Carter Alleges FDA Guidance Improperly Drives Compounding Enforcement

February 1, 2018 at 12:35 PM
FDA came under fire from Rep. Buddy Carter (R-GA) Tuesday (Jan. 30) for what he alleges is the agency's use of guidance documents as the basis for compounding enforcement actions. Carter’s concerns were buoyed by a new policy from the Department of Justice which bars use of guidance to create binding standards, or to take enforcement action based solely on noncompliance with guidance -- although there is some debate as to how that policy will impact FDA. Carter, who has...


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