In the EU, serialization comes from the Falsified Medicines Directive framework: most prescription medicines carry a unique identifier, including a serial number, which is checked when the pack is dispensed (see EU safety features). In the US, the Drug Supply Chain Security Act (DSCSA) requires a product identifier with a serial number on each package and supports the electronic exchange of transaction data between trading partners. Some serial numbers are randomized, and some systems link the serial numbers of packs to the case or pallet they are packed in, which is called aggregation.
Why it matters for labeling
A serial number is different on every pack, so it isn't part of the master artwork. The artwork reserves the space and specifies the format, and the real values are printed on the packaging line, usually in a Data Matrix. That shifts the risk: the artwork can be right while the printed code is wrong. What needs checking is the structure and placement of the code, that the human-readable text matches the encoded data, and that the batch and expiry date in the code match what is printed on the pack.
Common mistakes
- A specimen serial number from the artwork file printed on real packs
- Batch or expiry date in the code that differs from the printed text
- A code that grades well but encodes the wrong data
- Case labels and pack codes that don't match after aggregation