• Regulatory NewsRegulatory News

    FDA Offers Guidance on Final Rule for Antiseptic Washes

    As new risk information prompted the US Food and Drug Administration (FDA) to reevaluate the data needed for classifying certain antiseptic washes, FDA published new guidance last week to help small businesses better understand and comply with the final rule establishing that certain active ingredients, including triclosan and triclocarban, used in over-the-counter (OTC) antiseptic washes are not generally recognized as safe and effective (GRASE). Background On 6 ...
  • Regulatory NewsRegulatory News

    After Intense Scrutiny, FDA Set to Take Another Look at OTC Antiseptics

    The US Food and Drug Administration (FDA) will soon hold a meeting regarding the safety and efficacy of non-prescription antiseptic products, just months after raising concerns about the products to manufacturers. Background OTC topical antiseptics are generally used to prepare a site prior to injection to reduce the chance of site infection. While some of the products are currently distributed in single-use form, many are packaged in multiple-use packages like tubes th...
  • FDA Cites Chinese Company for Manufacturing Contaminated Wound Care Products

    A warning letter sent to a Chinese manufacturer by the US Food and Drug Administration (FDA) claims antiseptic wipes manufactured by the company were contaminated with several types of dangerous and potentially fatal bacteria. The 30 July 2012 letter was sent to Jiangsu Province Jianerkang Medical Dressing Co and authored by FDA's Office of Manufacturing and Product Quality, and references a September 2011 inspection conducted by the agency. The inspection revealed what...