Will The FDA Eliminate The Linear Barcode On Drugs?

During last week’s FDA DQSA supply chain stakeholder’s conference call I was heartened by Ilisa Bernstein’s comments about the linear barcode rule (she says the FDA just calls it “the barcode rule”).  The question was asked by a caller whether or not the linear barcode requirement might be dropped in light of the 2D barcode

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3 thoughts on “Will The FDA Eliminate The Linear Barcode On Drugs?”

  1. Dirk, As usual, well said. It’s long past time for the linear barcode to take a rest.
    In terms of providing input to the FDA, a few thoughts…
    I would propose going a bit farther down the 2D path, while perhaps giving the linear barcode folks a bit of leeway, at least temporarily. Four things that I’d propose:
    1) require ECC200 compatibility in the 2D barcodes;
    2) allow the linear barcodes to remain for say, 3yrs;
    3) place no constraints on the “dot” size to be used in the 2D codes; and,
    4) require the immediate removal of any product that has a “non-readable” code from the supply chain.

    Why these 4?
    1) ECC200 compatibility would drive the best readability possible with the 2D encoding, virtually eliminating the WORST thing possible, MISINFORMATION in the information systems.
    2) While ALLOWING the linear barcode to remain in use for a fixed period, this would allow those parties who cannot afford an immediate move to 2D to execute a longer transition from 1D to 2D. However, that allowance would sharply ENCOURAGE their transition as rapidly as possible by adding to their cost of placing both the 2D and linear codes, in terms of both processing costs ($ and time) and “real estate” on the products.
    3) By placing no constraints on the “dot” size of the 2D datamatrix, the supply chain would have some affordability flexibility in matching their reader costs to their mark size to their pocketbooks.
    4) In my experience, misinformation is FAR WORSE than NO information, and I would hold that in the pharmaceutical industry, this is particularly true.
    Other’s thoughts?

  2. Hi Dirk
    This issue is also pertinent to China where linear barcodes are currently the required format for Rx traceability. I’m told this data carrier was chosen due to the very large installed base of laser-based linear barcode readers and the difficulty of replacing them all at once. Developing a clear and sensible migration path from linear to 2D codes, recognising the realities in the supply chain, would be a useful exercise for the FDA to sponsor and catalyse. The output might even prove a template for persuading the Chinese to come on board with GS1 standards and datamatrix codes as the next phase of system development in China. With global (as well as federal) traceability in mind, addressing these practical issues early with clear guidance will pay dividends.
    Best, Mark

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