Pharmaceutical Jurisprudence Exam Notes

Section A: Multiple Choice Questions

  • Question 1: Which drug requires a prescription?

    • Tab Amlodipine 10mg requires a prescription.

  • Question 2: Based on the DDA 1952, which activity relates to "manufacture"?

    • Placing.

  • Question 3: Under the Poison Act 1952, what's the prohibited age for selling poison?

    • The sale of poison is prohibited for persons under the age of 18.

  • Question 4: According to the Control of Drugs and Cosmetics Regulations 1984, what item is prohibited in traditional medicine?

    • Traditional medicine prohibits L-Carnitine.

  • Question 5: What is the role of a quality control department in a manufacturing company?

    • Control all materials used.

  • Question 6: Who appoints inspectors under the Sale of Drugs Act 1952?

    • The Minister of Health appoints inspectors.

  • Question 7: Which drug belongs to the group of psychotropic substances?

    • Haloperidol.

  • Question 8: Who can prescribe any psychotropic substances?

    • Medical practitioners can prescribe any psychotropic substances.

  • Question 9: Which pharmaceutical product is regulated under the Poisons Act 1952 as a precursor chemical for illicit drug use?

    • Pseudoephedrine.

  • Question 10: What's the correct procedure for sampling under the Sale of Drug Act 1952?

    • The officer does not need to inform the seller that the sample is to be analysed.

  • Question 11: Under which Act/Regulation can a person be charged for possessing a product labelled with an unregistered name?

    • Control of Drugs and Cosmetic Regulations 1984 allow the person to be charged for possessing a product labelled with an unregistered name.

  • Question 12: What action is required if a few pieces of cosmetics are imported to assess market acceptance before notification?

    • Get written approval with or without condition issued by the Director of Regulatory Pharmacy, National Pharmaceutical Regulatory Agency (NPRA).

  • Question 13: Medicines Advertisement Board member(s).

    • Pharmacologist appointed by the minister.

  • Question 14: Which substance(s) are found in the First Schedule of the DDA 1952?

    • Raw opium and coca leaves.

  • Question 15: Based on Poisons Regulation 1952, how should poisons be stored?

    • In an unbroken package and in a locked cupboard.

  • Question 16: Authorized people to possess the substances under the Poisons (Psychotropic Substances) Regulations 1989.

    • Pharmacist, Customs officer, Medical practitioner.

  • Question 17: Types of business registration available under Companies Commission of Malaysia.

    • Franchise, Partnership, Wholesale.

  • Question 18: Objectives of Drug Control Authority (DCA).

    • Make policies, registration of products, issuance of notification note for cosmetics.

  • Question 19: Ethical practices considered universal when carrying out one's job.

    • Trustworthiness.

Section B: Short Answer Questions

  • Question 1: Functions of Centre of Compliance and Quality Control, NPRA.

    • Two functions of the Centre of Compliance and Quality Control, NPRA need to indicated.

  • Question 2: Examples of Group C class of drugs.

    • Four examples of Group C class of drugs need to indicated.

  • Question 3: The interpretation included in the Sale of Drugs Act 1952.

    • Two purposes included in the interpretation of the Sale of Drugs Act 1952 need to described.

  • Question 4: Issuance of Licence.

    • Issuance of licence need to explained.

  • Question 5: The term Bill used in the law terminology.

    • The term Bill need to described.

  • Question 6: Items that will be recorded in the Register of products.

    • Two items that will be recorded in the Register of products need to indicated.

  • Question 7: Kinds of gratifications that can be linked to corruption.

    • Four kinds of gratifications that can be linked to corruption need to indicated.

  • Question 8: The term advertisement as interpreted in the Medicines (Advertisement And Sale) Act 1956.

    • The term advertisement needs to be explained as interpreted in the Medicines (Advertisement And Sale) Act 1956.

  • Question 9: Prohibited diseases listed in Schedule (Section 3) of an unspecified act.

    • Four types of prohibited diseases need to be explained listed in Schedule (Section 3).

  • Question 10: Purpose of Industrial Co-ordination Act 1975.

    • The purpose of the Industrial Co-ordination Act 1975 need to described.

Section C: Modified Essay Questions

  • Question 1 (a): Challenges faced by NPRA.

    • Describe three challenges faced by NPRA in fulfilling its function and objectives.

  • Question 1 (b): Objectives of Asean Harmonized Cosmetic Regulatory Scheme.

    • Write two objectives of Asean Harmonized Cosmetic Regulatory Scheme.

  • Question 1 (c): Reasons for cosmetics sale and distribution to be controlled and regulated.

    • Explain four reasons for cosmetics sale and distribution to be controlled and regulated.

  • Question 2 (a): Procedures to import poisons by post under the Poisons Act 1952.

    • Describe the procedures to import poisons by post under the Poisons Act 1952.

  • Question 2 (b): Requirements of a prescription containing psychotropic substances.

    • Write four important requirements needed of a prescription containing psychotropic substances.

  • Question 2 (c): Form of control of narcotic drugs through The Single Convention of Narcotic Drugs 1961.

    • Describe the form of control of narcotic drugs through this convention.

  • Question 3 (a): The power of officers and inspectors to enter a premise based on the Sale of Drugs Act 1952.

    • Explain the power of officers and inspectors to enter a premise.

  • Question 3 (b): Prohibition of advertisements relating to certain diseases as controlled by the Medicines (Advertisement And Sale) Act 1956.

    • Discuss with examples the prohibition of advertisements relating to certain diseases.

  • Question 4 (a): Types of products that are to be manufactured, sold, supplied, imported, in relference possession and administered under The Control of Drugs And Cosmetics Regulations 1984.

    • Explain the five types of products.

  • Question 4 (b): Important points on the proceeding of the Medicine Advertisements Board.

    • Describe five important points.