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FDA drug listing regs

This article was originally published in The Tan Sheet

Executive Summary

Proposed rule in the Sept. 2. Federal Register would "codify" FDA's practice of annually sending hard copies of its computer listings of drug products in commercial distribution to companies for review, correction and return. The proposed rule would give mmore legal backing to FDA's procedure and require that the " compliance verification report," which is sent out annually in May, be returned within 30 days of receipt. An internal government study conducted two years ago "uncovered a substantial number of errors due a variety of causes" in FDA's computer listing, the notice explains. Currently, FDA regs call for twice-yearly updates from companies on drug products in distribution. Return of the marked-up compliance verification report would substitute once a year for the forms under the amended regulations. The comment period on the proposed rule ends Nov. 1.





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