Australian health regulators have issued new prescribing guidance aimed at reducing risks when practitioners use medicines off-label, prescribe unapproved therapeutic goods or arrange medicines to be compounded for an individual patient.

The guidance from the Australian Health Practitioner Regulation Agency and National Boards responds to concern about prescribing models in which commercial pressure, telehealth convenience or consumer demand can overtake a careful clinical assessment. Regulators have highlighted growing interest in products including unapproved peptides, medicinal cannabis and medicines used for weight management.

The change does not mean off-label prescribing, access to unapproved medicines or compounding is automatically unsafe or unlawful. Each can have a legitimate clinical role. The point of the guidance is that practitioners need to be able to justify why the option is appropriate for the individual patient and show that the usual professional safeguards have not been bypassed.

What the guidance is trying to prevent

Prescribing becomes higher risk when the clinical decision appears to begin with a product rather than with the patient’s needs. That can happen when a service markets itself around a particular medicine, when a short online consultation is designed mainly to provide access to a requested product, or when a prescriber has a financial relationship with the business supplying the medicine.

Ahpra and the National Boards say some practitioners have departed from established professional standards as demand for certain medicines has increased. They have also warned that telehealth prescribing and the use of medicines outside conventional approved pathways can require greater, not lesser, clinical rigour.

In practical terms, that means a practitioner still needs an adequate history, enough information to make a safe decision, consideration of alternative treatments, appropriate follow-up and a clear record of why the prescription is justified. A remote consultation does not remove those obligations.

Off-label prescribing is one of the areas that is often misunderstood. A medicine can be approved by the Therapeutic Goods Administration and included in the Australian Register of Therapeutic Goods, but a doctor may prescribe it for a condition, age group, dose or use that is outside the specific approved product information. That is an off-label use rather than an unapproved medicine.

Off-label prescribing is common in some parts of medicine and can be clinically appropriate when evidence and professional judgement support it. The key issue is whether the prescriber has assessed the evidence and risks for the patient rather than assuming that an approved medicine is automatically proven for every use.

An unapproved therapeutic good is different. It is a product that has not been included in the Australian Register of Therapeutic Goods for routine supply. Australia has pathways that can allow access to some unapproved products in defined circumstances, but those pathways do not turn the product into a generally approved medicine.

That distinction matters for products promoted online as experimental or cutting-edge treatments. The TGA has repeatedly warned about unapproved peptide products such as BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295. It says these products have not been evaluated by the regulator for safety, quality or effectiveness and that imported products may be poorly labelled or of uncertain composition.

In June, the TGA and Australia’s Chief Medical Officer said reports and hospital data had identified serious adverse effects associated with unapproved peptides, including liver injury, severe allergic reactions requiring hospital treatment and inflammatory complications.

Those warnings do not mean every medicine containing a peptide is unapproved. Insulin and a range of other peptide-based medicines are established therapeutic goods. The regulatory concern is about specific products being supplied or promoted outside the approved framework.

Why compounded medicines are different

Compounding is another legitimate but limited pathway. A pharmacist or certain other authorised health practitioners can prepare a medicine for an individual patient when a suitable approved, ready-made product is not appropriate or available.

A patient may, for example, need a different strength, a liquid instead of a tablet, or a formulation that avoids an ingredient to which they are allergic. In those circumstances, an individually prepared medicine can meet a real clinical need.

The TGA says compounded medicines are not individually evaluated for safety, quality and efficacy in the way registered commercial products are. Instead, the law regulates when compounding exemptions apply and how the product can be manufactured, supplied and advertised.

That is why regulators generally expect an approved medicine to be used when it can meet the patient’s needs. Compounding is not intended as a routine commercial shortcut around the approval system or as a way to mass-produce a substitute simply because a product is popular.

The TGA updated its detailed compounding guidance this month. It says the legal framework allows limited exemptions for patient-specific needs but places additional restrictions and expectations around higher-risk categories such as medicinal cannabis, some biological products, intravenous therapies and GLP-1 receptor agonist analogues.

Australia has already tightened rules around compounded GLP-1 products. Since October 2024, pharmacists have generally been prohibited from compounding GLP-1 receptor agonist analogues under the former exemption that had been used for weight-loss products. That followed safety and quality concerns during a period of strong demand.

Commercial influence is part of the concern

The new professional guidance also focuses on the relationship between prescribing and commercial models. Online healthcare can improve access, particularly for people in regional areas or those who have difficulty attending a clinic. The risk arises when the business model creates pressure to prescribe.

A clinic may earn revenue from consultations, from a linked pharmacy, from supplying a compounded medicine or from a narrow service built around one product category. None of those arrangements automatically proves inappropriate practice, but practitioners need to identify and manage conflicts of interest.

The clinical decision has to remain independent. A patient should not receive a medicine simply because an advertising funnel has already persuaded them that it is the answer, or because the service depends financially on converting an enquiry into a prescription.

That is particularly important with medicines promoted through social media, where claims can travel faster than the evidence and where consumers may not be able to distinguish an approved product from an experimental or unlawfully supplied one.

The TGA has made unapproved peptides a compliance priority in 2026 and has taken enforcement action against alleged unlawful importation, advertising and supply. Its warnings emphasise that products bought through websites, messaging apps or social platforms can contain uncertain ingredients and may not have been manufactured under Australian quality controls.

What patients should understand

The regulatory message is not that patients should reject every off-label, unapproved or compounded treatment. It is that those categories deserve a clear explanation.

A practitioner should be able to explain what the medicine is, whether the proposed use is approved, what evidence supports it, what important risks and uncertainties exist, what alternatives are available and what follow-up is required. Where informed consent is needed because the medicine is being used outside normal approval pathways, that discussion should be meaningful rather than a box-ticking exercise.

Patients can also ask whether the product is included in the Australian Register of Therapeutic Goods, why an approved alternative is not suitable, where a compounded product will be made and how adverse effects will be monitored.

The new guidance is ultimately about keeping professional standards consistent as prescribing models change. Telehealth, personalised medicines and new therapeutic products can expand access and choice, but they do not reduce the prescriber’s responsibility to make an evidence-based decision for the person in front of them.

For regulators, the next question is whether clearer guidance changes practice or whether further enforcement is needed where prescribing, compounding or advertising crosses legal and professional boundaries.