New guidelines for compounding of medicines

The Pharmacy Board of Australia has published revised guidelines on compounding medicines, which will take effect from 1 October 2024.

The new guidelines seek to provide greater clarity and direction on safe practice when compounding medicines. The Guidelines on compounding of medicines provide updated guidance on when it may be appropriate to compound a medicine, supported by a revised definition of a ‘commercial medicine’.

Other changes include:

  • a greater focus on risk assessment
  • reducing the duplication of information that is published in peer-reviewed references sources such as the Australian Pharmaceutical Formulary and Handbook (APF)
  • highlighting when the guidance for compounding of medicines for animal patients is different to the guidance for human patients
  • highlighting the legal requirements and the standards of practice published by the profession that are relevant to compounding which must be complied with in order to effectively apply the additional guidance published by the Board.

The guideline also reaffirms guidance for pharmacists when not to compound a medicine such as:

  • it would be the same as a medicine that already exists and is available and appropriate for the person
  • the pharmacy does not have the right equipment and/or the pharmacist doesn’t have the required knowledge and skills to compound the medicine safely
  • there is no evidence that it is a safe and appropriate treatment

The new guidelines can be found on the Pharmacy Boards website, so pharmacists can familiarise themselves before they take effect.

The Board has also released a consumer factsheet that pharmacists can share with consumers about compounded medicines.

 

 

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