FDA to Hold Intergovernmental and Public Meetings Regarding Compounding Regulations
As the meningitis outbreak tragedy continues to unfold, Food and Drug Administration (FDA) will hold, on December 19, 2012, an intergovernmental meeting regarding regulation of compounding pharmacies. Also on that day, from 3 to 5 PM, FDA will hold a public meeting entitled “Framework for Pharmacy Compounding: State and Federal Roles.'' On-site registration for the public meeting is on a first-come, first-served basis beginning at 2 PM. Public comments may be submitted by January 18, 2013, in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronically at www.regulations.gov. The public meeting will be Webcast on December 19, 2012, at 3 PM (EST) and can be accessed at https://collaboration.fda.gov/pharmacycompounding/. Additional details about the meetings are available in a Federal Register notice.