Antimicrobial monograph
This article was originally published in The Tan 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 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)...
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Healthcare antiseptics
Persistence/cumulative testing requirement should be eliminated for alcohol hand antiseptics in the Healthcare Antiseptic Drug Products Tentative Final Monograph for the antiseptic handwash/healthcare personnel handwash category, Elaine Larson, PhD, Columbia University, says in July 30 comments. Performance criteria threaten the availability of alcohol-based hand disinfectants, she says. Comments respond to FDA's reopening of the administrative record for the topical antimicrobial drug products monograph in May (1"The Tan Sheet" June 2, 2003, In Brief)...