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FDA/Industry Track and Trace Pilot Planning Sheds Further Light on Complex Web of DSCSA Implementation Challenges

May 16th, 2016

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The complexity of the web of issues that need to be worked through to arrive at a fully interoperable track and trace system in the U.S. for prescription pharmaceuticals by 2023 as mandated by the Drug Supply Chain Security Act (DSCSA) was in full display at an FDA pilot planning workshop in early April.

The workshop allowed FDA experts to hear the views of participants from across the supply chain on the key challenges, objectives, and evaluation methods that should be explored in the piloting initiatives called for under section 582(j) of DSCSA.

Participating in the workshop were drug manufacturers, repackagers, contract manufacturing organizations, wholesale distributors, third-party logistics providers, pharmacy dispensers, solution providers, consultants and a standards organization.

The discussions highlighted the many variables that the track and trace system must accommodate as different product types and configurations move through a plethora of pathways en route to the patient. 

[The story continues for subscribers on p. 2. Included are reviews of DSCSA implementation issues from a leading FDA official and an industry expert involved. Nonsubscribers can get information on IPQ subscriptions/licensing and individual story purchasing by contacting Wayne Rhodes ([email protected]).]

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