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Antimicrobials

This article was originally published in The Tan Sheet

Executive Summary

FDA meeting with CTFA to discuss testing of topical antimicrobials will be held Nov. 3 at 2 p.m. in Rockville, Md. The last industry/FDA meeting on the subject took place July 21, 1998, during which FDA officials questioned industry's request to include consumer hand sanitizers in the proposed Healthcare Continuum Model (1"The Tan Sheet" July 27, 1998, p. 16). In August, FDA denied a citizen petition from CHPA and CTFA requesting the agency not take any action on antimicrobial products until the antiseptic monograph is final (2"The Tan Sheet" Aug. 23, p. 10)

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Antimicrobial Citizen Petition From CHPA, CTFA Denied By FDA

FDA has denied the Consumer Healthcare Products Association's citizen petition requesting the agency not take any action on antimicrobial products until the antiseptic monograph becomes final. The Cosmetic, Toiletry & Fragrance Association and the Soap & Detergent Association partnered with CHPA on the June 12, 1998 petition.

Antimicrobial hand sanitizers target use by food handlers questioned by FDA.

ANTIMICROBIAL HAND SANITIZERS POSITION IN CONTINUUM MODEL CHALLENGED by FDA Anti-infective Drugs Division microbiologist David Bostwick during the first in a series of technical "feedback meetings" on antimicrobial food handler products held by the Center for Drug Evaluation & Research OTC Drugs Division in Rockville, Md. During the general session of the July 21 meeting, Bostwick questioned the inclusion of waterless hand sanitizers in the proposed Healthcare Continuum Model given the products' broad target use, which ranges from home food preparation to use by slaughterhouse workers. Other food handler antimicrobials provide better protection against organisms, Bostwick noted, asking "what is the rationale" for the inclusion of waterless hand sanitizers if the HCCM "already covers [them] in...other types of products."

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