State Regulators Seek FDA Regulation of Compounding Pharmacies

State regulators are requesting that the FDA regulate compounding pharmacies in the wake of the recent fungal meningitis outbreak.

The regulators would like the FDA to establish federal definitions for both manufacturers and compounding pharmacies, with the most important task being defining the exceptions.

Traditionally, compounding pharmacies make custom medications for patients in response to a prescription. In the case of the meningitis outbreak, the New England Compounding Center produced large amounts of medication without individual prescriptions. So far, the outbreak has led to the deaths of 39 people. A total of 620 people have been affected.

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