FDA Calls for New Rules for Compounding Pharmacies

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FDA Calls for New Rules for Compounding Pharmacies
FDA Calls for New Rules for Compounding Pharmacies

(HealthDay News) – The U.S. Food and Drug Administration is pushing for new rules to regulate compounding pharmacies, according to reports from the FDA's Dec. 19 meeting with state pharmacy regulators.

FDA Commissioner Margaret Hamburg, MD, met with state pharmacy regulators at a meeting at FDA headquarters in Silver Spring, MD, to discuss the oversight of compounding pharmacies in response to the three-month-old fungal meningitis outbreak resulting from contaminated injections produced at the New England Compounding Center in Framingham, MA.

Hamburg called for federal and state health inspectors to work together to oversee compounding pharmacies, which fall into a regulatory gray zone between various state and federal laws. The FDA argues that new laws are needed to regulate these so-called "nontraditional" compounding pharmacies. Under a proposed a new system, the FDA says these nontraditional pharmacies would have to register with the FDA and undergo regular inspections, similar to how large pharmaceutical manufacturers currently do. State pharmacy boards would continue to regulate small compounding pharmacies. Up to now, Congress has stalled efforts to pass legislation embracing the FDA proposal.

According to the FDA, "[our] primary goal since the onset of this outbreak has been to protect the public health. With the state and Federal partners, we are conducting thorough investigations of the relevant facilities, monitoring the voluntary recalls associated with these products to ensure that contaminated and potentially contaminated product is off of the shelves, and ensuring that information is communicated promptly and clearly to health care professionals and patients."

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