Law360, New York (May 01, 2015, 9:58 AM ET) -- In 2013, Congress enacted the Drug Quality and Security Act (DQSA), amending the Food, Drug and Cosmetic Act and creating a new category of federally regulated drug compounding establishments called outsourcing facilities.[1] Congress passed the legislation after the New England Compounding Center (NECC) incident in 2012, which left 64 people dead from a meningitis outbreak caused by contaminated mass-compounded sterile injectable drugs.[2]
The primary focus of the DQSA was to give FDA clear jurisdictional authority over mass-compounding pharmacies such as the NECC. One of the reasons...
The primary focus of the DQSA was to give FDA clear jurisdictional authority over mass-compounding pharmacies such as the NECC. One of the reasons...
To view the full article, register now.
No comments:
Post a Comment