Pharmacists must prepare and dispense compounded products in a manner that ensures their quality, safety, efficacy and compliance with legislative requirements (PSA,2018). While relevant state authorities will assess pharmacies on their facilities and procedures, a lot of quality assurance comes down to self-assessment. Depending on your scope of practise, a number of relevant standards can be used for self-assessment as listed in the Pharmacy Board of Australia's (PBA) Guidelines for compounding medicines (PBA, 2015).
All pharmacists are expected to conduct self-assessment audits to ensure quality and safety of the prepared medicines as a minimum. Accreditation reflects an agency’s dedication and commitment to meeting standards that demonstrate a higher level of performance and patient care (ACHC, 2019).
Further to this, Australian standard Quality Care 2020 introduces Complex Compounding as a new set of standards for those pharmacy’s that perform this service. There is a focus on quality systems, premises, safety and risk. For community pharmacies undertaking QCPP accreditation - you can contact the Pharmacy Guild of Australia.
When compounding sterile medicines in Australia, pharmacists are required by the PBA's Guidelines for compounding medicines to follow one of the following standards:
the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010), or
the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009), or
the USP–NF 〈797〉 Pharmaceutical Compounding – Sterile Preparation
Contact ACHC International about how to achieve Pharmacy Compounding Accreditation in Australia.