Scheduling of medicines and poisons
Key facts
- Medicines, chemicals and poisons in Australia are classified in a system known as 'scheduling,' which determines how freely available they are to the public.
- Scheduling is based on factors such as safety, potential misuse and where the product can be bought.
- Medicines with lower safety risks are usually less tightly controlled and may be available at supermarkets or pharmacies without a prescription.
- Higher-risk medicines may only be available with a prescription from your doctor to make sure they are safely used.
- The Poisons Standard (SUSMP) outlines the classification and regulations for all scheduled substances in Australia.
What is the schedule?
In Australia, medicines and chemicals are arranged into a schedule system. This schedule classifies them into categories based on how available they are to the public. There are 10 categories in the schedule.
When a medicine is first approved in Australia, the Therapeutic Goods Administration (TGA) will decide how it should be made available. For example:
- by prescription
- in pharmacies only
- at supermarkets
The 'Poisons Standard' is where the schedules are published. It is also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). This is a legal document that applies throughout Australia. It makes sure substances are controlled and accessible in a consistent way.
Why is the schedule important?
The schedule is designed to protect public health and safety. It makes sure that medicines and chemical substances are used safely and in a controlled way. Some medicines have a higher risk of causing harm than others. Also, some medicines are more likely to be misused, such as medicines that can lead to dependence or addiction.
When deciding how to schedule a medicine or chemical, the TGA considers things such as:
- the safety of the medicine
- the severity of the condition the medicine is meant to treat
- potential side effects
- effects if taken by accident
- effects of an overdose
- benefits or risks of making it easily accessible
Scheduling is a way of sorting out which medicines or poisons need to be tightly controlled and which don't. Some poisons are so dangerous that they are not allowed to be used at all.
What information is in the schedule?
The schedule has information about where a medicine or chemical can be bought and if a prescription is needed.
Each category has different rules for how a medicine or poison should be:
- labelled
- sold
- bought
- advertised
- stored (type of container or preparation)
- thrown away
The schedule also includes requirements for packaging and labelling of the product, which may include:
- warning statements
- directions for use
- the manufacturer's contact information
FIND A HEALTH SERVICE — The Service Finder can help you find doctors, pharmacies, hospitals and other health services.
How is the schedule classified?
Medicines and chemicals are grouped into 10 categories ('schedules') based on how much control is needed to keep you safe. These schedules decide how medicines and chemicals are made available to the public.
- The size of the medicine package affects its classification. Smaller packages of non-prescription medicines may be sold in a supermarket. Larger packages or higher doses are only sold in pharmacies. For example, mild pain relief medicines, such as paracetamol are classified as Schedule 2 when sold in packets of 20 tablets or less. Larger packets are classified as Schedule 3 and only a pharmacist may sell them.
- A combination of medicines can also change its schedule. For example, ibuprofen in Nurofen Double Strength Quickzorb is Schedule 2 (when sold in packets of 12 or fewer tablets). Nurofen Plus, which combines ibuprofen and codeine, is classified as Schedule 4.
- The form of the medicine can also influence its scheduling. For example, salbutamol (Ventolin) is classified as Schedule 3 when used as an inhaler. The nebuliser solution is classified as Schedule 4.
The Poisons Standard lists all medicines or poisons available in Australia and their classification schedule. The Australian Department of Health decides the proper schedule for each medicine or poison. However, it is up to each state and territory to legislate the scheduling of medicines in their area. This means that there may be slight differences in how certain medicines are regulated across states.
The schedule categories
Here is a breakdown of the 10 schedules:
|
Schedule 1 |
Currently not in use. |
|
Schedule 2 |
Pharmacy medicine — medicines that are available on pharmacy shelves or from a licensed person. A pharmacist or pharmacy assistant must be available to provide advice if needed. Examples include smaller packages of paracetamol and ibuprofen. |
|
Schedule 3 |
Pharmacist-only medicine — medicines that are available from a pharmacist without a prescription. These medicines are kept behind the counter at a pharmacy and need professional advice. Examples include larger packages of paracetamol and ibuprofen. |
|
Schedule 4 |
Prescription-only medicine — medicines that must be prescribed by an authorised healthcare professional, such as your doctor. They can be provided in hospitals or bought from a pharmacy with a prescription. Examples include tramadol, codeine-containing medicines and most benzodiazepines. |
|
Schedule 5 |
Caution — chemicals that are not likely to cause harm. They must have suitable packaging with simple warnings and safety directions on the label. Examples include bleach, kerosene and methylated spirits. |
|
Schedule 6 |
Poison — chemicals with a moderate risk of causing harm. They need special packaging with strong warnings and safety directions on the label. Examples include certain agricultural poisons. |
|
Schedule 7 |
Dangerous poison — chemicals with a high risk of harm, even in low doses. Strict rules may apply to their manufacture, sale, storage and use. An example is chlorine. |
|
Schedule 8 |
Controlled drug — medicines or chemicals with special rules to reduce the risk of misuse or dependence. Rules apply to how they are produced, supplied, sold, owned and used. These may only be prescribed by an authorised healthcare professional, who may need a special prescribing permit. Examples include medicines, such as morphine, fentanyl and oxycodone. |
|
Schedule 9 |
Prohibited substance — chemicals that may be abused or misused. They are illegal to produce, own, sell or use unless approved for medical or scientific research. This includes many illegal drugs. |
|
Schedule 10 |
Chemicals that are so dangerous they are completely banned from use. |
Some schedule 4 medicines have extra requirements for their prescriptions. While these medicines are considered safe, they have a risk of dependence and misuse. As a result, there are special rules to control their availability. These include medicines, such as:
- anabolic steroids
- benzodiazepines
- barbiturates
Not all medicines are scheduled. These are classified as 'unscheduled' and can be sold in supermarkets, grocery stores, health food stores and pharmacies. They often have labels with safety instructions.
ASK YOUR DOCTOR — Preparing for an appointment? Use the Question Builder for general tips on what to ask your GP or specialist.
Resources and support
- Therapeutic Goods Administration(TGA) provides more information about scheduling.
- You can check the scheduling of your medicine on the TGA's Product and Consumer Medicine Information page.
- Visit medsinfo for more information about your medicine.
- Call 1300 Medicine (1300 633 424) to speak with a registered pharmacist about your medicines.
You can also call the healthdirect helpline on 1800 022 222 (known as NURSE-ON-CALL in Victoria). A registered nurse is available 24 hours a day, 7 days a week.
Do you prefer to read in languages other than English?
- The Translating and Interpreting Service (TIS National) offers support for people who have limited or no English proficiency.
Learn more here about the development and quality assurance of healthdirect content.
Last reviewed: November 2024
