This study concludes that, until better regulatory controls and interventions are designed and implemented, public health goals of regulation will be compromised by business and self-interests.Sierra Leone was found to have enabling policy, legislative and regulatory instruments, but structural, process and intervention gaps exist. Outlet facilities exhibited sub-optimal quality on several dimensions, and professional and dispensing competencies were questionable in low socio-economic settings. However, pharmaceutical outlets present unique opportunities for enhancing access to medicines.In developing countries, like Sierra Leone (SL), community pharmacies are important sources of health care. However, questions have been raised about the quality of their services, and strategies used to regulate them.This study examines SL's regulatory framework and enforcement activities, as well as the quality of community pharmacy practice. Documents review, key informant, inspector, retailer and exiting patients' interviews were combined with observation of pharmaceutical outlets to collect both qualitative and quantitative data.