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 requirement contained in the Drug Quality and Security Act (DQSA) since some drug packages are too small to accommodate both barcodes. This is an excellent question and I was happy the caller asked it so directly.
In her response, Dr. Bernstein pointed out that the FDA had already done some work to look at the barcode rule a few years ago and now that the DQSA has passed, they intend to look at the barcode situation holistically. That is encouraging because it makes it clear that the FDA will at least consider eliminating the linear barcode requirement entirely at some point in the future. In my view, the linear barcode has outlived its usefulness and the FDA should jump at this golden opportunity to leave linear barcodes behind and bring the industry into the 2D world so it can begin to reap the benefits (see “Why NOW Is The Time To Move Away From Linear Barcodes”). They should look at the DQSA as an actual Congressional mandate to do so.
That’s right, the Drug Supply Chain Security Act, which is Title II of the DQSA, requires all non-exempt drug packages to include a 2D DataMatrix barcode on them before November 27, 2017 (repackaged drugs, before November 27 2018). Here is the exact wording from section 582(a)(9).
“PRODUCT IDENTIFIERS- With respect to any requirements relating to product identifiers under this subchapter—
(A) unless the Secretary allows, through guidance, the use of other technologies for data instead of or in addition to the technologies described in clause (i) and (ii), the applicable data—
(i) shall be included in a 2-dimensional data matrix barcode when affixed to, or imprinted upon, a package; and
(ii) shall be included in a linear or 2-dimensional data matrix barcode when affixed to, or imprinted upon, a homogeneous case; and
(B) verification of the product identifier may occur by using human-readable or machine-readable methods. …”
And under “Manufacturer Requirements”, section 582(b)(2),
(A) IN GENERAL- Beginning not later than 4 years after the date of enactment of the Drug Supply Chain Security Act, a manufacturer shall affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce. Such manufacturer shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction. …”
And under “Repackager Requirements”, section 582(e)(2),
(A) IN GENERAL- Beginning not later than 5 years after the date of enactment of the Drug Supply Chain Security Act, a repackager described in section 581(16)(A)—
(i) shall affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction in commerce;
(ii) shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction;
(iii) may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to subsection (a)(5)); and
(iv) shall maintain records for not less than 6 years to allow the repackager to associate the product identifier the repackager affixes or imprints with the product identifier assigned by the original manufacturer of the product. …”
The only problem is, there are a lot of companies out there in the supply chain that have made heavy investments in barcode readers that are only capable of reading linear barcodes, and they still have quite a few more years before they will start failing and need replacing. Some of those folks always cry out whenever the FDA starts making noises like they might allow manufacturers to eliminate the linear barcode.
My fear is that will cause the FDA to continue to require linear barcodes for some period of time after November 2017 when the 2D barcode will become a requirement. Requiring the new 2D barcode without removing the linear barcode requirement would be the worst possible outcome because it will take up more real estate on drug packages and it will delay the use of the 2D barcode which will delay the benefits to the industry and to patients. You need to be ready to counter the arguments of those who will fight to keep the linear barcode. Be ready when the FDA asks for public input on the matter sometime early next year.
And don’t forget to fill out the 2014 RxTrace U.S. Pharma Supply Chain Traceability survey. Click on the banner below to fill it out now. It only takes a few minutes and your input will help us understand the industry’s aggregated thinking on topics directly related to the DQSA. You will want to see the results in early 2014, so why not contribute your anonymous input now. If you have already filled out the survey, thank you!