NSW Health and the law governing Schedule 4 medicines in NSW
NSW Health is the state health department responsible for, among other functions, policy and regulatory oversight of medicines handling within NSW. In February 2026, NSW Health’s Pharmaceutical Services Unit issued a consultation (Ref H26/7192) proposing changes to strengthen controls on the administration of “cosmetic use substances”. The paper states the changes will be introduced in regulations made under the Medicines, Poisons and Therapeutic Goods Act 2022 (NSW) and that the Act is anticipated to commence in late 2026, with the Regulation commencing at the same time.
Cosmetic injectables are Schedule 4 “cosmetic use substances”
The consultation explains that multiple cosmetic injectables are classified as Schedule 4 (prescription only) substances under the Poisons Standard, including botulinum toxins, hyaluronic acid and its polymers, deoxycholic acid, collagen, calcium hydroxylapatite, polyacrylamide, polycaprolactone, and polylactic acid. It also notes Schedule 4 substances can only be prescribed or supplied by authorised practitioners.
What is this consultation process?
NSW Health is seeking stakeholder feedback on proposed regulatory changes that were not included in the earlier 2023 regulation consultation draft. The paper asks stakeholders to respond to consultation questions and submit responses by 5 pm (AEST) 20 February 2026, via an online form or by hardcopy, with an email contact provided for queries. NSW Health indicates the proposed changes aim to strengthen controls on cosmetic use substances to support safer, higher-quality cosmetic services for the community.
Download proposed changes
What are the proposed changes, and why are they being proposed?
NSW Health states it has been made aware that some operators may be unlawfully obtaining and distributing cosmetic use substances, including through overseas supply without required authorisations, multi-dosing from products intended for one patient, administering Schedule 4 substances without proper authority or prescription, and insufficient accountability of medical practitioners and nurse practitioners for medicines governance and clinic safety systems. The consultation proposes three changes intended to ensure cosmetic use substances are obtained through lawful pathways, administered only to individuals assessed and prescribed by a medical practitioner or nurse practitioner, and administered under policies and procedures overseen by a medical practitioner or nurse practitioner to protect patient health and safety.
Proposed change 1
It would require cosmetic use substances to be obtained via lawful pathways by limiting prescribing and administration to products that are either registered on the ARTG or otherwise authorised for supply under the Therapeutic Goods Act 1989 (including certain unregistered products manufactured by GMP-licensed manufacturers). The paper explicitly states this would prohibit administration of illegally imported, unregistered, and unregulated substances, and would also prohibit pharmacists compounding cosmetic use substances (including preparing multiple doses of botulinum toxin from a single vial without a TGA manufacturing licence).
Proposed change 2
It would introduce offences where a cosmetic use substance is administered to an individual unless it has been lawfully prescribed or lawfully supplied specifically for that individual. The paper describes scenarios captured, including administering to someone not named on the prescription or dispensed label, using product prescribed or supplied for another person, or using product held generally within a clinic rather than solely for the individual patient. The stated purpose is to remove ambiguity created by pooled or general stock use across patients and to improve traceability and patient safety.
Proposed change 3
It would make medical practitioners and nurse practitioners subject to the same compliance obligations as cosmetic clinic owners under the Regulation, including requirements around administration, storage, record-keeping, and risk management policies and procedures to protect patient health and safety. The paper expressly includes ensuring appropriate emergency equipment is available and that the nurse administering treatment is adequately trained to manage a medical emergency, and it frames the change as addressing NSW Health’s concern about insufficient prescriber accountability for medicines governance and clinic safety systems.
How Yooli aligns with the proposed direction (without disclosing proprietary framework details)
Yooli was designed to support compliant cosmetic injectables practice through enforceable workflow controls rather than reliance on informal processes.
Yooli’s model aligns with the proposed direction by supporting lawful procurement through an approved supply channel, maintaining structured stock custody controls, embedding patient identity and prescription traceability requirements, and supporting a clear accountability model between prescribers, nurses, and clinic operations. Yooli’s governance documentation includes policies that require Schedule 4 medicines to be ordered through an exclusive channel and to remain under the custody and control of authorised personnel, with defined receipt, verification, storage, and prohibition controls to prevent diversion and off-site movement.
Yooli was built to meet and exceed Australian regulatory expectations for cosmetic injectables so practitioners can operate safely and confidently within clear boundaries. By embedding medicines governance, prescribing and administration traceability, credentialing discipline, and emergency readiness into day-to-day workflows, Yooli reduces compliance friction for clinics while strengthening patient safety outcomes. The intention is that governance requirements are handled systematically, allowing cosmetic injectors and clinic teams to focus on what they do best: delivering high-quality patient care.
Move your clinic onto a safer, regulator-aligned injectables model with Yooli, the closed-loop cosmetic scripting platform that strengthens lawful supply, prescriber oversight, and full traceability so you can treat patients confidently and compliantly.
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