DSCSA product serialization becomes effective for manufacturers in 2017, Repackagers in 2018, Wholesalers in 2019, and Dispensers in 2020.
So what exactly is different about the barcodes we currently have in supply chain, versus what we soon will have in supply chain. The major difference is a standard of “symbology”, unifying to a data matrix standard for US marketed products AND a requirement, to encode specific data elements. Currently, various barcodes symbologies are used. We expect that many of these will continue to be used on labels, but in addition, each “saleable” unit of product must also contain a data matrix barcode.
The new data matrix will contain GS1 Application Identifiers. What these are, are context based identifiers applied specifically to pharmaceuticals. AI’s are numerical codes between 2 and 4 numeric digits that partition (split/demarcate) the barcode data into parts. The AI’s specific to pharmaceutical supply chain are listed below.
– (01) GTIN (Global Trade Item Number) – 14 digit GTIN which contains the encoded 10 digit NDC.
– (21) Serial Number Identifier (SNI) – variable length – up to 20 characters
– (10) Batch/Lot Number – Lot Number – variable length – up to 20 characters
– (17) Expiration Date – Expiration Date – fixed length – 6 digits – YYMMDD
Below is a pictorial representation of how these AI’s will be applied. In addition to this, we recommend you check out the article DSCSA 2017 Product Serialization, located in our Resources.