Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs

The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.

Date:         March 22-23, 2012

Time:         9:00 a.m. to 4:00 p.m.

Location:   FDA White Oak Campus
                    10903 New Hampshire Avenue
                    Bldg. 31, Room 1503
                    Silver Spring, Maryland 20993 

• Federal Register Notice
• Agenda (PDF - 25KB)
• Panel Members (PDF - 95KB)
• Slide Presentations
• Transcript: Day 1 - March 22, 2012 (PDF - 916KB)
• Transcript: Day 2 - March 23, 2012 (PDF - 309KB)

Visitor Information

All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB) for directions.

Webcast of Meeting

The webcast can be accessed via the following web link:

• https://collaboration.fda.gov/march2012part15/

If you have never attended a Connect Pro meeting before test your connection at:
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm

For Further Information Contact: Lee Lemley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 301-796-3441, FAX: 301-847-8753, email: OTCTechnologiesPublicMeeting@fda.hhs.gov.