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Child-resistant packaging

This article was originally published in The Tan Sheet

Executive Summary

CPSC proposed rulemaking requiring CRP for all 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 CPSC (1"The Tan Sheet" June 12, p. 4). In a 3-0 vote, the commission authorized 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 provide for 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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Oral OTC Switches Subject To Mandatory CR Packaging Under Proposed Rule

A proposed rule requiring all oral Rx-to-OTC switch drugs be packaged in child-resistant containers is being considered by the Consumer Product Safety Commission.

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