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Scheduling of medicines and poisons

12-minute read

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:

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:

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:

The schedule also includes requirements for packaging and labelling of the product, which may include:

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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 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:

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.

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Resources and support

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.

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