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FDA Meeting will Evaluate Safety of OTC Antiseptics

Aug 1, 2014

In light of safety concerns, the U.S. Food and Drug Administration (FDA) will be holding a meeting this September to evaluate the safety and efficacy of over-the-counter antiseptic products. According to RAPS, the meeting comes only months after the agency first raised the issue to manufacturers.

On Monday, the FDA announced in the Federal Register that its Nonprescripion Drugs Advisory Committee (NDAC) will meet in September 2014 to discuss non-prescription antiseptics. This includes hand washes and rubs used by healthcare personnel, surgical hand scrubs and rubs and skin preparations for preoperative and postoperative injections in patients. “The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective," the FDA said.

When healthcare professionals administer an injection, they use non-prescription antiseptics to prevent infection. These antiseptic products are often packaged for single-use, but they are also frequently sold in multiple-use packages. This allows the user to go back and use more of the product from the same package, such as a tube, at a later time point.

The problem, according to the U.S. Food and Drug Administration (FDA), is that the multiple-use packages are sometimes becoming contaminated after they have been opened. The agency warned that OTC antiseptics were implicated in four deaths, five would infections, and dozens of other infections last November. “We are requesting that manufacturers package antiseptics indicated for preoperative or pre-injection skin preparation in single-use containers” the FDA stated in response to these reports.

The FDA also wants manufacturers to place a label on antiseptics to indicate whether or not they are sterile, since they are not legally required to manufacture them sterile. There have been situations in the past were companies were warned by the FDA for manufacturing supposedly sterile products in an unsanitary environment.

According to RAPS, the FDA also issued new rules regarding antiseptic products used with water, which includes hand soaps; manufacturers would have to submit data showing that antibacterial hand soaps are safe and effective compared to non-antibacterial soaps, reports.

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