Tuesday, December 24, 2013

FDA Issues Proposed Rules for Antiseptic Drug Products


The U.S. Food and Drug Administration (FDA) issued a new proposed rule to amend its 1994 tentative monograph for OTC antiseptic drug products.  The FDA is proposing to establish new conditions under which OTC consumer antiseptic products are generally recognized as safe and effective ("GRASE").  The FDA states that additional safety and effectiveness data are necessary to support a GRASE ruling for OTC antiseptic active ingredients intended for repeated daily use by consumers.  The Proposed Rule does not affect hand sanitizers, wipes or antibacterial products used in hospitals and other healthcare settings.

According to the FDA, no evidence exists that these products are more effective in preventing illness than washing with regular soap and water.  Further, some antibacterial chemicals used in OTC consumer antiseptic soap products (such as triclosan) may affect certain hormones in the body and contribute to the growing problem of antibiotic resistance.

Based on the data currently available, the FDA finds with this new Proposed Rule that consumer antiseptic wash active ingredients can be considered neither safe nor effective for use in OTC consumer antiseptic wash drug products.  The new rule will be effective one year after it is finalized.  After the effective date, all OTC consumer antiseptic products that do not comply with all requirements in the monograph will be deemed misbranded if they are not subjects of approved New Drug Applications ("NDA").

The FDA is accepting public comment on the Proposed Rule, as well as new data or information, for 180 days.  After the comment period, the FDA will review all available data as well as newly submitted data to determine if the information is adequate in determining the safety and effectiveness of OTC consumer antiseptic active ingredients intended for repeated daily use.

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