USP to focus on "legally recognized" botanical drugs in developing monographs.
This article was originally published in The Tan Sheet
Executive Summary
USP WILL FOCUS ON "LEGALLY RECOGNIZED" BOTANICAL DRUGS in developing monographs, U.S. Pharmacopeial Convention Executive Director Jerome Halperin said May 22 at USP's Open Conference in Chicago, Ill. In setting standards for botanical products, Halperin said USP will only consider "approved new products or pre-1938 drugs that are still recognized" and "OTC drugs covered by [an FDA] monograph or an NDA."