The national therapeutic goods regulator has raided a compounding pharmacy in Melbourne as part of an ongoing probe into the alleged manufacture and supply of compounded weight loss drugs.
TGA officers and staff from the Victorian Pharmacy Authority arrived at Como Compounding Pharmacy in the inner-city suburb South Yarra on Thursday morning.
Officers spent more than five hours searching the premises, photographing documents and seizing items including equipment, glass bottles and postage parcels, that were sealed in evidence bags and removed from the shopfront.
The TGA said it also seized a large amount of medication including semaglutide, the active ingredient in Ozempic, as well as peptides and human growth hormones.
The regulator will allege these drugs have been unlawfully manufactured.
In a statement released late today, the TGA said it held "serious concerns around the safety and efficacy of the medication if it were to be dispensed to the public".
The pharmacy was previously owned by suspended pharmacist Nima Alavi, who was embroiled in the Essendon sports doping scandal and was under investigation by authorities.
Mr Alavi was found dead just before Christmas amidst a pharmacy board probe into his conduct.
Wider investigation into off-brand weight loss drugs
The ABC can reveal Como Compounding Pharmacy was also selling vials of a compounded version of the diabetes drug Mounjaro, dubbed the "King Kong" of weight loss drugs.
Compounding is legal, but pharmacists need to follow strict regulatory guidelines that dictate when and why a medicine might be compounded.
Mounjaro sold out within weeks of being launched in Australia last year.
In an email to a patient obtained as part of an ongoing Four Corners investigation, a Como staff member said "we do compound the active ingredient in Mounjaro for weight loss" and that the product was $1,265 for a vial that "can last up to three months" and could be posted around the country.
The news of the raid comes amidst increased scrutiny on compounding pharmacies.
Last year, the ABC revealed that some Australian pharmacists were compounding and selling their own versions of the active ingredients and shipping them to consumers across Australia due to a regulatory loophole.
Compounding is a way for specialist pharmacists and doctors to customise medications for patients or provide formulas which are not commercially available, but the regulator warned the laws were not intended for producing drugs on a mass scale.
The TGA has since issued a safety alert warning consumers that "compounded semaglutide-like products are 'unapproved' therapeutic goods and have not been evaluated by us for safety, quality and efficacy".
Como Compounding Pharmacy is listed as registered with the Victorian Pharmacy Authority, with a registration condition stating:
"The licensee is to commission an expert risk assessment of the operation of the sterile compounding facility every three years to determine the nature and extent of any risks with respect to product and patient safety."
Compounding pharmacies given a warning over copycat Ozempic
The head of the TGA, Professor Anthony Lawler, said there would be serious consequences for those who broke the law.
"It is important that pharmacists understand that they are most likely breaking the law if they are manufacturing or supplying medicines prior to receiving a prescription," he said.
"Consumers need to understand that the safety of compounded medicines are not assessed by the TGA, and they are not subject to the same controls over the quality or efficacy of the goods when compared with medicines approved for supply in Australia."
The ABC understands the action today is part of a wider probe examining whether compounding pharmacies were illegally mass producing compounded weight loss medications.
A ban on compounding certain classes of weight loss drugs is under consideration by the TGA, with a final decision to be made by June.
Como Compounding Pharmacy has been contacted for comment.
https://news.google.com/rss/articles/CBMibmh0dHBzOi8vd3d3LmFiYy5uZXQuYXUvbmV3cy8yMDI0LTAzLTAxL21lbGJvdXJuZS1jb21wb3VuZGluZy1waGFybWFjeS1yYWlkLW96ZW1waWMtd2VpZ2h0LWxvc3MtZHJ1Z3MvMTAzNTI4OTky0gEoaHR0cHM6Ly9hbXAuYWJjLm5ldC5hdS9hcnRpY2xlLzEwMzUyODk5Mg?oc=5
2024-03-01 06:30:17Z
CBMibmh0dHBzOi8vd3d3LmFiYy5uZXQuYXUvbmV3cy8yMDI0LTAzLTAxL21lbGJvdXJuZS1jb21wb3VuZGluZy1waGFybWFjeS1yYWlkLW96ZW1waWMtd2VpZ2h0LWxvc3MtZHJ1Z3MvMTAzNTI4OTky0gEoaHR0cHM6Ly9hbXAuYWJjLm5ldC5hdS9hcnRpY2xlLzEwMzUyODk5Mg
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