Under DSCSA, the smallest individual saleable unit, called a package, generally carries a product identifier made up of the NDC, a serial number, the lot number and the expiration date, in both a 2D Data Matrix barcode and human-readable form. Homogeneous cases, which contain a single product, lot and NDC, also need a product identifier. Trading partners must be able to exchange and verify this data. Enhanced requirements have been phased in by type of trading partner, and FDA has extended the exemption for small dispensers to November 27, 2027.
Why it matters for labeling
The identifier is part of the label artwork, and the encoded data has to match the human-readable text and the approved NDC, lot and expiry format. A change to the NDC, such as the move to a 12-digit format taking effect in 2033, will have to be reflected in the barcodes at every level that carries one.
Common mistakes
- Barcode data that doesn't match the printed text
- Serial number or lot formats that differ between the package and the case
- Assuming DSCSA applies to OTC products, when it generally covers prescription drugs
- Checking print quality but never checking the encoded data