THE new regulations and the ban on compounding of weight loss medications will be explained to pharmacists in a webinar by the Department of Health and Ageing on 14 Aug.
The TGA will continue to actively monitor the supply of Ozempic, Mounjaro and Trulicity and liaise with sponsors of GLP-1 RAs regarding supply status and availability of their medicines.
The amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) made last month, resulted in compounded GLP-1 RA products no longer being able to be manufactured by pharmacists, and supplied to patients (PD 22 May).
These amendments will apply to all medicines containing GLP-1 RA analogues, regardless of dosage form, compounded on or after 01 Oct this year.
The TGA said the illegal manufacturing of medicines through compounding has meant that these products are being provided in large quantities, without the regulation and evaluation that such volumes should undergo.
The regulatory body added that while its role is to evaluate and facilitate access to appropriate treatments, the risks, in this instance, have outweighed the benefit of access, and it recommended that the appropriate regulatory actions be taken.
Prof Robyn Langham, Chief Medical Adviser of the TGA, will conduct the webinar.
To register, CLICK HERE.
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