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March 2016

Drug Supply Chain Security Act and Oral Anticancer Medications: Are We Shortchanging Our Patients?

Author Affiliations
  • 1Fox Chase Cancer Center, Temple University Health System, Philadelphia, Pennsylvania
JAMA Oncol. 2016;2(3):295-296. doi:10.1001/jamaoncol.2015.5345

On November 27, 2013, President Barack Obama signed into law the Drug Quality and Security Act (HR 3204) in response to a fungal meningitis outbreak in 2012 that killed 64 people.1 The source of the fungal contamination of methylprednisolone injections was traced to a compounding pharmacy in Massachusetts.2 Whereas Title I of the act focuses on drug compounding, Title II, also known as the Drug Supply Chain Security Act (DSCSA), created a new section dealing with (1) tracing of prescription drugs through the pharmaceutical supply chain that requires all parties (eg, manufacturers, distributers, dispensers) to pass, receive, and maintain certain product information and (2) the licensing of manufacturers, wholesale distributors, and third-party logistics providers.

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