The Albanese Government is acting to protect Australians from the risks posed by injecting potentially unsafe and dangerous compounded replicas of weight loss products.
Compounded medications are personalised medicines for individual patients with a specific clinical need and are not subjected to the same safety regulations governing medicine approvals.
Compounded glucagon-like peptide-1 receptor agonists (GLP-1RA) products are not identical to the TGA-approved products Ozempic® (semaglutide) or Mounjaro® (tirazapetide). Unlike TGA-approved products, pharmacy-compounded products are not clinically evaluated by the independent regulator for safety, quality or efficacy.
The commercial-like scale and quality standards of compounded weight loss products has been the subject of increasing community concern, both in Australia and internationally. It has been repeatedly documented in the media, including concerns raised by individuals who have used these medicines.
The Government is acting to protect Australians through changes to the regulation of compounding, consistent with advice from the medicines regulator, the Therapeutic Goods Administration (TGA). This follows consultation with relevant stakeholders, and states and territories.
The new regulations will remove GLP-1 RAs, many of which claim to be replicas of Ozempic® or Mounjaro®, from the pharmacy compounding exemption.
At least 20,000 Australian patients are injecting these compounded replica weight loss products. The majority are using this for weight loss management.
There are increasing reports of patients coming to harm from GLP-1 RAs including the hospitalisation of a patient in Australia due to a serious adverse event.
Internationally, the U.S. Food and Drug Administration (FDA) has also warned consumers about the safety risks of injecting some compounded products, following an increase in adverse events in America.
Acting to protect Australians from the clear risk to human health posed by the large-scale manufacture of compounded injections has broad support across the health sector, including from:
- the Royal Australian College of General Practitioners,
- the Medical Board of Australia
- the Pharmacy Board of Australia
- Diabetes Australia,
- the Eating Disorders Alliance of Australia, as well as
- all state and territory health departments.
This change will take effect from 1 October 2024, to allow patients time to consult with their doctor and prepare alternative management plans appropriately, including, where necessary, sourcing a safer, regulated alternative.
Quotes attributable to Minister Butler:
“Australians should be able to have faith in the medications they use, including compounded medicines. This is a priority for the Government.
“We recognise there is a valid place for compounding in certain circumstances.
“To keep Australians safe, new regulations will remove GLP-1RA, such as those being misrepresented and sold as replica Ozempic® or Mounjaro®, from the pharmacy compounding exemptions.
“This action will not affect compounded medicines other than GLP-1 receptors.
“While I understand that this action may concern some people, the risk of not acting is far greater.
“You only have to look to the recent reports of individual impacted by large-scale compounding to realise the dangers posed.”
“This action will protect Australians from harm and save lives.”
Quotes attributable to Professor Robyn Langham AM, Chief Medical Adviser, TGA
“Removing glucagon-like peptide-1 receptor agonists (GLP-1 RAs), such as compounded copies of Ozempic® or Mounjaro®, from the pharmacy compounding exemption is the right action to take.
“The TGA will work with key medical, pharmacy and consumer stakeholders to support patients and their practitioners to navigate the change, and where appropriate help with guidance in finding alternative and safe medicines.”
