October 31, 2012
Congressional Report Details Regulatory Oversight of Compounding Pharmacies
This week, Congressman Edward J. Markey (D-Mass.) released a report, Compounding Pharmacies, Compounding Risk, which examines FDA and state Boards of Pharmacy regulation of compounding pharmacies. According to the report, the FDA has attempted to rein in activities of compounding pharmacies by issuing warning letters, but the nature of regulatory oversight and gaps in legal authority have led to 23 deaths and at least 86 serious illnesses or injuries in 34 states (not including the most recent outbreak). The report explained that state Boards of Pharmacy do not typically undertake enforcement actions that relate to the safety or scope of drugs made by compounding pharmacies. In spite of this deficiency, "FDA’s efforts to assure the safety of compounding pharmacies have been challenged at every juncture by some members of the compounding pharmacy sector." The report concluded:
This analysis makes clear that state regulators are not, or cannot, perform the same sort of safety-related oversight of compounding pharmacy practices that FDA has historically undertaken. But it is also clear that absent clear new statutory authority, FDA’s efforts will ultimately 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.