State vs Federal Drug Regulation in Australia

Two systems, one plant , and a lot of confusion in between

Somewhere around my third year reading the Poisons Standard for a living, I started keeping a small tally of the questions I got asked most often. Near the top, every single time: "But wait , is cannabis legal or not?" The honest answer is: it depends which layer of the system you're asking about, and those layers don't always line up neatly.

Australia runs a genuinely dual regulatory architecture when it comes to drugs. The Commonwealth sets the scheduling framework. States and territories write their own criminal law, their own possession offences, and , in some cases; their own parallel licensing regimes. For most substances that overlap is academic. For cannabis, it produces real, practical confusion for patients, clinicians, and anyone trying to read a news headline.

Let me try to unpick it properly.

What the federal government actually controls

The Therapeutic Goods Administration, sitting inside the Department of Health and Aged Care, administers the Therapeutic Goods Act 1989 (Cth). That Act gives the Commonwealth authority over what medicinal products can be supplied, imported, manufactured, and accessed in Australia. The scheduling classification of substances lives inside the Poisons Standard, formally titled the Current Poisons Standard under Section 52D of the Act, which is a legislative instrument updated periodically by the Secretary of the Department.

The Poisons Standard is where you find Schedule 4 (Prescription Only) and Schedule 8 (Controlled Drug) classifications, both of which are relevant to cannabis. Since February 2021, low-dose cannabidiol (CBD) products meeting specific criteria were down-scheduled to Schedule 3 (pharmacist-only), though in practice very few products have met all the criteria for that pathway and reached pharmacy shelves. Products containing tetrahydrocannabinol (THC) above trace thresholds sit in Schedule 8; a controlled drug, meaning tight record-keeping, state-specific permits, and prescriber authority requirements on top of federal access rules.

The TGA's access pathways for unapproved medicines, the Special Access Scheme (SAS) and the Authorised Prescriber (AP) scheme, are federal constructs. A product accessed via SAS Category B or through an AP approval is accessed lawfully under Commonwealth law. But that federal approval does not, by itself, remove state criminal exposure. That's where the split begins.

What states and territories actually control

Drug offences in Australia; possession, trafficking, supply, are overwhelmingly state and territory matters. Each jurisdiction has its own Drugs of Dependence Act, Controlled Substances Act, or equivalent, with its own schedules mirroring (but not identical to) the federal Poisons Standard. States reference the Poisons Standard but they are not bound to adopt every change automatically or uniformly.

This is not a theoretical problem. Take Schedule 8 cannabis. A TGA-approved SAS or AP prescription is a federal instrument. But whether a patient lawfully holding that prescription is protected from state possession law depends on whether the relevant state legislation recognises the federal access pathway and provides a corresponding exemption. In most Australian states that protection now exists in practice, but the mechanisms differ. Some states require a separate state permit for Schedule 8 substances regardless of federal approval. Queensland, for instance, historically required its own Health Department permit on top of an SAS approval, a fact that caught out more than a few prescribers in the early years of the medicinal cannabis framework.

ACT went further than any state in the other direction: in 2020 it decriminalised personal possession of small quantities of illicit drugs under the Drug Strategy Act 2020 and subsequent amendment, a decision entirely within territory legislative competence and one the Commonwealth has no power to override.

South Australia, meanwhile, has historically operated the Cannabis Expiation Notice scheme since 1987; one of Australia's longest-running diversion models, treating minor personal cannabis possession as an expiation (fine) rather than a criminal matter. The fine isn't trivial, but the criminal record implication is different from other states.

The short version: the Commonwealth tells you what a product is and how it may be prescribed. The state tells you what happens to you if you're holding it without the right paperwork.

The ARTG, GMP, and why product approval is a separate question again

There's a third layer people often conflate with scheduling: registration on the Australian Register of Therapeutic Goods (ARTG). A product on the ARTG has passed a full TGA evaluation for quality, safety and efficacy. Most medicinal cannabis products in Australia are not on the ARTG, they are accessed as unapproved therapeutic goods via SAS or AP pathways, which means they bypass full registration but must still meet Good Manufacturing Practice (GMP) manufacturing standards.

