One of the key drivers of regulatory reform is minimising the risks associated with healthcare. In order to achieve this, there is a need for the regulatory bodies to have a clear understanding of what comprises risk in the professions under their remit. The current paper examines ways in which risk could be conceptualised, assessed and managed in one of these professions: pharmacy. The authors review studies in healthcare management, safety science and human factors, and consider a range of views about the nature of risk and its relationship to pharmacy practice. This leads to an exploration of the implications for risk-based regulation (for example, revalidation), and of issues to be addressed in further work in this area. © 2011 Taylor & Francis.