Peptides and compounded medicines: Ahpra and TGA guidance and action

Ahpra’s September 2026 guidance on off-label, unapproved and compounded medicines, the TGA’s peptide focus and what clinics must check.

16 September 202611 min read

On 16 September 2026, Ahpra and the National Boards published new guidance on prescribing off-label, unapproved or compounded medicines, alongside a warning to practitioners about unsafe prescribing of unapproved peptides, medicinal cannabis and GLP-1 weight-loss drugs. Ahpra said it had been investigating these practices, particularly in high-volume and single-treatment business models, and listed inappropriate advertising as one of the red flags that can prompt it to act.

This sits within a broader shift. The TGA published guidance on compounded medicines on 14 May 2026, added unapproved peptide products to its compliance priority focus areas on 10 June 2026, and on 28 September 2026 announced Federal Court proceedings over alleged peptide advertising. For clinics in longevity, wellness, weight loss, sports medicine and men’s and women’s health, the marketing risk now comes from two regulators working together. This article was current at the time of writing; Ahpra says its guidance will be updated as new developments occur.

What changed

Ahpra guidance on off-label, unapproved and compounded medicines (16 September 2026)

Ahpra’s release said growing consumer demand for certain medicines, coupled with undue commercial influence, had led some practitioners to depart from established professional standards. It said regulatory action had been taken against practitioners over unsafe prescribing, that Ahpra does not need to wait for a notification, and that red flags such as unusual prescribing patterns or inappropriate advertising can lead it to raise concerns with the practitioner directly or notify other agencies where businesses are involved.

Ahpra said it and the TGA are working closely to identify where prescribing concerns may also involve the unlawful advertising, importation or supply of therapeutic goods. Case studies were published with the guidance, and the guidance page says it was first published in September 2026.

Ahpra interim conflict of interest guidance (September 2026)

The 16 September release said new conflict of interest guidance would follow shortly. Ahpra has since published interim guidance on managing financial or commercial conflicts of interest. It flags “one stop shop” clinics that prescribe and dispense a single medicine, and vertically integrated models, and says declaring a conflict on your website, in advertising or on social media is not sufficient disclosure.

TGA compounded medicines guidance (14 May 2026)

The TGA published Manufacturing, supplying and advertising compounded medicines lawfully. Its release says the guidance explains how pharmacists, medical practitioners and other relevant practitioners can lawfully compound medicines, including when exemptions from manufacturing licensing and ARTG inclusion may apply. It also outlines additional restrictions and expectations for higher-risk products, including biologicals, medicinal cannabis, GLP-1 receptor agonist analogues and intravenous (IV) therapies. The TGA asked practitioners who compound to check that their compounding, supply and advertising practices comply.

Peptides as a TGA priority (10 June 2026)

The TGA expanded its priority focus areas to include unapproved peptide products, citing increased detection of unlawful importation, supply and advertising. It said such products are often marketed for performance enhancement or anti-ageing, and that many peptide products supplied in Australia are not on the ARTG and have not been assessed for safety, quality or effectiveness.

Federal Court proceedings over peptide advertising (28 September 2026)

The TGA started Federal Court proceedings against A.C.N. 641 483 703 Pty Ltd (in liquidation), formerly BioV8 Pty Ltd, and two former directors. The TGA alleges that between 6 June 2024 and 14 July 2025 the company unlawfully advertised prescription-only peptides on its website and social media, and promoted them for serious diseases, conditions and disorders, including cancer, HIV/AIDS and mental illnesses. It alleges the directors aided, abetted, counselled or procured the advertising. These are allegations that have not been decided by the Court. Because the company is in liquidation, proceedings against it require the Court’s leave.

In announcing the case, the TGA said it will take legal action against all entities unlawfully operating in the peptide industry, naming health practitioners, compounding pharmacies, social media influencers and telehealth clinics where it identifies unlawful advertising of peptides.

Who it applies to

Ahpra’s guidance applies to all registered health practitioners who are authorised to prescribe scheduled medicines. That includes medical practitioners, nurse practitioners and other practitioners with prescribing rights.

