FDA seeks public comment on pharmacy compounding following fungal meningitis cases


Intravenous news: Infection Control Today report “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.”

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