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Introduction to Pharmaceutical Legistration

In the realm of pharmaceutical legislation, the classification and regulation of poisons play a pivotal role in ensuring public safety and proper medical practice. Poisons are categorized into several groups, each with specific restrictions on their sale and distribution.

Introduction to Pharmaceutical Legistration

Introduction to Pharmaceutical Legistration

The prescription must have

specify the number of times (not exceeding three) the psychotropic substance may be supplied at what intervals
total amount of psychotropic substance to be supplied and dose
Age,full name and address of the patient
full name,address and no tel of the prescriber
written,signed and dated by the prescriber itself

Psychotropic Substance can only be supplied or sold by:

A pharmacist working in Government hospital/clinic/dispensary
A licensed pharmacist upon a prescription prescribed by medical practitioner/dentist/veterinary surgeon
A regitered medical practitioner/dentist/veterinary surgeon for the purpose of treatment only

Part 1 Poison

NP-Non-scheduled poisons Non-scheduled poisons or over the counter products for retail sale
P2-Part ii Poisons retail sale restricted to Poison License Holder,Labelling requirements only
Group D Can only be sold as a dispensed medicine with an entry in the Poisons Book
Group C Can only be as a dispensed medicine with entry in the Prescription Book
Group B Can be dispensed only against prescription of a Registered Medical Practitioner,Dentist or Veterinary Surgeon as the case may be and with the prescription in the correct form as required by the law
Group A Can only be sold by a licensed wholesaler to a another licensed wholesaler or by a licensed wholesaler to be immediately exported to a purchaser outside Malaysia

Poison Regulations Involved Are

forms and fees for recording and documentation
regulations for hospitals & institutions realting of poisons handling
labeling of poison
Transport of poison
storage of Poison
Importation of Poison

The act that directly relate to pharmacy practice

Dangerous Drugs Act 1952
Poison List

Legistrations in Pharmacy practce

Sale of Drugs Act 1952
medicines (Advertisement and Sales)Act
Poison Act 1952-poison list
Registration of Pharmacy Act 1951

Pharmacy Law

advertisements relating to products,medical skills and services
practice of pharmacists
Importation,manufacturing,sale and use of poisons and products

Legistration

Advertisements Act (Medicines 1956)
Control of Drugs & Cosmeyics Regulation 1984
Poison Regulations
sales of Drug Act 1952
Poison Act 1952