The TGA’s chief medical advisor issued a gentle reminder at a recent conference appearance.
With off-label prescribing ability comes great responsibility.
That’s what Professor Robyn Langham AM, chief medical advisor at the TGA, told delegates at the 2026 Australasian Society of Cosmetic and Procedural Dermatologists Symposium in Melbourne this morning.
“This is something that, mea culpa, I was certainly guilty of doing a lot of off-label prescribing in my time [without] being aware of the legislative rules and requirements that sit behind them,” Professor Langham said.
Professor Langham reminded delegates that while off-label prescribing is allowed in Australia, when a healthcare professional decides to prescribe off-label that they then assume the role of the TGA in assessing the safety and efficacy of the treatment being prescribed for a certain individual.
“You need to ensure that the risks that you’re aware of have been explained to the patient as part of an informed consent process.”
For example, while the botulinum toxin (Botox) has cosmetic indications listed on the ARTG, hyaluronidase powder (Hyalase) does not.
“So, if you were to use hyaluronidase for a cosmetic process, you would need to understand the safety, efficacy and risks, and explain all of that to your patients and get informed consent from them [before you begin],” Professor Langham emphasised.
Similarly, there are several dermal reconstructive products (Rejuran, SkinVive and Restylane Volyme, for example) that are classified as medical devices by the TGA and have cosmetic indications listed on the ARTG – but only for certain body sites.
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“They may not necessarily include the breast, [or] they may not necessarily include the lower half of the face. But if you’re using a product that is registered as a device, [you need to] understand what the indication is. Because if you use it for a different indication, you’re using it off-label, and you have other responsibilities,” Professor Langham said.
Professor Langham then used figures from the TGA’s Database of Adverse Event Notifications to emphasise her point. There were 160 reports (cases) involving adverse events for botulinum-containing products between the launch of DAEN and 6 March 2026. Forty-six of these reports involved the product being used off-label – double the number of reports for the next highest adverse event (anxiety, 23).
“This is by no means a 100% collection of adverse events… but people are understanding where they do and don’t have off-label use and the problems associated [with it],” said Professor Langham.
The 2026 ASCPD Symposium was held in Melbourne from 20 to 22 March.
