FDA Developing Track and Trace Standards as Part of DSCSA Implementation

To protect consumers from drugs that may be counterfeit, stolen, or tainted, Food and Drug Administration (FDA) is advancing efforts to implement an advanced track and trace program. The Drug Supply Chain Security Act (DSCSA), enacted as Title II of the Drug Quality and Security Act in November 2013, authorizes FDA to create and implement a prescription drug tracking system that will make it possible to identify and track certain prescription drugs throughout the distribution process. “The ultimate goal is to identify each individual prescription drug package in a way that will enable rapid and accurate verification of the legitimacy of the product, which will be an important tool in the fight against counterfeit drugs,” states Ilisa Bernstein, PharmD, JD, deputy director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research in an FDA Voice blog entry. Bernstein also indicates that FDA will be issuing a draft guidance document with initial standards by November 27, 2014. The agency will host a public workshop on the standards May 8–9, 2014. The DSCSA will be the topic of a continuing pharmacy education session at the NABP 110th Annual Meeting on May 17, 2014, in Phoenix, AZ.