences and penalties under the Act and its
regulations:

Offence Penalty

I Supply of Group B Poisons by a licensed Fine not exceeding RM3000.00 or by


pharmacist without a prescription from a imprisonment for a term not exceeding one
registered medical practitioner year or both

II Failed to record the sale of paracetamol 500 Fine not exceeding RM5000.00 or by
mg tablet in the Prescription Book by licensed imprisonment for a term not exceeding two
pharmacist years or both

III Making false records of poison sale in the Fine not exceeding RM5000.00 or by
Poison Wholesale Sales Book imprisonment for a term not exceeding two
years or both

IV Supply of atenolol 100 mg tablet by a person Fine not exceeding RM3000.00 or by


without licence to a registered medical imprisonment for a term not exceeding one
practitioner year or both

A. I and II only

B. I, III and IV only

C. II and III only

D. All of the above

19. The following statements are TRUE:

I. The Act regulates the importation, possession, manufacture, compounding, storage, transport,
sale and use of poisons.

II. Importation of concentrated ethyl fluid is subjected to the licence issued by the licensing officer
and the fee of the licence is RM100.00.

III. Any poisons in respect of which an offence against the Act has been committed shall be
forfeited and delivered to the General Director of Health for disposal.

IV. A person may import into Malaysia a prepared medicine containing poison by parcel post for
his own personal use for a quantity reasonably required for one month’s usage.

A. I and II only

B. I, III and IV only

C. II and IV only

6
D. All of the above

20. A licensed wholesaler can sell poisons to:

I. Estate workers

II. A registered pharmacist

III. Majlis Perbandaran Ampang

IV. A researcher in Jabatan Kimia Malaysia

A. I and II only

B. II and III only

C. III and IV only

D. All of the above

21. The following particulars must be recorded in the Poisons Wholesale Sales Book EXCEPT:

I. Name and address of the purchaser

II. Quantity of poison sold and the purpose required

III. Serial number of the sales and the date of purchase

IV. Seller’s name, identity card number, signature and telephone number

A. I and II only

B. I, II and III only

C. III and IV only

D. IV only

22. The following statements are FALSE:

I. The Director of Pharmaceutical Services is the Licensing Officer for issuing licences for the
purpose of this Act.

II. Diphenhydramine syrup dispensed by a licensed pharmacist without prescription from


registered medical practitioner.

III. Tadalafil 2.5 mg tablet can be supplied by wholesale by registered medical practitioner to a
registered medical practitioner.

IV. Type A licence issued to any person whom the Licensing Officer may consider to be a fit and
proper person to hold such as licence.

A. I and II only

B. I, II and III only

C. III and IV only

D. All of the above

23. The following combinations are TRUE regarding recording of the sale or supply of poisons under
the Act:

7
Poisons Name of Records

I Group D Poison other than as dispensed medicine Poison Book

II Group B and C Poison on a prescription of a registered Prescription Book


medical practitioner by a licensed pharmacist

III Group B Poison for medical treatment by registered Day Book


medical practitioner

IV Group B Poison by wholesale by licensed wholesaler to Poison Wholesale Sales Book


a licensed pharmacist

A. I and II only

B. I, II and IV only

C. III and IV only

D. All of the above

24. The following statements are FALSE regarding supply of poison for the purpose of treatment by
professional men:

I. Diclofenac 50 mg tablet can be supplied by a veterinary officer to his client for the purpose of
animal treatment only.

II. Group A Poison can be supplied by a registered medical practitioner for the purpose of the
medical treatment of such patient only.

III. Amoxycillin 250 mg capsule can be supplied by a registered dentist Division II for the purpose
of the dental treatment of such patient only.

IV. Mefenamic acid 500 mg capsule can be supplied by a registered dentist Division I for the
purpose of the dental treatment of such patient only.

A. I and II only

B. I, III and IV only

C. II and III only

D. All of the above

25. A registered medical practitioner may administer to his patient for medical treatment of such patient
following poisons EXCEPT :

I. II and III only

II. Ipronidazole

III. Amidopyrine

IV. Ketoconazole

A. I and II only

B. II and III only

C. III and IV only

8
D. All of above

Questions 26 and 27 are based on the below statement.

Miss A is employed as a pharmacy assistant in a veterinary hospital wholly maintained by the


Government of Malaysia. Her duties among others are to supply medicine containing poison to any
person for the animal treatment of any animal tended by her on a prescription from a veterinary surgeon.

