FDA Pushes Hospitals To Buy From Registered Compounders

Law360, New York (January 10, 2014, 3:14 PM EST) -- The head of the U.S. Food and Drug Administration urged hospitals and doctors on Wednesday to limit their compounded-drug purchases to pharmacies that voluntarily register with the agency under a new law designed to increase compounding safety.

Under the Drug Quality and Security Act, which was enacted in November, compounders that elect to be classified as so-called outsourcing facilities would be subject to stricter oversight by the FDA. Outsourcing facilities must comply with current good manufacturing practices, submit to FDA inspections and report injuries linked to...
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