Decoding The FDA’s DSCSA Timeline

Many RxTrace readers probably saw the FDA press release last week that included the timeline chart called “Summary of Planned Implementation Timeframes for the Drug Supply Chain Security Act”.  If you did not see it, here is the link.  I found the text to be too small so I reproduced the chart using a larger

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2 thoughts on “Decoding The FDA’s DSCSA Timeline”

  1. Thanks as always. The Unique Device Identifier UDI program established a marking system and the requirements for a database first. These are enablers for anything which follows. I believe that, similarly, the first steps in DQSA need to be establishing the labeling systems and database requirements.

    Because a labeling system and tracking and tracing are wound up together in the DSCSA, who knows what the implementation plan really is?

    The UDI approach allows industry to make use of systems and begin to take advantage of supply chain opportunities now that they know what those requirements are.

    Awaiting your further insights.

    1. We have to be careful not to draw too many similarities, or unrealistic expectations of the FDA, in comparing UDI to DQSA (so hard to shift to DSCSA).

      UDI is to medical devices to what the NDC code is to drugs; a consistent identification of the product. The intent of UDI was to simply (I use that term loosely) to identify devices with a unique number, and have a database that stored information about those products. What it wasn’t ever intended to do was to create a unique record about each manufactured devices.

      What the FDA has to do for the Pharma industry is significantly different that what they had to do with the device industry. It involves labeling, but it involves a significantly larger effort to realize the “Track & Trace” effort… and a single “database” probably isn’t the answer.

      Creating a database to store static information about devices (<10k PMA or 510k/year) is a much easier putt than a designing a system to exchange data between multiple trading partners for a volume well into the Billions.

      The other item to consider… It took UDI 4+ years to actually release a regulation, I was getting ready the UDI Regulation back in Dec '10… it didn't come to fruition until Jul '13.

      Apples & Oranges

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