26. She shall enter in a record kept for such supply the following particulars:

I. The date on which the poison was supplied.

II. The name and quantity of the poison supplied.

III. The name of the person who supplied the poison.

IV. The name and address of the person to whom the poison was supplied.

A. I, II and III only

B. I and III only

C. II and IV only

D. All of the above

27. She shall label the container of the poison with the following particulars:

I. The name of the medicine.

II. The words "Controlled Medicine".

III. The name and address of the hospital.

IV. The words "For animal treatment only".

A. I, II and III only

B. I and III only

C. II and IV only

D. All of the above

28. The following statements are TRUE regarding "immediate personal supervision relating to Part I
Poisons:

I. Group A poisons may be sold under the immediate personal supervision of the

II. Every medicine containing any poison shall be prepared by or under the immediate personal
supervision of a registered medical practitioner.

III. A person working under the immediate personal supervision of a registered pharmacist may
dispense, compound or mix any poison with any other substance.

IV. Any compounding of any poisons with any other substance is required to be do under the
immediate personal supervision of any person, it shall not be deemed have been so done unless
such person has himself checked such compounding.

A. I only

B. II and IV only

9
C. II, III and IV only

D. All of the above

29. The following statements are TRUE regarding establishment and proceeding Poisons Board:

I. The Director of Pharmaceutical Services is the alternate Chairman of the Board

II. The Minister may appoint a Secretary to the Board who shall be a member of the Board and
have the right to vote.

III. No action or proceeding of the Board shall be questioned on the ground of any omission, defect
or irregularity in procedure not affecting the merits of the case

IV. The Board shall meet at such places and times as the Chairman may appoint and at any
meeting four members including the Chairman or member presiding shal form a quorum.

A. I and II only

B. II and III only

C. III and IV only

D. All of the above

30. Mr. A compounds and mix poison with other substance. The activities DO NOT contravene the Act
if:

I. Mr. A is a dentist compounding the preparation intended for medical treatment.

II. Mr. A is a manager of an estate hospital authorized by a registered medical practitioner.

III. Mr. A is a pharmacy assistant working in the private hospital in absence of a registered
pharmacist.

IV. Mr. A is a person working under immediate personal supervision of a registered medical
practitioner for the use of such patient.

A. I and II only

B. II and IV only

C. III and IV only

D. All of the above

For questions 31 - 40, please refer to the Poisons (Psychotropic Substances) Regulations 1989.

31. The following persons authorized to be in possession of psychotropic substance shall keep and
maintain a register to be called the 'Register of Psychotropic Substance Received, Delivered or
Administered":

I. A veterinary surgeon

II. A licensed pharmacist

III. A pharmacist in the public service

IV. A salesman from a licensed wholesaler engaged in the delivery

A. I and II only

10
B. I, II and III only

C. III and IV only

D. All of the above

32. The following statement is TRUE:

A. Custom Officer is empowered to issue certificates and authorisations for and export of
psychotropic substances.

B. An officer of the Postal Department, acting in the course of his duty shall not be authorised to
be in possession of psychotropic substances.

C. At the time of importation, the importer shall produce to the competent authority the import
authorisation relating to the psychotropic substances.

D. International carriage by ships may leave Malaysia with limited quantities of psychotropic
substances required during their journey for emergency cases.

33. Tablets of zopiclone which are delivered by an authorized person shall be recorded in the

A. Poisons Wholesale Sales Book

B. Supply Register for the Psychotropic Substances

C. Prescription Register for Psychotropic Substances

D. Register of Psychotropic Substances Received, Delivered or Administered.

34. A prescription containing alprazolam:

I. shall be kept for 2 years.

II. shall state the telephone number of the prescriber.

III. is valid for 120 days after the date of the prescription.

IV. shall be endorsed by the supplier at the time of supplying

A. III and IV only

B. I and II only

C. I and III only

D. All of the above

35. In carrying out his duty the following person may possess registered oxycodone syrup for the
purpose of medical treatment:

I. A biochemist

II. Master of a ship

III. A medical assistant at a private hospital

IV. A pharmacy assistant at a government clinic

A. I and II only

B. I and III only

11
C. II and IV only

D. All of the above

36. A pharmacist wrongly entered the date, name and the quantity of the psychotropic substance
received and delivered in the registerWhat action should he take according to the Regulations?

