GAO Issues Recommendations for Congress and the Secretary of Health and Human Services for Compounding Pharmacies

In a July 2013 report, the United States Government Accountability Office (GAO) recommends that “Congress should consider clarifying FDA’s authority to oversee certain entities that compound drugs.”

GAO indicates that there is a lack of consensus on when compounding becomes manufacturing and specifically that “there was not agreement on whether compounding pharmacies that are engaged in large-scale drug compounding, producing these drugs in anticipation of individual prescriptions or without prescriptions, and selling them across state lines, are engaged in the practice of pharmacy or are engaged in drug manufacturing.” The report also stated, “Officials from FDA and national pharmacy organizations we interviewed generally agreed that traditional drug compounding involves a patient-specific prescription for a customized medication that is not otherwise commercially available, and there was agreement that this type of compounding is part of the practice of pharmacy and generally overseen by the states.” The report highlights the NABP Compounding Action Plan and details how the initiative supports state boards of pharmacy efforts to ensure the safety of compounded drugs. GAO also provides an overview of actions taken in four states – California, Connecticut, Florida, and Iowa – in the wake of the 2012 outbreak of fungal meningitis, which was linked to contaminated drugs compounded by a facility in Massachusetts. State actions have included strengthening regulations and initiating inspection programs. The report includes information on FDA’s “for cause” inspections, which took place from February 2002 through May 2012, and on the inspections taking place from February 2013 to March 2013 of 31 pharmacies compounding “high-risk” sterile products.

In addition, GAO recommends Health and Human Services (HHS) Secretary Kathleen Sebelius direct the commissioner of the FDA to take steps to “consistently collect reliable and timely information in FDA’s existing databases on inspections and enforcement actions associated with compounded drugs.” It further advised HHS to provide greater distinction within those databases between FDA-approved drug manufacturers and compounding facilities. The full report, “Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight” (PDF) is available on the GAO Web site.