'Difficult To Compound' Drug List Gets Revived By FDA

Law360, New York (December 4, 2013, 5:39 PM EST) -- Armed with new authority to regulate compounding pharmacies, the U.S. Food and Drug Administration on Wednesday revived efforts to identify medicines that are especially hard for the specialty manufacturers to produce and ineligible for relaxed oversight.

In a request for public input, the FDA said it intends to create a list of “difficult-to-compound” drugs that under federal law would not be exempt from labeling standards, approval requirements and good manufacturing practices.

Under the newly passed Drug Quality and Security Act, compounders can register with the FDA...
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