Historical extemporaneous formulae: what are the risks?

Abstract

Pharmacists are sometimes required to prepare an extemporaneous product using a pharmacopoeial formulation that is not contained in the current pharmacopoeia. He must then evaluate the potential risks associated with preparing the formulation, including safety and efficacy issues. Formulae may be changed or removed from pharmacopoeias for several reasons including increased availability of commercial products, reduced role of the medication in current clinical practice, and safety concerns. The issue is discussed with reference to a case study.