From 5 November 2026, theMedicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026, will replace the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008 respectively.
The new framework modernises and clarifies how medicines, poisons and other therapeutic goods are regulated in NSW.
The Poisons and Therapeutic Goods Act is 60 years old and requires updating to reflect new models of healthcare delivery and digital advancements. The new framework improves clarity and consistency with other intersecting legislative frameworks, and provides flexibility while maintaining strong safeguards to protect public health and safety.
The new Medicines, Poisons and Therapeutic Goods Act 2022 and Medicines, Poisons and Therapeutic Goods Regulation 2026 commence on 5 November 2026.
The new laws are relevant to people and services that:
This includes health practitioners, health services, industry, and other authorised persons and organisations.
Detailed changes for health practitioners, licensees and authority holders are available via the Medicines, Poisons and Therapeutic Goods legislationwebpage.
New regulations have been introduced to reduce the harms associated with nitrous oxide misuse while maintaining access for legitimate food preparation, medical, and industrial purposes. The reforms include new restrictions on retail sales, purchase limits, sales hours, online delivery, product storage and recordkeeping requirements for certain businesses.
There are no changes to the therapeutic use of nitrous oxide, which will continue to be regulated under existing clinical and medicines frameworks.
For more information refer to Nitrous oxide regulation webpage.
The Regulation introduces changes to the administration of cosmetic use substances that strengthen patient safety and reduce the use of illegally imported and unlawful cosmetic products. The changes increase accountability for health practitioners and cosmetic service providers, ensuring safer prescribing, supply and administration practices. For more information see Cosmetic use substances.
Yes. The Bill and the Regulation, including the Regulation Impact Statement, were widely consulted on, including through public consultation on the NSW Government's "Have Your Say" website, as well as through targeted engagement with health practitioners, health services, industry and other stakeholders. Feedback from these consultations informed the Act and the Regulation.
For most stakeholders, core practices will continue as they do now. Some requirements have been clarified or updated, and there may be changes to processes, authorisations or record‑keeping. Guidance and resources will be provided to help stakeholders understand what applies to them. These resources are also available via the Medicines, Poisons and Therapeutic Goods legislationwebpage.
Stakeholders are encouraged to:
Further information will be shared ahead of commencement. Please refer to the Medicines, Poisons and Therapeutic Goods legislation webpage for updates.
NSW Health will provide a range of resources, including:
Resources will be released progressively ahead of commencement to support awareness, readiness and transition. Updates will be published on the Medicines, Poisons and Therapeutic Goods legislation update webpage.
NSW Health will focus on education, guidance and support to help stakeholders understand and meet their obligations under the new framework.
If you have an enquiry please submit it using the online enquiry form.
From 5 November 2026, prescriptions for psychostimulant medicines and Schedule 8 compounded medicines are not required to include a NSW Health approval number. Pharmacists will be able to dispense these prescriptions if they are otherwise valid and all legal, clinical and professional requirements for dispensing are met.
From 5 November 2026, the absence of an approval number will not make the prescription invalid and, on its own, should not be a reason to refuse dispensing.
Where NSW law requires an approval, the responsibility for obtaining that approval remains with the prescriber. Pharmacists are not required to confirm whether an approval has been obtained and should not treat the absence of an approval number on a prescription as evidence that an approval has not been granted.
Pharmacists must continue to exercise professional judgment and ensure that prescriptions comply with all requirements for lawful dispensing, including applicable legislative, professional and practice standards. This includes the use of SafeScript NSW to support safe and appropriate clinical decision-making.
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Yes. From 5 November 2026, prescriptions for Schedule 8 medicines may contain multiples of the same scheduled substance* in different strengths, formulations, and salts, so long as the items listed on the prescription contain the same Schedule 8 substance^.
For example, a single prescription containing:
would be valid for dispensing, assuming it meets all other legislative requirements, and the dispensing pharmacist deems that it is clinically appropriate to do so.
Note that the Pharmaceutical Benefits Scheme sets out its own prescription requirements and may include the need for a single product to be on a prescription. These should also be kept in mind when dispensing medicines which are eligible for subsidisation.
From 5 November 2026, the expiry period for Schedule 4D prescriptions will increase from 6 months to 12 months.
This change will also apply to prescriptions written before 5 November 2026.
As a result, there may be circumstances where a prescription that had previously expired may once again be valid for dispensing. Pharmacists are strongly encouraged to use their professional judgement when dispensing these prescriptions, as prescribers may use prescription expiry dates as a trigger to review a patient's treatment.
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Please see the DAA webpage for further information.
The information on this webpage 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.