Drug Quality and Security Act Signed Into Law

The bill attempts to regulate manufacturers such as the New England Compounding Center, which distributed contaminated injectable steroids that were linked to a 2012 fungal meningitis outbreak in which 64 people died.

President Obama on Nov. 27 signed into law H.R. 3204, the Drug Quality and Security Act, which clarifies the U.S. Food and Drug Administration's authority to regulate compounded drugs and creates a new, voluntary program for FDA to regulate entities engaged in batch compounding so they can register with the agency. The bipartisan bill had passed both houses of Congress on voice votes recently.

The bill attempts to regulate manufacturers such as the New England Compounding Center (NECC), which distributed contaminated injectable steroids. These products were linked to a 2012 fungal meningitis outbreak that killed 64 people. H.R. 3204 was introduced by U.S. House Energy and Commerce Committee Chairman Fred Upton, R-Mo., who says Michigan families were hit hardest by that outbreak, with 264 cases and 19 deaths, including three people living in Upton's district who died.

The president also signed into law H.R. 1848, the Small Airplane Revitalization Act of 2013, which requires the Federal Aviation Administration to advance the safety and continued development of small airplanes by reorganizing certification requirements for them in a final rule to be issued no later than Dec. 15, 2015.

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  • OHS Magazine Digital Edition - September 2020

    September 2020

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