The Medicines, Poisons and Therapeutic Goods Regulation 2026 commenced in New South Wales on 5 November 2026. Part 9 sets what must be in place when a nurse administers a cosmetic use substance under a prescriber’s direction: the prescriber has reviewed the patient, and every administration is recorded in writing, batch number included.
General information, not legal advice. These rules apply in New South Wales only, and guidance changes. Check the regulation and NSW Health’s guidance, or take professional advice, before you rely on this.
On 5 November 2026 the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 replaced the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008. Part 9 of the new regulation, sections 86 to 94, deals with what it calls cosmetic use substances: eight Schedule 4 substances that between them cover the standard injectables menu.
A cosmetic use substance may be administered by a medical practitioner or nurse practitioner in their own practice, or by a nurse. A nurse may do so only under a direction from a medical practitioner or nurse practitioner, or where the substance was lawfully supplied to that patient on prescription.
The medical practitioner or nurse practitioner giving the direction must have personally reviewed the patient, in person or by audiovisual link. The direction must be in writing and signed. It has effect for the period it states, which can be no more than six months from the date of that review. An oral direction is allowed only when the prescriber is physically present while the nurse administers. It covers that one administration, and it must be recorded in the patient’s medical record and signed.
The prescriber must be satisfied that the substance is on the Australian Register of Therapeutic Goods, approved for supply under the Commonwealth Therapeutic Goods Act, or supplied by a manufacturer that holds a manufacturing licence. The nurse must be satisfied of the same thing, and that appropriate emergency equipment is available.
A written direction has a set list of contents under section 90. It includes the patient’s name and address, the prescriber’s name, phone number and principal place of practice, the address where the substance will be administered, the name of the responsible provider, the date the patient was reviewed, how long the direction has effect, how many times and at what intervals the substance may be given and, for each administration, the name and form of the substance, the area of the face or body, the route if it is not obvious, and the quantity.
A nurse who administers under a direction must make a written record of each administration. It must contain the nurse’s name, the date, the batch number of the substance, and details carried over from the direction, including the patient’s name and address, the prescriber’s name and contact details, and the address where the substance was administered. NSW Health’s guidance sets out the full list. The nurse must give a copy to the prescriber who gave the direction and to the responsible provider.
The regulation calls the business that provides the treatment the responsible provider. Under section 93, the business and each prescriber it employs must make sure that treatments follow Part 9, that appropriate risk management policies and procedures are in place, that appropriate emergency equipment is available, and that every nurse who administers is adequately trained for a medical emergency.
The business must keep a copy of every direction and every administration record. The regulation’s general record rule, section 185, requires records to be kept for at least two years and to be available for inspection. Health records law sets its own retention period for the patient record, and that still applies.
Stock must be stored in a room or enclosure the public cannot access, apart from food, and in line with the storage conditions on its label. Under section 92 that duty falls on whoever occupies or controls the premises, and on a prescriber who obtains the stock.
Breaching Part 9 is an offence, and section 94 sorts its requirements into two categories. For the first, which includes who may administer, the prescriber’s review of the patient and the section 93 duties on policies, equipment and training, the maximum penalty is 200 penalty units or six months’ imprisonment, or both, for an individual, and 1,000 penalty units for a corporation. For the second, which covers the written direction, record-keeping and storage requirements, it is 50 penalty units for an individual and 250 for a corporation.
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