His report said the FDA has attempted to rein in compounding pharmacies by issuing warning letters, but gaps in compliance have led to 23 deaths and 86 serious illnesses in 34 states.
While the state Boards of Pharmacy do not enforce actions that related to the safety or scope of drugs made by these pharmacies, they have “challenged” the FDA’s efforts to ensure the safety of compounding pharmacies, the report said.
Ultimately, the FDA will be constrained by gaps in regulatory authority and “thwarted by an industry that has historically resisted a federal role for the oversight of its activities.”
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