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Antimicrobial ASTM Time-Kill Efficacy Test Advised By CTFA/SDA

This article was originally published in The Tan Sheet

Executive Summary

Bacterial time-kill test protocol developed by the American Society for Testing Materials should be designated for evaluating efficacy of finished topical antimicrobials in the pending antiseptics final monograph, a Nov. 28 industry citizen petition urges FDA

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Antimicrobial monograph

FDA is reopening administrative record for OTC topical antimicrobial drug products monograph until Aug. 27 to accept comments and data on OTC healthcare antiseptic drugs, agency says in 1May 29 Federal Register notice. Record for TFM closed in August 1995, but FDA has since received several petitions and comments containing new data on proposed non-monograph ingredients and testing criteria for antiseptic drugs. FDA has determined "good cause exists" to review new information, as it is relevant to final ingredient classification and testing criteria. Comments previously submitted need not be resubmitted, additional comments should only address data provided after 1995. Triclosan, salicylic acid among ingredients requested by industry for Category I status; CTFA and SDA have submitted data on test protocols, antimicrobial performance, filing four petitions in 2001 alone (2"The Tan Sheet" Dec. 10, 2001, p. 4)...

Antimicrobial monograph

FDA is reopening administrative record for OTC topical antimicrobial drug products monograph until Aug. 27 to accept comments and data on OTC healthcare antiseptic drugs, agency says in 1May 29 Federal Register notice. Record for TFM closed in August 1995, but FDA has since received several petitions and comments containing new data on proposed non-monograph ingredients and testing criteria for antiseptic drugs. FDA has determined "good cause exists" to review new information, as it is relevant to final ingredient classification and testing criteria. Comments previously submitted need not be resubmitted, additional comments should only address data provided after 1995. Triclosan, salicylic acid among ingredients requested by industry for Category I status; CTFA and SDA have submitted data on test protocols, antimicrobial performance, filing four petitions in 2001 alone (2"The Tan Sheet" Dec. 10, 2001, p. 4)...

CTFA, SDA Endorse Combo Hand-Cleansing Regimen In Healthcare Settings

Alcohol-based hand sanitizers should be combined with traditional hand-washing products in a situation-dependent regimen, CTFA and SDA state in a recent letter to the Centers for Disease Control & Prevention

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