AHPRA’s New Guidance on Off-Label, Unapproved and Compounded Medicines: What Australians Should Know

Published: September 2026

Australia’s medicines landscape is changing rapidly, with increasing interest in off-label medicines, unapproved therapeutic goods, compounded medicines and emerging treatments such as peptides.

In September 2026, the Australian Health Practitioner Regulation Agency (AHPRA), together with the relevant National Boards, published new guidance for registered health practitioners prescribing off-label, unapproved or compounded medicines.

The guidance is particularly relevant to modern models of healthcare, including telehealth and high-volume prescribing environments. It reinforces that prescribing decisions must be based on clinical need, appropriate evidence, professional judgement and informed consent — rather than simply on a person’s request for a particular medicine. (RACGP)

This article explains what the new guidance means, what the terms off-label, unapproved and compounded mean in Australia, and what patients should understand before considering these medicines.

What has AHPRA changed?

The September 2026 guidance does not create a new category of medicine or make off-label, unapproved or compounded prescribing illegal.

Instead, it provides further guidance to registered health practitioners about their existing professional and legal responsibilities when prescribing medicines outside their usual approved framework.

AHPRA’s guidance follows increasing regulatory attention on prescribing practices involving medicines such as unapproved peptides, medicinal cannabis and other prescription medicines, particularly where consumer demand, commercial interests or high-volume models of care may influence prescribing decisions. (RACGP)

AHPRA states that practitioners should have the necessary knowledge, skills and training to prescribe safely and should be able to demonstrate appropriate clinical reasoning for their prescribing decisions. (Medical Republic)

The guidance also includes case studies intended to help practitioners reflect on their prescribing decisions.

What does “off-label” mean?

An off-label medicine is a medicine that is included on the Australian Register of Therapeutic Goods (ARTG), but is prescribed for a use that differs from its approved indication or conditions of use.

For example, a medicine may be registered for one condition but prescribed for another condition, or it may be used at a different dose, duration, route or patient population from that described in its approved product information.

Off-label prescribing is not automatically unlawful or inappropriate.

However, it places greater responsibility on the prescribing practitioner to have sufficient knowledge of the medicine, assess whether there is a legitimate clinical reason for its use, consider available evidence and discuss relevant risks and benefits with the patient. AHPRA’s National Prescribing Competencies Framework specifically addresses prescribing medicines for unregistered indications. (AHPRA)

What is an unapproved medicine?

An unapproved therapeutic good is a therapeutic good that has not been included in the Australian Register of Therapeutic Goods (ARTG), unless an applicable exemption, approval or authority allows it to be lawfully accessed.

The TGA explains that therapeutic goods generally need to be included in the ARTG before they can be lawfully supplied in Australia. There are, however, specific pathways that allow certain unapproved therapeutic goods to be accessed in defined circumstances. (Therapeutic Goods Administration (TGA))

These pathways can include mechanisms such as the Special Access Scheme (SAS) or the Authorised Prescriber pathway, depending on the circumstances and the medicine involved.

Importantly, being legally accessible through an unapproved pathway does not mean that the product has been evaluated by the TGA in the same way as an ARTG-registered medicine.

What are compounded medicines?

A compounded medicine is a medicine prepared for an individual patient rather than supplied as a standard commercially manufactured product.

Compounding can sometimes be appropriate where an approved medicine does not meet a patient’s specific clinical requirements — for example, where a different formulation, dose or ingredient is required.

The TGA describes compounded medicines as unapproved therapeutic goods because the individual compounded product has not itself undergone the ARTG evaluation process for safety, quality and efficacy. (Therapeutic Goods Administration (TGA))

There are specific legal exemptions that can allow certain compounded medicines to be supplied without ARTG inclusion when the relevant requirements are met.

The TGA emphasises that these exemptions are limited and subject to conditions. (Therapeutic Goods Administration (TGA))

Why does AHPRA’s new guidance matter?

The central message is that the fact that a medicine is requested by a patient does not, by itself, establish a clinical reason to prescribe it.

