FDA calls for new rules for compounding pharmacies

FDA calls for new rules for compounding pharmacies
FDA calls for new rules for compounding pharmacies

HealthDay News -- The FDA pushed for new rules to regulate compounding pharmacies in an all-day meeting with state pharmacy regulators aimed at identifying and closing oversight gaps like the ones at the Massachusetts pharmacy that resulted in 39 deaths from fungal meningitis

FDA Commissioner Margaret Hamburg, MD, 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 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.

During the meeting, state pharmacy regulators expressed a need for federal help in a number of areas, including  a better definition of the compounding pharmacy label, as well as clearer distinctions between compounding and manufacturing.

Both states and the FDA said that communication between pharmacies, as well as the process by which pharmacies share inspection data, needs improvement.

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