AHPRA's off-label prescribing guidance: patient demand is not enough

A patient is in hospital with a perforated oesophagus.

The peptide product that caused it contained semaglutide at eight times the standard concentration. It was counterfeit. It was compounded and sold outside the therapeutic goods regulatory framework. And it was prescribed by a registered health practitioner to a patient who had requested it.

This is the context in which AHPRA released new guidance on 16 September 2026 on the professional obligations of practitioners who prescribe off-label, unapproved, or compounded medicines. The guidance is not a surprise. The regulatory direction has been telegraphed for months. But the specifics are worth reading carefully — particularly the part about surveillance.

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What the guidance actually says

The AHPRA framework sets out three core requirements for off-label and compounded prescribing.

Establish therapeutic need. Patient demand alone is not a valid reason to prescribe. The guidance is explicit: there must be a genuine clinical indication, supported by adequate evidence, or a documented failure or unsuitability of standard treatments. A patient who has seen a social media advertisement for a weight loss peptide and wants a prescription has not established therapeutic need by wanting it.

Ensure informed consent. The patient must understand that the medicine is unapproved and has not undergone TGA assessment for safety, efficacy, and quality in the way that a TGA-registered product has. This is not a form patients sign to waive liability — it is a clinical conversation in which the information is actually communicated.

Document thoroughly. Records must include a patient-specific risk/benefit analysis, clinical reasoning for the prescribing decision, documentation that informed consent occurred, disclosure of any conflict of interest, and notes to support continuity of care. The documentation bar is high and intentional — a short consultation note will not survive regulatory scrutiny.

The surveillance element is the part that changes the landscape for practitioners who had been relying on the absence of complaints as a proxy for compliance. AHPRA has stated it monitors practitioners with high prescribing rates of scheduled medicines, even when no complaint has been lodged. Real-time prescription monitoring must be checked before prescribing. Conflicts of interest — including financial relationships with compounding pharmacies or peptide suppliers — must be declared.

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Both sides of this

The case for this guidance is not complicated. Compounded peptide products exist in a regulatory grey zone that the therapeutic goods framework was not designed to accommodate at scale. A TGA-approved medicine undergoes assessment for quality, safety, and efficacy. A compounded product does not — and when supply chains are opaque, concentration errors and counterfeit substitution are predictable outcomes. One patient has already been hospitalised with a perforated oesophagus. The AHPRA guidance is, in this light, an attempt to reintroduce clinical judgement into a space that had become commercially driven.

The tension worth naming: genuine off-label prescribing — appropriately indicated, well-documented, patient-informed — is a routine and legitimate part of general practice. Many medicines are used off-label in well-supported clinical contexts: some antiemetics in hyperemesis gravidarum, some antidepressants at doses outside their registered range, some dermatologicals for conditions not listed in the approved indications. The guidance is not an attempt to eliminate off-label prescribing. It is an attempt to reestablish that it requires the same clinical rigour as any other prescribing decision.

The risk is that compliance anxiety leads some practitioners to become overly restrictive about genuinely indicated off-label use. The safeguard — and AHPRA makes this reasonably clear — is that the three requirements (need, consent, documentation) are achievable in a competently run consultation. They are not unreasonable. They are what defensible prescribing has always looked like.

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What this means for general practice this week

If you are prescribing compounded peptides, compounded hormones, or any other off-label product at scale — particularly via short telehealth consultations, particularly with a referring or supply relationship with the prescribing clinic — this guidance is directly addressed to your practice.

The documentation requirement alone should prompt a review of current records. Do your off-label prescribing files contain a risk/benefit analysis? Is informed consent documented with enough specificity that it reflects an actual clinical conversation, not a signature? Have you checked real-time prescription monitoring before each prescription?

If you have not already done this review, now is the right time. AHPRA has stated clearly that high prescribing rates attract proactive scrutiny, and further guidance on managing conflicts of interest is forthcoming.

For the broader cohort of GPs who do not prescribe peptides but are asked about them by patients: this guidance gives you clear language for the conversation. There is no approved PBS-funded compounded semaglutide or retatrutide product. A clinical assessment to determine whether an approved GLP-1 receptor agonist is indicated — with appropriate PBS criteria met — is the legitimate path. Patient preference for a cheaper compounded version is not a clinical indication.

The person coming to you with a social media screenshot and a request for a prescription is not wrong to ask. But the answer that protects them — and you — is one grounded in clinical reasoning, not market demand.

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Verdict: yes — read the guidance, review your documentation, and understand that proactive surveillance is already happening.

The regulatory direction has been clear for months. The perforated oesophagus made it urgent.

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Sources cited

1. New guidance on off-label prescribing — Medical Republic, 16 September 2026
2. Patient suffers torn oesophagus after counterfeit peptide use — RACGP newsGP
3. Peptide prescribing crackdown — AHPRA, 16 September 2026