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FDA Listing Proposed Rule Would Add Burdens To Code System – Industry

This article was originally published in The Tan Sheet

Executive Summary

If FDA starts assigning companies National Drug Code numbers as it has proposed, it would "undo needed flexibility" for industry, the Consumer Healthcare Products Association says

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An FDA proposed rule for changes to the National Drug Code system does not adequately distinguish regulatory requirements for export-only and imported-for-export products, the Consumer Health Products Association says Jan. 26

FDA To Hold Drug Code Meeting, Extends Proposed Rule Comment Deadline

FDA has planned a public meeting to discuss proposed changes to the National Drug Code (NDC) system in the agency's proposed rule on "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs," according to a notice published in the Oct. 31 Federal Register

Establishment registration proposed rule

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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