From October, compounding pharmacies in Australia will be prohibited from producing replica versions of the popular diabetes and weight loss drugs, Ozempic and Mounjaro.
This decision by the Therapeutic Goods Administration (TGA) addresses mounting concerns over the safety, quality, and regulatory compliance of compounded medications.
Ozempic is a crucial medication for managing type 2 diabetes and aiding in weight loss by regulating blood sugar levels. Its effectiveness has led to high demand, which compounding pharmacies have attempted to meet by creating their own versions of the drug. Compounded medications can vary in dosage and formulation, potentially leading to ineffective or harmful outcomes. Unlike commercially produced drugs, compounded medications do not undergo the same stringent approval processes.
The Federal Government has raised concerns about compounded glucagon-like peptide-1 receptor agonists (GLP-1RA) products, noting that they are not identical to the TGA-approved medications semaglutide (sold as Ozempic) or tirzepatide (sold as Mounjaro). This means that patients using compounded Ozempic might face inconsistent dosing and unverified purity, which can result in inadequate treatment or adverse reactions.
To address this issue, new regulations will remove these compounded products from the pharmacy compounding exemption. Health and Aged Care Minister Mark Butler emphasised that this measure is essential for saving lives.
“While I understand that this action may concern some people, the risk of not acting is far greater,” Minister Butler stated.
He clarified that the four-month period before the regulatory change takes effect is intended not for the industry, but to allow patients time to transition.
The rising demand for semaglutide and tirzepatide has led to significant shortages of these medications. The TGA has advised general practitioners not to start new patients on these drugs unless there are no suitable alternatives available.
These shortages are anticipated to continue until at least the end of the year.