AHPRA’s new guidance states that patient demand alone is not a valid reason to prescribe a medicine. Practitioners are expected to determine whether prescribing is clinically justified based on their professional judgement, available evidence and the individual circumstances of the patient. (RACGP)

This is particularly relevant to newer healthcare models where patients may research a particular medicine online before speaking with a practitioner.

A patient may arrive at a consultation already knowing the name of a medicine they would like to discuss. The prescribing decision, however, remains a clinical decision for the appropriately qualified practitioner.

Clinical need comes before the medicine

AHPRA’s guidance places emphasis on establishing therapeutic need.

The updated National Prescribing Competencies Framework states that prescribers should consider unapproved therapeutic goods, compounded products and medicines for unregistered indications where a registered medicine is unavailable or inappropriate, and where adequate information exists to support their use and the potential benefits and risks have been considered and documented. (AHPRA)

This means a responsible prescribing process should start with the person’s clinical circumstances rather than with a predetermined product.

The practitioner may consider:

• the person’s medical history
• current medicines
• relevant diagnoses or symptoms
• previous treatments
• potential contraindications
• available evidence
• potential benefits and risks
• whether an approved medicine is available and appropriate
• whether the proposed medicine is clinically justified
• whether additional monitoring is required.

The exact assessment required will depend on the medicine and the individual circumstances.

Informed consent is an important part of the process

When a medicine is unapproved, compounded or being used off-label, patients need enough information to understand what that means.

AHPRA’s prescribing framework specifically requires practitioners to obtain and document informed consent and ensure the person understands the use of the medicine and its associated risks and benefits. (AHPRA)

In practical terms, a patient may need to understand:

• Is the medicine approved in Australia? If not, the practitioner should explain its unapproved status and the relevant access pathway.
• Is the medicine being used outside its approved indication? If so, the practitioner should explain that the proposed use is off-label.
• Why is this medicine being considered? The clinical reasoning and therapeutic need should be explained.
• What are the potential benefits and risks? Patients should have an opportunity to ask questions and consider alternatives.
• What alternatives are available? Informed decision-making involves understanding relevant options, not simply being presented with one predetermined medicine.

What does this mean for telehealth?

The new guidance is particularly relevant to telehealth and other digital models of healthcare.

AHPRA states that prescribing through electronic, telephone or other digital communication channels must comply with relevant legislation, guidelines and policies. The National Prescribing Competencies Framework also highlights the need to understand and manage the risks associated with electronic prescribing and virtual care. (AHPRA)

Telehealth itself is not prohibited.

However, the method of consultation does not remove the practitioner’s professional responsibilities.

A practitioner still needs enough information to make an appropriate clinical assessment and prescribing decision.

AHPRA has also previously warned that some emerging healthcare models can create risks where services are designed around a predetermined medicine or outcome rather than individual clinical need. (AHPRA)

Why high-volume prescribing is receiving attention

AHPRA’s September 2026 guidance follows increasing regulatory attention on high-volume prescribing models and businesses centred around particular medicines or treatment outcomes.

AHPRA has stated that it may investigate prescribing practices involving high rates of prescribing or compounding of scheduled medicines, including where there has not been a complaint. (RACGP)

This does not mean that every practitioner working in telehealth or prescribing compounded or unapproved medicines is doing anything wrong.

Rather, it reinforces that the clinical standard remains important regardless of the business model or setting in which healthcare is delivered.

AHPRA and the National Boards previously made this principle clear in their joint statement on professional responsibilities for prescribing and dispensing medicines: practitioners remain individually responsible for meeting the professional standards expected of them, regardless of whether care is provided through a traditional practice, technology platform or another model. (AHPRA)

What about compounded medicines?

Compounding is another area addressed by both AHPRA and the TGA.

The TGA explains that compounded medicines can be appropriate in limited circumstances where a commercially available medicine does not meet an individual patient’s clinical needs.

