FDA Requests Label Changes, Single-use Packaging for Certain Antiseptic Products

摘要

The Food and Drug Administration Nov. 13 issued a request asking manufacturers to voluntarily change packaging and labeling for some over the counter topical antiseptic products, including single-use pads, wipes and swabs. The announcement, part of the agency's ongoing evaluation of these products, comes nearly a year after it had convened a public hearing and solicited stakeholder comments to examine concerns about microbial contamination of antiseptic patient preoperative skin preparation products following several reports of infection outbreaks and related product recalls. Since that time, the FDA has been looking at a range of issues related to intrinsic and extrinsic contamination, with one of the primary questions being whether these products should be required to be manufactured sterile.