If there is production information found elsewhere on the label must it also be in the AIDC data carrier as PI information?

Modified on Wed, 28 Aug at 8:17 PM

In principle information that is on the label and is generally considered production control information must also be in the data carrier as a PI as part of the UDI.


However, as sometimes that information is on the label purely to comply with local or regional requirements and not truly for production control, there is allowance to request an exemption from the US FDA.


An example might be where both a manufacture date and an expiry date are printed on the label, however the manufacturing date is there for local regulatory reasons and only the expiration date is used for production control.

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