Beauty and aesthetic businesses offering cosmetic injectable services in New South Wales need to prepare for significant changes to medicines regulation commencing on 5 November 2026.

On that date, the:

Medicines, Poisons and Therapeutic Goods Act 2022 (NSW)

and

Medicines, Poisons and Therapeutic Goods Regulation 2026 (NSW)

will replace the longstanding Poisons and Therapeutic Goods Act 1966 and Poisons and Therapeutic Goods Regulation 2008.

The new framework modernises the way medicines, poisons and therapeutic goods are regulated in NSW and introduces specific requirements affecting businesses and health practitioners involved with cosmetic-use substances.

For cosmetic clinic owners, prescribing practitioners, nurses and other people involved in cosmetic injectable services, now is the time to review existing systems before the new requirements commence.

When Do the New NSW Laws Start?

The new legislation commences on:

5 November 2026

Until then, the existing NSW Poisons and Therapeutic Goods framework continues to apply.

Businesses should therefore prepare for the transition but should distinguish between:

• requirements currently in force
• requirements commencing on 5 November 2026.

Why Is NSW Changing Its Medicines Legislation?

The legislation being replaced is approximately 60 years old.

The NSW Government has introduced the new framework to modernise medicines and poisons regulation and better accommodate contemporary healthcare delivery, technology and business practices.

The new framework regulates activities including:

• prescribing
• supply
• administration
• possession
• storage
• transport
• disposal

of medicines, poisons and therapeutic goods.

Importantly for the aesthetics industry, NSW Health has specifically identified cosmetic-use medicines as an area requiring stronger regulatory safeguards.

Why Are Cosmetic Medicines Receiving Particular Attention?

NSW Health has identified concerns within parts of the cosmetic industry involving matters such as:

• unlawfully obtained cosmetic-use substances
• products sourced through inappropriate overseas channels
• administration without appropriate authority
• inadequate prescribing arrangements
• inappropriate handling of products intended for individual patients
• inadequate clinical governance
• insufficient practitioner accountability.

The 2026 reforms are intended to increase accountability for practitioners and businesses involved in cosmetic medicines.

What Are Cosmetic-Use Substances?

The NSW framework identifies particular Schedule 4 prescription-only substances used for cosmetic purposes.

These include substances associated with cosmetic injectable treatments, including certain products involving:

• botulinum toxins
• hyaluronic acid and its polymers
• calcium hydroxylapatite
• collagen
• deoxycholic acid
• polyacrylamide
• polycaprolactone
• polylactic acid.

The exact legal requirements should always be checked against the current NSW legislation and NSW Health guidance.

These Are Prescription-Only Medicines

A fundamental point for clinic owners is that cosmetic use does not turn a prescription medicine into an ordinary beauty product.

Schedule 4 medicines are prescription-only medicines.

Their cosmetic purpose does not remove requirements concerning:

• prescribing
• supply
• administration
• possession
• storage
• record keeping.

Beauty salon owners should therefore treat cosmetic injectable medicine management as part of a healthcare compliance system rather than ordinary salon stock management.

Who Can Prescribe Cosmetic-Use Medicines?

Under the NSW framework, prescribing authority depends on the practitioner and applicable medicines legislation.

Medical practitioners and nurse practitioners can have authority relevant to cosmetic-use medicines within their lawful professional scope.

Businesses should not assume that every Ahpra-registered health practitioner has identical prescribing authority.

Professional registration, scope of practice, prescribing authority and NSW medicines legislation all need to be considered.

Registered Nurses and Cosmetic Medicines

Registered nurses can play an important role in cosmetic injectable services, but being a registered nurse does not itself provide unrestricted authority to prescribe cosmetic medicines.

Where a nurse administers a cosmetic-use medicine under a practitioner’s direction, the applicable NSW requirements concerning that direction must be satisfied.

Under the incoming framework, nurses administering cosmetic-use medicines under this pathway must act under the direction of an appropriately authorised medical practitioner or nurse practitioner.

