FDA Pushes Hospitals To Buy From Registered Compounders

By Greg Ryan (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 their products to the agency, among other requirements.

Registering as an outsourcing facility is completely...

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