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Antimicrobial monograph

This article was originally published in The Rose Sheet

Executive Summary

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 agency has since received several petitions, comments containing new data on proposed non-monograph ingredients, testing criteria for antiseptic drugs. FDA will review new information because it is relevant to final ingredient classification and testing criteria, agency says. Comments previously submitted need not be resubmitted, and additional comments should only address data provided after August 1995. Triclosan, salicylic acid are among the 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 Rose Sheet" Dec. 10, 2001, p. 4)...

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Persistence/cumulative testing requirement should be eliminated for alcohol hand antiseptics in the Healthcare Antiseptic Drug Products Tentative Final Monograph for the antiseptic handwash/health care personnel handwash category, Elaine Larson, RN, PhD, Columbia University, states in comments to FDA July 30. Performance criteria threaten the availability of alcohol-based hand disinfectants, she says. Although ethyl and isopropyl alcohol are Category I for safety and efficacy in the 1994 TFM, the Health Care Personnel Handwash test outlined in the monograph requires products to exhibit cumulative ("persistent" or "residual") antimicrobial effect. Alcohol-based products, however, lack this effect, Larson adds, noting these items therefore must be reformulated to contain biocidal ingredients to display a cumulative effect. Comments respond to FDA's reopening of the administrative record for the topical antimicrobial drug products monograph in May (1"The Rose Sheet" June 2, 2003, In Brief)...
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