TGA cracks down on unlawful medicine products

The TGA has accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd (YSCP) regarding the advertising of prescription-only compounded medicines for weight loss.

Between 23 November 2023 and 20 June 2024, the YSCP website featured order forms for semaglutide (the active ingredient in Ozempic) and tirzepatide. The TGA raised concerns that these order forms unlawfully advertised prescription-only medicines. Following an investigation, YSCP acknowledged that its website likely promoted the use or supply of prescription-only medicines in violation of the law.

Semaglutide and tirzepatide are prescription-only medicines in Australia, and advertising prescription medicines, including compounded ones, directly to the public is prohibited. While compounding pharmacies may promote their compounding services to consumers, they are not allowed to advertise the use or supply of prescription medicines.

Furthermore, as of 1 October 2024, under amendments to Schedule 5, Item 6 of the Therapeutic Goods Regulations 1990, pharmacists will no longer be permitted to compound and supply Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) products such as semaglutide.

Advertising prescription medicines to the public can create inappropriate demand for these products and undermine the relationship between patients and their healthcare providers. Treatment options should always be determined by a health professional in consultation with their patients.

The undertaking is enforceable for a period of 3 years and requires YSCP to:

• Ensure compliance with all regulatory requirements under the Therapeutic Goods Act 1989 (the Act) when advertising therapeutic goods.

• Engage an external qualified compliance professional to advise YSCP on relevant regulatory procedures.

• Cover the costs associated with its compliance with the enforceable undertaking.

Pharmacies, including those offering compounding services, must understand their legal obligations under the Act before advertising or supplying therapeutic goods.