A clinical trial drug which is not registered or listed on the Australian Register of
Therapeutic Goods must be labeled, stored, prescribed and administered either: –
a) Where the substance or a similar substance is currently included in the NSW Poisons
List (or is exempt from the NSW Poisons List), in accordance with that Schedule (or
exemption), or,
b) Where there is no similar substance on the NSW Poisons List, as a Schedule 4
substance.