One of the surprising things about industry preparations for the Drug Supply Chain Security Act (DSCSA) is how hard it is to make label changes to add the new DSCSA product identifier barcode (see “The DSCSA Product Identifier On Drug Packages”). The artwork changes necessary take a lot longer than everyone originally expected. Companies with hundreds of different drug packages to redesign may have trouble getting all the work done by the November 27, 2017 deadline (2018 for repackagers). If you have thousands of different packages, you had better have a large team working on the artwork changes right now.
What’s the problem? All you need to do is add a new 2-dimensional (2D) barcode and change the way the lot and expiration data are presented, and a few other things. If your package is large, and you already have lots of extra white-space on your package or label, maybe it’s no big deal to add the new barcode and human readable data (see “I’ve Changed My Mind, Follow GS1’s HRI Specification”). But if your product is smaller than your fist—probably more than 60% of Rx drug packages in the U.S. supply chain today—you will discover that adding the new barcode will take a lot of thought. Some packages will take a lot of very creative thought. And others will just not have room for all of the new elements required by the DSCSA no matter what you do.
If you think the old linear barcode is going away and can be removed at the same time the new 2D barcode is added, you are wrong. Nothing in the DSCSA allows you to remove that old linear barcode. The FDA (linear) Barcode Rule of 2006 remains intact with no sunset in sight (see “Will The FDA Eliminate The Linear Barcode On Drugs?”, “Why NOW Is The Time To Move Away From Linear Barcodes”, and “FDA Still Receives Requests For Exemptions From 2006 Barcode Rule”). If you could have removed the linear at the same time you add the 2D barcode, you might not have needed any additional space. That’s because 2D barcodes are a lot more space-efficient than linear barcodes. But you can’t, so now you must find some additional room.
There are lots of things to take into consideration when redesigning your labels to accommodate compliance with the DSCSA. Here are just a few.
Don’t reduce the size of the 2D barcode or it may become unreadable. Wholesale distributors demand a grade “C” or better (unfortunately the Healthcare Distribution Management Association, HDMA, has not published their new DSCSA barcode quick guide yet, see “Important HDMA Webinar On Barcoding for DSCSA”, but you can look for the old version of that guidance on their website).
Don’t put the new 2D barcode right next to the old linear barcode. In fact, try to widely separate them if possible. This allows a person to aim their reader at the barcode of their choosing without inadvertently picking up the other barcode. Make sure you leave enough Quiet Zone (white space) on either end of the linear barcode. You need a Quiet Zone around all four sides of the 2D barcode but fortunately the dimension necessary is smaller than the linear. See GS1’s General Specifications for the correct Quiet Zone dimensions for each symbology.
Remember that the linear barcode on your product is part of the static artwork. It gets printed at the same time the other static data is printed. The new DSCSA product identifier 2D barcode and the human readable text will be different on every package so it cannot be statically printed in advance. You could possibly pre-print these labels with the static, and then the dynamic information, but that is not what most companies are doing. Most companies will print the dynamic information just prior to label application.
You cannot chose where to put the new DSCSA product identifier in a vacuum. You must chose a location on your package that your line printers are able to print on. You must also consider where the product identifier will be located to enable your collection of aggregation data, even if you don’t plan to collect that data until some time in the future. Some aggregation data collection solutions only work if the 2D barcode is visible on one particular surface of the package. This is frequently a big constraint on the location of your product identifier.
Be careful about how you define your serial numbers (see “DSCSA ‘Serial Numbers’“). Use of too many characters, especially in combination with alpha characters, may cause your 2D barcodes to blow up into a much larger image than you intended (see “Why NOW Is The Time To Move Away From Linear Barcodes” for examples and a full explanation). If you elect to use certain approaches to serial number randomization (the DSCSA does not require randomization of serial numbers but it is necessary for drugs entering the European Union after February 9, 2019) you may find that the 2D barcodes vary greatly in size on each package (see the five part series on serial number randomization that starts with “Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations”).
If your drug’s label is so small that you just cannot figure out how to fit all the existing information plus all the new information required by the DSCSA, Congress intended for you to apply for an exception to the DSCSA product identifier requirements. Section 582(a)(3)(A)(ii) requires the FDA to publish guidance that…
“…establish[es] a process by which the Secretary determines exceptions, and a process through which a manufacturer or repackager may request such an exception, to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with this section;…”
That guidance is one of those that were due last November but are still not available at this writing (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”). If you are confident you will be able to make a good case for your product being too small, you might want to set it aside for now and wait for that guidance. Watch RxTrace for news of its publication. I’ll be right on top of it.
You will need to coordinate the timing of the static printing of the label/carton stock with your new artwork, and the dynamic application of the new DSCSA product identifier barcode and human readable so that when you are ready to turn on your DSCSA serialization-capable line solution, your labels/cartons are ready to print on. You can’t apply the new product identifiers until both are ready to go.
I’ve talked with some drug manufactures who believe that it is necessary to apply to the FDA to get approval of the changes they make to their labels to accommodate the new DSCSA Product Identifier before they begin using them on their products. Make your own decisions on that, but make sure you study DSCSA Section 582(a)(8), “Label Changes”. That section reads:
“Changes made to package labels solely to incorporate the product identifier may be submitted to the Secretary in the annual report of an establishment, in accordance with section 314.70(d) of chapter 21, Code of Federal Regulations (or any successor regulation).”
The annual report is not a request for approval but a way of making the FDA aware of your “minor” change. The DSCSA text above refers to Section 21 CFR 314.70(d), “Supplements and other changes to an approved application”. That section is available here: http://www.ecfr.gov/cgi-bin/text-idx?SID=45db33df767d616435d77e5a93740559&mc=true&node=pt21.5.314&rgn=div5#se21.5.314_170. See also “Guidance for Industry Changes to an Approved NDA or ANDA” and “Guidance for Industry Changes to an Approved NDA or ANDA Questions and Answers”, although these last two guidance documents pre-date the DSCSA by more than a decade.
Whatever you do, don’t wait until the last minute to begin thinking about how you will redesign your drug labels. This is a necessary step in the preparation for the November 27, 2017 DSCSA deadline and reports are, it will take you longer than you think to complete.