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NSW Government
Animal Ethics Infolink
A NSW DPIRD and Animal Research Review Panel initiative

The use of scheduled substances in animal research

Animal Research Review Panel Policy 14
Revised 27 June 2025
D25/4046

Introduction

This guideline aims to assist researchers, establishments and animal ethics committees (AECs) on the use of scheduled substances in animal research. The following NSW legislation is applicable to this guideline:

  • Animal Research Act 1985
  • Medicines, Poisons and Therapeutic Goods Act 2022
  • Poisons and Therapeutic Goods Regulation 2008 / Poisons and Therapeutic Goods Act 1966

Use of scheduled substances

Scheduled substances are classified under the Poisons and Therapeutic Goods Act 1966 into schedules based on potential risks and regulatory controls.
The use of scheduled substances for the purpose of animal research must be approved by the AEC as part of a research project. The provisions of the Poisons and Therapeutic Goods Act 1966 and the Medicines, Poisons and Therapeutic Goods Act 2022 must be complied with in all aspects of the use of any restricted drug, including for ordering, supply, handling and storage. Further information on scheduled substances can be found here.

Only scientifically qualified persons in charge of a laboratory or department, or those under their direct personal supervision, are authorised to possess or use Schedule 2, 3 or 4 substances for research or instructional purposes. The prescribing of scheduled substances for animals is restricted to registered veterinarians, who may prescribe to safeguard animal welfare based on clinical judgement, even if this deviates from the AEC-approved protocol. In these circumstances, researchers must advise the AEC of the event.
Schedule 8 and 9 substances require additional authorisations from NSW Health. Researchers and establishments should contact NSW Health for further information on the authorisations required, to ensure their compliance with the Poisons and Therapeutic Goods Act 1966.

Pentobarbitone Sodium

The use of pentobarbitone sodium in an animal research project must be approved by the AEC as per any scheduled substance (see previous section). However, there are additional regulatory requirements for secure storage and record-keeping for pentobarbitone sodium under section 65 of the Poisons and Therapeutic Goods Regulation 2008. Researchers and establishments should contact NSW Health for further information, to ensure their compliance with the Poisons and Therapeutic Goods Act 1966.