In late November and December, FDA issued three more guidances on implementing the provisions of DSCSA – the track and trace (Title II) component of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). Title I of DQSA addresses compounding. The three new DSCSA guidances cover:● the situations in which FDA will delay enforcing transaction requirements beyond the May 1, 2015 deadline ● annual reporting by Rx drug wholesale distributors and third-party logistics providers, and ● standards for exchanging transaction information among trading partners. [The three guidances will be reviewed in more detail, along with an update on FDA’s progress and goals in implementing DSCSA from FDA Compliance Office Director Elisa Bernstein, in IPQ’s January, 2015 Monthly Update.]
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