Selected Resources on Federal Oversight of Compounding Pharmacies (CRS Report for Congress)
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| Release Date |
March 21, 2013 |
| Report Number |
R42837 |
| Report Type |
Report |
| Authors |
Judith M. Glassgold, Specialist in Health Policy; Susan Thaul, Specialist in Drug Safety and Effectiveness; Janet Kinzer, Information Research Specialist |
| Source Agency |
Congressional Research Service |
Summary:
n September 2012, the Centers for Disease Control and Prevention (CDC), the Tennessee Department of Health, the Food and Drug Administration (FDA), and other state health departments1 began investigating a rare, non-contagious2 outbreak of fungal meningitis. As of March 4, 2013, 20 states have reported 720 infections (including fungal meningitis and other conditions) and 48 deaths.3 Patients at risk are those who received injections of contaminated, preservative-free methylprednisone acetate produced by the New England Compounding Center (NECC) after May 2012.4 On October 4, 2012, the FDA verified that NECC was the source of the contaminated products.5 There has been extensive news coverage of the outbreak, which raised issues about the safety of compounded drugs and the role of federal and state governments in regulating compounded drugs and compounding pharmacies.6 A number of policy questions about FDA authority and resources were raised in congressional hearings held by the Energy and Commerce Committee of the U.S. House of Representatives and the Health, Education, Labor, and Pensions Committee of the U.S. Senate.7 This report provides selected resources on the federal government's oversight of compounded drugs and compounding pharmacies, with an emphasis on relevant federal law and regulation and the activities of federal agencies related to and following the 2012 fungal meningitis outbreak. Resources from three states that have direct roles in this outbreak through licensing NECC, or reporting and tracking the fungal meningitis outbreak, are included as well.