The TGA’s advertising rules apply to anyone who advertises therapeutic goods. In this area that commonly includes:

longevity, anti-ageing, wellness and IV therapy clinics
weight-loss, men’s health and women’s health services, including telehealth
sports medicine and performance clinics
compounding pharmacies
business owners and directors, including people who are not registered practitioners
influencers, content creators and agencies.

What the rules require

A genuine therapeutic need

Ahpra’s guidance says off-label, unapproved or compounded medicines should only be prescribed when a medicine on the ARTG is unavailable or inappropriate and there is adequate evidence to support use. It states: “Patient demand alone is not a valid reason to prescribe a medicine.”

A thorough assessment

Good care includes a thorough assessment covering medical history, an appropriate physical examination or investigations where relevant, and social, mental health and substance use history, including checking real-time prescription monitoring. The guidance says a thorough assessment “cannot be adequately completed in a brief, online consultation.”

Informed consent, including financial consent

Patients must understand that the medicine is not approved for the intended use, or has not been assessed by the TGA for safety, efficacy and quality, and the risks and benefits compared with alternatives. Informed consent includes financial consent, and practitioners must give a plan to stop treatment if benefit is not shown.

Documentation

Records must document a patient-specific risk and benefit analysis, the reasoning and the consent. The guidance says pre-filled templates are not adequate for individual assessment. Adverse events must be reported to the TGA.

Conflicts of interest

The guidance says conflicts are inherent when working in an organisation that prescribes and dispenses a single medicine, and that single-treatment telehealth models present an inherent conflict that must be recognised, managed and disclosed to patients. It states that “A declaration of a conflict on a website is not sufficient”, and that practitioners must be prepared to show financial or commercial interests did not influence care.

No advertising of prescription-only or unapproved medicines to the public

The Therapeutic Goods Act 1989 prohibits advertising prescription medicines to the public, and separately prohibits advertising therapeutic goods that are not on the ARTG, subject to limited exceptions. The TGA’s health services guidance says compounded medicines are not exempt from the advertising requirements. Its prescription medicines guidance gives “Peptides”, “BPC 157”, “CJC 1295” and “Ipamorelin” as examples of direct or indirect references to prescription medicines, and lists peptides and IV drip therapies among services that risk unlawful promotion when a business presents itself as a way to obtain them.

No restricted or prohibited representations

Claims about treating serious diseases, conditions or disorders cannot be used in advertising without TGA approval or permission. The BioV8 proceedings involve allegations of this kind.

What it means for your marketing

Website

Remove references to peptides, named peptides and their abbreviations, compounded formulations and similar medicines from public pages, including treatment menus, FAQs, blog posts and metadata. “Peptide therapy” is a class reference. Also remove claims about performance, ageing, recovery or serious conditions that are tied to these medicines.

Booking systems, catalogues and prices

A public menu that lets people choose a named peptide, an IV formulation or a compounded product, or that lists prices for them, is likely to be treated as advertising. The TGA’s guidance says this applies even behind a login or membership area.

Telehealth funnels

Ahpra says single-treatment telehealth models are particularly concerning, citing brief consultations and limited assessments. Marketing that promises a quick online consultation leading to a particular product works against both regulators’ guidance. Promote a consultation about the patient’s health concerns, and let the clinical assessment decide what follows.

Social media and influencers

Ahpra’s release specifically warned against advice from online influencers without clinical knowledge, and the TGA has named influencers in its peptide warning. Do not engage creators to discuss peptides, “stacks”, vials or injection routines, or to share discount codes for prescription treatments. The TGA’s health services guidance says clinics that engage creators should give clear instructions and ensure content complies.

Practitioner profiles and endorsements

Do not show practitioners endorsing a medicine. The Advertising Code prohibits testimonials and endorsements from health practitioners, and the National Law prohibits testimonials in advertising for regulated health services.

Conflict of interest statements

If your business prescribes and supplies, a website disclaimer is not enough. Build disclosure into each consultation and record it.

Email, SMS and in-clinic material

Mass communications about prescription medicines are unlikely to be exempt. Posters, menus and brochures in waiting areas are also covered.

Directors and business owners

The BioV8 proceedings allege that directors aided and abetted the advertising. Owners should not assume liability sits only with the company.

