In September, AHPRA and the National Boards released new guidance on prescribing off-label, unapproved and compounded medicines. It doesn’t create new rules, but it makes AHPRA’s expectations very clear, and cosmetic injectables were named as one of the high-volume prescribing areas behind it. So here’s a quick refresher on what it means for us and the conversations we should be having with every patient. 

What counts as off-label? 

A treatment is off label when a TGA-registered medicine is used differently from its approved Product Information. That includes a different treatment area, dose, route or patient group. Off-label use is legal and often well supported by evidence, but it comes with extra responsibility around assessment, consent and documentation. 

Toxin 

A quick reminder for toxin: all lower face toxin treatments are off label, with one exception. Botox is TGA approved on label for platysma bands. Everything else in the lower face is off label, including: 

• Masseter

• DAO

• Mentalis

• Lip flip and perioral lines

• Gummy smile 

• Platysma with any product other than Botox

Dermal Filler
Off-llabel isn’t just a toxin issue. Every filler product has its own approved intended purpose, and some treatment areas may fall outside it depending on the product you’re using. Areas to double check include:  

• Tear trough

• Nose

• Temples

• Forehead

• Neck and décolletage

• Hands 

Because this varies between products, always check the Instructions for Use for the specific filler you’re injecting. If an area isn’t listed, treat it as off label and have the same conversation with your patient. 

Start with a genuine reason to treat

AHPRA is clear that patient demand alone isn’t a valid reason to use an off-label medicine. Every off-label treatment should be backed by a proper assessment, a clear clinical reason and a reasonable expectation that it will help. Make sure your prescriber knows exactly which areas you’re planning to treat during the consultation, so the prescribing decision matches the treatment. 

The conversation to have with every off-label patient 

Before treating, make sure your patient understands: 

• That it’s off label and what that means. Keep it simple, for example: “This product is approved in Australia for some areas, but this particular area isn’t one of its approved uses.” 

• Why you’re recommending it. Share your clinical reasoning and the evidence behind it.

• The risks and benefits. Include side effects specific to that area and be honest about what we know less about.

• Their alternatives. This includes on-label options, other treatments, or choosing not to treat at all.

• The cost. AHPRA now spells out that informed consent includes financial consent.

• The plan if it doesn’t work. Agree on treatment goals and what happens if they aren’t met.

• That they can ask anything. Check they’ve understood before going ahead. 
  
  

Your consent form has your back, if the conversation actually happens. 

Every Juv’ae consent form states that the patient has discussed with their practitioner the areas considered off label. That signature only protects you and your patient if the conversation genuinely took place, so please don’t let it become a tick-box moment. 

Why this matters 

AHPRA has said it may look into prescribing patterns even without a complaint being made. Good conversations and good notes are your best protection, and they’re also what builds trust and keeps patients coming back. This is something Juv’ae nurses already do brilliantly, so think of this as a chance to make sure we’re all doing it consistently. 

References 

Australian Health Practitioner Regulation Agency. Prescribing off-label, unapproved or compounded medicines. September 2026. 

Australian Health Practitioner Regulation Agency. Prescribing off-label, unapproved or compounded medicines: Case studies. September 2026. 

Australian Health Practitioner Regulation Agency. Guidelines for registered health practitioners who perform non-surgical cosmetic procedures. September 2025.

Australian Health Practitioner Regulation Agency. National Prescribing Competencies Framework.  

Therapeutic Goods Administration. BOTOX (AbbVie Pty Ltd): new indication, platysma bands.