Published and maintained by the Therapeutic Goods Administration (TGA), the Poisons Standard has legal force as a legislative instrument under the Therapeutic Goods Act 1989 (Cth). It is not itself an Act of Parliament, but Commonwealth, state, and territory medicines and poisons legislation adopts its scheduling decisions, giving those decisions practical legal effect throughout Australia.
Substances are assigned to one of ten schedules (Schedule 1 through Schedule 10, though Schedule 1 is currently empty) based on assessments of toxicity, potential for misuse, and the degree of oversight needed at the point of supply. Schedule 2 covers pharmacy medicines; Schedule 4 covers prescription-only medicines; Schedule 8 covers controlled drugs (such as opioids and certain cannabinoids); and Schedule 9 designates prohibited substances , those with very high potential for misuse and no currently accepted therapeutic use at the general population level, except under specific research or regulatory exemptions. Schedule 10 lists substances considered so hazardous that no legitimate use justifies their supply.
The Poisons Standard is a living document, reviewed on an ongoing basis. Scheduling proposals may be initiated by the TGA itself, by an applicant (such as a pharmaceutical sponsor), or by the Secretary of the Department of Health and Aged Care. The independent Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) advise on decisions. Amendments are registered on the Federal Register of Legislation and take effect on the date specified in each amending instrument.
For practitioners, researchers, pharmacists, and consumers, the current version of the Poisons Standard is the primary reference for determining whether a substance is prescription-only, controlled, prohibited, or available over the counter , and under what conditions. Schedules can change; consulting the current version of the instrument (not a secondary summary) is standard professional practice.
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