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This report was created to assist the Food and Drug Administration (FDA) in their evaluation of the use of phenoxybenzamine hydrochloride (phenoxybenzamine HCl; UNII code: X1IEG24OHL), which was nominated for use as a bulk drug substance in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.

The aim of this report was to describe how phenoxybenzamine HCl is used in clinical research and practice to diagnose, prevent, or treat disease. Due to the broad, exploratory nature of this aim, scoping review methodology was used. Following the scoping review framework, a systematic literature review was conducted and healthcare practitioners were consulted to identify how phenoxybenzamine HCl has been used historically and currently. 1-3 Assessment of study quality and risk of bias were not performed because the aim of this report was not to make specific recommendations on the use of this substance in clinical practice. 1, 4, 5 Rather, the aim was to summarize the available evidence on the use of phenoxybenzamine HCl and thereby assist the FDA to determine whether there is a need for the inclusion of this substance on the 503B Bulks List.