WIDESPREAD demand for diabetes drugs such as Ozempic and Mounjaro has allegedly tested the exemption, given by the TGA for medicines approvals, to compounding pharmacies who are now producing replica weight loss medications on a large scale, ABC has reported.
It identified at least seven compounding pharmacies and telehealth companies that have been quietly selling off-brand versions of the popular weight loss medications and shipping them to consumers across Australia for months.
The TGA said in a statement that Novo Nordisk was the pharmaceutical company authorised to supply approved products containing semaglutide.
"Compounded therapeutic goods have not been evaluated by the TGA for safety, quality and efficacy," the TGA explained.
"The compounding exemptions in the Therapeutic Goods Regulations 1990 [legislation] do not apply if a pharmacist...is compounding products for bulk supply in anticipation of patients' needs," a spokesperson said in a statement.
The TGA warned bulk supply could land pharmacists in "hot water".
"Compounding medicines on a commercial-like scale has the potential to adversely affect many patients, as they are not subject to rigorous testing for safety and quality," the spokesperson added.
The TGA also warned practitioners prescribing and dispensing compounded medication "should consider their individual legal and professional responsibility in prescribing and dispensing an 'unapproved' product, including compounded semaglutide-like products".
"Prescribing a compounded product may expose pharmacists to liability if a patient has a negative outcome, particularly if a TGA approved product is available to treat the patient's medical condition," the TGA stated.
The Pharmacy Board of Australia said, "we are aware of individual concerns about the compounding of semaglutide".
"To date, however, the concerns have not related to the health, conduct or performance of an individual pharmacist which would bring the concern within the jurisdiction of the Board." JG
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