However, compounded medicines are not individually evaluated by the TGA for safety, quality and efficacy in the same way as medicines entered on the ARTG. (Therapeutic Goods Administration (TGA))

The TGA’s 2026 guidance states that compounded medicines may be exempt from ARTG inclusion in specific circumstances, including certain medicines compounded for a particular person following a valid prescription or request. (Therapeutic Goods Administration (TGA))

This does not mean that any compounded medicine can automatically be manufactured or supplied.

The relevant Commonwealth, state and territory requirements, professional obligations and conditions of the applicable exemption must all be considered.

A significant point for consumers: unapproved does not mean “TGA approved”

An important distinction is the difference between lawful access and TGA approval.

A medicine accessed through an unapproved pathway has not necessarily been evaluated by the TGA for quality, safety and efficacy in the same way as an ARTG-registered medicine.

The TGA defines an unapproved therapeutic good as one that is not included in the ARTG. Such goods can only be manufactured, supplied or advertised where an applicable exemption, approval or authority exists. (Therapeutic Goods Administration (TGA))

Patients should therefore be cautious about language suggesting that an unapproved medicine is “TGA approved” simply because there is a lawful pathway through which it can be accessed.

What does this mean for peptides?

Peptides have received particular attention from Australian regulators during 2026.

AHPRA’s new guidance specifically arrives during increased regulatory scrutiny of prescribing practices involving unapproved peptides. (RACGP)

The important point for consumers is that the word “peptide” does not itself determine whether a substance is approved, unapproved, prescription-only, compounded or otherwise regulated.

Each medicine or substance needs to be considered according to its actual regulatory status and the circumstances in which it is being supplied.

Where a peptide is an unapproved therapeutic good, additional requirements and risks may apply.

The appropriate question is therefore not simply:

“Can I get this peptide?”

A more appropriate starting point is:

“Is there a clinically appropriate reason for this medicine to be considered in my individual circumstances, and what regulatory pathway applies?”

What about advertising these medicines?

The regulatory environment extends beyond prescribing.

The TGA has issued extensive updated guidance during 2026 concerning the advertising of prescription medicines, unapproved therapeutic goods and compounded medicines.

Prescription medicines generally cannot be advertised to the Australian public, except in limited circumstances. The TGA has specifically stated that this prohibition also applies to advertising services where the advertising directly or indirectly promotes prescription medicines. (Therapeutic Goods Administration (TGA))

The TGA’s 2026 guidance also states that advertising unapproved therapeutic goods to the public is prohibited unless an applicable exception applies. This includes compounded medicines. (Therapeutic Goods Administration (TGA))

Importantly, the TGA distinguishes between advertising a health service and advertising the therapeutic goods involved in that service.

A health service may be promoted, but the advertising must not inadvertently become advertising for a prescription medicine or unapproved therapeutic good. (Therapeutic Goods Administration (TGA))

This distinction is increasingly important for websites, social media, search advertising and other digital communications.

What should patients look for when considering these medicines?

A regulated healthcare pathway should allow a person to understand who is responsible for their clinical care.

Questions a patient may reasonably ask include:

1. Who is the prescribing practitioner?

The person making the prescribing decision should be an appropriately qualified and authorised practitioner.

2. Is there an individual clinical assessment?

The prescribing decision should be based on the individual’s circumstances rather than simply on a request for a particular product.

3. Is the medicine approved in Australia?

If it is not included on the ARTG, ask what lawful access pathway applies.

4. Is the proposed use off-label?

If so, ask the practitioner to explain what that means and why the medicine is being considered.

5. Is the medicine compounded?

If so, ask why a compounded formulation is clinically appropriate and what regulatory requirements apply.

6. Are the risks, benefits and alternatives explained?

Informed consent requires meaningful information about the proposed medicine and relevant alternatives.

7. Is there appropriate follow-up?

Prescribing is not simply about supplying a medicine. Appropriate monitoring and continuity of care may be important depending on the medicine and the patient’s circumstances.

What does this mean for GL Vitality Drips?

