The fungal meningitis outbreak traced in September to steroids from the New England Compounding Center is forcing Congress to revisit a gray area of the law that has frustrated regulatory authorities for years.
NECC Crisis Festered in Ambiguity That Reigns Over Compounding
As FDA, Congress and the courts stumbled, compounding pharmacies such as NECC took advantage of a gray area of the law. Legislators will get another try; one proposed subjecting such pharmacies to cGMP requirements.