Legislation Introduced for Federal Regulation of Large Compounding Labs Similar to NECC, Which Was Responsible for Fungal Meningitis Outbreak Targeted by Lawsuits
Legislation introduced in the U.S. Senate is the first bipartisan bill in Congress aimed at implementing direct federal oversight of large specialty compounding laboratories similar to New England Compounding Center (NECC). NECC was the source of tainted pain medication that caused a fungal meningitis outbreak which according to the Centers for Disease Control and Prevention and press reports has sickened more than 730 people and led to 54 deaths in 20 states.
The new legislation would subject large compounding operations such as NECC to direct federal regulation by the Food and Drug Administration (FDA), rather than by state pharmacy boards that have previously overseen these companies. It also sets minimum standards for ingredients used by all compounding pharmacies.