Australia Releases Updated Drug Schedule

Regulatory NewsRegulatory News | 01 June 2015 |  By 

Australia has updated a legislative instrument designed to advise the country's states and territories on the scheduling and labeling of medicines and poisons.


In Australia, like in many other countries, medicines and other chemicals are classified in a schedule system. The schedule is organized by the level of regulatory control required for different substances based on their safety and use.

The legal basis for drug scheduling in Australia is found in paragraph 52(D) of The Therapeutic Goods Act 1989. Scheduled substances are listed in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), commonly known as The Poison Standard.

In SUSMP, "poisons" are defined broadly as "any substance or preparation scheduled." Accordingly, a wide range of substances are required to be scheduled, including pharmaceuticals, cosmetics, blood and blood components, pesticides and agricultural chemicals and recreational drugs.

The schedules increase in restrictiveness from Schedule 2 Pharmacy Medicines, which are generally considered safe and can be used without supervision or prescription, to Schedule 9 Prohibited Substances, which includes drugs such as marijuana and heroin that are restricted outside of permitted research.

A final schedule, referred to as Schedule 10/Appendix C contains substances that are prohibited for "sale, supply and use." This includes highly dangerous substances, as well as specific uses for substances also found in less restricted schedules.

Schedule 1 is not used and is intentionally left blank in the SUSMP text. Additionally, many substances are not scheduled, such as antacids or lubricating eye drops.

Updates to SUSMP

Periodically, SUSMP is updated to include additional recommendations made by the Therapeutic Goods Administration's (TGA) Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling.

The 7th edition of SUSMP came into effect on 1 June 2015 and "provide[s] a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling of poisons in Australia."

The new edition includes changes to the placement of existing chemicals as well as new entries for medicines. Some of the newly scheduled medicines include the psoriatic arthritis drug ampremilast as well as ombitasvir, paratipraver and dasabuvir, which are used in combination with ritonavir to treat hepatitis C.


TGA Press Release


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy