Why were compounded semaglutide and tirzepatide banned in Australia?
What compounding is, what changed on 1 October 2024, the safety problems the TGA found, and what the rules mean now.
Written for Australia. Other country versions are coming.
Since 1 October 2024, Australian pharmacists may not compound (make up their own version of) any GLP-1 medicine, in any form. The TGA said compounded products had not been checked for safety or quality, were being made at commercial scale, and could contain unknown ingredients. Medicines on the Australian register were not affected.
Key takeaways
- From 1 October 2024, a change to the Therapeutic Goods Regulations stopped pharmacists compounding any GLP-1 receptor agonist, in any dosage form.1
- The TGA said compounded semaglutide-like products had not been evaluated for safety, quality or efficacy, and some telehealth services were offering them in December 2023.3
- In March 2024 the TGA tested a product sold as compounded semaglutide and found ten times the labelled vitamin B12; a patient was reportedly hospitalised with nerve damage.6
- In September 2026 a product sold as retatrutide held no retatrutide but about 8 times the approved semaglutide level; the user tore their oesophagus vomiting.7
On this page
- What is compounding, and what changed on 1 October 2024?
- Why did the TGA ban compounded GLP-1 medicines?
- What went wrong with compounded and fake semaglutide?
- Can you still get compounded semaglutide in Australia?
- Has anyone been penalised over compounded GLP-1 medicines?
- What if you were using a compounded product?
- Questions people ask
- How we researched this
What is compounding, and what changed on 1 October 2024?
Compounding is when a pharmacist makes a medicine from raw ingredients for one patient. Since 1 October 2024, pharmacists may not compound any GLP‑1 medicine, whatever the form.1,2
- Semaglutide and tirzepatide are prescription-only medicines in Australia. A doctor or other authorised prescriber decides whether either suits you.10
- We don't publish prices or say where to get a medicine. The TGA says price information about compounded medicines must not be advertised at all.9
- Every risk of the registered medicines is in Guide 5: Side effects and risks.
- This post explains a rule and the reasons given for it. It is not legal advice.
Compounding has a normal place in pharmacy. The TGA gives the example of making a liquid for a child who can't swallow tablets.2 It is meant to be done one patient at a time, after a prescription arrives.3
The change came through an amendment to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6). The TGA said it applies "to all medicines containing GLP-1 RA analogues, regardless of dosage form, compounded on or after 1 October 2024".1
Why did the TGA ban compounded GLP-1 medicines?
The TGA named three risks: unknown ingredients, batches made before any prescription existed, and no safety or quality checks. State health officials and Ahpra agreed unanimously that the rules should tighten.4
In December 2023 the TGA warned of an "emerging trend" for telehealth providers to offer compounded semaglutide-like products.3 These were "unapproved" goods, it said, and it had not evaluated them.3 Ozempic was in short supply at the time.3
When it opened a consultation in February 2024, the TGA listed its concerns:4
- the unknown nature and safety of the ingredients used;
- compounding outside the rules, which allow it only for an individual patient after a valid prescription;
- no evaluation of safety and quality, unlike medicines on the Australian Register of Therapeutic Goods (ARTG).
It also pointed to the scale. GLP‑1 medicines are sterile products with "high-risk active substances", and some pharmacies were making them at commercial scale.4 Ahpra, which regulates doctors and pharmacists, later linked the ban to "bulk-scale manufacturing".5
Why the business model mattered. Ahpra described services built to supply "a single pre-determined medicine", sometimes with the prescriber and pharmacy linked to the same business.5
The TGA had been down this road before. In 2021 it removed medicinal cannabis from the same compounding exemption, for similar reasons.4
Builds a printable sheet of questions for an appointment about weight or diabetes medicines. Free.
What went wrong with compounded and fake semaglutide?
TGA testing found products that did not match their labels. One product sold as compounded semaglutide had ten times the stated vitamin B12; one "retatrutide" product was mostly semaglutide at about 8 times the approved strength.6,7
The red vials (March 2024)
The TGA tested a product labelled as semaglutide with L‑carnitine and vitamin B12, in blue-capped vials.6 It found:6
- ten times the labelled amount of vitamin B12;
- L‑carnitine at 0.5 to 0.7 mg per mL, against a label of 100 mg per mL;
- an unexpected red colour, and supply by regular mail rather than through a pharmacy.
Injecting it was alleged to have put a patient in hospital with peripheral neuropathy, which is nerve damage in the hands or feet.6 The TGA could not find where it was made.6
The fake retatrutide (September 2026)
Retatrutide is an experimental medicine still in human trials. Neither the TGA nor any comparable overseas regulator has approved it.7 The TGA tested a product sold under that name in an unmarked vial after a serious reaction.7
- It contained no retatrutide.7
- It held undeclared semaglutide, about 8 times the level in registered semaglutide products.7
- The person had uncontrollable vomiting, tore their oesophagus (food pipe) and needed hospital care.7
That product was not a pharmacy compound; it was a counterfeit. The TGA says any retatrutide outside a trial "could be a counterfeit product".7 Our post on retatrutide in Australia has the detail.
- Wrong dose. Unapproved products may contain undisclosed or incorrectly dosed ingredients, the TGA says.7
- Infection and allergy. Non-sterile injections raise the risk of infection and severe allergic reactions (anaphylaxis).7
- Severe vomiting. Too much semaglutide caused vomiting bad enough to tear the oesophagus in the 2026 case.7
- Registered medicines carry risks too, including pancreatitis and gallbladder problems. Those are listed in each PI and in Guide 5.
Can you still get compounded semaglutide in Australia?
Not legally from an Australian pharmacy. Pharmacists have not been allowed to compound any GLP‑1 medicine since 1 October 2024.1
Other routes carry their own rules:
- Importing. The TGA says it is illegal to import Ozempic-like products without a valid prescription, even for personal use.2 Unapproved peptide imports are allowed only if every condition of the Personal Importation Scheme is met.8
- At the border. The TGA works with Australian Border Force. Unlawful imports may be seized and destroyed, and you may lose the money paid.8
- Online sellers. The TGA warns that some online clinics may be run by organised crime, and their products may be fake.2
- Labels like "research use only". These do not change whether a product is a regulated therapeutic good.8
Has anyone been penalised over compounded GLP-1 medicines?
Yes. In April 2025 the TGA accepted a court-enforceable undertaking from a compounding pharmacy whose website had order forms for semaglutide and tirzepatide.10
The forms were online from November 2023 to June 2024. The pharmacy acknowledged its website "likely unlawfully promoted" prescription-only medicines.10 The undertaking runs for 3 years and requires an outside compliance adviser.10
The TGA explained why it treats this as serious. Advertising prescription medicines "can create an inappropriate demand" and undermine the relationship between a patient and their health practitioner.10 It has also said illegal promotion of Ozempic contributed to the shortage that left people with diabetes without it.11
For the unapproved peptide market more broadly, the TGA lists import interventions, seizures, infringement notices and civil or criminal penalties as possible actions.8
What if you were using a compounded product?
The TGA's advice in 2024 was to speak to your GP about other treatment.1 Registered medicines have been assessed for safety and quality; compounded versions were not identical to them.2
- Supply is back. As of February 2026 the TGA advised there were no shortages of any GLP‑1 medicine in Australia, according to the PBAC.13 See our Ozempic shortage timeline.
- Leftover vials. For compounded semaglutide of unknown origin, the TGA advises taking remaining vials to your local pharmacy for safe disposal.6
- Side effects. Report them to the TGA, and keep the product if you can.6,16
Our guide on choosing where to get care covers red flags with online services. For the rules on online scripts, see getting a GLP‑1 script online.
Questions people ask
Is compounded semaglutide legal in Australia?
No pharmacist may compound semaglutide, or any other GLP‑1 medicine, from 1 October 2024.1
Does the ban cover compounded tirzepatide?
Yes. The rule covers all medicines containing GLP‑1 receptor agonists, and tirzepatide acts on the GLP‑1 receptor as well as GIP.1,12
Why was compounded semaglutide banned?
The TGA cited unknown ingredients, commercial-scale batches made before any prescription, and the absence of safety and quality checks.4
Can I import semaglutide for personal use?
The TGA says importing Ozempic-like products without a valid prescription is illegal, even for personal use. Unlawful imports may be seized.2,8
Are 'peptide' versions sold online the same thing?
No. The TGA says unapproved peptide products have not been assessed and may be fake or wrongly dosed.7,8
How we researched this
On 12 Oct 2026 we read the TGA's December 2023 safety alert, February 2024 consultation notice, June 2024 blog and media release, March 2024 and September 2026 safety advisories, its peptide regulation page and its April 2025 enforcement release. We also read Ahpra's June 2024 statement.
We found no TGA estimate of how many Australians used compounded GLP‑1 medicines, so we give none. We don't name businesses involved in enforcement, or publish prices.
Before you move on
- Australian pharmacists may not compound any GLP-1 medicine since 1 October 2024.
- The TGA cited unknown ingredients, commercial scale and no safety checks.
- TGA testing has found compounded and fake products that did not match their labels.
- Importing without a prescription is illegal, and imports can be seized.
More from the Australia blog
The monthly Australia update
An independent guide to GLP‑1 medicines. We don't sell medicines, take drug-company money or earn clinic commissions. Once a month: PBS decisions, TGA approvals, safety notices and recalls. How we write
Sources
- Therapeutic Goods Administration. Update on the glucagon-like peptide-1 receptor agonists (GLP-1 RAs) pharmacy compounding changes. Media release, 18 June 2024. tga.gov.au
- Therapeutic Goods Administration. What you need to know about compounded weight-loss medicines. Blog, 3 June 2024. tga.gov.au
- Therapeutic Goods Administration. Compounding safety information: semaglutide-like products. Safety alert, 15 December 2023. tga.gov.au
- Therapeutic Goods Administration. Consultation to remove glucagon-like-peptide-1 (GLP-1) receptor agonist analogues from the pharmacist extemporaneous compounding exemption. Media release, 29 February 2024. tga.gov.au
- Ahpra and National Boards. Concerns raised over emerging models of care (joint statement on prescribing and dispensing: "bulk-scale manufacturing prompting a TGA ban on the compounding of these medications from October 2024"). 3 June 2024. ahpra.gov.au
- Therapeutic Goods Administration. Substandard semaglutide vials. Safety advisory, 28 March 2024. tga.gov.au
- Therapeutic Goods Administration. TGA tests counterfeit retatrutide product following serious adverse event report. Safety advisory, 14 September 2026. tga.gov.au
- Therapeutic Goods Administration. How we regulate therapeutic peptide products (Personal Importation Scheme conditions; Border Force seizures). Checked 12 October 2026. tga.gov.au
- Therapeutic Goods Administration. Applying the Advertising Code rules: price information. Updated 21 July 2026. tga.gov.au
- Therapeutic Goods Administration. Media release on a court-enforceable undertaking by a compounding pharmacy about advertising compounded weight-loss medicines (order forms for semaglutide and tirzepatide, November 2023 to June 2024). 7 April 2025. Listed under tga.gov.au media releases; not linked here because its address names the business.
- Therapeutic Goods Administration. Advertising Ozempic and GLP-1 receptor agonists is prohibited. Updated 11 March 2025. tga.gov.au
- Eli Lilly. Mounjaro (tirzepatide) Australian Product Information, version A14.0, October 2026. medsinfo.com.au Section 5.1 ("Tirzepatide is a long-acting GIP and GLP-1 receptor agonist").
- Pharmaceutical Benefits Scheme. PBAC advice on equitable access to GLP-1 obesity treatments (priority groups; "a slow and managed roll-out"; "As of February 2026, the Therapeutic Goods Administration (TGA) advises that there are no shortages of any GLP-1 medication in Australia"). pbs.gov.au
- Healthdirect Australia. How healthdirect can help you ("call triple zero (000) for an ambulance immediately"; nurse helpline 1800 022 222, 24 hours a day). healthdirect.gov.au
- Healthdirect Australia. Poisoning (Poisons Information Centre, 13 11 26, any time). healthdirect.gov.au
- Therapeutic Goods Administration. Reporting adverse events for consumers (online, or through your GP, nurse practitioner, midwife or pharmacist). Updated 2 September 2026. tga.gov.au
Last checked 12 Oct 2026 · Next review due 12 Apr 2027 · Report an error
How this post was made. Written by the GLP Guidebook team from the sources above. It's general information, not medical advice. Talk to a qualified doctor, nurse or pharmacist before starting, stopping or changing any medicine. How we write