Author: Dr Owen Bradfield, MIPS Chief Medical Officer
Background
In September 2026, Ahpra released new guidance to support practitioners who prescribe off-label, unapproved or compounded medicines. The guidelines respond to concerns about single-treatment telehealth models where high volumes of medicines (particularly peptides, medicinal cannabis and GLP-1 weight-loss medicines) are prescribed following limited assessment and inadequate communication of risks.
Practitioner responsibilities
Rather than prohibiting the prescribing of these medicines, the guidelines recognise this can have a legitimate place in patient care. However, practitioners must: The standard of care. Civil liability law across Australia holds GPs to the standard of a reasonable professional peer, regardless of how relaxed the prescribing pathway is.
1. Establish therapeutic need
To demonstrate sound clinical reasoning, patients must be adequately assessed. This may include obtaining a relevant medical history (including mental health and substance use history), conducting a physical examination and ordering investigations. Patient demand alone (such as through social media) is not a legitimate reason to prescribe a medicine. Before prescribing, practitioners should have the knowledge and experience needed to prescribe the medicine safely.
2. Obtain informed consent
Patients need to know if a medicine is being used outside its approved indication or is not included on the Australian Register of Therapeutic Goods (ARTG), which means it has not been assessed by the Therapeutic Goods Administration (TGA) for quality or safety. Practitioners should explain any evidence supporting the proposed treatment, its benefits and risks, alternatives (including why approved medicines are not considered appropriate), costs and the proposed monitoring or review arrangements.
“The purpose of obtaining consent is not simply to obtain a patient's agreement to the prescription. It is to enable a genuinely informed decision about a treatment for which there may be greater uncertainty.”
3. Document the clinical reasoning
The health record should outline why the medicine was appropriate for that particular patient, including the clinical indication, relevant risk–benefit considerations and the basis for the decision. Informed consent discussions and the patient's understanding should also be recorded.
4.Comply with legal and regulatory obligations
4. Comply with legal and regulatory obligations. Practitioners must comply with legal and regulatory requirements, including state and territory drugs and poisons legislation, TGA requirements and obligations to check real-time prescription monitoring databases.
Case scenarios: what does poor practice look like?
Case scenarios: what does poor practice look like?
The guidelines include a number of case studies, designed to help practitioners apply the principles to real-world prescribing decisions. The take-home messages from these case studies are that:
- patient preference is relevant to shared decision-making, but a patient’s request for a medicine is not a clinical indication and does not replace clinical judgement
- brief telehealth consultations that limit the information available to the practitioner may create safety concerns
- practitioners should check real-time prescription monitoring systems before prescribing monitored medicines
- financial benefits (for example), from only prescribing a product supplied by a related company may undermine independent clinical judgement, particularly where patients are not offered reasonable alternatives.
These examples highlight that Ahpra’s focus is on the quality and independence of prescribing decisions rather than on the medicines themselves.
What happens if you don't follow the guidance?
Failing to consider this guidance without reasonable excuse could lead to regulatory action by Ahpra. Ahpra may also investigate practitioners with high rates of prescribing or compounding of scheduled medicines even where it has not received a complaint.
Checklist for practitioners
Before prescribing an off-label, unapproved or compounded medicine:
- Ensure there is a genuine therapeutic need for the medicine.
- Adequately assess the patient.
- Consider whether there is a suitable alternative that is approved, on-label and/or not compounded.
- Consider the available evidence and communicate the benefits, risks and alternatives to the patient.
- Document your decision-making and conversations with the patient.
- Identify, avoid or control, and disclose any conflicts of interest.
Cover for prescribing unapproved peptides under the MIPS Indemnity Insurance Policy
Finally, members should be aware of recent changes to the cover available under the 2026-27 MIPS Indemnity Insurance Policy.
From 1 July 2026, MIPS has removed cover for claims arising out of, or in connection with the prescribing of peptides that are not approved by the TGA and not listed on the ARTG, unless agreed to in writing by Us, or unless you hold specialist endocrinologist or oncologist registration or are following a treatment plan provided by a specialist endocrinologist or oncologist.
Before prescribing any peptide, check whether it is listed on the ARTG. If it is not listed on the ARTG, you will only be covered if MIPS agrees in writing or one of the specialist exceptions above applies. Remember to review the current Member Handbook for the full terms and conditions of the MIPS Indemnity Insurance Policy.
References
- Ahpra. Prescribing off-label, unapproved or compounded medicines. September 2026. Available at: https://www.ahpra.gov.au/Resources/Prescribing-off-label-unapproved-or-compounded-medicines
- Therapeutic Goods Administration. Understanding your responsibilities when importing, compounding and supplying unapproved peptide products. Safety advisory, 13 April 2026. Available at: https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products
- MIPS. Member Handbook: Combined Product Disclosure Statement and Financial Services Guide. Available at: https://www.mips.com.au/Resources/Publications
All information on this page is of a general nature only and is not intended to be relied upon as, nor to be a substitute for, specific legal or other professional advice. No responsibility for the loss occasioned to any person acting on or refraining from action as a result of any material published can or will be accepted by MIPS.
You should seek legal or other professional advice before relying on any content, and practise proper clinical decision making with regard to the individual circumstances.
Information is only current at the date initially published.
If in doubt, contact our claims and 24-hour medico-legal advice and support team on 1300 698 573.
You should consider the appropriateness of the information and read the Member Handbook Combined PDS and FSG before making a decision on whether to join MIPS.
