Industry Wants FDA Help, Guidance on New Drug Tracking System

The FDA may be falling behind its schedule for implementing a national drug tracking system intended to prevent counterfeit and substandard medicines from entering the supply chain.

Drug distributors and pharmacists told Bloomberg BNA the implementation of the tracking system has been slow and the Food and Drug Administration is behind on issuing guidance needed by industry. The Drug Supply Chain Security Act (DSCSA) outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs within the U.S. by 2023. The DSCSA is part of the Drug Quality and Security Act (Pub. L. ...