From 5 November 2026, the Poisons and Therapeutic Goods Act and Regulation will be replaced by the:
The new Act and Regulation support safe, modern healthcare practices and business operations. These laws set clear rules to control the supply of scheduled substances and therapeutic goods in NSW, with the primary goal of protecting public health and safety.
This fact sheet outlines key legislative changes relevant to medical practitioners.
This is an increase from the previous period of 6 months. Schedule 4D medicines include those that are anabolic-androgenic steroidal medicines.
The new Act and Regulation still require you to apply for an approval from the NSW Health to prescribe, issue a direction to supply or administer some medicines in certain situations.
More exemptions now apply to the requirement for an approval. These have been broadened to recognise specialist expertise and the specific circumstances of certain patients, for example, when prescribing, supplying, or administering a medicine for palliative treatment. See full list of exemptions.
The Act and Regulation strengthen controls to mitigate the increased risks associated with high-dose opioid prescribing and supply.
An approval is now required to prescribe, supply, or administer morphine, oxycodone, fentanyl, or hydromorphone, used individually or in combination, in a total daily dose exceeding 100mg oMEDD (oral Morphine Equivalent Daily Dose).
Some exemptions apply and include prescribing up to a 3-day supply for urgent pain relief. This applies in all settings and for all patients.
When prescribing Schedule 8 medicines, the key principles listed at Safe prescribing of high-risk medicines should be followed.
More information on approvals and how to apply can be found on the Medicine approvals webpage.
Registration and notification are now required to prescribe, supply, and administer medicines under the NSW OTP. To register and notify these activities, use SafeScript NSW.
OTP Standards now guide the activities under the OTP and compliance is mandatory.
Prescriptions for OTP medicines must not be given to the patients. They must be sent directly to the pharmacy for dispensing.
More information is available on NSW Opioid Treatment Program.
All health practitioners must comply with:
These standards will be published and circulated as soon as they become available.
For example, multiple strengths of morphine could be written on the same prescription. Each listed item must still comply with the prescription requirements in the Regulation.
Note, separate requirements may apply for medicines subsidised under the PBS.
You must now record the balance of Schedule 8 medicines in a drug register at least once every 3 months. Previously, this was only required in March and September.
For private and public hospitals, the stocktake requirement remains 6-monthly and may be conducted in any month (it is no longer limited to March and September).
In private practice, an authorised practitioner is responsible for keeping a compliant drug register on the practice premises where Schedule 8 medicines are kept. Please ensure you are aware of any obligations you may have.
Unregistered products are no longer permitted to be supplied as urgent use medicines.
If you need medicines for non-urgent use, you can continue to obtain these from a wholesaler.
You can no longer self-prescribe Schedule 8 and Schedule 4D medicines or obtain them via wholesale for self-administration.
Information on self-prescribing and prescribing for family members is available in the Good medical practice: a code of conduct for doctors in Australia.
Samples of Schedule 4D and Schedule 8 medicines are no longer permitted. You must issue a written order for samples for other scheduled medicines.
If you work in a public health entity, you must continue to comply with NSW Ministry of Health Policy Directive on Medicines Handling.
If you work in a private health facility or private correctional centre, you must comply with the facility or centre's medicines policies and procedures.
The labelling of scheduled substances is no longer listed in the Regulation. Scheduled substances must be labelled as per the requirements of the Poisons Standard.
Repeats can be given back to the patient to have dispensed at their pharmacy of choice.
Handwritten prescriptions must be legible.
Refer to Cosmetic use substances for information on the requirements for health practitioners and businesses that obtain, prescribe, supply or administer cosmetic use substances.
To reduce the harms associated with nitrous oxide misuse, while maintaining access for medical and industrial purposes and legitimate food preparation, new restrictions will apply to the supply of nitrous oxide. These include controls on:
Detailed information on these new restrictions is available on Nitrous oxide regulations.
The Act and Regulation set out penalties for offences associated with unauthorised activities.
Penalties are classified in 5 tiers and differ for individuals and corporations. They range from 20 to 400 penalty units for individuals and 100 to 2000 penalty units for corporations.
More information can be found in the offences and penalties section of the Act and the Regulation. Further information on compliance notices and penalties will also be available at a later date.
Further definitions and terminology can be found at Key definitions and terminology.
Supporting information to help understand the requirements of the legislation is available on Medicines, Poisons and Therapeutic Goods legislation.
This information is provided for general guidance only. While reasonable care has been taken to ensure the accuracy, reliability, and currency of the information, users should refer to the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 for full and current legal requirements.
