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U.S. Department of Health and Human Services

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Drug Safety Oversight Board Meeting, June 21, 2012

Public Summary

The Drug Safety Oversight Board (DSB or Board) discussed the following topic:

  • Sterility Requirements for Antiseptic Preoperative Skin Preparations

The views expressed by non-CDER employees are those of the individual and not necessarily the opinion of their respective government agency or institution.

The Office of New Drug’s Division of Nonprescription Clinical Evaluation (DNCE) and Division of Nonprescription Regulation Development (DNRD) sought input from the Board regarding potential regulatory actions related to antiseptic products used for pre-operative and injection skin preps.

The Board discussed standards for FDA-regulated sterile products, including testing of marketed sterile products and impediments, if any, to sterility requirements of antiseptic products.