Off-Label, Unapproved or Compounded: AHPRA's New Prescribing Guidance and What It Means for Cosmetic Injectors
Hi Facecoachers,
AHPRA has published new guidance on prescribing off-label, unapproved or compounded medicines.
It was reviewed on 16 September 2026. It applies to all registered health practitioners authorised to prescribe scheduled medicines.
This guidance is directly relevant to cosmetic medicine because off-label use is common in aesthetics. Botulinum toxin may be used outside approved sites, microbotulinum toxin may be used for skin quality, fillers may be used beyond a registered indication, and products such as PLLA and polynucleotides may be used in evolving ways.
Off-label prescribing is not automatically wrong.
But it does carry additional responsibilities. The new guidance makes those responsibilities much harder to overlook.
Read the full AHPRA guidance on prescribing off-label, unapproved or compounded medicines, as well as the accompanying AHPRA case studies.
First, what do these terms mean?
Term | Meaning |
Off-label | A medicine included on the ARTG used for a purpose or in a manner that differs from its TGA-approved Product Information. This includes a different indication, dose, route of administration, or use in a patient of an age or gender outside the registered use. |
Unapproved | A medicine that is not included on the ARTG, but which may be accessed under certain pathways and conditions. |
Compounded | A preparation, mixture or alteration made by a pharmacist or doctor for a specific patient when commercially available products are unsuitable or unavailable. Compounded medicines are unapproved and have not been assessed by the TGA for safety, quality and efficacy before supply. |
The first practical step is to know exactly what your product’s Australian Product Information covers.
If you inject outside that information, you are dealing with off-label use and the extra responsibilities apply.
Why this matters in cosmetic medicine
AHPRA is particularly concerned about healthcare models that capitalise on limited consumer knowledge.
The guidance highlights single-treatment telehealth models involving:
A single medicine being prescribed
Very brief consultations
Limited patient assessment
Inadequate discussion of risks and benefits
Restricted treatment options
Conflicts of interest created by prescribing and dispensing one product
This is interesting because aesthetic medicine can easily become product-led rather than patient-led.
A patient may arrive asking for a particular toxin, filler or treatment trend. That request is relevant to the consultation, but it is not, by itself, a therapeutic indication.
AHPRA is explicit: patient demand alone is not a valid reason to prescribe a medicine.
The four responsibilities every prescriber needs to understand
1. Establish a genuine therapeutic need
AHPRA says off-label, unapproved or compounded medicines should only be prescribed when:
An ARTG-listed medicine is unavailable or inappropriate
There is adequate evidence supporting the proposed use
The potential benefits and risks have been identified, evaluated and documented
There is a clear clinical indication
Other treatments have not worked or are inappropriate
The assessment needs to be thorough. It should consider:
Medical history and current medicines
The patient’s views, expectations and motivations
Physiology and relevant examination findings
Social history
Mental health history
Substance use history
RTPM or equivalent checks where relevant
Investigations and monitoring requirements
AHPRA states that a thorough assessment cannot be adequately completed in a brief online consultation.
That should make every clinic review its appointment structure. If prescribing occurs in a few seconds or a few minutes, the assessment is unlikely to meet the expected standard.
We suggest documenting not only what the patient wants, but why the proposed treatment is clinically appropriate for that individual patient.
Your management plan should include treatment goals, alternatives, monitoring, patient information and a plan to stop or change treatment if benefit is not demonstrated.
2. Shared decision-making and informed consent
Consent for off-label use needs to be specific.
The patient should understand:
That the proposed use is off-label, if applicable
Whether the medicine is unapproved
Whether the product has been assessed by the TGA for the intended use
The known and uncertain risks
The expected benefits and limitations
Alternative treatments
The option of no treatment
The costs, including future maintenance or revision costs
Possible side effects and complications
The treatment goals
When treatment will be discontinued if it is not beneficial
This includes financial consent.
The patient needs enough information to compare the proposed treatment with other options and with no treatment at all. Information should be provided in a way the patient can understand, without overstating likely outcomes.
For botulinum toxin treatments, update your consent process to include a four-week symptom window for iatrogenic botulism. Written aftercare instructions should be provided for every botulinum toxin treatment, including symptoms that require escalation and who the patient should contact.
This should sit alongside your broader patient suitability assessment, including motivation, expectations and screening for psychological concerns such as BDD.
3. Document the individual clinical reasoning
This is one of the most important parts of the new guidance.
AHPRA says that pre-filled health record templates are not adequate to document an individual patient assessment.
Templates can support consistency. They cannot replace clinical reasoning.
For each off-label, unapproved or compounded treatment, the record should show:
The reason for use
The patient-specific risk–benefit analysis
Why an ARTG-listed option was unavailable or inappropriate, where relevant
The evidence or clinical information supporting the decision
Alternatives discussed
Consent and financial consent
The limitations of the product or intended use
The plan for monitoring and follow-up
The plan to discontinue treatment if benefit is not demonstrated
Records should also support continuity of care. This is particularly important when the prescriber is different from the practitioner administering the treatment.
