Revised guidance published - Compounding of sterile injectable medicines

01 Aug 2017

Revised guidance about the compounding of sterile injectable medicines has been published today but will not take effect until 1 February 2018.

The Pharmacy Board of Australia (the Board) has published revised guidance titled Compounding of sterile injectable medicines, to replace the currently postponed section ‘Expiry of compounded parenteral medicines’ of its Guidelines on compounding of medicines (the guidelines).

This section of the guidelines is intended to provide additional guidance to pharmacists who compound sterile injectable medicines, which carries additional risks for patients if such medicines are not physically, chemically and microbiologically stable when being administered to a patient.

The guidance will take effect on 1 February 2018 so pharmacists can become familiar with the content and implement any required changes in their compounding practice during the six month implementation period.

The supporting frequently asked questions on the compounding of medicines have also been updated, with additional information to help pharmacists apply the revised guidance in their practice.

Postponed guidance

In April 2015, the Board postponed implementation of the section ‘Expiry of compounded parenteral medicines’ of the guidelines in response to feedback from stakeholders that the guidance would inhibit or impact access to compounded parenteral medicines by patients.

Since that time, the Board has conducted several rounds of further consultation with stakeholders including pharmacists, pharmacy organisations, government, the Therapeutic Goods Administration and the public on draft revised guidance. This was to ensure that the views of all stakeholders were captured and taken into consideration in the Board’s further development and finalisation of its guidance. Submissions to the February 2016 public consultation can be accessed on the Board’s website.

Revised guidance

The Board’s guidance highlights the importance of compliance with relevant standards and processes that support assigning appropriate beyond use dates for compounded sterile injectable medicines. The Board is of the view that the guidance provides appropriate safeguards for the public while supporting access to these medicines by patients.

The revised guidance is available as a stand-alone document in the Codes, Guidelines and Policies section of the Board website. On implementation of the guidance on 1 February 2018, it will be incorporated into the full set of Guidelines on compounding of medicines.

The updated FAQ are available in the FAQ and Fact Sheets section.

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