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Friday, April 5, 2013

Selected Resources on Federal Oversight of Compounding Pharmacies

Judith M. Glassgold
Specialist in Health Policy

Susan Thaul
Specialist in Drug Safety and Effectiveness

Janet Kinzer
Information Research Specialist

In 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.

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.

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. After a brief background section, the selected resources presented in this report appear in the following order:

  • federal law; 
  • congressional hearings; 
  • proposed legislation (current and previous Congresses); 
  • congressional support agency products; 
  • FDA agency guidance and regulations, meetings, and related documents; 
  • FDA actions on drug compounding; 
  • other federal agency actions and resources; 
  • selected state resources; and 
  • articles from legal, professional, and scientific journals.

Date of Report: March 21, 2013
Number of Pages: 19
Order Number: R42837
Price: $29.95

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