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Belmont Health Law Journal

Abstract

Part I of this Note will illustrate the problems posed by drug counterfeiting and drug diversion, describe current solutions being used to address these problems, and conclude with a discussion of federal legislation that seeks to fix these weaknesses in the pharmaceutical supply chain, focusing on the tracking and tracing requirements that the DSCSA imposes on supply chain participants. In Part II, this Note will examine the development of blockchain technology as well as examine its defining characteristics. Part III will explore current industry efforts to apply blockchain technology to supply chain uses and contends that blockchain is uniquely fit to meet the DSCSA tracking and tracing requirements and fix the weak points in the global pharmaceutical supply chain that allow counterfeit or diverted drugs to enter into the legitimate wholesale market. This Note concludes with a recommendation that the Federal Drug Administration (FDA) continue to monitor industry progress and make accommodations necessary with regard to enforcement of DSCSA requirements, including potentially extending its deadline for compliance, so as to ensure that members of the pharmaceutical industry have appropriate time to properly develop and implement the best possible supply chain solution, solutions that will likely rely on blockchain technology at some point in the future.

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