Daily Rules, Proposed Rules, and Notices of the Federal Government
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The recent outbreak of fungal meningitis associated with drugs produced and sold by New England Compounding Center has raised serious questions about the regulation of pharmacy compounding (Refs. 1 and 2). Historically, regulation of pharmacy compounding has focused on drawing a line between traditional pharmacy compounding and other manufacturing. Generally, day-to-day oversight of traditional pharmacy compounding has been seen as the primary responsibility of the States, which license pharmacies and regulate the practice of pharmacy, while other manufacturing falls under the purview of FDA. Going forward, FDA believes the focus should be shifted from attempting to draw a bright line between traditional pharmacy compounding and other manufacturing to clearly defining traditional pharmacy
FDA recognizes that the States play a critical role in the oversight of traditional pharmacy compounding, which can include compounding a customized medication in response to a prescription by a licensed practitioner based on the identified medical need of a particular patient for the compounded product. However, a category of “non-traditional” compounding has evolved in the last decade that FDA believes requires additional oversight. The Agency is working with Congress to consider new authorities regarding “non-traditional” compounding pharmacies. In recognition of the States' role, FDA has also reached out to its State partners by inviting representatives from all 50 States to an intergovernmental meeting.
The intergovernmental meeting will be an opportunity for the 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 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 public meeting announced in this document will be held after the intergovernmental meeting described above. FDA is holding this public meeting to share the results of the intergovernmental meeting with interested stakeholders. At the public meeting, FDA representatives and participants from the intergovernmental meeting will summarize the results of the intergovernmental meeting.
The following references have been placed on display in the Division of Dockets Management (see
1. The Fungal Meningitis Outbreak: Could It Have Been Prevented? Statement of Margaret A. Hamburg, M.D., before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations (
2. Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak: Margaret A. Hamburg, M.D., before the Senate Committee on Health, Education, Labor, and Pensions (