At GL Vitality Drips, we believe consumers should be able to understand the regulatory environment surrounding modern medicine without confusing education with prescribing.

GL Vitality Drips does not diagnose medical conditions, prescribe medicines or independently determine whether a medicine is clinically appropriate for an individual.

Where a prescription medicine or other therapeutic good is being considered, clinical decisions are made by the appropriately qualified prescribing practitioner.

Our role is to provide a structured, practitioner-guided journey and support the administrative and coordination aspects of that process.

The prescribing practitioner remains responsible for the clinical assessment, prescribing decision, informed consent and ongoing clinical management.

This distinction is particularly important as Australian regulators continue to clarify expectations around off-label, unapproved and compounded medicines.

The broader message from AHPRA

The September 2026 guidance reinforces a relatively straightforward principle:

A medicine should be prescribed because a qualified practitioner has determined that it is clinically appropriate for an individual patient — not simply because the patient has requested it or because a particular medicine is commercially popular.

For off-label, unapproved and compounded medicines, additional considerations may apply because the regulatory status and evidence base can differ from those of an ARTG-registered medicine.

The updated guidance does not mean that every off-label, unapproved or compounded medicine is inappropriate.

Rather, it reinforces the importance of clinical need, appropriate evidence, professional judgement, informed consent, documentation and patient-centred care.

For consumers, understanding these distinctions can help make conversations with registered health practitioners more informed and transparent.

Key takeaways

• Off-label prescribing is not automatically unlawful, but requires appropriate clinical judgement and consideration of evidence and risks.
• Unapproved therapeutic goods are not the same as ARTG-registered medicines.
• Compounded medicines are unapproved therapeutic goods, although specific legal exemptions can permit their supply in defined circumstances.
• Patient demand alone is not a sufficient clinical reason for prescribing.
• Informed consent is particularly important when medicines are unapproved, compounded or used outside their registered indication.
• Telehealth does not remove professional prescribing obligations.
• Healthcare business models should not replace individual clinical assessment.
• Advertising rules are separate from prescribing rules, and the public advertising of prescription medicines and unapproved therapeutic goods is generally prohibited.
• Consumers should understand who is prescribing, why a medicine is being considered, its regulatory status, and what alternatives and risks have been discussed.

References

• Australian Health Practitioner Regulation Agency (AHPRA) (2026), Prescribing off-label, unapproved or compounded medicines, AHPRA, September 2026. (RACGP)
• Australian Health Practitioner Regulation Agency (AHPRA) (2025), National Prescribing Competencies Framework, 3rd ed., AHPRA. (AHPRA)
• Australian Health Practitioner Regulation Agency (AHPRA), Medical Board of Australia, Nursing and Midwifery Board of Australia and Pharmacy Board of Australia (2024), Joint statement on professional responsibilities for prescribing and dispensing medicines, 3 June 2024. (AHPRA)
• Therapeutic Goods Administration (TGA) (2026), Compounded medicines, Australian Government Department of Health, Disability and Ageing, updated 14 May 2026. (Therapeutic Goods Administration (TGA))
• Therapeutic Goods Administration (TGA) (2026), Manufacturing, supplying and advertising compounded medicines lawfully, Australian Government Department of Health, Disability and Ageing, updated 8 September 2026. (Therapeutic Goods Administration (TGA))
• Therapeutic Goods Administration (TGA) (2026), Complying with the restrictions on advertising prescription medicines to the public, Australian Government Department of Health, Disability and Ageing, updated 23 June 2026. (Therapeutic Goods Administration (TGA))
• Therapeutic Goods Administration (TGA) (2026), Advertising health services that involve therapeutic goods, Australian Government Department of Health, Disability and Ageing, updated 18 June 2026. (Therapeutic Goods Administration (TGA))

Related reading

• Special Access Scheme (SAS) in Australia: What the TGA Says About Unapproved Therapeutic Goods
• What Is the ARTG? Understanding Australia’s Register of Therapeutic Goods
• Approved vs Unapproved Therapeutic Goods: What Is the Difference?