Resources from FDA: Framework for Pharmacy Compounding: State and Federal Roles

Framework for Pharmacy Compounding: State and Federal Roles

A public meeting “Framework for Pharmacy Compounding: State and Federal Roles,” was held on Wednesday, December 19, 2012 from 3:00 p.m. to 5:00 p.m. ET at the FDA White Oak Campus, The Great Room, Building 31, Room 1503, 10903 New Hampshire Avenue, Silver Spring MD.  The Federal Register¹ notice announcing this meeting published November 28, 2012. 

Purpose
The purpose of this public meeting was to share with interested stakeholders the results of the intergovernmental meeting held earlier on December 19, 2012.  The intergovernmental meeting was held to provide an opportunity for State officials to discuss a variety of issues regarding their views on the role of the FDA and the States in the oversight of compounding.  At the public meeting, FDA representatives and participants from the intergovernmental meeting summarized the results of the intergovernmental meeting.
Meeting Materials

• Agenda (PDF 99.6KB)²  
• Issues for Discussion (PDF 72.8KB)³
• “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak” Statement of Margaret A. Hamburg, M.D., Commissioner for Food and Drugs, before the Committee on Health, Education, Labor and Pensions, U.S. Senate, November 15, 2012    ⁴

Transcript (PDF 267KB)⁵

Archived Webcast (Closed Captioned)⁶ 

Public Participation:  Submit Comments by January 18, 2013 to Docket No. FDA-2012-N-1154
In order to obtain public comment, FDA is also soliciting either electronic or written comments on the issues discussed, including:

• Given existing authorities and resources, are the States currently able to provide the needed oversight of pharmacy compounding and consumer protection?
• What should the Federal role be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution?  Is there a way to re-balance Federal and State participation in the regulation of pharmacy compounding that would better protect the public health?  What strategies should be developed to further strengthen Federal/State communications?
• Do you see a role for the States in enforcing a Federal standard for “non-traditional” compounding?  If so, what role?  What factors would affect a decision by your State to take on such responsibility?

The deadline for submitting comments is January 18, 2013.  Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov⁷ 

Additional Stakeholder Resources:Multistate outbreak of fungal meningitis and other infections