The Therapeutic Goods Administration (TGA) has accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd (YSCP), regarding advertising of prescription-only compounded medicines for weight-loss.
Between 23 November 2023 and 20 June 2024, the YSCP website included order forms for semaglutide, the active ingredient in Ozempic, and tirzepatide. The TGA was concerned that these order forms unlawfully advertised prescription-only medicines. Following the TGA's investigation, and in response to the TGA's concerns, YSCP acknowledged that its website likely unlawfully promoted the use or supply of prescription-only medicines.
Semaglutide and tirzepatide are prescription-only medicines in Australia. It is unlawful to advertise prescription medicines, including those that are compounded, directly to the public. While compounding pharmacies are permitted to promote their compounding services to consumers, they are prohibited from advertising the use or supply of prescription medicines.
Further, from 1 October 2024 under amendments to Schedule 5, Item 6 of the Therapeutic Goods Regulations 1990, compounded Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) products, such as semaglutide, can no longer be compounded by pharmacists and supplied to patients.
Advertising prescription medicines to the public can create an inappropriate demand for these medicines and undermine the relationship between a patient and their treating health practitioner. Appropriate treatment options should be determined by a health professional in consultation with their patient.;
The undertaking Enforceable undertaking: Your Solution Compounding Pharmacy is enforceable for a period of 3 years and requires YSCP to:
- ensure that YSCP does not advertise therapeutic goods in any way which is in breach of the regulatory requirements of the Therapeutic Goods Act 1989 (the Act)
- engage an external qualified compliance professional to advise YSCP on relevant regulatory procedures, and
- pay the costs of YSCP's compliance with the enforceable undertaking.
Pharmacies, including those providing compounding services, have a responsibility to understand their legal obligations under the Act before advertising or supplying therapeutic goods. The TGA has recently updated its guidance on advertising health services, which includes guidance for promoting compounding services.
The TGA will continue to take enforcement action against alleged the unlawful import, supply, manufacture and advertising of therapeutic goods, including medicines containing GLP-1 RAs, when such activities are detected.
If you suspect non-compliance in relation to the advertising of therapeutic goods, you can report it to the TGA at any time.
