From 5 November 2026, the Poisons and Therapeutic Goods Act and Regulation will be replaced by:
This information outlines the requirements that will apply from 5 November 2026 onwards.
From 5 November 2026, the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 will introduce changes to the handling of medicines in healthcare settings.
This page provides healthcare settings with a guide on changes that will apply to them and should be read in conjunction with the information for health practitioners.
New mandatory standards will apply.
In addition to the NSW Health approved list, a residential care facility’s (RCF) medicines governance committee (however named, such as Medicines Advisory Committee) may approve any Schedule 2, 3, 4 and 8 medicine as an urgent use medicine. This is a change from the requirements of the current legislation where urgent use medicines are limited to those approved by NSW Health.
The medicines governance committee must approve written protocols that guide registered nurses on when these medicines may be used, stored, administered and recorded.
Approved urgent use medicines can be obtained from a retail pharmacy and be stored at the facility for urgent or emergency use. Urgent use medicines can be requested from a retail pharmacy on a signed and dated order from the Director of Nursing (DON), or the nominated RCF manager where there is no DON.
Where an RCF does not have a medicines governance committee, only medicines on the NSW Health approved list may be obtained for urgent use.
The medicine must be supplied in the manufacturer’s original pack.
The authorised person for a RCF is now responsible for keeping a compliant drug register on the premises. They must ensure that individuals employed or engaged at the RCF comply with the drug register requirements and obligations.
The daily entries in the drug register remain the responsibility of the health practitioner who undertakes the S8 medicine activity, including receiving stock, supplying, administering or recording the loss of a medicine. All these activities must be observed and the drug register entries countersigned by a witness.
The inventory of Schedule 8 medicines must be recorded every 3 months. The only exception is for residential care facilities run by a public health entity where this remains every 6 months. This is no longer limited to the months of March and September.
In addition to the requirements of the Medicines, Poisons and Therapeutic Goods Act 2022 and its supporting Regulation, residential care facilities must also apply the Australian Government Department of Health and Aged Care’s Guiding Principles for medication management in residential aged care facilities. These principles support the safe and quality use of medicines and provide guidance on medication management, including access to and administration of medicines within residential care facilities.
Private health facilities licensed under the Private Health Facilities Act 2007 may now obtain any Schedule 2, 3, 4, or 8 medicine.
The licensee of a private health facility must ensure that medication management policies and procedures are developed and implemented for the following:
Medication management policies and procedures must be approved by the medical advisory committee.
Private health facility policies and procedures must not be inconsistent with NSW Health Standards, including the Medicine Storage Standards, Vaccination Standards and OTP Standards.
Managed correctional centres must develop, implement and comply with policies and procedures for medication management, including access, storage and accountability.
The management company for a managed correctional centre must ensure policies and procedures are developed, implemented and maintained for the following:
Policies and procedures:
From 5 November, responsibility for storing Schedule 4D and Schedule 8 medicines in managed correctional centres will be shared between the management company and the authorised practitioner, or an appointed person. Storage of these medicines must comply with the Medicine Storage Standards.
The new legislation introduces changes to the way patients are treated under the NSW Opioid Treatment Program (OTP). Providers of OTP services should familiarise themselves with the OTP legislative requirements.
Schedule 4D and 8 medicines must be stored as per Medicine Storage Standards.
Private and public hospitals, and Justice Health managed correctional centres must record the balance of S8 medicines in a drug register every 6 months. This stocktake can be conducted in any month and is no longer limited to March and September.
For all other health facilities and correctional centres, the balance of S8 medicines must be recorded in a drug register at least once every 3 months. Previously, this was only required in March and September.
The Act and Regulation outline penalties for offences associated with unauthorised activities.
Penalties are classified into 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 is available in the Act and Regulation. Further information on compliance notices and penalties will be published at a later date.
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 legal requirements.