Conflicts of interest must be actively managed.
AHPRA notes that conflicts are inherent where an organisation prescribes and dispenses a single medicine. A declaration on a website is not enough. You must be able to demonstrate that commercial interests did not influence patient care.
If your clinic only prescribes one company’s product, document why that product is clinically suitable for that patient and what alternatives were considered.
Finally, adverse events must be reported to the TGA through the Adverse Event Management System. This applies to all therapeutic goods, including off-label, unapproved and compounded medicines.
4. Take the regulatory warning seriously
AHPRA and the National Boards are working with other regulators to understand prescribing patterns.
They may investigate practitioners with high rates of prescribing or compounding of any scheduled medicine, even if no complaint has been received.
The guidance identifies poor practice such as:
Prescribing without a legitimate indication because the patient requested it
Consultations lasting only a few seconds or minutes
Failing to obtain relevant mental health or substance use history
Not checking RTPM before prescribing a monitored medicine
Prescribing only the product supplied by a company with which the practitioner is associated
Failing to declare or manage conflicts of interest
We suggest treating these examples as an internal audit checklist.
What about unapproved medicines and compounding?
Some unapproved therapeutic goods can be accessed through lawful pathways.
The TGA access pathways include:
Special Access Scheme (SAS): access to some unapproved products for an individual patient, case by case
Authorised Prescriber (AP) scheme: an Australian-registered medical practitioner may apply to access a specified unapproved good, or class of goods, for a defined class of patients in their immediate care
Before using the SAS or AP pathway, prescribers are expected to consider clinically appropriate products already included on the ARTG.
Compounded medicines are also unapproved. They are made for a specific patient when a commercially available medicine is unsuitable or unavailable. They are not a convenient way to bypass the TGA framework or create a mass-market cosmetic product.
How this connects with the AHPRA cosmetic guidelines
The AHPRA guidelines for non-surgical cosmetic procedures remain essential reading.
They state that administering or advertising unapproved or unregistered products is unlawful unless an exemption applies, such as certain medicines dispensed or extemporaneously compounded by practitioners.
They also require practitioners to work within their education, training, competence, authorisation and scope of practice.
The National Prescribing Competencies Framework, third edition, published in September 2025, includes new Competency 4.3. This competency addresses adequate and current knowledge when prescribing:
Unapproved therapeutic goods
Compounded products
Medicines for unregistered indications, meaning off-label prescribing
This sits alongside the cosmetic guidelines, not instead of them.
The public advertising of prescription-only cosmetic injectables remains prohibited. Do not use public advertising to promote prescription-only products, including brand names, product categories, nicknames, prices or treatment packages.
A practical checklist for cosmetic injectors
Before your next off-label prescription, ask:
Is the product included on the ARTG?
What does the approved Product Information actually cover?
Is the proposed use off-label?
Is there a clear therapeutic need?
Is an ARTG-listed alternative unavailable or inappropriate?
What evidence supports the proposed use?
Have risks, benefits, costs and alternatives been discussed?
Has the patient understood that the use is off-label or unapproved?
Have you documented patient-specific reasoning rather than relying on a tick-box template?
Have you considered social, mental health and substance use history?
Have you checked RTPM where relevant?
Have conflicts of interest been disclosed and properly managed?
Is there a plan to monitor, review and discontinue treatment?
Do you know how to report an adverse event through AEMS?
For NSW practitioners, remember that prescribers must personally review patients before issuing a written direction, use TGA-approved substances, maintain batch-level administration records for two years and share accountability for clinic governance.
Building stronger cosmetic medicine practice
This new AHPRA guidance reinforces a simple principle: cosmetic medicine must remain clinical medicine.
The fact that a treatment is popular, profitable or requested on social media does not establish a clinical indication.
Good governance means knowing your products, understanding the evidence, assessing the patient properly, documenting your reasoning and being prepared to say no when treatment is not appropriate.
For practitioners wanting a structured review of these issues, the Monash University course, Patient Suitability, Governance, Compliance and Ethics of Non-Surgical Cosmetic Medicine, is a 12-week, fully online intensive requiring 144 notional hours.
It is designed for AHPRA-registered doctors and nurses and includes:
Advertising legislation
AHPRA and NMBA guidelines
Body dysmorphia assessment
State, council and poisons legislation
Patient consent
Ethics
National governance frameworks
Basic patient suitability assessment for lasers, botulinum toxins and soft tissue fillers
The next intake begins 1 February 2027. Monash University certification is included, and the course is designed to fit around the working lives of busy practitioners.
Use FIRST50STUDENTS at checkout where applicable.
The regulatory environment is moving quickly. Investing in structured education is one practical way to keep your prescribing, documentation and patient care aligned with current expectations.
Regards, Mike Clague
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