A. Correct the information that were wrongly entered R22

B. Make a marginal noteinitial and put down the date.

C. Cancel the entry made by underline it and make a note.

D. Make a footnote, specify the date on which the correction was made

37. The following combinations are classified as psychotropic substances:


-
I. Aminorex

II. Mesocarb -

Ill. Lisdexamphetamine -

IV. Chloral hydrate

A. I and IV only

B. I, II, and III only

C. II, III and IV only X

D. All of the above

38. Choose the correct combinations for X, Y, and Z regarding the import of psychotropic substances.

Every psychotropic substance specified in the ___X___ which is imported into Malaysia, or brought to
Malaysia in transit, from a country which is a party to the Convention shall be accompanied by a valid
and subsisting ___Y___ duly issued by the competent authority of the country from which it is exported;
and the person having the possession or control of such psychotropic substance shall, on demand by
any Drug Enforcement Officer, any police officer not below the rank of inspector or any senior officer of
Customs, produce such export authorization for his ___Z___.

X Y Z

A Poisons list Import authorization endorsement

B Second schedule Export authorization approval

C First schedule Import authorization inspection

D Second schedule Export authorization inspection

39. The following persons shall dispose psychotropic substance in their possession the presence of a
Drug Enforcement Officer:

I. A registered dentist Division who is required to keep and maintain "Prescription Register for
Psychotropic Substance". I
II. A pharmacist in the public service who is required to keep and maintain Supply Register for
Psychotropic Substance". -

12
III. A licensed pharmacist who is required to keep and maintain Production Register for
Psychotropic Substance".

IV. The holder of a permit issued under Regulation 15 who is required to keep and maintain
"Register of Psychotropic Substance Received, Delivered or Administered

A. I, II and III only

B. I and III only

C. II and IV only

D. All of the above

40. The following combinations are TRUE:

Purposes Name of Records

Export of psychotropic substances Register of Psychotropic Substances Received,


I Delivered or Administered

Sale or supply for other than medical, Supply Register for Psychotropic Substances
II dental or animal treatment

Supply for medical, dental and animal Prescription Register for Psychotropic
III treatment Substances

Manufacture of psychotropic substances Production Register for Psychotropic


IV Substances

A. I and III only

B. I, II and IV only

C. II, III and IV only

D. All of the above

For questions 41 - 60, please refer to the Sale of Drugs Act 1952 and Control of Drugs and
Cosmetics Regulations 1984.

41. The Director of Pharmaceutical Services shall have the powers to issue:

I. written directive relating to the recall of notified cosmetic. Y


Il. written approval to any person to import any cosmetic in-transit. Y
III. exemption to any person to import any cosmetic for teaching purpose in a school of pharmacy.

IV. certification on any matter relating to any cosmetic as may be required by the importing country
of such cosmetic.

A. I and II only

13
B. I, Ill and IV only

C. II, Ill and IV only

D. All of the above Answer

Questions 42 and 43 are based on the following statement

The officers inspected a traditional medicine manufacturing plant which was producing suspected
unregistered product. The product was seized for further investigation. The Secretary to the Drug
Control Authority later confirmed that the product was not a registered product.

42. The manufacturer has contravened the following Regulation(s):

I. Regulation 7(1)(a)

II. Regulation 7(1)(b)

III. Regulation 7(1A)(h)

IV. Regulation 7A

A. I only

B. I and II only

C. Il and Ill only

D. I, Ill and IV only

43. The penalty for the above offence is:

A. Section 12 of the Act.

B. Section 18(1) of the Act.

C. Section 20(4) of the Act.

D. Section 26(1)(k) of the Act.

44. Powers conferred upon the Chief Minister include:

I. Direct the manner for drugs disposal upon conviction. Y


II. Extend the period of forty-eight hours of complaint of the seizure.

III. Make regulations to improve the carrying out of the provisions of the Act.

IV. Appoint such number of officers within a State as may be necessary for the purposes of the Act. Y
A. I and II only

B. I and IV only d
C. Il and III only

D. All of the above

45. The notification notes issued by the Director of Pharmaceutical Services allows any cosmetic to be:

I. possessed.

14
II. manufactured.

Ill. sold in the country.

IV. imported into Malaysia.

A. I and II only

B. I, Il and III only

C. Ill and IV only

D. All of the above

46. The Yang di-Pertuan Agong may appoint

A. officers.

B. analysts.

C. inspectors.

D. Drug Enforcement Officers.

47. The following licence is issued by the Drug Control Authority:

I. manufacturer's licence

II. import licence

III. clinical trial import licence

IV. wholesaler's licence

A. I and II only

B. I, Il and III only

C. Ill and IV only

D. None of the above

48. The Director of Pharmaceutical Services may issue such written directives or guidelines to any
person or a group of persons which in particular relate to:

I. change of particulars of a product.

Il. product quality, safety, efficacy and labelling.

