How Pharmacists Dispense Unapproved Medicines

Most medicines dispensed at Australian pharmacies are unapproved , and that's by design

Around 90 per cent of medicinal cannabis products dispensed in Australia are not listed on the Australian Register of Therapeutic Goods (ARTG). That number surprises a lot of people. It surprised me the first time I read it in a TGA access data summary a few years back, and I'd already spent considerable time buried in the Poisons Standard by then.

The short version is this: "unapproved" does not mean "illegal to supply." It means the product hasn't completed the full ARTG registration process. A parallel set of access pathways exists specifically so that prescribers and pharmacists can lawfully handle such products, and understanding those pathways matters if you want to understand how medicinal cannabis actually moves through the Australian healthcare system.

What "unapproved" actually means under the TGA framework

The Therapeutic Goods Act 1989 (Cth) governs what can be manufactured, supplied, and imported as a therapeutic good in Australia. Registration on the ARTG is the standard route to market , it involves evaluation of quality, safety, and efficacy data. Most pharmaceutical medicines you'd pick up at a pharmacy have been through this process.

Medicinal cannabis products, with a small number of exceptions, have not. Most arrive at the pharmacy via one of two TGA access pathways: the Special Access Scheme (SAS), specifically Category B notifications, or the Authorised Prescriber (AP) pathway. Both are lawful, regulated routes. They are not loopholes.

Under the SAS Category B pathway, a medical practitioner notifies the TGA each time they want to prescribe an unapproved product for a specific patient. Under the Authorised Prescriber pathway, a practitioner applies once for approval to prescribe a particular unapproved product to a class of patients without needing to notify the TGA for each individual. The TGA's own published access data shows AP approvals have grown substantially since the pathway was expanded in 2020.

The pharmacist's legal obligations before dispensing

Here's where it gets specific. A pharmacist cannot simply receive a script for an unapproved medicinal cannabis product and fill it without checking several things. The obligations stack up across federal and state/territory law simultaneously.

First, the schedule matters enormously. Products containing THC above certain thresholds are listed as Schedule 8 (Controlled Drugs) under the Poisons Standard. That triggers state and territory-level controlled drug requirements on top of the federal TGA framework , things like state health department permits, record-keeping registers, and in some jurisdictions, restrictions on quantity supplied per dispensing. CBD-predominant products below the Schedule 8 threshold typically sit at Schedule 4 (Prescription Only), which carries fewer procedural layers but is still prescription-only.

Second, the pharmacist must verify that the prescription has a valid TGA access approval behind it; either an SAS approval number or evidence the prescriber holds an Authorised Prescriber status for that specific product class. Without one of those, dispensing an unapproved medicine is not permitted.

Third, and this is the one that catches people out in practice: pharmacists must also comply with their state or territory's poisons legislation. The Poisons Standard sets the national scheduling framework, but each jurisdiction's own Act gives it legal force locally. A pharmacist in the ACT operates under the Medicines, Poisons and Therapeutic Goods Act 2008 (ACT). A pharmacist in Victoria operates under a different instrument. The obligations differ in detail even when the scheduling is identical nationally. I've spent enough late evenings cross-referencing these instruments that Trevor, my sourdough starter, has seen more of my kitchen bench than I have.

Good Manufacturing Practice and the supply chain

Before the product even reaches the pharmacist, it must have been manufactured to Good Manufacturing Practice (GMP) standards. The TGA requires this for unapproved products supplied via SAS or AP pathways. For imported medicinal cannabis products, the overseas manufacturer must hold a TGA-recognised GMP clearance or equivalent.

This is where the quality story sits. GMP compliance means testing, batch records, and documented processes; which means that a product reaching a pharmacy counter has at least passed that quality gate, even if it hasn't gone through full ARTG evaluation. It's not a substitute for registration, but it does mean the supply chain has a regulated floor.

Products also need to be stored appropriately. Schedule 8 products require secure storage under controlled drug regulations. Pharmacists bear that responsibility from the moment product arrives in their dispensary.

What the pharmacist does at the point of dispensing

Once everything checks out, valid script, verified access approval, appropriate scheduling, correct storage, the pharmacist can dispense. But a few more steps apply before the product leaves the counter.

Labelling requirements under the TGA's unapproved medicines framework still apply. The product must be labelled appropriately for the specific patient. For Schedule 8 products, the dispensing must be recorded in the state-controlled drug register. Some jurisdictions require real-time reporting into a state-managed database; the ACT's SafeScript system, for instance, applies to Schedule 8 medicines.

Counselling obligations also apply. Under the Pharmacy Board of Australia's guidelines and the relevant professional codes, a pharmacist has a duty to provide appropriate advice to the patient at the point of dispensing. That doesn't translate to therapeutic promises, it means explaining how the product is to be used as prescribed, storage requirements, and what to do if there's a concern. The professional obligations here are the same as for any controlled medicine.

Where the system gets complicated: product variability

I'll be direct about something that gets papered over in a lot of explainers: the unapproved pathway, by definition, means pharmacists are sometimes handling products that differ meaningfully between batches, between manufacturers, or even between formulations that share a common name. Full ARTG registration requires demonstrated consistency. SAS and AP products do not face the same evidentiary bar.

This creates real complexity for pharmacists doing product substitution if a prescribed product is unavailable. Unlike registered generics, where bioequivalence data exists, substituting one unapproved medicinal cannabis product for another is not straightforward. The bioavailability profiles can differ depending on formulation type, carrier oils, and whether the product is full-spectrum, broad-spectrum, or an isolate. The first-pass metabolism of oral cannabis products, worth reading about at First-Pass Metabolism; adds further variability.

In my view, this is the part of the current framework that most needs attention as the sector matures. The TGA has acknowledged it; the pathway for more products to achieve full registration exists, and the incentives for manufacturers to pursue it are growing. But right now, pharmacists bear a disproportionate amount of the product-knowledge burden in a category where the regulatory floor is lower than many people realise.

The role of the prescriber-pharmacist relationship

In practice, the system works because of communication between prescribers and dispensing pharmacists that goes beyond what the paperwork alone requires. Prescribers holding AP status tend to build working relationships with specific compounding or dispensing pharmacies that have built expertise in the product category. This isn't formalised in the legislation, it's emergent practice.

The TGA's published guidance for pharmacists handling unapproved medicines runs to several pages and is worth reading directly if you want the unfiltered version. The document "Access to unapproved therapeutic goods, guidance for consumers" and the corresponding guidance for health professionals are both available at tga.gov.au. The legislation itself; the Therapeutic Goods Act 1989, is the primary instrument.

What the framework demonstrates, taken as a whole, is that Australia chose to build lawful access pathways rather than leave patients and practitioners in a grey zone. Whether the architecture is optimal is a fair question. But the scaffolding is real, it is regularly updated, and the pharmacists working within it are carrying out a regulated professional function, not an informal one.

Sources

• Access to medicinal cannabis products; Therapeutic Goods Administration (TGA)
• Therapeutic Goods Act 1989 (Cth), Federal Register of Legislation
• Poisons Standard (SUSMP), Therapeutic Goods Administration (TGA)
• Guidance on the Special Access Scheme; Therapeutic Goods Administration (TGA)

, Marcus Hale, Regulatory researcher, TGA & access law