Release of revised Pharmacy Board of Australia Guidelines on compounding of medicines

05 Aug 2024

Revised guidelines published today by the Pharmacy Board of Australia 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 revised guidelines also reaffirm longstanding guidance for pharmacists about when not to compound a medicine, including if:

• 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.

Additional resources

Along with the revised guidelines, the Board has published a consumer fact sheet which can be used by pharmacists in practice to inform consumers about how a compounded medicine is different to other medicines.

The Board has also updated the document containing background information on the regulation of compounding by pharmacists, which is set out in relevant legislation and administered by other regulatory bodies. It provides an explanation of the regulatory environment in which the Board’s Guidelines on compounding of medicines should be applied by pharmacists when compounding medicines.

The FAQ for pharmacists on the compounding of medicines and other published resources will be reviewed and updated by 1 October 2024.

The new guidelines come into effect from 1 October 2024. You can access the guidelines and more information about pharmacy and compounding at the Pharmacy Board of Australia’s website.