Online Program

State trends in regulating compounding pharmacies following the meningitis outbreak

Tuesday, November 5, 2013 : 10:45 a.m. - 11:00 a.m.

Andrea Garcia, JD, MPH, Health & Science - Strategy, American Medical Association, Chicago, IL
Valerie Nagoshiner, Legislative Affairs, Tennessee Department of Health, Nashville, TN
Compounding pharmacies are at the center of controversy after a rare outbreak of fungal meningitis that was traced to injections compounded by the New England Compounding Center (NECC). Up to 14,000 people received the tainted injections, leaving 590 people in 19 states with meningitis or another infection. Traditionally, compounding pharmacies mix ingredients to make a customized medication for individual patients with special needs. For decades, pharmacy compounding practices were regulated solely by state Boards of Pharmacy, and the drugs made by compounding pharmacies were not required by FDA to be approved as “new drugs.” However, some compounding pharmacies have exceeded the scope of traditional compounding producing thousands of doses for sale through interstate commerce.

In 2013, state and federal policymakers will be considering what laws could have prevented the fungal meningitis outbreak. This abstast will focus on the changes states make in their legal framework governing compounding pharmacies in 2013. To date, legislation has been introduced in Massachusetts, Mississippi, New Jersey, New Hampshire, Tennessee, South Carolina and Virginia. The legal changes will be analyzed and trends from the states will be identified

Learning Areas:

Public health or related laws, regulations, standards, or guidelines

Learning Objectives:
Identify trends in state law to better regulate compounding pharmacies following the fungal meningitis outbreak.

Keyword(s): Law, Public Health Legislation

Presenting author's disclosure statement:

Not Answered