III. the appointment of directors in local drug manufacturing companies.

IV. records and statistics pertaining to manufacture, sale, supply, import or export of any products.

A. I and III only

B. I, Il and IV only

C. Il and IV only

D. All of the above

15
49. In the case of any conviction under the Act:

I. The name and occupation of the person who commits the offence may be published
in any newspaper. -

II. The person who without authority removes any seal placed by any officer shall be liable to a
fine of RM5000.00. RIl RM500 X
-

III. Any drug to which the conviction relates shall be forfeited and shall be disposed as directed by
the Chief Minister.

IV. The body corporate that commits an offence of manufacturing any product without any licence
shall be liable to a fine not exceeding RM25,000.00 or to imprisonment for a term not exceeding
three years or to both.

A. I and III only

B. II and IV only X

C. III only X

D. All of the above X

50. The register of the products registered under the Regulations shall:

I. Contain the expiry date of the product.

II. Be kept and maintained by the Secretary. -

III. Contain the name and address of the product registration holder. -

IV. Be preserved for a period of two years from the date of last entry in such register.

A. I and II only X

B. II and III only

C. III and IV only X

D. All of the above

51. The following statements are TRUE regarding clinical trial import licence under the Regulations:
exceeding 3 year s

not
I. A clinical trial import licence shall be valid for five years.
~
X

R12(2)
II. Any number of registered products may be included in a clinical trial import licence. X (not applicable (

III. A clinical trial import licence authorises the licensee to import any product for purposes of
clinical trial.

IV. An application for a clinical trial import licence shall be made in Form 4 and accompanied with
a processing fee of RM 500.00.

A. I, II and III only X

B. I and IV only X

C. III and IV only

D. All of the above X

52. The following statements are offences under the Act:

I. Import by post unregistered aspirin tablets.

16
II. Selling an unregistered ketum capsule to a friend.

III. Selling a registered misai kucing product to a friend

IV. Promoting a slimming product using the Facebook platform

A. I and II only

B. I, II and IV only

C. III and IV only

D. All of the above

53. The following substances are prohibited in a traditional medicine preparation:

I. Caffeine -

II. Charcoal

III. Salbutamol - in poison list (1st sched)

IV. Soy protein

A. I and II only

B. I and III only

C. II, III and IV only X

D. IV only X

54. Madam FAA arrives in Malaysia after spending two weeks in Seoul shopping for cosmetics and
beauty products. She carried with her as part of her personal luggage, 72 pieces snail serum facial
masks made in Korea. The facial masks are not notified cosmetics. The instruction of use is one mask
daily. The following statements are TRUE regarding the case above:

I. She may be fined up to RM50,000.00.

II. She will be given a notification note upon arrival.

III. She contravened Regulation 18A(1)(a) of the Regulations. -

IV. She is allowed to bring in a maximum of 30 pieces of facial mask. -

A. I and II only X

B. II and III only X

C. III and IV only

D. II, III and IV only

55. An article intended to be used on humans or any animal for medicinal purposes is a "drug” under
the Act if it is for the following purposes:

I. Including anaesthesia. -

II. Diagnosing a disease. -

III. Controlling body weight. ~

IV. Practising contraception. -

17
A. I and II only

B. I, III and IV only

C. II, III and IV only

D. All of the above

56. The manufacturing of a product for teaching or research purposes may be exempted from the
requirement of registration in relation to the manufacturing, sale, supply, possession, and administration
of such product if the application for the exemption is made by the following persons:

I. Dean of a school pharmacy.

II. Head of a training institution.

III. Pharmacist at a retail pharmacy.

IV. Researcher at a research institution.

A. I and II only

B. I, II and IV only

C. III and IV only

D. All of the above

57. The following statements are FALSE regarding the person responsible for placing the notified
cosmetic in the market:

I. Report to the Director of Pharmaceutical Services for any serious adverse events.

II. Maintain proper records in the manner determined by the Director of Pharmaceutical Services.

III. Comply to the directives issued by the Minister of Health and conditions imposed by the Director
of Pharmaceutical Services.

IV. May apply for the issuance of the notification note to the Director of Pharmaceutical Services
and the processing fee is refundable.

A. I and II only

B. I, Ill and IV only

C. Ill and IV only

D. All of the above

58. The following statement is FALSE:

A. Written application may be made to the Secretary and payment of RM5.00 to inspect the
register.

B. The Authority may at any time and without assigning any reason, reject the registration of any
product.

C. Cancellation of registration of any product in the licence will affect the position of other products
listed in the licence.

