Safety Concerns Prompt FDA to Evaluate OTC Antiseptics

FDA-to-Evaluate-OTC-AntisepticsJust months after raising concerns to manufacturers, the U.S. Food and Drug Administration (FDA) will be holding a meeting to discuss whether or not non-prescription antiseptic products are safe and effective, RAPS reports.

Over-the-counter antiseptics are used to reduce the risk of infection during an injection. They are distributed in both single-use form and multiple-use packages; with the latter, the product is available in a package such as a tube that allows users to apply more antiseptic later.

The FDA announced a September 2014 meeting of its Nonprescripion Drugs Advisory Committee (NDAC) in the Federal Register on Monday. The meeting will go over the safety and efficacy of different antiseptic products, including 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.

Last November, the FDA warned that OTC antiseptics were linked to at least four deaths, five wound infections, and dozens of other infections. The agency said that the products were contaminated after being opened. The proposed solution to manufacturers was that they manufacture single-use antiseptic products. “We are requesting that manufacturers package antiseptics indicated for preoperative or pre-injection skin preparation in single-use containers” the FDA stated.

Antiseptics do not have to be manufactured sterile. Because of this, the FDA also wants to the products to carry a label indicating whether they are sterile or not. In the past, companies have been warned by the FDA for manufacturing products that were supposed to be sterile in an unsanitary environment. In December 2013, the FDA also issued a new rule regarding hand soaps, which are antiseptic products used with water. Manufacturers would have to submit data showing that antibacterial hand soaps are safe and effective compared to non-antibacterial soaps, RAPS reports.

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