Stakeholder support for Health Minister Mark Butler's decision to ban compounded replicas of weight loss products.
Minister Butler has responded to the emergence of unapproved compounded glucagon-like peptide-1 receptor agonists that seek to copy approved products, including Novo Nordisk's OZEMPIC )semaglutide) and Lilly's MOUNJARO (tirazapetide).
Minister Butler said new regulations will remove the unapproved copies 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," said Minister Butler's statement.
The change will take effect from 1 October. Minister Butler said the timeline will allow patients time to consult with their doctor and source an approved alternative.
“Australians should be able to have faith in the medications they use, including compounded medicines. This is a priority for the Government." he said.
“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," added Miniter Butler.
A range of stakeholders included the decision, including the Society for Hospital Pharmacists Australia.
"The Society of Hospital Pharmacists of Australia (SHPA) welcomed today’s announcement from Health Minister Mark Butler that new regulations taking effect from 1 October 2024 will prevent the supply of inappropriately compounded glucagon-like peptide-1 receptor agonists (GLP-1RA) products," said the association.
"The TGA has consulted with SHPA on this matter over the past few months, including meeting with our Compounding Services Leadership Committee members," it said.