18
D. Product registration holders shall immediately inform the Director of Pharmaceutical Services
of any adverse reactions from the use of the registered product.

59. The following are the different characters in 'product variant’

A. Colours, fragrance, shape

B. Colours, fragrance, flavours

C. Appearance, flavours, colours

D. Colours, fragrance, appearance

60. The following statements are TRUE regarding legal proceeding and evidence under the Act:

I. All proceedings of an offence against this Act shall be taken before a High Court.

II. There shall be served with the summons a copy of the analyst's certificate, if any, on which the
prosecution is based.

III. The summons in any such proceedings shall not be made returnable in less than fourteen days
from the day on which it is served.

IV. The certificate of analysis issued by the analyst is sufficient as evidence unless the defendant
requires that the analyst is called as a witness.

A. I and IV only

B. I, Il and Ill only

C. II, Ill and IV only

D. All of the above

For questions 61 - 75, please refer to the Registration of Pharmacists Act 1951 and its
Regulations.

61. A registered pharmacist in Malaysia has been sentenced to two months imprisonment in a
neighbouring country due to drug related offences. If it comes to the knowledge of the Pharmacy
Board, it may inquire into the case under the following provision(s) of the Act:

I. Section 17(1)(a)

II. II. Section 17(1)(b)

III. IlI. Section 13(7)(b)(i)

IV. IV. Section 17(1)(c)

A. I only

B. I and II only

C. Il and Ill only

D. IV only

62. The Minister need not consult the Pharmacy Board regarding the:

I. Amendment to the Second Schedule by order published in the Gazette.

II. Decision for the appeal against the removal of registered pharmacists name from the register.

19
III. Imposition of restrictions and conditions on any person provisionally registered under paragraph
6(1)(b).

IV. Registration of a provisionally registered pharmacist having a qualification in pharmacy other


than the qualifications specified under the First Schedule.

A. I and lI only

B. Il only

C. Il and III only

D. Ill and IV only

63. The custodian of the Register is the

A. Minister.

B. Secretary to the Board.

C. Director of General Health.

D. Director of Pharmaceutical Services.

64. A provisionally registered pharmacist who has satisfactory experience wishes to apply for full
registration shall be in

A. Form 2.

B. Form 3.

C. Form 5.

D. Form 6.

65. The following statements are TRUE of the Committee of Inquiry:

I. Members shall be appointed by the Registrar.

II. The decision of a Committee of Inquiry shall be by a majority.

III. The period of the appointment of members shall be three years.

IV. It may investigate infamous or disgraceful conduct of a registered pharmacist.

A. I, II and III only

B. I and III only

C. II and IV only

D. All of the above

66. The following statements are TRUE regarding provisional registration for pharmacists:

I. Provisional registration is solely for the purpose of obtaining experience.

II. Application for provisional registration shall be submitted to the Registrar.

III. Limited to persons who hold any qualification specified in the First Schedule.

20
IV. The Minister after consulting the Board may amend the First Schedule by order published in
the Gazette.

A. I and II only

B. I, II and IV only

C. III and IV only

D. All of the above

67. A provisionally registered pharmacist shall engage in employment as a pharmacist in the following
approved premises which fulfil the criteria for the purpose of training:

I. Private hospitals

II. Retail pharmacies

III. Higher educational institutions

IV. Pharmaceutical manufacturers

A. I, II and IV only

B. Ill only

C. None of the above

D. All of the above

68. The following statements are TRUE regarding the Act:

I. The word 'Dispensary' can be used by dental surgeons.

II. The title of pharmacist can only be used by person registered under the Act.

III. If a person not registered under the Act uses the title pharmacist, he shall be guilty of an offence.

IV. Conviction of a person guilty of an offence under Section 7 of the Act has to be of an offence.
made in a high court.

A. I and II only

B. I and III only

C. II and III only

D. I, II and IV only

69. The following interpretations are TRUE under the Act or its Regulations:

I. "therapeutic substance" means drug as defined in the Sale of Drugs Act 1952.

II. "psychotropic substance" means any of the substances specified in the Third Schedule to the
Poisons Act 1952.

III. "poison" means any article deemed to be a poison within the meaning of the Poisons Act 1952
or of any other written law relating to poisons in force in Malaysia.

IV. "Dangerous drug" means any drug or substance which is for the time being comprise in the First
Schedule to the Dangerous Drugs Act 1952 or any corresponding schedule to any other written law
relating to dangerous drugs in force in Malaysia.

