In the EU, the expiry date is shown in clear terms, normally as month and year, on the outer and immediate packaging. In the US, 21 CFR 211.137 covers how the date is expressed and 21 CFR 201.17 covers where it appears on the label. The date is based on stability data and can only be changed on the basis of such data. It is usually shown next to the batch or lot number.

Why it matters for labeling

The same date is often written in two forms: month and year in the printed text, and a full date in the barcode, in the GS1 format of year, month and day. Both have to represent the same expiry. The date is variable data printed on the packaging line, so the artwork reserves the space and specifies the format, and the real value has to be checked on the printed pack.

Common mistakes

  • Printed text and barcode showing different expiry dates
  • Ambiguous formats, such as 03/04, that can be read two ways
  • An abbreviation or format that is right for one market but not another
  • A placeholder date from the artwork file printed on real packs

Sources