FDA to Judge: Enforcement Decisions Are Discretionary Blocking imports of every shipment of active pharmaceutical ingredient (API) intended for compounding is an impossible feat requiring resources beyond the FDA’s means, the agency told an appeals court May 13, calling KV Pharmaceuticals’ claims it should have done so “absurd.”

Washington Drug Letter

May 20, 2013  | Vol. 45 No. 20

 

FDA to Judge: Enforcement Decisions Are Discretionary

Blocking imports of every shipment of active pharmaceutical ingredient (API) intended for compounding is an impossible feat requiring resources beyond the FDA’s means, the agency told an appeals court May 13, calling KV Pharmaceuticals’ claims it should have done so “absurd.”

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