NSW Health has released a new consultation proposing tighter regulatory controls on cosmetic use substances, signalling a further escalation of oversight in the cosmetic injectables sector.
According to the consultation paper, the proposed changes are intended to ‘strengthen controls on the administration of cosmetic use substances’ and to ‘ensure safer, higher-quality cosmetic services for the community’.
The consultation paper outlines amendments that would strengthen professional accountability and introduce new offences and penalties for the unlawful prescribing, supply and administration of cosmetic injectables. The changes are aimed at addressing ongoing concerns about illegal supply chains, unsafe clinical practices and fragmented responsibility within cosmetic clinics.
Key facts at a glance
- NSW Health has released a consultation on proposed regulatory changes to cosmetic use substances.
- The proposals apply to Schedule 4 cosmetic injectables, including botulinum toxin and dermal fillers.
- Tighter controls are proposed on the lawful sourcing of cosmetic injectables through approved supply pathways, and only using ARTG-registered or otherwise authorised products.
- Individualised prescribing and administration for named patients would be required; vial splitting, aliquoting and the use of shared or general clinic stock would be prohibited.
- Medical practitioners and nurse practitioners would carry expanded accountability when directing treatment.
- Prescribers would be responsible for storage, record-keeping and clinical governance requirements.
- New offence provisions and penalties are proposed for unlawful prescribing, supply or administration.
These proposed changes form part of the transition to NSW’s new medicines and poisons framework. The Medicines, Poisons and Therapeutic Goods Act 2022 will replace the Poisons and Therapeutic Goods Act 1966 when it commences, anticipated to be late 2026, with the accompanying Regulation currently being finalised and due to commence at the same time.
NSW Health notes that the cosmetic-specific measures will be included in the Medicines, Poisons and Therapeutic Goods Regulation and were not part of the Regulation consultation draft released during the public consultation period in 2023.
While NSW Health’s proposal applies only within New South Wales, it aligns with existing expectations clarified by Queensland Health regarding the lawful sourcing, storage and administration of Schedule 4 cosmetic injectables, with NSW now proposing to formalise similar expectations through offence provisions and prescriber accountability.
Why the changes are being proposed
According to NSW Health, the proposed reforms have been driven by increasing evidence that some operators in the cosmetic industry are unlawfully sourcing and administering Schedule 4 cosmetic use substances. Identified areas of concern include the importation of unapproved products from overseas suppliers, the practice of multi-dosing from single-use vials, and the administration of prescription-only substances without a lawful prescription or direction.
The consultation paper also highlights insufficient oversight by medical practitioners and nurse practitioners in some clinic settings, particularly in relation to how medicines are obtained, stored and administered, and whether appropriate policies, procedures and emergency protocols are in place.
Scope of substances affected
The proposed changes apply to cosmetic use substances classified as Schedule 4 (prescription only) under the Poisons Standard, including botulinum toxins, hyaluronic acid and its polymers, calcium hydroxylapatite, collagen, deoxycholic acid, polycaprolactone, poly-L-lactic acid and polyacrylamide.
Under existing regulation, these substances may only be prescribed or supplied by authorised practitioners and must be obtained through lawful access pathways, such as licensed wholesalers, manufacturers or importers, in compliance with Therapeutic Goods Administration requirements.
Proposed change 1: tightening lawful supply pathways
The first proposed reform would explicitly prohibit the prescribing, directing or administering of cosmetic use substances that are not registered on the Australian Register of Therapeutic Goods or otherwise authorised for supply under the Therapeutic Goods Act 1989.
If adopted, medical practitioners and nurse practitioners would only be permitted to prescribe or direct administration of products that meet these criteria. Nurses administering under direction would similarly be restricted.
NSW Health states this change is intended to eliminate the use of illegally imported, unregistered or unregulated injectables and to prevent pharmacists from compounding cosmetic injectables without an appropriate TGA manufacturing licence, including the preparation of multiple doses from a single vial.
The proposal directly targets practices such as vial splitting and aliquoting, which the regulator says compromise sterility and product stability.
Proposed change 2: individualised prescribing and administration offences
A second key reform would introduce new offences where a cosmetic use substance is administered to an individual without a prescription or supply specifically naming that patient.
Under the proposal, penalties would apply if a nurse administers a cosmetic injectable to a person other than the individual named on the prescription or dispensed label, uses a product prescribed for another patient, or administers a substance drawn from general clinic stock rather than supplied for a specific individual.
NSW Health argues this measure is necessary to reinforce the requirement for individual clinical assessment and prescribing, and to close loopholes that have enabled batch or stock-based administration of prescription-only injectables in some clinics.
Proposed change 3: expanding accountability to prescribers
Perhaps the most significant shift is proposed change three, which would place medical practitioners and nurse practitioners under the same regulatory obligations as cosmetic clinic owners.
Under this model, prescribers would be directly responsible for ensuring compliance with all relevant regulatory requirements, including medicine storage and record-keeping, staff training, risk management systems, and access to appropriate emergency equipment.
The consultation paper makes clear that practitioners who obtain cosmetic medicines for a clinic and issue prescriptions or directions would be accountable not only for the medicines themselves, but also for the clinical governance structures that support safe patient care.
‘This provision will obligate the medical practitioner or nurse practitioner obtaining medicines for the clinic, and issuing the prescriptions or directions for administration, to be accountable for the medicines and the health and safety processes and procedures in that clinic,’ states NSW Health.
The proposed changes sit alongside a broader suite of reforms reshaping the cosmetic sector, including strengthening professional standards, advertising restrictions and enforcement activity by the Therapeutic Goods Administration.
Consultation timeline and next steps
NSW Health is seeking submissions from practitioners, clinic owners and industry stakeholders by 5pm (AEST) on 20 February 2026. Feedback will be used to assess the practical and regulatory impact of the proposals before finalising the Regulation.
With commencement anticipated in late 2026, the proposals signal a clear expectation that cosmetic medicine practitioners will be held to higher standards of accountability, documentation and governance, reflecting the increased regulatory scrutiny in the cosmetic medicine sector.
