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Child-resistant packaging

This article was originally published in The Rose Sheet

Executive Summary

Consumer Product Safety Commission proposed rulemaking requiring child-resistant packaging for future oral Rx-to-OTC switch drugs to proceed following June 23 vote. Currently, CRP is required for most oral Rx drugs but not for products that switch OTC unless specifically requested by the CPSC (1"The Rose Sheet" June 19, In Brief). In a 3-0 vote, the commission authorizes the general counsel to draft a proposed rule for Federal Register publication. The rule would apply to switch applications submitted to FDA more than 180 days after a final reg is published; CPSC notices usually allow a 75-day comment period. Commissioner Mary Gall voiced concerns about placing added burdens on manufacturers but voted to move forward with the proposed rulemaking so comments can be heard from interested parties

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