A. I and II only

21
B. I, III and IV only

C. III and IV only

D. All of the above

70. The following statements are TRUE regarding the registration of pharmacists:

I. A person shall be entitled to be a fully registered pharmacist under this Act after gaining
experience as required under Section 6A.

II. The Pharmacy Board may, upon application in writing, temporarily register a person who is
registered as a pharmacist outside Malaysia.

III. The name of a registered pharmacist may be removed from the register by the Pharmacy Board
if such person has permanently left Malaysia.

IV. The Board may extend for not more than one year from the period of employment if the Board
is not satisfied with the performance of the provisionally registered pharmacist.

A. I and II only

B. I, III and IV only

C. II, III and IV only

D. All of the above

71. The following statements are TRUE of a body corporate:

I. The Minister shall issue a certificate of registration to the body corporate.

II. A registered pharmacist shall be the superintendent of a body corporate at any time.

III. It may appeal to the Minister if it is aggrieved by any of the punishments imposed by the Board.

IV. If it fails to obtain an annual certificate for the coming year, its name will be removed

from the register without any appeal.

A. I and II only

B. II and III only

C. III and IV only

D. All of the above

72. The following is the duty of the Secretary of the Pharmacy Board:

I. . Nominate the Chairman of any Committee of Inquiry.

II. Responsible for the maintenance of the register of pharmacists.

III. Publish in the Gazette a list of all registered pharmacists and bodies corporate.

IV. Remove the name of a registered pharmacist from the register if such person is decreased.

A. I, II and III only

B. II and IV only

C. III and IV only

22
D. None of the above

73. Every application for full registration shall be accompanied by such documents and fee as
prescribed under the Regulations:

I. A fee of RM100.00

II. Two recent passport size photographs of the applicant

III. A certified true copy of the appointment letter as provisionally registered pharmacist

IV. A certificate of satisfactory experience issued under subsection 6A(2) of the Act or a certificate
of exemption issued under section 6A(7) of the Act or a certificate issued by the Minister under
subsection 6B(3) of the Act

A. I and III only

B. I, II and IV only

C. II and IV only

D. All of the above

74. The following is the correct order regarding any person who seeks to make a complaint against a
registered pharmacist:

I. Make a complaint to the Secretary of the Board

II. The Board appoints a Committee of Inquiry

III. Secretary of the Board refers the complaint to the Board

IV. The Committee of Inquiry makes an investigation and reports to the Board

A. I, II, III, IV

B. I, III, II, IV

C. II, I, III, IV

D. III, II, I, IV

75. Under the Act, the Board may make regulations for and in respect of all or any of the following
matters:

I. The registration of bodies corporate.

II. The establishment of a Committee of Inquiry to inquire into complaints or information regarding
any misconduct by any registered pharmacist.

III. The examination prescribed or set by the Board to be passed by any person before he is eligible
to apply to be admitted to the register under this Act.

IV. The pupillage, the conditions under which the practical training of apprentices or students shall
be conducted and any other matter relating to the training and qualification of pharmacists.

A. I and II only

B. I and III only

C. II, III, and IV only

23
D. All of the above

For questions 76 - 85, please refer to the Medicines (Advertisement and Sale) Act 1956.

76. An advertisement relating to the following may be approved by Medicine Advertisements Board for
the public.

I. Registered supplements to relieve symptoms of osteoarthritis.

II. Herbal medicine to improve the conditions of human kidney function.

III. Services relating to the treatment of mental disorders by a private hospital.

IV. Services relating to the treatment of osteoarthritis by a traditional practitioner.

A. I only

B. I and III only

C. II and III only

D. All of the above

77. The advertisement approval is issued:

I. by the Board.

II. by the Chairman of the Board.

III. according to the language to be used.

IV. to a website which is registered in another country.

A. I only

B. III only

C. I and III only

D. II and IV only

78. In the context of advertisement, substance recommended as a medicine in relation to the sale of
an article consisting or comprising a substance, among others could refers to:

I. wrapper or container in which the article is sold.

II. advertisement meant for the Federal Government.

III. health supplement information written in the pharmacy journal.

IV. placard or document exhibited at the place where the article is sold.

A. I and III only

B. I and IV only

C. II and IV only

D. All of the above

79. The Minister may approve the publication of an advertisement which refers to any skill or service
relating to medical matters by:

I. a private clinic.

24
II. a private hospital. -

III. the Malaysian Medical Association. S4A (bb)


IV. the Malaysian Pharmacists Society.

A. I and II only

B. II and III only

C. III and IV only

D. All of the above

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77777, Kota 7, Selangor.

