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Pharmaceutical Distributors Seek Extra Measures From US FDA To Compel Orderly DSCSA Transition

 
• By Bowman Cox

The Healthcare Distribution Alliance urges the agency to set transitional milestones and other expectations that would spur preparations during the coming year of enforcement discretion.

Orderly transition
A process for achieving an orderly transition. • Source: Shutterstock

The US Food and Drug Administration should add milestone dates in 2024 so pharmaceutical distribution trading partners can ensure an orderly transition to a package-level product tracing system during the post-deadline stabilization period, the Healthcare Distribution Alliance proposed.

Key Takeaways

  • Most trading partners want an orderly transition to the package-level drug product tracing system required under DSCSA, but some would be happy with a string of last-minute delays.

The alliance, which represents pharmaceutical distributors, also called for the FDA to set and communicate additional expectations intended to motivate...

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