Semaglutide compounding safety alert 📢

Semaglutide compounding safety alert  

The TGA has published a safety alert about pharmacists compounding semaglutide-like products. In the alert, the TGA highlights: 

  • compounding is reserved for when registered products are unavailable, have failed or are unsuitable for a patient 
  • pharmacists are exempt from manufacturing licence requirements to compound a prescription for an individual patient 
  • batch compounding in anticipation of a prescription is unlawful 
  • it is illegal to advertise prescription-only medicines to the public (Note that this includes social media) 
  • clinicians should consider their individual legal and professional responsibilities in prescribing and dispensing compounded medicines 
  • pharmacists should refer to Pharmacy Board of Australia Guidelines regarding professional responsibilities and requirements when compounding 

With regards to compounded semaglutide-like compounding, the TGA has highlighted safety risks published by the FDA about compounders using sodium or acetate salt forms of semaglutide.

The TGA also highlights to consumers that the compounded product is not identical to the approved product and is not evaluated for safety, quality and efficacy.  

for more information, visit Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss | FDA