Pharmacists will be banned from compounding all medicines containing GLP-1 receptor agonists under a crackdown against commercial exploitation being proposed by the TGA.
The push comes amid a rise in concerns about compounding pharmacies and telehealth providers exploiting a regulatory “loophole” to manufacture commercial quantities of popular medications such semaglutide (Ozempic) to people seeking to lose weight.
Among them is Woolworths-backed telehealth corporate Eucalyptus Health, which has been selling its own pharmacist-compounded semaglutide product since December to get around supply difficulties with genuine Ozempic.
The move sparked a barrage of criticism, with the RACGP and Ozempic manufacturer Novo Nordisk warning of potential safety issues given compounded versions of the injectable are not subject to the same testing as the genuine article.
Compounding – also known as extemporaneous dispensing – was originally granted an exemption from TGA regulation as it was intended to cover the one-off preparation of a single unit of a product by a pharmacist for an individual patient in response to an unmet need. However some companies have adopted US-inspired business models of having pharmacists prepare large batches of copies of popular pharmaceutical products.
Last week, the TGA unveiled its own plan to intervene under the same restrictions preventing compounding of medicinal cannabis products.
“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,” the regulator said in a statement (link here).
“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 plan was now subject to consultation, but had already received in-principle endorsement from state and territory officials, the TGA said.
“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,” it said.
“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 ban has been supported by experts, including Professor Michael Cowley of the Monash Biomedicine Discovery Institute.
“The compounded versions have not been clinically tested in the same rigorous way as the approved versions have,” he said.
“The production facilities of the compounded versions are not inspected for safety in the same way as the manufacturing facilities of the approved versions are. The safety of the compounded versions has not been clinically tested.
“In short, we cannot be sure that the compounded versions are as safe and effective as the approved versions, and there is no adverse event tracking of the compounded medicines.”
The TGA stressed there was still a place for pharmacist compounding focussed on individual patients.
“The TGA notes the well-established role of pharmacist compounding, including in preparing medicines for individual patients in a community pharmacy or hospital settings,” it added.
“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.”
A final decision would be progressed by June 2024, the TGA said.