TGA moots crackdown on semaglutide compounding

While some experts back a ban, telehealth company Eucalyptus says it would deny thousands life-changing medication.

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The TGA has opened a “targeted” consultation to update the Therapeutic Goods Regulations 1990 to prevent pharmacists from compounding semaglutide.

The consultation, which was announced yesterday, will gather stakeholder views on proposed amendments to the extemporaneous compounding exemption, which exempts medicines compounded on a per-script basis from assessment by the TGA.

The amendments aim to mitigate risks associated with the compounding of GLP-1 receptor agonists, which include semaglutide-like medicine.

“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,” said the regulator.

“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.”

Speaking at today’s hearing for the federal diabetes inquiry, deputy secretary of DoHAC’s health products regulation group Professor Anthony Lawler said that the amendment was “not without precedent as a regulatory action”.

The changes mirror those made in 2021 regarding medicinal cannabis products, which amended the extemporaneous compounding exemption to require more regulatory oversight for these products.

Some experts have already expressed support for the changes.

“I support the amendment because the compounded versions are similar to, but not the same as, the clinically tested and approved drugs,” said Monash Biomedicine Discovery Institute obesity expert Professor Michael Cowley in a release.

He expressed concerns over the lack of clinical testing and safety inspections for facilities making compounded drugs when compared to their TGA-approved counterparts.

“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.”

In a letter to stakeholders regarding the consultation, sighted by the ABC, the TGA conceded that enforcing product quality standards in compounding pharmacy had been a challenge and posed quality and safety problem.

The TGA previously told TMR that regulation of compounding falls under the jurisdiction of practitioners’ boards, while the Pharmacy Board pointed to local and commonwealth legislation, and back to the TGA.

Beyond safety concerns, Professor Lawler said at today’s diabetes hearing that semaglutide was “being compounded, in our view, in ways that are not consistent with the exemptions”.

These exemptions “include being manufactured on an individual patient basis or being manufactured following receipt of a prescription rather than in anticipation of a prescription”, he said.

Speaking to TMR, Dr Matt Vickers, clinical director of one of the telehealth companies prescribing compounded Ozempic – Eucalyptus, under the brands Juniper and Pilot – held fast on the safety and efficacy of their operation.

“Eucalyptus practitioners only facilitate compounded semaglutide prepared by two specifically selected compounding pharmacies,” he said.

“Those pharmacies were chosen based on their exceptional track records in safety and quality.

“Our partner pharmacies only begin compounding medication for individual patients in connection with a valid script from a practitioner.

“Medications then go through sterility testing before being shipped.”

In January, the TGA, AHPRA and the state and territory Chief Health Officers and Chief Pharmacists unanimously agreed that the current regulatory framework for compounding needed strengthening.

The group also generally agreed on a national approach to restrict compounding of medicines containing GLP-1 RAs.

Dr Ana Svensson, senior medical director at Novo Nordisk, the sponsor of the diabetes turned weight-loss wonder drug Ozempic, told TMR that NN supported the TGA’s proposal to exclude GLP-1 RAs from extemporaneous compounding exemptions.

Dr Vickers said Eucalytpus would continue to work with the TGA to find an “appropriate balance” between ensuring patient safety and allowing access to semaglutide, which has been in short supply since 2022.

“Eucalyptus is supportive of ensuring compounded semaglutide meets the strictest of safety standards such as those it has required from its compounding pharmacy partners,” he said.

“However, a complete ban on compounded semaglutide would be disproportionate while global shortages persist and would deny thousands of Australians access to medication that is changing their lives for the better.

“This includes diabetics accessing compounded medication given the ongoing global shortage of GLP-1s.”

The TGA will make its decision by June.