Benzethonium Chloride Review Prior To Final Monograph Urged By Lonza
This article was originally published in The Tan Sheet
Executive Summary
A safety review of benzethonium chloride as a Category I active ingredient in the healthcare antiseptic products monograph should be conducted by FDA before completing the rule, chemical ingredient supplier Lonza suggests.
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Safety and efficacy studies on the use of benzethonium chloride in finished-product formulas bear out a Category I classification in the healthcare antiseptic monograph, chemical ingredient supplier Lonza says in a May 15 citizen petition to FDA
Benzethonium chloride antimicrobial agent dermal toxicity, PK data sought by FDA.
BENZETHONIUM CHLORIDE DERMAL TOXICITY, PHARMACOKINETIC STUDY NEEDED before FDA will consider the agent for Category I (generally recognized as safe and effective) status as an antimicrobial hand or body wash ingredient, Division of Anti-Infective Drug Products Veterinary Medical Officer Terry Peters, DVM, said at an agency "feedback" meeting in Rockville, Md. April 1. Addressing representatives of the ingredient's supplier, Lonza, Inc., and the firm's outside consultant, Toxicology/Regulatory Services President Gerald Schoenig, agency toxicologist Peters also recommended the ingredient testing be done according to final product formulations, noting that according to data Lonza presented, absorption of the ingredient in ethanol, rather than water, is as high as 36%. Schoenig said he expected absorption rates would be lower if the tests were conducted in a finished product formulation with water as a vehicle.
HEALTH CARE ANTISEPTICS TFM INCLUDES FIVE CATEGORY I INGREDIENTS
HEALTH CARE ANTISEPTICS TFM INCLUDES FIVE CATEGORY I INGREDIENTS alcohol 60-95%, iodine tincture USP, iodine topical solution USP, povidone-iodine 5-10%, and isopropyl alcohol 70- 91.3%. However, only two ingredients alcohol 60-95% and povidone- iodine 5-10% -- are considered Category I (safe and effective) for all three health care antiseptic indications: patient preoperative skin preparation; antiseptic handwash or health care personnel handwash; and surgical hand scrub. The tentative final monograph for topical health care antiseptic drug products appears in the June 17 Federal Register.