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Serialized Drugs Start to Trickle in at Wholesale Distributors

By September 27, 2016May 17th, 2021DSCSA, Serialization, Track and Trace

DSCSA deadlines are just around the corner, and we’ve begun to see some serialized products show up at wholesale distributors.

Manufacturers were given four years between DSCSA enactment and the serialization deadline, so kudos to those who got there ahead of scheduled. By test driving these early examples – both the good and the bad – wholesalers and manufacturers can learn a lot about serialized labeling. I discussed some sample labels shared by AmerisourceBergen in the HDA pilot program in my May 25 blog. We continue the discussion here, taking an in-depth look at some of the serialized products I have come across so far.

  1. 2D matrix on the topsert, but nothing on the bottle itselfA topsert, or outsert, is a sheet of printed product information that’s folded into a small square and glued on top of pharmaceutical packaging, such as a bottle or carton. Some serialization packaging solutions on the market utilize topserts to print a helper code. The helper code is then associated with the real serial number that’s printed on the bottle itself during packaging. Topserts can be very beneficial to aggregation stations, where a scanner can easily read all face-up topserts, associating their codes through inference to the real serialization codes on the packages themselves, saving time and, ultimately, money.I’ve noticed many products already have these topsert helper codes in a 2D matrix format on the tops of bottles. But the bottles themselves are not yet serialized. The explanation could be that manufacturers have already ordered millions of these serialized topserts and are using them on products today, ahead of schedule, so that they can quickly and easily transition to shipping serialized product in the future.The challenge? At the wholesaler, these bottles go through high-speed scanners during the shipping process. Scanners could easily become confused and have difficulty isolating the “real” data when two 2D matrix codes are printed on the same package. Wholesalers need to think through finding solutions that scan the correct serial number without slowing down the shipping process.
  1. 2D matrix as a sticker on the bottom of the bottleStickers present a lot of unknowns. The obvious questions people ask are, “Will it fall off at some point” and “What happens if it does?”If a 2D matrix falls off before it’s shipped out, the bottle can’t be scanned. The shipping process stops. Here’s another scenario: Say the 2D matrix stayed on the bottle when it was shipped, but the product was later returned by the pharmacy. Will the 2D matrix sticker stay on the returned bottle during this entire journey? If the sticker is not there, how do you handle the return without the serial number?

    Disclaimer: The bar codes in this picture are reproductions by LSPediA. They are not related to any FDA registered drug products. All data contained in the picture is LSPediA property.

  1. GTIN code and GS1 compliant GTIN codeIn my June 22 blog, The Serialization Numbers Game: NDC, GTIN, and Product Identification, I talked about the need to register with GS1 for a company prefix and GTINs. Adopting GTIN (plus a serial number to form sGTIN) as a serialization identification standard seems like a natural fit in many ways. But, for companies unfamiliar with how the GS1 organization works, there are still some kinks to work out.The biggest misconception is around how one acquires a GTIN. Given that it’s only a fourteen-digit number (in the U.S.) that identifies the manufacturer’s product, many businesses mistakenly believe that they can simply add a few digits to their NDC and call it a day – voila, GTIN! Not so. You may be able to get away with that for a while, but eventually your self-made GTIN will catch up with you, causing confusion with partners, and possibly rendering your drug products unacceptable to distributors.A walk in the warehouse reveals that some GTINs are constructed with no relation to the NDC numbers. It’s a mystery to me how these GTINs came to be and what precautions it will have once trading partners are tracking products and product catalogs using GTIN the as the identifier.

    Disclaimer: The bar codes in this picture are reproductions by LSPediA. They are not related to any FDA registered drug products. All data contained in the picture is LSPediA property.

  1. Case-level 2D matrix at the corner of the packageSimilar to what AmerisourceBergen pointed out on May 22, the placement of case labels is critical as it impacts readability and scanning efficiency. Cases endure damages during shipping, especially in the corners. When a case label consists of two identical images wrapped around the corner, one 2D is flush with the corner. The newly revised HDA label guide recommends two mirrored images so that the 2D matrix codes are placed away from the corner. Surprisingly, I did not see a single case in the warehouse during my visit where the case labels were compliant with these recommendations. This tells me that wholesale distributors and manufacturers need to have some discussions before serialization can be successful in the supply chain.

    Disclaimer: The bar codes in this picture are reproductions by LSPediA. They are not related to any FDA registered drug products. All data contained in the picture is LSPediA property.

All of these kinks can and will get worked out. Because if they don’t, manufacturers and suppliers risk returned shipments, brand damage, and upset customers.

How LSPediA Can Help

Serialization execution is full of complexities and challenges: A label that looks good to you may cause a major mishap further down the supply chain.

You have 13 months left go get compliant. Don’t waste another moment – pick up the phone and call LSPediA. I can provide the help you need on serialization and labeling so you can sleep at night knowing your shipment will clear all the checking points in the supply chain.
About LSPediA

LSPediA helps pharmaceutical manufacturers and distributors plan, design, and implement processes and solution to meet serialization global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include serialization gap analysis, strategic planning, solution architecture, vendor selection, line execution, CMO management, supplier management, implementation, and more.

We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.