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FDA denies OTC monitoring request

This article was originally published in The Tan Sheet

Executive Summary

A request by the Synthetic Organic Chemical Manufacturers Association for FDA to implement a program for monitoring the impurity profiles of imported OTC drugs is denied. The agency's Oct. 13 1response to SOCMA's 2006 citizen 2petition says FDA's existing sampling and testing program for drug products and its good manufacturing practice inspection and surveillance efforts are "more comprehensive and appropriate" than SOCMA's recommendations (3"The Tan Sheet" Nov. 5, 2007). FDA denied most of SOCMA's other provisions, including requests to identify foreign facilities as a significant risk factor in inspections and risk-ranking foreign and domestic drug firms together. However, the agency did accede to the association's request for a publicly available database of foreign and domestic drug manufacturers, mainly because FDA is already developing such a system

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