I'll admit I got this wrong for years in early briefings: assuming "TGA approval" meant ARTG registration. It often doesn't. The SAS is explicitly designed for unapproved goods. The onus of responsibility for clinical appropriateness sits with the prescribing doctor, not with a prior TGA efficacy assessment.

Industrial hemp: the agricultural wild card

There's a fourth thread running under all of this, and it's mostly missed in policy discussions: industrial hemp.

Hemp cultivation for fibre, seed, and low-THC purposes is licensed at the state level under agricultural legislation; not the Poisons Standard, because hemp (defined by THC content below 1% in most Australian states) falls outside the scheduling framework altogether when grown under licence. Victoria, New South Wales, Queensland and others have their own Hemp Industries Acts or equivalent provisions. The Commonwealth's role here is minimal.

But hemp-derived CBD extract from those crops? Back inside the federal system the moment it's processed for human consumption. This boundary, between raw agricultural product and therapeutic good; is where a notable amount of regulatory grey has developed over the last five years, particularly as food-grade hemp seed products (which are legal) blurred into CBD-adjacent marketing territory.

State cannabis licensing schemes: a separate beast

The Office of Drug Control (ODC), a division of the Department of Health, administers the federal licensing framework under the Narcotic Drugs Act 1967 (Cth) for cannabis cultivation and manufacture. This is distinct from both the TGA's access framework and from state law. A cultivator needs an ODC licence to grow legally; they also need to satisfy state land-use and agricultural laws in the jurisdiction where their grow site sits.

The interaction between the ODC regime and state agriculture departments has been a genuine friction point, particularly for smaller producers who found themselves completing two parallel licence processes with overlapping but non-identical requirements. An industry submission to a 2023 Senate committee inquiry noted the duplication plainly; the ODC has since taken some steps toward clearer guidance, but the structural dual-licensing reality hasn't changed.

I spent most of last Saturday cross-referencing the ODC's current licence register against updated state compliance guidance. Not exactly how I planned to spend the afternoon, Trevor (my sourdough starter) sat neglected on the bench, but the variation between jurisdictions is genuinely significant if you're trying to map the full chain from seed to patient.

Why this split matters for patients and clinicians

Practically, the dual system creates compliance obligations that don't always flow intuitively from federal approval alone. A clinician in Western Australia prescribing a Schedule 8 product via the AP pathway still needs to hold; or apply for, the relevant state S8 prescribing authorisation, and their patient may need a corresponding state permit. In Victoria the process has been further integrated. In other states the requirements are still materially distinct steps.

For patients, the upshot is that "my doctor says it's legal" and "the TGA says I can access it" are necessary but not always sufficient descriptions of the full regulatory picture. The state layer is real. It matters. And, my measured view here; it is frankly harder to navigate than it needs to be, particularly for patients in regional areas where prescriber access is already limited.

Understanding what the scheduling classifications actually mean is a foundation piece. The distinction between Schedule 4 and Schedule 8 products, CBD-dominant versus THC-containing formulations, shapes which access pathway applies, what documentation a prescriber needs, and what state-level obligations follow.

The system is not broken so much as it is the product of constitutional architecture that was never designed with medicinal cannabis in mind. Section 109 of the Constitution means Commonwealth law prevails over inconsistent state law; but where state law adds requirements rather than contradicting them, those requirements stand. Dual compliance is the result.

Sources

• Medicinal cannabis: About, Therapeutic Goods Administration (TGA)
• Poisons Standard (Current), Federal Register of Legislation
• Licences and permits; Office of Drug Control (ODC)
• Cannabis, Alcohol and Drug Foundation (ADF)

, Marcus Hale, Regulatory researcher, TGA & access law