Dispute with compounder may show limits of FDA's authority

08/19/2013 | PharmaLive.com

The FDA's recent battle with NuVision Pharmacy underscores challenges in the agency's efforts to regulate compounding pharmacies that refuse to obey enforcement actions, Ed Silverman writes. The FDA may use the pharmacy's refusal to carry out a recall as an example of why Congress needs to explicitly lay out the agency's authority to regulate compounding pharmacies, he writes.

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