Summer Salad

January/February 2009

FocusSummer Salad

Compounded medicines and ‘off label’ prescribing

A case for more guidance

Volume 38, No.1, January/February 2009 Pages 16-20

Romano A Fois

Barry T Mewes

Andrew McLaughlin

Iqbal Ramzan


Interest by prescribers and pharmacists in the provision of individualised pharmaceutical therapy in the form of compounded medicines has grown in recent times. However, there have also been a number of case reports of patient harm associated with these medicines.


To highlight areas for clinicians and pharmacists to consider when prescribing or dispensing compounded medicines, which are consistent with quality use of medicines principles.


Regulators of pharmaceutical products have expressed concerns with the production, marketing and use of compounded medicines dispensed by pharmacists. This has prompted debate over the need for more regulation of these products. We propose an expansion of off label prescribing guidelines to include a risk based assessment of pharmaceutical quality, a consumer information/education strategy and the development of a code of practice for pharmacists engaging in compounding. These strategies recognise a shared responsibility among prescribers, dispensers and regulators to achieve contemporary quality, safety, and efficacy standards and support the quality use of compounded medicines.

There has been a recent rise in the prescribing and dispensing of compounded medicines both in Australia and overseas. These activities are proposed to offer benefits by individualising pharmaceutical therapy to patients’ needs. However, case reports of patients coming to harm following the use of compounded medicines and the absence of regulated processes for evaluating these medicines for quality, safety and efficacy, warrant a review of the activities and responsibilities of prescribers, pharmacists and regulators concerning compounded medicines.

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