Therapeutic Goods Regulations 2022

In this regulation – container, when used in relation to any therapeutic substance, means any vessel, bottle, tube, capsule, tin, box, case, wrapper, cover or other like receptacle or envelope that immediately contains the substance;Poisons List has the same meaning as in the Poisons Act 1971; therapeutic substance means a substance supplied for therapeutic use; therapeutic use has the same meaning as in the Commonwealth Act; unscheduled therapeutic substance means a therapeutic substance that is not specified in any of the Schedules to the Poisons List.

A person specified in item 1, 2 or 4 of Schedule 8 to the Therapeutic Goods Regulations 1990 of the Commonwealth must not supply an unscheduled therapeutic substance for therapeutic use unless the person complies with the standards constituted by the following orders made under section 10 of the Therapeutic Goods Act 1989 of the Commonwealth:Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines;Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines. Fine not exceeding 20 penalty units.

The label on a container containing a therapeutic substance must show the following details:the words "KEEP OUT OF REACH OF CHILDREN" in red on a white background; if the substance is intended for external use only, the word "POISON", or the words "FOR EXTERNAL USE ONLY", in red on a white background; if the substance is intended for the treatment of a person, the name of the person; if the substance is intended for the treatment of an animal, the species of animal and the name of the animal's owner.

In addition to the requirements of subregulation (3), the label on a container containing a therapeutic substance that is supplied on prescription must show the following details:the directions for use; the prescription reference number; the date on which the prescription was supplied, unless that date is clear from the prescription reference number.

The provisions of subregulations (3) and (4) are complied with if the information referred to in those subregulations is shown by tags, brands or marks, or statements printed or in clear writing on the container.