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Legislation: Usa – U.S. Senate backs bill to regulate bulk drug compounding

Legislation: Usa – U.S. Senate backs bill to regulate bulk drug compounding


Usa - 2013/11/18

November 18, 2013 - Reuters.com

November 22, 2013 - Cen.Acs.org

November 27, 2013 – Reuters.com

President Barack Obama signed a bill into law, known as the Drug Quality and Security Act, which clarifies the law regarding drug compounding and creates a new category of compounding pharmacies known as “outsourcing facilities”. It also creates a national set of standarts to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medications into the drug supply. The new law creates a category of compounding outsourcing facilities that will be able to sell to hospitals in bulk. The facility can choose to register with the U.S. Food and Drug Administration (FDA), in which case it will undergo regular inspections and be subject to tighter quality controls. The law will also create national standards to track and trace drugs amid growing concerns over counterfeit drugs.