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Australia to End Pharmacists from Compounding Ozempic

Pharmacists have been compounding copies of weight loss drugs like Ozempic and Mounjaro, but the Therapeutic Goods Administration (TGA) warns that this practice is endangering patients.

The Australian government is planning to prohibit pharmacists from compounding replicas of popular weight loss medications such as Ozempic and Mounjaro due to safety concerns.

Compounding involves a pharmacist mixing various ingredients to replicate another drug. While this process is typically done to accommodate specific patient needs, like allergies or different dosage requirements, compounded products lack TGA approval and have not undergone safety, quality, or efficacy evaluations.

Medicines Australia cautions that compounded medicines may contain counterfeit or illegally imported ingredients, with each formulation varying in quality.

In response to a growing number of complaints about compounded medicines, the Pharmacy Council of New South Wales disclosed that 13.5 percent of the total complaints received were related to these products.

Health Minister Mark Butler emphasized the rising community concerns surrounding compounded weight loss products.

Following consultations with stakeholders, the government has decided to ban the compounding of glucagon-like peptide-1 receptor agonists to prevent risks associated with products that differ from TGA-approved drugs like Ozempic and Mounjaro.

The move has garnered support from various medical, pharmacy, and health organizations, with reports of adverse events increasing among the estimated 20,000 patients using these compounded products.

Internationally, the U.S. FDA has also cautioned consumers about safety risks associated with certain compounded products following a surge in adverse events.

The ban, effective from October 1, allows patients time to consult with their healthcare providers and explore safer, regulated alternatives if necessary.

While some GPs prescribe Ozempic off-label for weight loss management despite its intended use for type 2 diabetes, the TGA discourages this practice.

Due to a national shortage of Ozempic, pharmacists might be tempted to create their own versions of the medication, prompting the TGA to advise doctors to consider alternative medications for continuous supply.

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