The prescriber retains important responsibilities in relation to patient assessment and direction.

Designated Registered Nurse Prescribers

The new NSW framework also recognises designated registered nurse prescribers.

However, this does not provide unrestricted independent prescribing authority for cosmetic-use medicines.

NSW Health states that designated RN prescribers:

• 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 nurse practitioner
• can administer a cosmetic-use medicine lawfully prescribed by a medical practitioner or nurse practitioner and dispensed from a pharmacy.

Clinic owners should therefore not assume that a nurse’s prescribing endorsement automatically permits independent cosmetic injectable prescribing.

Patient Assessment Remains Essential

Cosmetic prescribing should never be treated as an administrative formality.

The patient needs to be appropriately assessed before a cosmetic-use medicine is prescribed or a direction for administration is issued.

The incoming NSW requirements should also be considered alongside the Ahpra and National Board guidelines for registered health practitioners performing non-surgical cosmetic procedures, which have applied nationally since September 2025.

These frameworks place significant emphasis on:

• patient suitability
• informed consent
• appropriate prescribing
• practitioner competence
• complication management
• clinical governance.

Remote Assessment Does Not Remove Prescriber Responsibility

Where the applicable requirements permit patient assessment through audiovisual consultation, the consultation still needs to constitute an appropriate clinical assessment.

A remote prescribing system should not simply exist to generate prescriptions for patients who have not been adequately assessed.

Clinic owners using telehealth prescribing arrangements should review those arrangements before 5 November 2026.

Written Directions

Where a nurse administers a cosmetic-use substance under the direction of a medical practitioner or nurse practitioner, businesses should ensure the direction satisfies the requirements applying under the NSW legislation.

This includes appropriate documentation.

Clinic systems should clearly establish:

• who assessed the patient
• who prescribed the medicine
• who issued the direction
• who administered the medicine
• what was administered
• when it was administered
• relevant treatment and medicine records.

Do not rely on informal verbal arrangements between practitioners as a substitute for compliant clinical documentation.

Cosmetic Medicines Must Be Obtained Lawfully

Clinic owners should review exactly where their cosmetic medicines come from.

Prescription medicines used in Australian cosmetic practice should be obtained through lawful Australian supply pathways.

Particular caution should be exercised with products:

• purchased directly from overseas
• ordered through international marketplaces
• obtained from unknown intermediaries
• supplied without appropriate Australian regulatory documentation.

The fact that a product is widely used overseas does not automatically establish that it can lawfully be supplied or administered in Australia.

ARTG and Therapeutic Goods

Cosmetic clinics also need to understand the difference between NSW medicines legislation and Commonwealth therapeutic-goods regulation.

The Therapeutic Goods Administration regulates therapeutic goods at the Commonwealth level.

Where a therapeutic good is required to be included in the Australian Register of Therapeutic Goods, the relevant Australian regulatory requirements must be satisfied.

However, businesses should avoid using “ARTG-listed” as a generic description for every cosmetic injectable product.

Different therapeutic goods can have different regulatory pathways.

The correct question is whether the particular product is lawfully supplied in Australia under the applicable therapeutic-goods framework.

Imported Cosmetic Medicines

NSW Health has specifically identified illegally imported cosmetic products as a patient-safety concern.

Clinics should therefore audit product sourcing before the new laws commence.

Do not assume that:

“The overseas manufacturer says it is approved.”

or

“Other Australian injectors use it.”

establishes lawful Australian supply.

Clinics should be able to identify the legitimate supply chain for the medicines they use.

Multi-Patient Product Use Requires Particular Care

NSW Health has identified multi-dosing from cosmetic products intended for one patient and one procedure as an area of concern, particularly where aliquoting or product sharing can compromise sterility or stability.

Clinic owners should therefore review:

• manufacturer instructions
• product labelling
• dispensing arrangements
• patient-specific supply
• storage
• sterility
• preparation
• administration procedures.

Businesses should not create their own product-sharing practices simply to reduce product wastage or treatment costs.

