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Pharmacy Compounding After The Drug Quality And Security Act, Erika Lietzan

Faculty Publications

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act ("DQSA"), which amends the Federal Food, Drug, and Cosmetic Act ("FDCA") to add statutory provisions addressing drug compounding and supply chain issues. This article discusses Title I of this legislation, known as the Compounding Quality Act, and draft compounding guidances subsequently issued by the Food and Drug Administration ("FDA"). Section I provides a brief history of FDA's regulation of compounding activities before the Compounding Quality Act's enactment. Section II reviews the Compounding Quality Act and FDA's new draft guidances. Section III considers some of the …