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 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:
- the unknown nature and safety of the ingredients used in manufacture
- compounding outside of the current exemptions that specify manufacture only on an individual patient basis and only after receipt of a valid prescription, and
- the absence of evaluation of these medicines for safety and quality that is a feature of other drugs, that are evaluated by the TGA and entered onto the Australian Register of Therapeutic Goods (ARTG).
The TGA notes the well-established role of pharmacist compounding, including in preparing medicines for individual patients in a community pharmacy or hospital settings. Such medicines are prepared using formulations from established formularies such as the Australian Pharmaceutical Formulary, and address patient need where commercially available medicine formulations are not clinically appropriate.
In 2021, the extemporaneous compounding exemption was amended to carve out medicinal cannabis products to ensure greater regulatory oversight of compounding operations due to the high-risk nature of these medicines. Similarly, the TGA is proposing immediate changes to the Regulations to remove all medicines containing GLP-1 RAs from the compounding exemption, thereby precluding the compounding of these medicines by compounding pharmacists.
The TGA met with state and territory Chief Health Officers and Chief Pharmacists and the Australian Health Practitioner Regulation Agency (Ahpra) in January 2024 to discuss this 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.
The consultation is an opportunity for identified stakeholders to provide their views on the proposed amendments and advise of any potential unintended consequences. The TGA will consider all responses in determining its next steps. A final decision will be progressed by June 2024.
