Report finds gaps in state regulation of compounding pharmacies

State Boards of Pharmacy do not "consistently oversee" the safety of drugs made by compounding pharmacies, according to a congressional report released on Monday by Rep. Edward Markey (D-Mass.). According to the report, which is based on a review of media reports and publicly available documents from FDA and the boards, most of the state enforcement of compounding pharmacies is not related to safety but to "traditional" pharmacy violations, including billing violations or failure to have an on-site licensed pharmacist. The report also found that FDA's efforts to assure the safety of compounding pharmacies have been challenged by members of the compounding sector, and that "absent clear new statutory authority," 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." ...