Real World Product Serialization: Report from the Warehouse

By March 6, 2019 March 14th, 2019 DSCSA, Serialization, VRS

When LSPediA sponsored the HDA’s 2018 serialization survey, we found that half of all generic drug manufacturers and two-thirds of all branded drug manufacturers expected 100 percent of their products would be serialized by Nov 27, 2018, the deadline under the Drug Supply Chain Security Act.

Those numbers got me wondering: What about the other half of generic manufacturers and the remaining third of branded manufacturers? Did they give up their prescription drug business altogether? Or did they resort to stocking up on grandfathered products before November?

Warehouse worker scans a serialized carton.

Even though manufacturers have invested lots of time and money into DSCSA serialization compliance, the LSPediA team found that many products still won’t scan up to standards.

At the time of the survey, wholesale distributors reported that they saw about one out of four products in their warehouses were serialized. Three months later, I still wondered: What’s changed?

What we found: By the numbers

To find out, the LSPediA team conducted an inventory scan a few weeks ago at one of our wholesale distributor’s warehouses. The team scanned everything on the shelf and here’s what we found:

  • 3 out of every 10 products are serialized: 32 percent of inventory is serialized, a 7-point improvement from three  months ago. There still are 68 percent of grandfathered products on the shelf. It will take time to turn over this grandfathered inventory, and our study found a 7 percent decrease in grandfathered products, a good indication that those drugs slowly are turning over.
  • 1 out of every 3 serialized products fails the GS1 standard: We scanned all the 2D barcodes on hand and found a lot of errors. The successful scans were all the same – they read the barcodes perfectly and parsed all four data elements: GTIN, Serial Number, Lot, Expiry Date.
  • The failed scans all failed in unique ways, with four errors being the most common:
    1. 00 dating in the 2D barcode
    2. Distorted 2D barcode
    3.  Not GS1 compliant
    4. Using old QR codes

We did find other reasons products failed to scan besides lacking a GS1-compliant code. For example, one product carried 3 barcodes in close proximity. To read the correct 2D barcode, the operator would need to block the other two codes with her hand, then scan it. This made the scanning process difficult and slow.

Wasted time and money?

Now, let’s fast- forward to November, when all serialized products must be verified when they’re returned or subject to product notification. Drugs failing the verification scan will start causing major supply-chain issues and – worse – could trigger an investigation.

To comply with the DSCSA, manufacturers have invested heavily in modern printing and packaging systems, and EPCIS systems. It’s astonishing to see that much of those investments are for naught.

When companies embark on a project as important as drug serialization, it’s critical that they get it right the first time. We think partnering with the right vendor is a critical step to get on the right track. LSPediA engineers test all 2D labels during the EPCIS implementation process, ensuring that products from our clients are scannable and readable for any wholesale distributors and dispensers.

If you’ve got doubts or questions about your product serialization, give us a call. We see ourselves as advisors rather than salespeople, and partners rather than mere vendors. Experience the LSPediA difference today with our robust EPCIS system and Notifier® Verification Router Service. To learn more, sign up for our weekly newsletter or register for our next free VRS webinar.