Medicines are regulated to ensure their safety, effectiveness and quality.
The Commonwealth’s Therapeutic Goods Administration (TGA) regulates medicines and therapeutic goods in Australia. For more information see How therapeutic goods are regulated in Australia.
Additionally, each state or territory has its own laws that determine where consumers can buy a particular medicine. The NSW Ministry of Health Pharmaceutical Services is responsible for administering the laws that govern access to medicines and poisons.
The differences in law that exist across Australia today are historical. Before Federation, each of the colonies (which would later become the states) had its own laws governing medicines, poisons and the practice of pharmacy. When the Constitution of Australia came into effect in 1901, the Commonwealth was given limited powers regarding medicine control, with most power remaining with the states.
Currently, the Commonwealth controls the subsidisation of the cost of medicines, the registration of products and manufacturers, and the import and export of medicines. Meanwhile, the states and territories control other aspects of access to medicines and poisons. While differences still exist, significant effort has been made over the last 50 years to align the medicines and poisons laws across the states and territories.
In Australia, medicines and poisons are classified into Schedules that regulate how medicines and posions are made available and how they are distributed. The scheduling system categorises medicines and poisons based on their potential for harm, their therapeutic use, and the level of control needed to ensure public health and safety. More information can be found on the TGA’s website at Scheduling basics of medicines and chemicals in Australia.
Prescription medicines are categorised into either Schedule 4 or Schedule 8.
Medicines classified under “Schedule 8” are also known as “controlled drugs” or “drugs of addiction” and have strict legislative controls. Examples of these medicines include:
You can find other examples on the Schedule 8 medicines webpage.
Schedule 8 medicines are prescription medicines that have a recognised therapeutic need but also a high risk of misuse, abuse, and dependence. In some circumstances, the doctor will need to get an approval or permission to prescribe or supply these medicines. For more information see Approval requirements for certain medicines.
Consumers should be aware of these legal issues when receiving treatment with these medicines.
It is a legal requirement for a pharmacist to keep repeat prescriptions for certain medicines at the pharmacy where the original prescription was dispensed.
The medicines that this applies to are those listed in Schedule 8 medicines and Schedule 4 Appendix B drugs - Special restricted substances.
In these cases, the pharmacist cannot give back the repeat prescription to take elsewhere when a future supply is needed.
If you are travelling, or cannot get back to this pharmacy for a resupply you can either: