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.
From 5 November 2026, under the Medicines, Poisons and Therapeutic Goods Act and Regulation you will no longer need to:
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See below for changes to prescription requirements that apply from 5 November 2026.
Prescribers will no longer need to include the NSW Health approval number on prescriptions for:
Schedule 4D prescriptions will be valid for 12 months, which is an increase from the previous period of 6 months. Schedule 4D medicines include those that are anabolic androgenic steroids.
The timeframe for reporting outstanding prescriptions has changed. If a prescriber requests medicine supply via phone (verbal), email, or fax, they must still issue the prescription immediately and send it to the pharmacist within 24 hours.
You now have 14 days (previously 7) to receive the prescription before notifying NSW Health.
More than one product may be included on an S8 prescription for the same medicine. 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.
All health practitioners must comply with the following:
The following apply from 5 November 2026:
The owner of the pharmacy is now responsible for keeping a compliant drug register on the pharmacy premises. They must ensure that individuals employed or engaged at the pharmacy comply with the drug register requirements of the Regulation.
The daily entry obligations into a drug register are still the responsibility of the pharmacist on duty who undertakes the S8 medicine activity, such as receiving stock, supplying, or destroying a medicine.
You must now record the balance of S8 medicines in a drug register at least once every 3 months, previously only required in March and September.
Note for hospitals - 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).
Entries in drug registers identifying animals have been extended to include identifier numbers. This means that if the entry is for an animal and there is no owner or address, the identifier number of the animal can be used instead.
From 5 November 2026, urgent use medicines from pharmacies are restricted to registered products. Medicines must be registered on the Australian Register of Therapeutic Goods (ARTG) for supply as urgent-use medicines. Exceptions for veterinary products are listed below.
Orders for urgent-use medicines must be written and signed by an authorised person as stated below, and a record of these requests kept for 2 years.
Medical and nurse practitioners can be supplied with any registered Schedule 4 and Schedule 8 medicines for emergency or urgent use. The registered medicine is not limited to those listed on the PBS Prescriber Bag orders.
Veterinary practitioners can be supplied with scheduled substances for animal use. Substances must be:
Residential care facilities can be supplied with any Schedule 2, 3, 4, or 8 medicine when:
First aiders can be supplied with salbutamol, terbutaline, adrenaline, naloxone, glucagon, glyceryl trinitrate. You must ensure that the first aider holds a current first aid certificate issued by a registered training organisation, or as approved by the NSW Health Secretary.
Masters of vessels and racing yachts can be supplied with Schedule 2, 3, 4 or 8 substances as required and published by the Australian Maritime Safety Authority , Australian Sailing Limited , or as ordered by the Health Secretary.
Further requirements are listed in the Regulation.
Wholesale supply in this context is when you supply a medicine to another party for it to be sold or distributed by them.
The new Act and Regulation permit more extensive wholesale supply arrangements from a pharmacy in various settings. Records of a wholesale supply must be made and kept for 2 years.
Pharmacists in a community pharmacy can wholesale supply Schedule 2, 3, 4, and 8 medicines in the following circumstances:
Pharmacists in public health entities can wholesale supply Schedule 2, 3, 4, and 8 medicines:
More information will be available in the Medicines Handling Policy Directive.
Pharmacists in private health facilities can wholesale supply Schedule 2, 3, 4, and 8 medicines:
Public health entities and private health facilities are defined in the webpage on Overview of the NSW medicines, poisons and therapeutic goods legislation .
Registration and notification are required to prescribe, supply and administer medicines under the NSW OTP.
SafeScript NSW should be used to register and notify these activities.
OTP Standards now guide the activities under the OTP and compliance with these is mandatory.
More information is available in the Opioid treatment Program - Legislative requirements webpage.
Pharmacists supplying medicines in a Dose Administration Aid (DAA) must ensure the DAA is labelled as per the requirements of Appendix L of the Poison Standard. The label must also include:
If a third party has packed the DAA on behalf of the pharmacist, the label must also include a reference number that links the relevant prescriptions to the manufacturing instructions used to prepare the DAA.
Where a supplying pharmacist* engages a third-party to pack a DAA, the following requirements apply:
Refer to the TGA provides further guidance on GMP licence requirements.
*a supplying pharmacist is the pharmacist who dispenses the patient's prescriptions and supplies the packed DAA to the patient.
If a pharmacist arranges for a DAA to be packed by a pharmacist at another pharmacy who does not hold a GMP licence, the pharmacist who packs the DAA is considered the supplying pharmacist and they are responsible for all aspects of dispensing, including:
Changes have been made to the requirement for a prescriber to obtain approval from the NSW Ministry of Health to prescribe, supply or administer certain medicines. The medicines and circumstances requiring approval, including exemptions, are listed on the Medicine approvals webpage.
From 5 November 2026, changes include:
Please note:
To help reduce harms associated with the misuse of nitrous oxide, new restrictions will apply to its supply for non-therapeutic purposes. These measures are intended to support the safe and responsible supply of nitrous oxide and limit access where there is a risk of misuse.
More information is available at Nitrous Oxide Regulations.
The Act and Regulation outline offences and maximum penalties 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.
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 the Medicines, Poisons and Therapeutic Goods legislation webpage.
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 legal requirements.
