Sterile injectable compounding guidance update


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The Pharmacy Board has released revised guidance around compounding of sterile injectables, to take effect from February 2018

The Board’s new guidance, Compounding of sterile injectable medicines, replaces the currently postponed section, Expiry of compounded parenteral medicines, of its Guideline on compounding of medicines.

This section of the guidelines aims to provide additional guidance to pharmacists who compound sterile injectable medicines, as these carry additional risks for patients if the medicines are not physically, chemically and microbiologically stable when being administered to a patient.

The Board says the guidance will come into effect on 1 February 2018 so as to give pharmacists the opportunity to familiarise themselves with the content, and to implement any required changes in their compounding practice during the six-month implementation period.

A supporting FAQ has also been updated, with extra information to help pharmacists apply the revised guidelines in their practice.

As for the section “Expiry of compounded parenteral medicines” of the guidelines, its implementation was postponed in April 2015 following feedback from stakeholders that the guidance would “inhibit or impact access to compounded parenteral medicines by patients”.

The Board has advised that since that time, it has conducted several rounds of further consultation with stakeholders including pharmacists, pharmacy organisations, the TGA and the public on draft 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,” says the Board.

“The Board is of the view that the guidance provides appropriate safeguards for the public while supporting access to these medicines by patients.”

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