Common mistakes we see

“Research use” or “wellness” framing. Relabelling a peptide offer does not change what is being promoted.
Treating compounding as an exemption. Compounded medicines are not exempt from the advertising requirements.
Protocol menus. Named programs or “stacks” with prices and dosing schedules.
Health claims. Recovery, longevity, immunity or disease-related claims attached to products.
Short consult promises. “Five-minute online consult” messaging for products that Ahpra says need a thorough assessment.
Disclaimer reliance. “Speak to your practitioner” or a conflict notice in the footer. The TGA says disclaimers do not exempt material from the restrictions, and Ahpra says website declarations are not sufficient disclosure.

A practical checklist

Search all public content for “peptide”, named peptides and abbreviations, “compounded”, IV formulation names and similar terms.
Remove treatment menus, catalogues and price lists that name prescription or unapproved medicines, including in member areas.
Remove claims about serious diseases, conditions or disorders.
Remove testimonials and practitioner endorsements of products.
Rewrite telehealth pages to describe a consultation and assessment, without suggesting a product will be prescribed.
Remove “quick consult” or “instant approval” messaging.
Set up conflict of interest disclosure within each consultation, and document it.
Brief influencers, affiliates and agencies in writing, and review their content.
Check email and SMS sequences, in-clinic menus and printed material.
Make sure directors and owners understand they may be personally exposed.

How this fits with other rules

Ahpra and the National Boards. The September 2026 guidance must be read with each Board’s code of conduct and the National Prescribing Competencies Framework. It builds on Ahpra’s telehealth guidance, updated on 7 October 2025, and its medicinal cannabis guidance of 9 July 2025.

TGA. Advertising, importation and supply are governed by the Therapeutic Goods Act 1989 and its regulations. Since 1 October 2024, GLP-1 RA analogues can no longer be compounded by pharmacists and supplied to patients. The TGA’s compliance principles for 2026 and 2027 list weight-loss medications, medicinal cannabis and therapeutic goods used in cosmetic procedures among focus areas, with peptides added on 10 June 2026. In its May 2026 release the TGA quotes civil penalties of up to $1.65 million per breach for individuals and $16.5 million per breach for corporations.

Access pathways. Ahpra’s guidance notes that some unapproved goods can be accessed through the TGA’s Special Access Scheme or Authorised Prescriber scheme. These are prescribing pathways, not permission to advertise.

National Law section 136. Directing or inciting a practitioner to engage in unprofessional conduct is an offence for anyone, registered or not. Ahpra’s conflict of interest guidance gives maximum penalties of $60,000 for an individual and $120,000 for a body corporate.

Frequently asked questions

Can we advertise that we offer peptide therapy?

The TGA’s guidance lists “peptides” as a class reference to prescription medicines and lists peptides among services that risk unlawful promotion when a business presents itself as a way to obtain them. Advertising a consultation, without referring to these medicines, is the approach the guidance points to.

Are compounded products treated differently for advertising?

No. The TGA says compounded medicines are not exempt from the advertising requirements, and Ahpra describes compounded medicines as unapproved medicines that have not been assessed by the TGA.

Is prescribing off-label medicines prohibited?

No. Ahpra recognises off-label, unapproved and compounded medicines can play an important role. Its guidance sets out the extra care required, including a genuine therapeutic need, a thorough assessment and informed consent.

Can a short telehealth consultation be enough?

Ahpra’s guidance says a thorough assessment cannot be adequately completed in a brief, online consultation, and real examples of poor practice include consultations lasting between a few seconds and a few minutes.

We only own the business. Can we be pursued?

The TGA’s advertising rules apply to anyone who advertises, and its BioV8 proceedings allege directors aided and abetted unlawful advertising. Section 136 of the National Law also applies to people who are not registered.

Need a hand?

Peptide, IV and compounded medicine offers tend to appear across many pages, menus and social posts. Our TGA advertising compliance service reviews them against the current guidance, and our AHPRA compliance audit covers the practitioner side, including conflicts and testimonials. Our compliance training can help owners and staff understand where the lines sit.

This article is general guidance based on the published rules, not legal advice. Final responsibility for advertising sits with the registered practitioner, and complex situations may need independent legal advice.