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80. The above advertisement has contravened

A. Section 3

B. Section 4 Cabortion )

C. Section 4A (service(

D. Section 4B (meds)

81. The following statements are TRUE regarding the Act:

I. In the context of the Act, “word” includes letter and numeral. - S(2)

II. A written sanction is needed to prosecute offences under the Act. ~ S6F

III. The Board may invite any one or more persons to attend the Board meeting and the person
shall have no right to vote. R3

IV. Any person contravene Section 6 shall be subjected to a fine not exceeding RM3000.00 or
imprisonment not exceeding one year. or both SGE

A. I and II only

B. I, II, and III only

C. I and IV only

25
D. All of the above

82. The following online advertisement was found circulating the Facebook messenger chat group.

Sentosa Orthopedic Clinic Services

Are you experiencing hands and feet numbness? Try our innovative ABC capsules now!

ABC capsules are also effective for the treatment of diabetes. Safe and endorsed by health care
professionals. Please enquire by texting 017-245365 (Dr GHT)

This advertisement contravenes the following section of the Act.

A. Section 3

B. Section 4A

C. Section 4B

D. None of the above

83. Mr.S, a traditional practitioner advertises his special concoction of medicine in the form of a
leaflet. The capsules were produced in his clinic and they were indicated to treat joint pain. With
regards to the Act, the advertisement

A. contravenes section 3.

B. contravenes section 4B.

C. may be advertised if it is approved by the Act.

D. may be advertised if it is approved by the Health Minister.

84. The following statements are FALSE regarding the Act:

I. The Board may add to, delete from or amend the Schedule from time to time by order.

II. advertisements relating to abortion medicines can be advertise by private clinic after getting
approval from the Board.

III. “public hospital” includes public clinic, public dispensary or other public institution for the
reception of the sick patient.

IV. prohibition advertisements relating to certain diseases under Schedule shall not apply to any
advertisement published by the Federal Government

A. I and II only

B. II, III and IV only

C. IV only

D. All of the above.

85. The powers vested upon the Minister under the Act or its Regulation include to:

I. cancel the approval previously issued.

II. amend the Schedule after consulting the Board.

26
III. exempt any person from the payment of fee for the application for approval of advertisement.

IV. authorize in writing any pharmacist in the public service to exercise the powers of an
authorized officer under the Act.

A. I and II only

B. II, III and IV only

C. IV only

D. All of the above

For questions 86 - 90, please refer to the Dangerous Drugs Act 1952 and its Regulation.

86. The following is required for importation of amphetamine

A. e-Permit by the custom department.

B. Import authorization by the Minister.

C. Type E Licence by the Licensing Officer.

D. Written approval from the Drug Control Authority.

87. A registered pharmacist shall not supply any dangerous drug to any person authorized under
Regulation 8 unless the following conditions are fulfilled:

I. He has entered in the Register the amount and form of drug supplied.

II. The drug sold, if sent by post to the purchaser, must be sent by registered or insured post.

III. He is reasonably satisfied that the signature affixed to the order is in fact the signature of the
authorized person purporting to sign it

IV. He has received an order in writing signed by the purchaser stating his name and address
and the name and quantity of the drug to be purchased.

A. I, II and III only

B. I and III only

C. II and IV only

D. All of the above

88. The following statements are TRUE relating to "cannabis":

I. It is a dangerous drug which is for the time being comprised in the Part III of the First Schedule
to the Act.

II. It can be imported into Malaysia under and in accordance with the authorization in the Form B
set out in the Second Schedule to the Act.

III. The Minister of Health may authorize any public officer to cultivate cannabis for research,
educational, experimental, or medical purposes.

IV. The Minister may make regulations for prohibiting the cultivation, production, possession, sale
and distribution of cannabis.

A. I and II only

27
B. I and IV only

C. III and IV only

D. All of the above

89. Every prescription issued by a registered medical practitioner for the supply of a dangerous drug
for the medical treatment of a patient must:

I. specify the address of the person giving it.

II. specify the total amount of the drug to be supplied.

III. specify the name and address of the person for whose treatment it is given.

IV. be in writing and signed by the person giving it with his usual signature and dated by him.

A. I, II and III only

B. I and II only

C. III and IV only

D. All of the above

90. The Minister have a power under the Act and its regulations EXCEPT:

I. may appoint such persons as he may think fit to be Drug Enforcement Officers for the purposes
of this Act.

II. may make regulations for the further, better and more convenient carrying out of the provisions
or purposes of this Act.

