Poisons Standard (SUSMP): Medicines and Poisons Scheduling in Australia

The Poisons Standard / SUSMP

The Poisons Standard is also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). It is made by the Therapeutic Goods Administration under section 52D of the Therapeutic Goods Act 1989 (Cth). Therapeutic Goods Act sponsor obligations The Standard is a legislative instrument, and it is updated three times a year – in February, June, and October.

The Poisons Standard classifies medicines and poisons into Schedules. These Schedules reflect the level of regulatory control required for each substance.

While the Commonwealth creates the Standard, state and territory drugs, poisons and controlled substances legislation gives legal effect to its scheduling decisions.

Schedules 2 to 5

Schedules 2 to 5 cover medicines with varying levels of control. Schedule 2 contains pharmacy medicines, which are considered safe for use following self-medication advice from a pharmacist. Examples include low-strength ibuprofen, loratadine, and some proton pump inhibitors (PPIs). PBS pharmaceutical benefits scheme providers may dispense these medicines.

Schedule 3 lists pharmacist only medicines, requiring personal supervision and counsel from a pharmacist before supply. Substances in this schedule are available without a prescription, but require a pharmacist’s professional advice. Examples include salbutamol, low-dose orlistat, and previously, codeine combinations.

Schedules 4 and 5 represent medicines with stricter controls. Schedule 4 contains prescription only medicines, requiring a prescription from an authorised prescriber such as a medical, dental, optometrist, midwife or nurse practitioner. Schedule 5 lists substances of a hazardous nature, requiring caution in handling, use and storage, and often includes household chemicals. From 1 February 2018, all over-the-counter products containing codeine were moved to Schedule 4.

Schedules 6 to 9

Schedules 6 to 9 outline progressively more restricted substances based on their potential for harm. Schedule 6 substances are classified as poisons and carry a moderate potential for harm, necessitating strong warnings and appropriate safety packaging. Schedule 7 substances are designated as dangerous poisons, indicating a high potential for harm and requiring restricted availability to those with specialised knowledge.

Schedule 8 substances are controlled drugs. These are substances that should be available for therapeutic use, but require restrictions to minimise abuse, misuse, and the risk of physical or psychological dependence. Examples include morphine, fentanyl, methylphenidate, and alprazolam (since 2014).

Schedule 9 substances are prohibited substances, and their manufacture, possession, sale, or use is generally prohibited by law. Exceptions exist for medical or scientific research, or for analytical, teaching, or training purposes with approval. Notably, MDMA and psilocybin were reclassified to Schedule 8 from 1 July 2023 when prescribed by authorised psychiatrists for specific conditions; otherwise, they remain Schedule 9.

State enforcement and labelling

Each state and territory in Australia has its own legislation governing drugs, poisons, and controlled substances. Examples include the Poisons and Therapeutic Goods Act 1966 (NSW), the Drugs, Poisons and Controlled Substances Act 1981 (Vic), and the Medicines and Poisons Act 2019 (Qld). This legislation generally incorporates the Poisons Standard (SUSMP) and establishes offences related to the unauthorised supply, possession, or prescribing of scheduled substances.

State and territory authorities are responsible for enforcing these laws. Scheduling decisions are made following public consultation, involving the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS). The TGA Delegate considers factors such as risks and benefits, public health needs, and toxicity when making these decisions, as outlined in Section 52E.

Labels for scheduled substances must adhere to specific requirements outlined in Part 3 of the SUSMP. These requirements include the use of designated signal headings such as 'Caution', 'Poison', 'Dangerous Poison', and 'Keep out of reach of children'.