FDA Issues Proposed Rule for Antiseptic Drug Manufacturers

Registrar Corp informs the over-the-counter drug industry that FDA has issued a new proposed rule to establish new conditions under which over the counter antiseptic products are generally recognized as safe and effective.

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FDA Antiseptic Drug Product Rules
All OTC consumer antiseptic products that do not comply with all requirements in the monograph will be deemed misbranded.

Hampton, VA (PRWEB) December 23, 2013

The U.S. Food and Drug Administration ("FDA") has issued a Proposed Rule to amend the 1994 Tentative Final Monograph for over-the-counter ("OTC") antiseptic drug products. FDA is proposing to establish new conditions under which OTC consumer antiseptic products are generally recognized as safe and effective ("GRASE"). 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.

FDA states that although millions of Americans use antibacterial soaps, no evidence exists that these products are more effective in preventing illness than washing with regular soap and water. FDA further states that 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.

Due to recent scientific developments and a change in the use pattern of OTC consumer antiseptic products, FDA is requiring new data to analyze the risk-to-benefit ratio for the drug for repeated daily use. If the active ingredient does not provide clinical benefits beyond washing with regular soap and water, but increases risks from reproductive toxicity or carcinogenicity, the risk-to-benefit ratio shifts, and the active ingredient is no longer GRASE. Accordingly, as there is not sufficient data showing that the use of OTC consumer antiseptic products provides any additional benefit over washing with regular soap and water, FDA is now requiring data from clinical outcome studies demonstrating a reduction in infections through the use of OTC consumer antiseptic products before a final GRASE determination can be made.

Based on the data currently available, 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. FDA acknowledges that manufacturers will need time to comply with a final rule based on this proposed rule, and states that an effective date one year after publication of a final rule is appropriate, due to the potential safety considerations associated with use of OTC consumer antiseptic products. At the one year 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").

FDA is accepting public comment on the Proposed Rule, as well as new data or information, for 180 days. After the comment period, 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.

Companies that buy or sell OTC consumer antiseptic products should stay informed of the developments during this period before a Final Rule is issued. For companies considering conducting clinical outcome studies on the products in question, data must be submitted to FDA showing that OTC consumer antiseptic products provide a clinical benefit beyond washing with regular soap and water. If sufficient data is not supplied to FDA, publication of a final rule may result in these products no longer being considered GRASE by FDA.

Registrar Corp will be providing additional information on FDA's over-the-counter ("OTC") antiseptic drug products and will alert industry when the final rule is published. Tweet Registrar Corp (@RegistrarCorp) if you have specific questions. Or, for any questions related to U.S. FDA Regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

About Registrar Corp: Registrar Corp is a FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Drug Establishment Registrations and Drug label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 19 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations.


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