Therapeutic goods and records have been seized from a pharmacy in South Yarra, Melbourne, as part of an ongoing investigation into the alleged unlawful manufacture, supply and export of therapeutic goods including prescription only medication.
Therapeutic Goods Administration (TGA) officers, with the assistance of the Victorian Department of Health and the Victorian Pharmacy Authority (VPA), executed a search warrant on a pharmacy yesterday and seized a number of items which will be subject to further analysis and examination by the TGA.
Among the items seized was a large amount of medication including semaglutide, peptides, and human growth hormones, which the TGA will allege have been unlawfully manufactured.
The TGA held serious concerns around the safety and efficacy of the medication if it were to be dispensed to the public.
Professor Anthony Lawler, Deputy Secretary of the Department of Health and Aged Care and head of the TGA, said there were serious consequences for those who break the law with respect to the import, manufacture, advertising, supply or export of therapeutic goods.
“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, except in very limited circumstances.
“Individuals and businesses, including pharmacists and pharmacies, must understand and comply with their legal obligations under the with respect to the import, manufacture, advertising, supply or export of therapeutic goods.
“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.”
Consequences for non-compliance with relevant laws may include not only financial penalties, but also civil or criminal proceedings.
Patients who may have concerns in regard to any medications dispensed by their pharmacy should speak to their doctor in the first instance.
Concerns regarding clinical practice are a matter for the Australian Health Practitioner Regulation Agency (AHPRA), who have a formal complaints process in place for members of the public to raise concerns about the performance of registered health practitioners.
All three agencies will continue to work in collaboration to assess the significant number of materials seized, as their investigations continue under relevant laws and regulations.
We are not able to provide any further information until the investigations are concluded.
If you suspect non-compliance in relation to therapeutic goods, you can online to the TGA.