Federal Government Bans Replica Ozempic, Mounjaro Manufacturing

In a crackdown against an international racket involving compounding pharmacists, the federal government has ordered a ban on manufacturing replica versions of Ozempic and Mounjaro, which are widely used for weight loss.

The drugs, Ozempic (semaglutide) and Mounjaro (tirzepatide), designed to treat type 2 diabetes, are sometimes prescribed off-label to overweight and obese people.

The ban follows an investigation by ABC Network's Four Corners about a registered Australian pharmacist, who was manufacturing replica Ozempic and Mounjaro, and exporting the drugs illegally to the United States, The ABC News reported.

The Total Compounding Pharmaceuticals (TCP) drugs, when injected, reportedly led to serious side effects among patients, such as nerve damage and vomiting blood, the investigation revealed.

The industry will get a four-month transition period before the ban is implemented, after which exemptions to compounding active ingredients in drugs like Ozempic would be removed.

Now, compounding pharmacists can legally reproduce brand-name drugs during shortages. However, these replica drugs are exempted from the safety regulations that govern brand-name medicines, The Guardian reported.

"Those exemptions have never allowed the sort of large-scale manufacturing that we're seeing in this market with products pretending to be Ozempic or Mounjaro. And frankly, they pose a very significant safety risk," Federal health minister Mark Butler said.

From October, compounding similar weight-loss products or compounded glucagon-like peptide-1 receptor agonists (GLP-1RA) would be banned.

An estimate of 20,000 Australians have been using compounded weight loss medications, though the actual number could be higher. Since most of the people use compounded GLP-1RA for weight loss, the ban on compounded drugs would not affect diabetes patients, Butler pointed out.