TGA officers executed a search warrant on a Sydney residence linked to an individual suspected of being involved in the manufacture and sale of compounded semaglutide on 27 March 2024.
In the execution of this warrant, several items were seized from the residence. These will be subject to further analysis and examination by the TGA.
The warrant and seizure were part of an ongoing investigation into the alleged unlawful manufacture, supply and export of therapeutic goods, including prescription-only medicines. This included medical professionals in Australia and overseas being sent faxes promoting the medicines.
The TGA is also aware that several patients have suffered adverse events from the medication after it had been sent to them via the post.
Professor Anthony Lawler, Deputy Secretary of the Department of Health and Aged Care and head of the TGA, said this matter represented a serious breach of trust.
"Not only have health professionals been duped into believing this was a legitimate pharmacy, but they have then referred their patients to have their prescriptions filled. Some patients have also suffered additional medical issues caused by this substance," Professor Lawler said.
"The TGA will continue to dedicate resources to investigate this matter and take appropriate enforcement action against anyone found to have breached the law.
"I would also recommend health practitioners to exercise deep caution when receiving unsolicited advertisements, particularly by fax, and particularly when the source of these advertisements is unknown. Clinical judgement should be used in these cases, recognising that there may be elevated clinical risk for patients where medicines are not assessed by the TGA for safety, quality and efficacy," Professor Lawler added.
Given the potential health harms of these products, the TGA also published a related safety alert on the substandard semaglutide vials. The TGA is urging consumers to exercise extreme caution when purchasing medicines from unknown websites and not to use compounded semaglutide offered or issued without a prescription, or where the origins of its manufacture cannot be determined.
If you suspect non-compliance in relation to therapeutic goods, we encourage you to report illegal or questionable practices and suspected non-compliant advertising to us online.
If you think you may be experiencing a side effect after using a medicine or vaccine or a problem involving the use of a medical device, seek advice from a health professional as soon as possible.
If the side effect was unintended and unfavourable, please retain a sample and report the suspected adverse event to the TGA.
Businesses, including pharmacies, must understand and comply with their legal obligations under the Therapeutic Goods Act 1989 with respect to the import, manufacture, advertising, supply or export of therapeutic goods.
