BRIEF—TGA update on GLP-1 RAs pharmacy compounding changes

Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6 have been made resulting in compounded glucagon-like peptide-1 receptor agonist GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients, Australia’s Therapeutic Goods Administration (TGA) has announced.

These amendments will apply to all medicines containing GLP-1 RA analogues, regardless of dosage form, compounded on or after October 1, 2024.

The TGA acknowledges the importance of medicines like Novo Nordisk’ Ozempic (semaglutide), and Eli Lilly’s Mounjaro (tirzepatide) and Trulicity (dulaglutide) for the health and wellbeing of the people who require them, and the need to have a reliable supply in the community.

The drugs are currently approved for the treatment of diabetes and obesity.

The TGA added it is encouraging patients who have been accessing these compounded products to speak to their GP about alternative treatment and general healthcare plans.

While it recognizes shortages cause significant anxiety for patients, it is important that the alternative treatments accessed during shortages are safe and of good quality.