Use must comply with the applicable legislation, lawful supply arrangements and product requirements.

Clinic Stock Should Be Reviewed

Businesses should review how prescription cosmetic medicines are:

• ordered
• received
• possessed
• stored
• allocated
• supplied
• administered
• recorded
• disposed of.

Do not assume that ordinary retail stock-control procedures are adequate for prescription medicines.

The responsible health practitioners and clinic operators should understand who has authority to possess and control medicines at every stage.

Storage

Prescription medicines must be stored in accordance with applicable legal and product requirements.

Clinics should review:

• access controls
• temperature requirements
• refrigeration where applicable
• manufacturer storage instructions
• stock security
• expiry-date monitoring
• record keeping.

A salon refrigerator or unlocked product cupboard should not automatically be assumed suitable for prescription medicines.

Clinical Governance

One of the broader themes of the reforms is greater accountability.

Cosmetic businesses should therefore have clear clinical governance arrangements identifying who is responsible for:

• patient assessment
• prescribing
• medicine procurement
• medicine storage
• administration
• infection prevention
• treatment records
• complication management
• emergency procedures
• adverse events
• practitioner competence.

A clinic should not operate through a collection of loosely connected contractors without clearly defined responsibilities for clinical safety.

Clinic Owners Have Responsibilities Too

Business owners should not assume that medicines compliance is solely the responsibility of the individual injector.

NSW Health specifically identifies cosmetic clinics and businesses involved in obtaining, prescribing, supplying and administering cosmetic-use substances as relevant to the new framework.

A clinic’s operating model therefore needs to support lawful practice.

Business owners should understand enough about the regulatory system to identify obvious compliance risks and establish appropriate policies and procedures.

Infection Prevention and Control

Cosmetic injections penetrate the skin and require appropriate infection-prevention procedures.

Clinic systems should address:

• hand hygiene
• aseptic technique
• skin preparation
• single-use equipment
• sharps
• clinical waste
• environmental cleaning
• medicine handling
• blood and body-fluid incidents.

These requirements should be considered alongside NSW public health requirements applying to skin-penetration procedures.

Sharps

Injectable clinics need appropriate systems for sharps.

This includes:

• approved sharps containers
• safe disposal procedures
• immediate disposal after use
• staff training
• procedures for needlestick injuries.

Used needles must never be recapped or handled in a manner that creates unnecessary injury risk.

Treatment Records

Cosmetic medicine records should be sufficiently detailed to establish what occurred during treatment.

Depending on the circumstances, records may include:

• patient assessment
• medical history
• contraindications
• prescriber
• prescription
• administration direction
• product
• batch or lot number
• quantity
• treatment area
• administering practitioner
• date
• consent
• adverse events
• aftercare
• follow-up.

Records should also satisfy applicable professional, medicines and privacy requirements.

Complication Management

Cosmetic injectable clinics should have systems for foreseeable complications.

These should identify:

• who is clinically responsible
• what staff should do
• when treatment must stop
• escalation procedures
• emergency contacts
• referral pathways
• documentation requirements
• follow-up arrangements.

Practitioners should be appropriately trained to recognise complications associated with the procedures they perform.

Advertising Is a Separate Compliance Area

The NSW medicines reforms do not replace the national rules applying to cosmetic procedure advertising.

Clinics should separately consider:

• Therapeutic Goods Administration advertising restrictions
• Ahpra and National Board advertising requirements
• Australian Consumer Law.

Prescription-only medicines cannot simply be promoted to the public in the same way as ordinary beauty products.

The use of alternative terminology does not necessarily avoid advertising restrictions.

The New Laws Do Not Replace Ahpra Requirements

The NSW reforms should be viewed as another layer of regulation.

Registered health practitioners must continue to comply with:

• Ahpra requirements
• National Board standards
• professional scope of practice
• non-surgical cosmetic procedure guidelines
• advertising requirements.

