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Animal Research S4 and S8 Drug Use Guidelines

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Section 1 - Introduction

(1) The use of restricted substances (Schedule 4 “S4" drugs) and drugs of addiction (Schedule 8 "S8" drugs) in animals used for research and teaching purposes is controlled under the following legislation:

  1. Animal Research Act 1985 No 123
  2. Poisons and Therapeutic Goods Act 1966 No 31
  3. Poisons and Therapeutic Goods Regulation 2008
  4. Drug Misuse and Trafficking Act 1985

(2) Additionally, the Animal Research Review Panel, the statutory body under the Animal Research Act, has issued the following policy: The use of restricted drugs and the conduct of restricted acts of veterinary science in animal research (ARRP policy 14, revised 27 February 2014).

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Section 2 - S4 Drugs

(3) Researchers can use S4 drugs (“restricted substances”) for animals in approved projects provided that:

  1. the Animal Care and Ethics Committee has approved the use of the drug in that project;
  2. the drug is ordered in accordance with the provisions of the Poisons and Therapeutic Goods Regulation 2008 from the holder of a wholesaler’s licence or wholesaler’s authority. Such an order must be in writing and include the name of the Chief Investigator and the Animal Ethics Approval Number; and
  3. additional guidelines established by the Animal Research Review Panel (ARRP Policy on the Use of Restricted Drugs in Animal Research) are followed.
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Section 3 - S8 Drugs

(4) Researchers can use S8 drugs (“drugs of addiction”) for animals in approved projects provided that:

  1. the Animal Care and Ethics Committee has approved the use of the drug in that project;
  2. a NSW Health “Application for Authority to Possess or Supply Schedule 8 or Schedule 9 Substances, Prohibited Drugs/Plants for the Purpose of Research, Instruction, Analysis or Treatment of Animals” has been completed and approved;
  3. the drug is ordered from the holder of a wholesaler’s licence or wholesaler’s authority. Such an order must be in writing and include:
    1. the name of the Chief Investigator;
    2. the Animal Ethics Approval Number; and
    3. the NSW Health authority number. The initial order should be accompanied by a copy of the authority from NSW Health.
  4. the drug is handled and held as required by the New South Wales Poisons and Therapeutic Goods Act 1966, and its Regulation 2008; and
  5. additional guidelines established by the Animal Research Review Panel (ARRP Policy on the Use of Restricted Drugs in Animal Research) are followed.