Changing dosage form monographs is the next step in the US Pharmacopeia’s (USP) project to update standards. Efforts have focused on a priority list drafted by the US Food and Drug Administration (FDA) and the USP has advanced its proposals for diphenhydramine to the public review stage.
“The use of modern analytical approaches, coupled with key general chapters, could rapidly advance solutions that otherwise might take years to accomplish”, Roger Williams, CEO of USP, said.
Regulators, industry and other interested parties discussed OTC products at a FDA and USP workshop last week.
