FDA review of benzethonium chloride

Evaluation of data submitted by Lonza to support its request that benzethonium chloride be classified a Category I active ingredient in the healthcare antiseptics monograph will be included in final rule, FDA tells the firm in a Nov. 5 letter. "The agency intends to fully consider all relevant data on benzethonium chloride available to us before making a decision on the ingredient's status in the final rule," letter says. However, FDA adds, because the agency is developing the rule, it is required to limit communication with interested parties and is unable to meet with Lonza on the subject. Chemical ingredient supplier requested FDA complete a safety review of benzethonium chloride prior to finalizing the rule in a Sept. 17 letter (1"The Rose Sheet" Oct. 29, p. 8)...