TGA consulting on removing GLP-1 receptor agonist analogues from pharmacist compounding exemption
Australian medicines regulator the Therapeutic Goods Administration (TGA) has begun a targeted consultation process as part of a proposal to change the Therapeutic Goods Regulations 1990 to remove all medicines containing glucagon-like-peptide-1 (GLP-1) receptor agonist analogues (GLP-1 RAs), including semaglutide-like medicines, from the pharmacist extemporaneous compounding exemptions.
While the expansion of the scale of manufacture of compounded goods in Australian pharmacies reflects international trends, 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.
The current proposal aims to mitigate safety risks that may be present in the compounding of GLP-1 RAs. These risks may include:
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