The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products. Currently, patient preoperative skin preparations are not required to be sterile, and bacteria can contaminate these products at the time of manufacture or during product use. Contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes. At this public hearing, FDA is interested in obtaining public comment about certain scientific and product use issues related to patient preoperative skin preparations
Date: December 12, 2012
Time: 9:00 a.m. to 4:00 p.m.
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring
8727 Colesville Road
Silver Spring, MD 20910
- Federal Register Notice
- Federal Register Notice (Correction)
- Agenda (PDF - 15KB)
- Panel Members (PDF - 23KB)
- Transcript: Wednesday, December 12, 2012 (PDF - 307KB)
For Further Information Contact: Lee Lemley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-796-3441, FAX: 301- 847-8753, E-mail: CDER-AntisepticPreOpPublicMeeting@fda.hhs.gov
Webcast of Meeting
This meeting will not be webcast by FDA.
The public hearing is free, and seating will be on a first-come, first-served basis. Attendees who do not wish to make an oral presentation do not need to register. If you wish to make an oral presentation during the hearing, you must register by submitting either an electronic or written request by close of business on Friday, December 7, 2012 to CDER-AntisepticPreOpPublicMeeting@fda.hhs.gov
- Weber, D.J., W.A. Rutala, and E.E. Sickbert-Bennett, “Outbreaks Associated with Contaminated Antiseptics and Disinfectants,” Antimicrobial Agents and Chemotherapy, 51:4217-4224, 2007.
- The United States Pharmacopeia 35-National Formulary 30. The United States Pharmacopeial Convention, Inc., MD, “Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use,” Chapter 1111:691, 2012. To view citation visit: USP-NF Online
- Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting transcript, available at: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP)