The Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) is inviting public comment through Jan. 18, 2013, on a framework for pharmacy compounding. The recent outbreak of fungal meningitis associated with drugs produced and sold by New England Compounding Center (NECC) has raised serious questions about the regulation of pharmacy compounding.
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, the FDA says it 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 compounding that should be primarily overseen by the states and higher risk non-traditional pharmacy compounding that would require compliance with federal standards. In addition, there are open questions about whether, and to what degree states should enforce federal standards, what that oversight should look like, and the appropriate level of communication and coordination required to make the system of state and federal oversight seamless and effective.
The 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.
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, Rm. 1061, Rockville, MD 20852 or electronic comments to http://www.regulations.gov.
The following references have been placed on display in the Division of Dockets Management:
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
(http://www.fda.gov/NewsEvents/Testimony/ucm327664.htm), November 14,
2. Pharmacy Compounding: Implications of the 2012 Meningitis
Outbreak: Margaret A. Hamburg, M.D., before the Senate Committee on
Health, Education, Labor, and Pensions (http://www.fda.gov/NewsEvents/Testimony/ucm327667.htm), November 15, 2012.
Source: Federal Register Volume 77, Number 229/Docket No. FDA-2012-N-1154