Compounded Weight Loss Medication in Australia: What to Know

by Burst Health

Compounded weight loss medication became a widely discussed topic in Australia during 2023 and 2024, against a backdrop of public interest in weight management and global supply constraints for certain prescription medicines. The regulatory position on this topic has since changed substantially. From 1 October 2024, amendments to the Therapeutic Goods Regulations 1990 mean that certain compounded weight loss products can no longer be lawfully prepared and supplied by Australian pharmacists.

This article is educational only. It is not a guide to obtaining compounded weight loss products, which cannot be lawfully compounded in Australia for weight management use under current regulations. Anyone considering weight management treatment should speak with a registered prescriber about options that have been evaluated and registered by the Therapeutic Goods Administration (TGA) and are lawfully available in Australia.

What Pharmacy Compounding Is in Australia

Pharmacy compounding is a long-established practice in which a pharmacist prepares a medicine individually for a specific patient, based on a prescription, where a commercially manufactured product is not suitable. Legitimate clinical scenarios for compounding include:

  • a patient has a genuine allergy or intolerance to a non-active ingredient (excipient) in a commercial product

  • a commercial formulation is not available in the strength or form the patient clinically requires

  • an extemporaneous preparation is needed in a clinical setting where no commercial product exists

Compounded medicines are prepared under conditions set by the Pharmacy Board of Australia and the relevant state pharmacy legislation. However, compounded products are not evaluated, registered or supplied under the same system that applies to commercial prescription medicines. They do not carry the same assurance of quality, safety and performance that comes from TGA evaluation and entry on the Australian Register of Therapeutic Goods (ARTG).

How Compounded Weight Loss Products Emerged

Between 2022 and 2024, global supply of several prescription medicines used in weight management was strained. Patient and public interest in weight loss treatment grew substantially during the same period. Against this backdrop, some pharmacies in Australia began compounding products intended to replicate aspects of certain registered weight management medicines.

According to information published by the Department of Health and the TGA, tens of thousands of Australians were estimated to be using these compounded products at the time the regulatory change was being considered. The TGA has since described the compounded products as replicas that were not evaluated for quality, safety or performance, and has raised concerns about reports of adverse events, including hospitalisation.

This was not routine compounding. It was compounding at a scale and for a purpose that the regulatory exemption had not been designed to support.

The TGA Rule Change on 1 October 2024

From 1 October 2024, amendments to Schedule 5, Item 6 of the Therapeutic Goods Regulations 1990 removed glucagon-like peptide-1 (GLP-1) receptor agonist analogues from the pharmacist extemporaneous compounding exemption. The effect of the change is that products based on these active ingredients can no longer be lawfully compounded by Australian pharmacists and supplied to patients for weight management.

The TGA has published detailed consumer and clinician guidance on the rule change, including the reasoning behind it. The Department of Health has also published a ministerial announcement outlining the policy intent of the change.

Patients who had been prescribed compounded products before the rule change should discuss the situation with their prescriber and pharmacist to understand how the change applies to their care and what lawful alternatives may be available.

Why the TGA Acted

The TGA and the Department of Health have been clear about the reasons for the restriction. Their published rationale includes:

  • compounded weight loss products had not been evaluated by the TGA for quality, safety or performance

  • the active ingredients involved are sterile injectable products that present higher risk when not manufactured under controlled conditions

  • reported adverse events included hospitalisation, according to published TGA statements

  • counterfeit and unregistered products were being supplied in association with the compounding activity

  • direct-to-consumer advertising of compounded prescription products was identified as a regulatory concern, because advertising prescription-only medicines to consumers is prohibited under the Therapeutic Goods Act 1989

Taken together, these concerns led the regulator to conclude that the continued supply of compounded replica products for weight management carried risks that the compounding exemption was not intended to cover.

The Current Status of Compounded Weight Loss Products

The current position in Australia can be summarised as follows:

  • compounded versions of GLP-1 receptor agonist analogues cannot lawfully be compounded by Australian pharmacists for weight management use

  • supply of unregistered therapeutic goods in Australia is a regulatory offence and can lead to enforcement action

  • the authoritative source for what is lawfully available is the ARTG, searchable at artg.tga.gov.au

  • the TGA has issued safety alerts about counterfeit and unregistered weight loss products reported in circulation

Enforcement action by the TGA in this area is a matter of public record. Where a product is offered outside these regulatory boundaries, patients should exercise caution and can report concerns to the TGA.

What Patients Considering Weight Management Should Do Now

For anyone considering prescription treatment for weight management, the most useful next step is a conversation with a registered healthcare practitioner. During that conversation, the prescriber can:

  • conduct a full clinical assessment

  • discuss TGA-registered medications that may be appropriate

  • explain eligibility criteria, including PBS subsidies where relevant

  • provide guidance on expected follow-up and monitoring

  • refer to specialist care where clinically indicated

Patients can also check the ARTG directly to confirm whether a specific product is registered for supply in Australia. If a product is being promoted for weight management that cannot be found on the ARTG, that is a reason for caution, and concerns can be reported to the TGA.

Frequently Asked Questions

Can I still get a compounded weight loss injection in Australia?

No. Since 1 October 2024, GLP-1 receptor agonist analogues can no longer be lawfully compounded by Australian pharmacists for weight management use. Products that are offered outside this regulatory framework should be treated with caution.

Why did the TGA restrict compounded products in this area?

The restriction applies specifically to the class of active ingredients used in compounded weight loss replicas. The TGA’s rationale is that compounding of these products at scale for weight management use was not what the pharmacist compounding exemption was designed to permit, and that the products carried risks that were not being managed through the usual regulatory system.

Are compounded products different from TGA-registered medicines?

Yes. Compounded products are prepared individually by a pharmacist for a specific patient. Registered medicines are evaluated by the TGA and listed on the ARTG after assessment of quality, safety and performance. The two categories are not equivalent.

Were there reported health risks from compounded products?

According to TGA and Department of Health statements, yes. Concerns included reports of adverse events including hospitalisation, counterfeit products, and products being supplied without appropriate regulatory oversight.

What should I do if I was prescribed a compounded weight loss product before the rule change?

Speak with your prescriber. They can advise on what the rule change means for your care, whether an alternative TGA-registered medicine may be appropriate, and how to manage the transition.

Further Information

For authoritative information on compounded weight loss medicines, the TGA rule change and prescription medicines in Australia, useful sources include:

  • The Therapeutic Goods Administration, consumer explainer on compounded weight-loss medicines (tga.gov.au)

  • The Therapeutic Goods Administration, media release on the rule change (tga.gov.au)

  • Department of Health, ministerial release on unsafe compounding of replica weight loss products (health.gov.au)

  • The Australian Register of Therapeutic Goods (artg.tga.gov.au)

  • Healthdirect Australia (healthdirect.gov.au)

This article is general information only and does not replace individualised medical advice. Please speak with a registered Australian healthcare practitioner about your own circumstances.

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