Compliance with NSW medicines legislation does not automatically establish compliance with professional regulation, and vice versa.

The New Laws Do Not Apply Australia-Wide

These changes apply in New South Wales.

Other states and territories have their own medicines and poisons legislation.

Businesses operating across multiple Australian jurisdictions should not automatically apply the NSW framework to clinics elsewhere.

However, the reforms demonstrate the increasing regulatory attention being given to cosmetic medicine in Australia.

What NSW Cosmetic Clinics Should Do Before 5 November 2026

Businesses offering cosmetic injectable treatments should use the transition period to conduct a structured review.

1. Review every cosmetic medicine used

Identify:

• product
• supplier
• Australian regulatory status
• supply pathway
• storage requirements.

2. Review prescribing arrangements

Document:

• who prescribes
• their authority
• how patients are assessed
• how prescriptions and directions are documented.

3. Review nurse administration arrangements

Ensure nurses understand:

• who can direct administration
• documentation requirements
• their professional scope
• applicable NSW requirements.

4. Audit medicine storage

Check:

• security
• access
• temperature
• expiry management
• records.

5. Review clinical governance

Clearly allocate responsibility for:

• medicines
• prescribing
• administration
• infection control
• complications
• emergencies.

6. Review treatment records

Ensure records allow the clinic to identify exactly:

• who was treated
• who prescribed
• who administered
• what product was used
• when treatment occurred.

7. Review policies and procedures

Update written procedures before the new legislation commences.

8. Review practitioner credentials

Verify:

• Ahpra registration
• professional scope
• prescribing authority
• competency
• insurance.

9. Review advertising

Remove marketing that may breach:

• prescription medicine advertising restrictions
• Ahpra requirements
• Australian Consumer Law.

10. Monitor NSW Health Guidance

NSW Health is continuing to publish supporting information for practitioners and industry ahead of commencement.

Clinics should use current NSW Health guidance rather than relying solely on older industry summaries.

Key Date

5 November 2026

The Medicines, Poisons and Therapeutic Goods Act 2022 and Medicines, Poisons and Therapeutic Goods Regulation 2026 commence in NSW on this date.

Businesses should aim to complete their compliance review before commencement, not wait until the new laws are already operating.

Where to Check Current Information

The primary source for implementation guidance is NSW Health Pharmaceutical Services.

Businesses should also refer to:

• NSW legislation
• Ahpra
• the practitioner’s relevant National Board
• Therapeutic Goods Administration
• professional indemnity insurer
• appropriately qualified legal or regulatory advisers where necessary.

Because detailed regulatory guidance can continue to be updated during an implementation period, clinics should re-check NSW Health information immediately before 5 November 2026.

Final Takeaway

The November 2026 reforms are particularly important for NSW cosmetic injectable clinics.

They reinforce a fundamental principle:

Cosmetic injectable medicines are prescription medicines operating within a healthcare regulatory framework — not ordinary beauty products.

Clinic owners should be able to demonstrate a clear and lawful chain from:

patient assessment → prescribing → lawful medicine supply → storage → direction → administration → documentation → follow-up.

Where any part of that chain is unclear, it should be reviewed before the new legislation commences.

The transition period provides NSW clinics with an opportunity to strengthen their systems before 5 November 2026.

Important Disclaimer

This article provides general educational information and is intended as a regulatory alert for NSW beauty and cosmetic businesses.

It does not constitute legal, medical or regulatory advice.

The Medicines, Poisons and Therapeutic Goods Act 2022 and Medicines, Poisons and Therapeutic Goods Regulation 2026 commence on 5 November 2026. Businesses and practitioners should refer directly to the legislation and the latest NSW Health Pharmaceutical Services guidance for the requirements applying to their individual circumstances.

Stay Connected: Subscribe to NSW Health’s Pharmaceutical Services updates and monitor official ABA communications for further regulatory guidance leading up to the November 5 commencement date. https://www.health.nsw.gov.au/pharmaceutical/Pages/medicine-laws-cosmetics.aspx