THE TGA began a targeted consultation process last week to remove all medicines containing GLP-1 receptor agonist analogues (GLP-1 RAs), including semaglutide-like medicines known as 'Ozempic copies', from the pharmacist extemporaneous compounding exemptions.
While the expansion of the scale of manufacturing of compounded goods in Australian pharmacies reflects international trends, the TGA stated public health and safety concerns have emerged around the complexity and commercial scale of some compounding of extemporaneously prepared GLP-1 RAs, which are sterile medicines containing high-risk active substances.
As part of a proposal to change the Therapeutic Goods Regulations 1990, the TGA has met with state and territory chief health officers and chief pharmacists and the Australian Health Practitioner Regulation Agency (Ahpra) to discuss the ongoing issue.
There was unanimous agreement that current regulatory arrangements regarding compounded medicines should be strengthened to provide improved public protection, with broad support expressed for a national approach to restrict compounding of medicines containing GLP-1 RAs.
Monash University's Biomedicine Discovery Institute's obesity expert Michael Cowley supports the TGA's move.
"I support the amendment because the compounded versions are similar to, but not the same as, the clinically tested and approved drugs.
"The compounded versions have not been clinically tested in the same rigorous way as the approved versions have," commented Cowley.
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