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What NSW Health says applies to cosmetic use substances from 5 November 2026.
NSW Health states that the Medicines, Poisons and Therapeutic Goods Act 2022 and Regulation 2026 commence on 5 November 2026. Every line below is NSW Health’s own words, from four of its pages, with a link to the page it came from.
Nothing is reworded, and nothing here says what a particular clinic has to do.
How this list is kept
NSW Health’s pages were read on 07/10/2026. ClinicTrace Australia checks every quoted line against NSW Health’s live pages once a week.
When the new laws commence
The Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW) form the primary legislative framework that regulates the supply of medicines, poisons, and therapeutic goods in New South Wales.
NSW Health, Medicines, Poisons and Therapeutic Goods legislation update. Current as at 3 July 2026.
The Medicines, Poisons and Therapeutic Goods Regulation 2026 has now been published, and the Medicines, Poisons and Therapeutic Goods Act 2022 and Regulation will commence on 5 November 2026.
NSW Health, Medicines, Poisons and Therapeutic Goods legislation update. Current as at 3 July 2026.
This webpage outlines the requirements that will apply from 5 November 2026 onwards.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
What the Regulation changes for cosmetic use medicines
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.
NSW Health, Frequently asked questions on the new Medicines, Poisons and Therapeutic Goods legislation. Current as at 4 September 2026.
The changes increase accountability for health practitioners and cosmetic service providers, ensuring safer prescribing, supply and administration practices.
NSW Health, Frequently asked questions on the new Medicines, Poisons and Therapeutic Goods legislation. Current as at 4 September 2026.
Which substances are cosmetic use substances
Cosmetic use substances are Schedule 4 (prescription only) medicines that are used for cosmetic procedures and include:
- Botulinum toxins (commonly used as anti-wrinkle injections)
- Dermal fillers and similar products, including:
- calcium hydroxylapatite,
- collagen,
- hyaluronic acid and its polymers,
- polyacrylamide,
- polycaprolactone,
- polylactic acid.
- Deoxycholic acid
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Directions from a medical practitioner or nurse practitioner
A medical practitioner or nurse practitioner can only prescribe or give a direction for the administration of a cosmetic substance if the substance:
- is included on the Australian Register of Therapeutic Goods (ARTG), or
- is approved for supply under section 19 or 19A of the Therapeutic Goods Act 1989, or
- is supplied by a manufacturer that has a manufacturer's licence under the Therapeutic Goods Act 1989
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Before prescribing or giving a written direction for the use of these substances, the prescriber must personally review the patient in person or via video consultation.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
A verbal direction is only allowed if the prescriber is physically present at the time of administration.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Written directions are valid for 6 months and must be signed by the medical practitioner or nurse practitioner.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
The direction must include:
- the patient details (name and address)
- the prescriber details and contact information
- the address where the substance will be administered
- name of the responsible provider (clinic or business name)
- the date of patient review
- how long the direction applies for, and
- how often the substance may be administered.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
For each cosmetic use substance used for treatment the direction must include the following:
- name and form of the substance
- administration area of the face or body
- route of administration (if not obvious)
- quantity to be administered
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Medical practitioners and nurse practitioners must keep a record of all written or verbal directions.
- Records of verbal directions must include the patient's street address.
- A copy of these records must be provided to the responsible provider (business owners or operators).
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Who may administer a cosmetic use substance
Cosmetic use substances may only be administered by the following authorised health practitioners:
- Medical practitioners and nurse practitioners - as part of their lawful practice.
- Nurses if they:
- are acting in the course of their nursing practice, and
- are directed by a medical practitioner or nurse practitioner to administer the substance, or
- administer a cosmetic use substance that has been lawfully prescribed and dispensed for the patient.
- In a hospital, administration may occur by a person acting under the direction of a medical or nurse practitioner.
- For animals, administration is limited to veterinary practitioners or a person acting under their direction.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
No other person is permitted to administer cosmetic use substances.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Designated registered nurse (RN) prescribers may prescribe, supply, administer, or issue a direction to supply or administer registered scheduled medicines as per their endorsement and prescribing partnership agreement.
NSW Health, Legislation changes for nurse practitioners and endorsed nurses. Last updated 24 August 2026.
Designated registered nurses:
- cannot prescribe, supply, administer, or issue a direction to supply or administer unregistered scheduled medicines
- cannot issue a direction to supply or administer cosmetic use medicines
- cannot administer a cosmetic use medicine without a direction from a medical practitioner or a nurse practitioner
- can administer a cosmetic use medicine to a patient lawfully prescribed by a medical practitioner or nurse practitioner and dispensed from a pharmacy.
NSW Health, Legislation changes for nurse practitioners and endorsed nurses. Last updated 24 August 2026.
A nurse administering a cosmetic use substance
A nurse administering a cosmetic use substance must:
- ensure emergency equipment is available
- confirm the substance to be administered is approved or lawfully supplied (ARTG listed, approved or supplied under the Therapeutic Goods Act as outlined above)
- make a written record for each administration, and include the:
- nurse’s name
- date of administration
- batch number of the substance administered
- patient name and address
- treatment details, including:
- prescriber name, principal place of practice and telephone number,
- address of premises that substance is being administered
- name of the responsible provider
- date that patient was reviewed by the prescriber
- the period of time the direction for administration is valid for and the number of times and intervals between the administration
- for each substance administered, the name, form, quantity and route (if not apparent) of administration, and the part the patient's face or body to which administration will occur
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
A copy of the administration record must be provided to:
- the medical practitioner or nurse practitioner who gave the direction to administer the cosmetic use substance
- the responsible provider of the business.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Storage
Cosmetic use substances must be stored:
- in a non-public area
- separate from food
- in a way that prevents contamination if containers break or leak
- in line with the label’s storage instructions.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
These requirements apply both to clinics generally and to practitioners who obtain substances for administration.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Businesses providing cosmetic procedures
Businesses providing cosmetic procedures must ensure:
- all cosmetic procedures comply with the legislation
- appropriate risk management policies and procedures are in place
- appropriate emergency equipment is available at all times
- nurses who administer cosmetic substances are trained to respond to medical emergencies
- prescriber directions and records of administration are made and kept for 2 years.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Responsible providers (business owners and operators) must keep copies of all:
- written or verbal directions for administering a cosmetic use substance, as provided by medical practitioners or nurse practitioners
- records of administration by nurses.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Offences and penalties
The Act and Regulation outline penalties for offences associated with unauthorised activities.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Penalties are classified in 5 tiers and differ for individuals and corporations.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
They range from 20 to 400 penalty units for individuals and 100 to 2000 penalty units for corporations.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
Further information on compliance notices and penalties will be published at a later date.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
NSW Health's disclaimer on its page
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.
NSW Health, Cosmetic use substances. Current as at 6 July 2026.
The legislation itself
NSW Health’s pages link the Medicines, Poisons and Therapeutic Goods Act 2022 and the Medicines, Poisons and Therapeutic Goods Regulation 2026 on the NSW legislation website. Both are listed in the New South Wales legislation register, with NSW Health’s pages about them.
This tool describes what you enter and links to each publisher’s own source. It is not legal advice and does not say whether a clinic meets any requirement.