Regulation of Pharmaceuticals in the Environment: The USA

Abstract

The fate of pharmaceuticals in the environment has been studied for more than 50 years, with the presence and potential effects acknowledged shortly thereafter [1–5]. It has gradually become apparent that risk assessments developed for the usual chemical contaminants cannot be applied carte blanche to pharmaceuticals, because they are developed to be highly active and specific in biological systems at low levels [6–9]. Therefore, when applying risk assessment models to the environmental assessment of pharmaceuticals, regulators must take into account not only the complexity of the entity to be protected (the ecosystem at large) but also the complexity of the regulated article (pharmaceuticals).