III. to delegate to any fit and proper officer authority to exercise any of the powers and functions
vested in the Minister by this Act.

IV. exempt from any of the provisions of this Act or the regulations any hospital, infirmary,
dispensary maintained by a public authority.

A. I only

B. I and II only

C. I, II and III only

D. III and IV only

For questions 91-94, please refer to the Code of Ethics for Pharmacists 2018.

91. The pharmacist has been convicted of selling unregistered product that are unsafe, ineffective and
of poor quality. He has breached:

A. Principle 7

B. Principle 5

C. Principle 3

D. Principle 4

28
92. "Explain the options available to patients and the public, including risks and benefits, to help them
make informed decisions, make sure the information given is impartial, relevant, accurate and up
to date".

The above statement refers to the following principle:

A. Be Responsible of Your Working Practices

B. Develop Your Professional Knowledge and Competence

C. Use Professional Judgement in the Interests of Patients and the Public

D. Encourage Patients and the Public to Participate in Decisions About Their Care

93. "A pharmacist possessed and sold medicines labelled with "Kementerian Kesihatan Malaysia"
without a valid document or authorization for his personal financial gain".

Which principles were breached?

I. Principle 1

II. Principle 2

III. Principle 6

IV. Principle 7

A. I and II only

B. II and III only

C. III and IV only

D. IV only

94. Pharmacist Q has sold expired medications to a patient. The following statements are TRUE related
to the above situation:

I. He has breached Principle 6 of the code

II. The pharmacist failed to protect patient privacy as in Principle 3 of the Code.

III. The pharmacist failed to practice safe procedure as suggested in Principle 1 of the Code.

IV. The pharmacist failed to take the responsibility to provide a service as in Principle 7 of the Code.

A. I and II only

B. I, III and IV only

C. II and IV only

D. All of the above

For questions 95 - 97, please refer to the Framework for Good Governance in Medicine.

95. The selection of medicines into the formulary which forms the basis for the procurement by
specialists is vulnerable to corrupt practice when

I. they declare conflict of interest.

II. non evidence-based literature is accepted to support the products.

29
20920
III. samples are given freely to the specialists resulting in indiscriminate use. pg

IV. aggressive promotion of products contributes to inappropriate prescribing trends.

A. I and II only X

B. I, II and III only X

C. III and IV only

D. All of the above

96. According to Good Governance for Medicines (GGM) regarding the inspection of manufacturers
and issuing of manufacturer's license

A. the lead auditor is to be rotated.

B. passive behaviour should be adopted to avoid confrontation.

C. the power and influence of body language should be ignored.

D. the team leader should be able to easily influence team members. X

97. A pharmacist in a public hospital took 10 tablets of diazepam from the outpatient dispensary and
sold them to a patient for RM20.00. He then pocketed the money. The pharmacist has committed

A. theft

B. bribery

C. cheating

D. disgraceful conduct

For questions 98 - 100, please refer to the Malaysian National Medicines Policy (Dasar Ubat
Nasional, DUNas) 3rd Edition 2017-2021.

98. The following statements are TRUE regarding strategies to ensure provision of Safe and Quality
Use of Medicines:

I. Developing human capital, capacity and capability. -


a
partnership collaboration

II. Engaging media personnel on quality use of medicines. -

III. Strengthening of Antimicrobial Stewardship programme. -

IV. Enhanced community engagement to encourage safe and effective use of medicines by
consumers. -

A. I and III only Y

B. II and IV only X

C. II, III and IV only

D. All of the above

99. The following statements are TRUE regarding strategies to ensure adequate and equitable access
to quality medicines. page 14

I. Implementation of the Generic Medicines Policy. -

30
II. Continuous exemption of tariff and duties on all medicines.

III. Strengthening of pharmaceutical care practices in public health facilities.

IV. Rationalisation of medicines pricing system in the public and private sector.

A. I and II only

B. I, II and IV only

C. III and IV only

D. All of the above

100. The following statements are TRUE about Malaysian National Medicines Policy:

I. The policy focuses on 4 main components.

II. It is an official document that defines and prioritize goals of the country's pharmaceutical
sector.

III. It establishes framework and strategy plans for the implementation of pharmaceutical
initiatives in public and private sectors.

IV. The principal objective is to improve health outcomes of Malaysians by promoting equitable
access to essential medicines, promoting rational use of medicines and ensuring quality,
safety, effectiveness and affordability of medicines.

A. I and IV only

B. II and III only

C. II, III and IV

D. All of the above

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