New compounding guideline

THE Pharmacy Board of Australia has released its long-awaited guideline on the Compounding of Sterile Injectable Medicines, with the document replacing the section Expiry of compounded parental medicines’ in the Board’s Guidelines on compounding of medicines.

The subject of extensive consultation, the revised guidance will come into effect on 01 Feb 2018, with a six month implementation period “so pharmacists can become familiar with the content and implement any required changes in their compounding practice”.

In Apr 2015 the Board postponed implementation of the section on expiry of compounded parenteral medicines after feedback from stakeholders that the document would inhibit or impact access to compounded injectables.

Since then the Board has undertaken several rounds of further feedback on a draft guidance document ( PD 29 Jul 2015, PD 02 Feb 2016, PD 05 Sep 16 and PD 23 Dec 16).

The final guidance document “highlights the importance of compliance with relevant standards and processes that support assigning appropriate beyond use dates for compounded sterile injectable medicines,” the Board said in a statement yesterday.

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

Currently the revised guidance is available as a standalone document in the Codes, Guidelines and Policies section of the Board website at pharmacyboard.gov.au.

Once it becomes implemented on 01 Feb next year it will be incorporated into the full set of .

A Frequently Asked Questions document is also available for download by CLICKING HERE.