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Establishment registration proposed rule

This article was originally published in The Tan Sheet

Executive Summary

CHPA is concerned FDA's proposed rule on "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs" would make "substantial changes" to the OTC monograph system, the group notes in an Oct. 12 letter requesting an extension of the comment period for the proposal, which appeared in the Aug. 29 Federal Register. CHPA asks the agency to extend the comment period by 60 days to Jan. 26. "It is clear that the detail of the proposed rule and the numerous complex scenarios it may create for entities along the supply chain, the need to examine carefully the information contained in the proposed rule" and its impact on member companies will require more time to form a response, CHPA says. Some of the changes that apply to all pharmaceutical manufacturers "may be felt more acutely" by the OTC industry, particularly the effect of assigning a National Drug Code to manufacturers of monograph drugs, the group says...

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