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Oral OTC switches

This article was originally published in The Rose Sheet

Executive Summary

Consumer Product Safety Commission is considering a staff proposal to require that all oral Rx-to-OTC switch drugs be packaged in child-resistant containers, CPSC Poison Prevention Project Manager Suzanne Barone, PhD, announces at a meeting in Bethesda, Md. June 7. Currently, the Poison Prevention Packaging Act calls for child-resistant packaging (CRP) for most oral Rx drugs, but not for products that switch to OTC unless it is specifically requested by the commission. CPSC already requires CRP for hair regrowth ingredient minoxidil (1"The Rose Sheet" Nov. 23, 1998, p. 8). The proposed rule would not cover other types of switches, such as topical preparations or transdermal patches

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Child-resistant packaging

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

Child-resistant packaging

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

Minoxidil Spray Applicator Child-Resistant Features Required By Late 1999

OTC minoxidil metered finger mechanical sprayer applicators and extender attachments are required to include child-resistant features by November 1999 under a Consumer Product Safety Commission final rule published in the Federal Register Nov. 16.

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